TY - JOUR AB - BACKGROUND: Sexual dysfunction is common in women with vulvodynia. OBJECTIVE: The purpose of this study was (1) to evaluate whether extended-release gabapentin is more effective than placebo in improving sexual function in women with provoked vulvodynia and whether there is a relationship between treatment outcome and pelvic pain muscle severity that is evaluated by palpation with standardized applied pressure and (2) to evaluate whether sexual function in women with provoked vulvodynia would approach that of control subjects who report no vulvar pain either before or after treatment. STUDY DESIGN: As a secondary outcome in a multicenter double-blind, randomized crossover trial, sexual function that was measured by the Female Sexual Function Index was evaluated with gabapentin (1200-3000 mg/d) compared with placebo. Pain-free control subjects, matched by age and race, also completed Female Sexual Function Index for comparison. RESULTS: From August 2012 to January 2016, 230 women were screened at 3 academic institutions, and 89 women were assigned randomly to treatment. Gabapentin was more effective than placebo in improving overall sexual function (adjusted mean difference, 1.3; 95% confidence interval, 0.4-2.2; P=.008), which included desire (mean difference, 0.2; 95% confidence interval, 0.0-3.3; P=.04), arousal (mean difference, 0.3; 95% confidence interval, 0.1-0.5; P=.004), and satisfaction (mean difference, 0.3; 95% confidence interval, 0.04-0.5; P=.02); however, sexual function remained significantly lower than in 56 matched vulvodynia pain-free control subjects. There was a moderate treatment effect among participants with baseline pelvic muscle pain severity scores above the median on the full Female Sexual Function Index scale (mean difference, 1.6; 95% confidence interval, 0.3-2.8; P=.02) and arousal (mean difference, 0.3; 95% confidence interval, 0.1-0.6; P=.01) and pain domains (mean difference, 0.4; 95% confidence interval, 0.02-0.9; P=.04). CONCLUSION: Gabapentin improved sexual function in this group of women with provoked vulvodynia, although overall sexual function remained lower than women without the disorder. The most statistically significant increase was in the arousal domain of the Female Sexual Function Index that suggested a central mechanism of response. Women with median algometer pain scores >5 improved sexual function overall, but the improvement was more frequent than the pain domain. We hypothesize that gabapentin may be effective as a pharmacologic treatment for those women with provoked vulvodynia and increased pelvic muscle pain on examination. AD - Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ. Department of Clinical and Translational Sciences, University of Tennessee Health Science Center, Memphis, TN. Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ. Electronic address: phillina@rutgers.edu. School of Public Health, Division of Epidemiology, Biostatistics & Environmental Health, University of Memphis, Memphis, TN. Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, Rochester, NJ. AN - 30365922 AU - Bachmann, G. A. AU - Brown, C. S. AU - Phillips, N. A. AU - Rawlinson, L. A. AU - Yu, X. AU - Wood, R. AU - Foster, D. C. AU - Gabapentin Study, G. C1 - Disclosure statement: the authors report no conflict of interest. C2 - PMC6310649 DA - Jan DB - Medline DO - 10.1016/j.ajog.2018.10.021 DP - NLM ET - 20181024 IS - 1 KW - Adult Confidence Intervals Cross-Over Studies *Delayed-Action Preparations/tu [Therapeutic Use] Double-Blind Method Female *Gabapentin/tu [Therapeutic Use] Humans Middle Aged *Pain Measurement Patient Satisfaction/sn [Statistics & Numerical Data] *Pelvic Floor/pp [Physiopathology] Prognosis Reference Values Risk Assessment Severity of Illness Index *Sexual Dysfunction, Physiological/dt [Drug Therapy] Treatment Outcome *Vulvodynia/dt [Drug Therapy] Vulvodynia/pc [Prevention & Control] 0 (Delayed-Action Preparations) 6CW7F3G59X (Gabapentin) L1 - internal-pdf://3313963152/8 Bachmann 2019.pdf N1 - Bachmann, Gloria A Brown, Candace S Phillips, Nancy A Rawlinson, Leslie A Yu, Xinhua Wood, Ronald Foster, David C Gabapentin Study Group Dawicki D Bonham A Dworkin R Balabathula P Bachour C Brooks I Dulin T Horton F Sakauye M Thoma L Villa E Wang J Ling F Nyirjesy P Fosbre S Hartmann D Queenen J Pulsinelli W Taylor D Wesselmann U S0002-9378(18)30905-0 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2019 SN - 1097-6868 SP - 89.e81-89.e88 ST - Effect of gabapentin on sexual function in vulvodynia: a randomized, placebo-controlled trial T2 - Am J Obstet Gynecol TI - Effect of gabapentin on sexual function in vulvodynia: a randomized, placebo-controlled trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medc&AN=30365922http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:30365922&id=doi:10.1016%2Fj.ajog.2018.10.021&issn=0002-9378&isbn=&volume=220&issue=1&spage=89.e1&pages=89.e1-89.e8&date=2019&title=American+Journal+of+Obstetrics+%26+Gynecology&atitle=Effect+of+gabapentin+on+sexual+function+in+vulvodynia%3A+a+randomized%2C+placebo-controlled+trial.&aulast=Bachmann VL - 220 ID - 22 ER - TY - JOUR AB - BACKGROUND: Vulvodynia is a disabling condition in which pelvic floor muscles' (PFM) hypertonicity plays an important role. AIM: To evaluate biometric changes in PFM in women with vulvodynia undergoing kinesiotherapy treatment protocol (KTP). METHODS: A single-blinded randomized controlled trial of 57 women with vulvodynia randomly assigned to either KTP + amitriptyline or amitriptyline alone (controls) for treatment. Four-dimensional translabial ultrasound assessed PFM regarding symphysis-levator distance at rest, anorectal angle at rest, excursion of the levator plate angle, and levator hiatal narrowing. Volunteers underwent a vaginal examination for a cotton swab test (CST), fulfillment of Friedrich criteria score and PFM power of contraction, and completed a diary of sexual pain and frequency of vaginal intercourse. Outcomes were assessed at baseline and after 8 weeks of treatment. OUTCOMES: Primary outcomes were differences in biometric parameters assessed by four-dimensional translabial ultrasound after treatment, between groups. Secondary outcomes were changes in clinical variables (CST, Friedrich criteria, PFM power of contraction, frequency of intercourse, and intensity of sexual pain) between groups and correlation analysis between biometric parameters and clinical variables. RESULTS: Only the KTP group had statistically significant changes in biometric parameters after treatment (symphysis-levator distance: 0.22 +/- 0.2, 95% CI = 0.1-0.4, P = .008; levator hiatal narrowing: -0.33 +/- 0.2, 95% CI = -1 to -0.2, P = .04). Comparisons between groups showed that symphysis-levator distance (0.3, 95% CI = 0.2-0.6, P = .005) and excursion of levator plate angle (4.9, 95% CI = -0.4 to 10.1, P = .02) improved significantly after KTP treatment. Clinical variables showed greater improvement in the group treated with KTP for CST (difference of -3.7, 95% CI = -7 to -0.4, P = .01), Friedrich criteria (difference of -1.9, 95% CI = -3.2 to -0.6, P = .003), PFM power of contraction (0.3, 95% CI = 0.1-0.6, P = .05) and intensity of sexual pain (reduction of 1.7, 95% CI = -3.1 to -0.2, P = .01). Some clinical and biometric variables correlated positively, for example, frequency of vaginal intercourse and anorectal angle (P = .04; r = 0.25), or inversely, for example, pain intensity at CST and anorectal angle (P = .004, r = -0.31). CLINICAL IMPLICATIONS: This study provides evidence on efficiency of a physical therapy protocol for improvement of symptoms of vulvodynia and hypertonicity changes. CONCLUSION: This pilot study suggests that KTP for women with vulvodynia promoted significant changes in PFM biometric measures, consistent with alterations in hypertonicity and clinical improvement. Bardin MG, Giraldo PC, Martinho N. Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial. J Sex Med 2020;XX:XXX-XXX. AD - Faculty of Medical Sciences, University of Campinas - UNICAMP, Campinas, Sao Paulo, Brazil. Electronic address: bardinmarcela@gmail.com. Department of Obstetrics and Gynecology, University of Campinas - UNICAMP, Campinas, Sao Paulo, Brazil. Faculty of Medical Sciences, University of Campinas - UNICAMP, Campinas, Sao Paulo, Brazil. AN - 32819864 AU - Bardin, M. G. AU - Giraldo, P. C. AU - Martinho, N. DA - Aug 17 DO - 10.1016/j.jsxm.2020.07.020 ET - 2020/08/21 KW - Female, Women's Sexual Health Medical (Nonpharmacotherapy) Management Pain Physical Therapy Sexual Pain Disorders L1 - internal-pdf://3435925663/148 Bardin 2020.pdf N1 - Bardin, Marcela Grigol Giraldo, Paulo Cesar Martinho, Natalia eng Netherlands J Sex Med. 2020 Aug 17. pii: S1743-6095(20)30770-0. doi: 10.1016/j.jsxm.2020.07.020. PY - 2020 SN - 1743-6109 (Electronic) 1743-6095 (Linking) ST - Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial T2 - J Sex Med TI - Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial UR - https://www.ncbi.nlm.nih.gov/pubmed/32819864 https://www.jsm.jsexmed.org/article/S1743-6095(20)30770-0/fulltext ID - 23 ER - TY - JOUR AB - This study compared group cognitive-behavioral therapy (12-week trial), surface electromyographic biofeedback (12-week trial), and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Subjects were 78 women randomly assigned to one of three treatment conditions and assessed at pretreatment, posttreatment and 6-month follow-up via gynecological examinations, structured interviews and standard questionnaires pertaining to pain (Pain Rating Index and Sensory scale of the McGill Pain Questionnaire, vestibular pain index, pain during intercourse), sexual function (Sexual History Form, frequency of intercourse, Information subscale of the Derogatis Sexual Functioning Inventory), and psychological adjustment (Brief Symptom Inventory). As compared with pretreatment, study completers of all treatment groups reported statistically significant reductions on pain measures at posttreatment and 6-month follow-up, although the vestibulectomy group was significantly more successful than the two other groups. However, the apparent superiority of vestibulectomy needs to be interpreted with caution since seven women who had been assigned to this condition did not go ahead with the intervention. All three groups significantly improved on measures of psychological adjustment and sexual function from pretreatment to 6-month follow-up. Intent-to-treat analysis supported the general pattern of results of analysis by-treatment-received. Findings suggest that women with dyspareunia can benefit from both medical and behavioral interventions. AN - 11275387 AU - Bergeron, S. AU - Binik, Y. M. AU - Khalife, S. AU - Pagidas, K. AU - Glazer, H. I. AU - Meana, M. AU - Amsel, R. DO - 10.1016/S0304-3959(00)00449-8 IS - 3 KW - Adult Analysis of Variance *Biofeedback, Psychology *Cognitive Behavioral Therapy *Dyspareunia/su [Surgery] *Dyspareunia/th [Therapy] Female Follow-Up Studies Humans Pain Measurement Prospective Studies Treatment Outcome Vagina/su [Surgery] Vulvovaginitis/su [Surgery] Vulvovaginitis/th [Therapy] Behavior Therapy Biofeedback, Psychology Dyspareunia L1 - internal-pdf://0576589921/Bergeron-2001-A randomized comparison of group.pdf N1 - Bergeron, S Binik, Y M Khalife, S Pagidas, K Glazer, H I Meana, M Amsel, R RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2001 SN - 0304-3959 SP - 297-306 ST - A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis T2 - Pain TI - A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis UR - https://www.ncbi.nlm.nih.gov/pubmed/11275387 VL - 91 ID - 6 ER - TY - JOUR AB - OBJECTIVE: This 13-week randomized clinical trial aimed to compare group cognitive-behavioral therapy (GCBT) and a topical steroid in the treatment of provoked vestibulodynia, the most common form of dyspareunia. METHOD: Participants were 97 women randomly assigned to 1 of 2 treatment conditions and assessed at pretreatment, posttreatment and 6-month follow-up via structured interviews and standard questionnaires pertaining to pain (McGill Pain Questionnaire, 11-point numerical rating scale of pain during intercourse), sexual function (Female Sexual Function Index, intercourse frequency), psychological adjustment (Pain Catastrophizing Scale, Painful Intercourse Self-Efficacy Scale), treatment satisfaction, and participant global ratings of improvements in pain and sexuality. RESULTS: Intent-to-treat multilevel and covariance analyses showed that both groups reported statistically significant reductions in pain from baseline to posttreatment and 6-month follow-up, although the GCBT group showed significantly more pain reduction at 6-month follow-up on the McGill Pain Questionnaire. The 2 groups significantly improved on measures of psychological adjustment, and the GCBT group had significantly greater reductions in pain catastrophizing at posttreatment. Both groups' sexual function significantly improved from baseline to posttreatment and 6-month follow-up, and the GCBT group was doing significantly better at the 6-month follow-up. Treatment satisfaction was significantly higher in the GCBT group, as were self-reported improvements in pain and sexuality. CONCLUSIONS: Findings suggest that GCBT may yield a positive impact on more dimensions of dyspareunia than a topical steroid, and support its recommendation as a first-line treatment for provoked vestibulodynia. AN - 26727408 AU - Bergeron, S. AU - Khalife, S. AU - Dupuis, M. J. AU - McDuff, P. DO - 10.1037/ccp0000072 IS - 3 KW - Adaptation, Psychological *Adrenal Cortex Hormones/tu [Therapeutic Use] Adult Catastrophization/dt [Drug Therapy] Catastrophization/px [Psychology] Catastrophization/th [Therapy] *Cognitive Behavioral Therapy Coitus/px [Psychology] Dyspareunia/dt [Drug Therapy] Dyspareunia/px [Psychology] *Dyspareunia/th [Therapy] Female Humans *Psychotherapy, Group Self Efficacy Self Report Surveys and Questionnaires Treatment Outcome Vulvodynia/dt [Drug Therapy] Vulvodynia/px [Psychology] *Vulvodynia/th [Therapy] Young Adult 0 (Adrenal Cortex Hormones) Behavior Therapy Cognitive Therapy Dyspareunia L1 - internal-pdf://1544949857/22 Bergeron 2016.pdf N1 - Bergeron, Sophie Khalife, Samir Dupuis, Marie-Josee McDuff, Pierre RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2016 SN - 1939-2117 SP - 259-268 ST - A randomized clinical trial comparing group cognitive-behavioral therapy and a topical steroid for women with dyspareunia T2 - J Consult Clin Psychol TI - A randomized clinical trial comparing group cognitive-behavioral therapy and a topical steroid for women with dyspareunia UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med13&AN=26727408http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:26727408&id=doi:10.1037%2Fccp0000072&issn=0022-006X&isbn=&volume=84&issue=3&spage=259&pages=259-68&date=2016&title=Journal+of+Consulting+%26+Clinical+Psychology&atitle=A+randomized+clinical+trial+comparing+group+cognitive-behavioral+therapy+and+a+topical+steroid+for+women+with+dyspareunia.&aulast=Bergeron VL - 84 ID - 5 ER - TY - JOUR AB - OBJECTIVE: To estimate whether treatment gains for provoked vestibulodynia participants randomly assigned to vestibulectomy, biofeedback, and cognitive-behavioral therapy in a previous study would be maintained from the last assessment-a 6-month follow-up-to the present 2.5-year follow-up. Although all three treatments yielded significant improvements at 6-month follow-up, vestibulectomy resulted in approximately twice the pain reduction as compared with the two other treatments. A second goal of the present study was to identify predictors of outcome. METHODS: In a university hospital, 51 of the 78 women from the original study were reassessed 2.5 years after the end of their treatment. They completed 1) a gynecologic examination involving the cotton-swab test, 2) a structured interview, and 3) validated pain and sexual functioning measures. RESULTS: Results from the multivariate analysis of variance conducted on the pain measures showed a significant time main effect (P<.05) and a significant treatment main effect (P<.01), indicating that participants had less pain at the 2.5-year follow-up than at the previous 6-month follow-up. Results from the multivariate analysis of variance conducted on sexual functioning measures showed that participants remained unchanged between the 6-month and 2.5-year follow-up and that there were no group differences. Higher pretreatment pain intensity predicted poorer outcomes at the 2.5-year follow-up for vestibulectomy (P<.01), biofeedback (P<.05), and cognitive-behavioral therapy (P<.01). Erotophobia also predicted a poorer outcome for vestibulectomy (P<.001). CONCLUSION: Treatment gains were maintained at the 2.5-year follow-up. Outcome was predicted by pretreatment pain and psychosexual factors. Level of evidence: Ii. AN - 18165405 AU - Bergeron, S. AU - Khalife, S. AU - Glazer, H. I. AU - Binik, Y. M. DO - 10.1097/01.AOG.0000295864.76032.a7 IS - 1 KW - Adult *Biofeedback, Psychology Dyspareunia Female Follow-Up Studies *Gynecologic Surgical Procedures Humans Pain Measurement Treatment Outcome *Vulva/su [Surgery] Vulvar Vestibulitis/px [Psychology] *Vulvar Vestibulitis/su [Surgery] *Vulvar Vestibulitis/th [Therapy] L1 - internal-pdf://4240773233/58 Bergeron 2008.pdf N1 - Bergeron, Sophie Khalife, Samir Glazer, Howard I Binik, Yitzchak M RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} | RAYYAN-LABELS: uppföljningsstudie PY - 2008 SN - 0029-7844 SP - 159-166 ST - Surgical and behavioral treatments for vestibulodynia: two-and-one-half year follow-up and predictors of outcome T2 - Obstet Gynecol TI - Surgical and behavioral treatments for vestibulodynia: two-and-one-half year follow-up and predictors of outcome UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med7&AN=18165405http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:18165405&id=doi:10.1097%2F01.AOG.0000295864.76032.a7&issn=0029-7844&isbn=&volume=111&issue=1&spage=159&pages=159-66&date=2008&title=Obstetrics+%26+Gynecology&atitle=Surgical+and+behavioral+treatments+for+vestibulodynia%3A+two-and-one-half+year+follow-up+and+predictors+of+outcome.&aulast=Bergeron VL - 111 ID - 9 ER - TY - JOUR AB - OBJECTIVE: This randomized clinical trial compared a novel cognitive-behavioral couple therapy (CBCT) and topical lidocaine for provoked vestibulodynia. METHOD: Participants were 108 women (M age = 27.06) and their partners randomized to one of two treatments and assessed at pre- and post-treatment and 6-month follow-up via questionnaires pertaining to the primary outcomes of women's pain (numerical rating scales of pain intensity and unpleasantness), and secondary outcomes of pain anxiety (Pain Anxiety Symptoms Scale), both partners' sexual function (Female Sexual Function Index; International Index of Erectile Function), sexual distress (Female Sexual Distress Scale Revised), pain-related psychological distress (Pain Catastrophizing Scale), treatment satisfaction, and global ratings of improvements in pain and sexuality. RESULTS: Intent-to-treat multilevel analyses showed that for women, CBCT yielded significantly more improvements than lidocaine in pain unpleasantness at 6-month follow-up, pain anxiety and pain catastrophizing at post-treatment and 6-month follow-up, and sexual distress at post-treatment, and resulted in better treatment satisfaction and global sexuality improvements at both time points. Partners significantly improved in their sexual function, sexual distress, and pain catastrophizing from pre- to post-treatment and pre-treatment to 6-month follow-up, with no significant group differences. Partners in the CBCT condition reported significantly greater treatment satisfaction at both time points, and greater sexuality improvements at post-treatment. CONCLUSIONS: CBCT yielded better outcomes on more dimensions of provoked vestibulodynia than lidocaine. (PsycInfo Database Record (c) 2021 APA, all rights reserved). AD - Department of Psychology. School of Psychology. Department of Social and Preventive Medicine. Department of Obstetrics and Gynecology. Department of Psychology and Neuroscience and Department of Obstetrics and Gynecology. AN - 34014693 AU - Bergeron, S. AU - Vaillancourt-Morel, M. P. AU - Corsini-Munt, S. AU - Steben, M. AU - Delisle, I. AU - Mayrand, M. H. AU - Rosen, N. O. DA - Apr DO - 10.1037/ccp0000631 IS - 4 KW - Adult Anxiety/psychology Catastrophization/psychology Cognitive Behavioral Therapy/*methods Couples Therapy/*methods Female Humans Intention to Treat Analysis Lidocaine/*therapeutic use Male Pain/psychology *Pain Management Patient Satisfaction Sexual Behavior Sexual Partners/*psychology Surveys and Questionnaires Vulvodynia/*therapy L1 - internal-pdf://0471797951/58-Bergeron-2021.pdf N1 - Bergeron, Sophie Vaillancourt-Morel, Marie-Pier Corsini-Munt, Serena Steben, Marc Delisle, Isabelle Mayrand, Marie-Helene Rosen, Natalie O eng CAPMC/ CIHR/Canada Canada Research Chair Randomized Controlled Trial 2021/05/21 J Consult Clin Psychol. 2021 Apr;89(4):316-326. doi: 10.1037/ccp0000631. PY - 2021 SN - 1939-2117 (Electronic) 0022-006X (Linking) SP - 316-326 ST - Cognitive-behavioral couple therapy versus lidocaine for provoked vestibulodynia: A randomized clinical trial T2 - J Consult Clin Psychol TI - Cognitive-behavioral couple therapy versus lidocaine for provoked vestibulodynia: A randomized clinical trial UR - https://www.ncbi.nlm.nih.gov/pubmed/34014693 VL - 89 ID - 35 ER - TY - GEN AN - NCT04057755 AU - Bohm-Starke, N. CY - Karolinska Institutet DA - May 15 KW - Vulvodynia N1 - No Results Available Drug: botulinum toxin A|Drug: NaCl Change in self-reported dyspareunia last month measured by VAS 0-100|Change in pain at tampon insertion last week, measured by VAS 0-100|Change in pelvic floor hyperactivity/tonus,|Safety aspects regarding adverse events of BTA|Change in quality of Life (WHOQOL-BREF)|Change in quality of Life (EQ5D)|Change in sexual function|Change in sexual distress|Change in level of stress|Change in level of anxiety Female Phase 3 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2016-000375-25 June 15, 2019 PB - Available from: https://ClinicalTrials.gov/show/NCT04057755 PY - 2016 ST - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia TI - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia ID - 41 ER - TY - GEN AN - NCT02393911 AU - Bornstein, J. CY - Western Galilee Hospital-Nahariya DA - March KW - Vulvodynia|Vulvar Vestibulitis N1 - No Results Available Dietary Supplement: Low Oxalate Diet Change in vaginal microbiome composition of women with localized provoked vulvodynia following three months of low oxalate diet|Level of dyspareunia following three months of low oxalate diet in women with localized provoked vulvodynia Female Phase 3 70 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label) 0146-14-NHR February 2017 PB - Available from: https://ClinicalTrials.gov/show/NCT02393911 PY - 2015 ST - dmlpv TI - Dysbiosis in Localized Provoked Vulvodynia (LPV) ID - 52 ER - TY - JOUR AB - PURPOSE: To evaluate the efficacy of a combination of subtotal perineoplasty and interferon (IFN) infiltration of the remaining anterior vestibule in the treatment of vulvar vestibulitis. BASIC PROCEDURES: Nineteen women with vulvar vestibulitis were randomized to undergo either a total perineoplasty or a subtotal perineoplasty without removal of the anterior vestibule. The second group was further treated 6 weeks later with injection of the anterior vestibule by IFN. Differences in outcome between the groups were analyzed using Fisher's exact test. MAIN FINDINGS: The combination of subtotal perineoplasty and IFN injections was successful in 7 of 10 women, similar to the outcome of the group undergoing total perineoplasty (6 of 9 patients). CONCLUSION: A combination of subtotal perineoplasty and IFN injections to the anterior vestibule is as effective as total perineoplasty and has less surgical complications. AD - Department of Obstetrics and Gynecology, Carmel Medical Center and the Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa. mdjacob@tx.technion.ac.il AN - 9251955 AU - Bornstein, J. AU - Abramovici, H. DB - Medline DO - 10.1159/000291409 DP - NLM IS - 1 KW - Adolescent Adult Combined Modality Therapy Dyspareunia/et [Etiology] Dyspareunia/th [Therapy] Female Humans Interferon alpha-2 Interferon-alpha/ad [Administration & Dosage] *Interferon-alpha/tu [Therapeutic Use] Recombinant Proteins Treatment Outcome Vulvitis/co [Complications] Vulvitis/su [Surgery] *Vulvitis/th [Therapy] 0 (Interferon alpha-2) 0 (Interferon-alpha) 0 (Recombinant Proteins) Interferons L1 - internal-pdf://4162851007/57-Bornstein-1997.pdf N1 - Bornstein, J Abramovici, H RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 1997 SN - 0378-7346 SP - 53-56 ST - Combination of subtotal perineoplasty and interferon for the treatment of vulvar vestibulitis T2 - Gynecol Obstet Invest TI - Combination of subtotal perineoplasty and interferon for the treatment of vulvar vestibulitis UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med4&AN=9251955http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:9251955&id=doi:10.1159%2F000291409&issn=0378-7346&isbn=&volume=44&issue=1&spage=53&pages=53-6&date=1997&title=Gynecologic+%26+Obstetric+Investigation&atitle=Combination+of+subtotal+perineoplasty+and+interferon+for+the+treatment+of+vulvar+vestibulitis.&aulast=Bornstein VL - 44 ID - 34 ER - TY - JOUR AB - UNLABELLED: Topical application of the calcium antagonist nifedipine has demonstrated effectiveness in treating chronic anal fissure, without adverse effects. Like chronic anal fissure, vulvodynia is associated with muscle hypertonicity and an inflammatory infiltrate. We conducted a double-blind placebo-controlled study to investigate the effectiveness of 2 concentrations of topical nifedipine cream in the treatment of vulvodynia. Thirty participants were alternately assigned to 3 topical treatment groups: .2% nifedipine, .4% nifedipine, and placebo. All administered the cream to the vestibule 4 times daily for 6 weeks. For all 3 treatment groups, mean pain intensity on vestibular touch, assessed by the Q-tipped cotton test, pain from speculum insertion, and reports of pain during sexual intercourse was reduced at post-treatment compared with pre-treatment. These improvements remained at 3 months' follow-up. The effectiveness of nifedipine in treating vulvodynia did not exceed that of placebo. PERSPECTIVE: The topical application of both nifedipine and a placebo reduced pain in women with vulvodynia. This study highlights the need for controlled trials of treatments for vulvodynia and raises doubts about studies conducted without comparison to placebo. AN - 20537958 AU - Bornstein, J. AU - Tuma, R. AU - Farajun, Y. AU - Azran, A. AU - Zarfati, D. DO - 10.1016/j.jpain.2010.03.016 IS - 12 KW - Administration, Topical Adult *Calcium Channel Blockers/ad [Administration & Dosage] Double-Blind Method Female Humans *Nifedipine/ad [Administration & Dosage] Treatment Outcome *Vulvodynia/dt [Drug Therapy] Young Adult 0 (Calcium Channel Blockers) I9ZF7L6G2L (Nifedipine) Nifedipine L1 - internal-pdf://2018578545/60 Bornstein 2010.pdf N1 - Bornstein, Jacob Tuma, Ruba Farajun, Yaniv Azran, Audrey Zarfati, Doron RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2010 SN - 1528-8447 SP - 1403-1409 ST - Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study T2 - J Pain TI - Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med8&AN=20537958http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:20537958&id=doi:10.1016%2Fj.jpain.2010.03.016&issn=1526-5900&isbn=&volume=11&issue=12&spage=1403&pages=1403-9&date=2010&title=Journal+of+Pain&atitle=Topical+nifedipine+for+the+treatment+of+localized+provoked+vulvodynia%3A+a+placebo-controlled+study.&aulast=Bornstein https://www.jpain.org/article/S1526-5900(10)00443-8/fulltext VL - 11 ID - 10 ER - TY - JOUR AB - OBJECTIVE: To evaluate the efficacy of vestibuloplasty (vestibular undercutting without excision) to treat severe vulvar vestibulitis. DESIGN: Prospective randomisation of patients scheduled for surgery to undergo either perineoplasty or vestibuloplasty. Differences in outcome between groups were analysed using Fisher's exact test. SETTING: The Vulvar Clinic and referral centre for vestibulitis, Kupath Holim Health System, Department of Obstetrics and Gynaecology, Carmel Medical Centre, Rapapport Faculty of Medicine, Hatechnion, Haifa, Israel. SUBJECTS: Twenty-one women with vulvar vestibulitis. RESULTS: Vestibuloplasty failed to relieve symptoms in 10 women, while perineoplasty resulted in complete resolution of symptoms in 9/11 women (P < 0.002). CONCLUSIONS: The poor outcome of vestibuloplasty, if also reported by other centres, may render it an unacceptable treatment for vulvar vestibulitis. Vestibuloplasty aims to denervate sensitive vestibular tissue, and its failure may suggest that innervation disturbances are not the main cause of the syndrome. AD - Department of Obstetrics and Gynaecology, Carmel Medical Centre, Rapapport Faculty of Medicine, Hatechnion, Israel. AN - 7654645 AU - Bornstein, J. AU - Zarfati, D. AU - Goldik, Z. AU - Abramovici, H. DA - Aug DB - Medline DO - 10.1111/j.1471-0528.1995.tb11405.x DP - NLM IS - 8 KW - Adolescent Adult Female Humans Prospective Studies Treatment Outcome *Vulva/su [Surgery] *Vulvitis/su [Surgery] L1 - internal-pdf://2355695791/52-Bornstein-1995.pdf N1 - Bornstein, J Zarfati, D Goldik, Z Abramovici, H Comment in (CIN) RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 1995 SN - 0306-5456 SP - 652-655 ST - Perineoplasty compared with vestibuloplasty for severe vulvar vestibulitis T2 - Br J Obstet Gynaecol TI - Perineoplasty compared with vestibuloplasty for severe vulvar vestibulitis UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med3&AN=7654645http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:7654645&id=doi:10.1111%2Fj.1471-0528.1995.tb11405.x&issn=0306-5456&isbn=&volume=102&issue=8&spage=652&pages=652-5&date=1995&title=British+Journal+of+Obstetrics+%26+Gynaecology&atitle=Perineoplasty+compared+with+vestibuloplasty+for+severe+vulvar+vestibulitis.&aulast=Bornstein VL - 102 ID - 30 ER - TY - GEN AN - NCT01704443 AU - Brotto, L. A. CY - University of British Columbia DA - April KW - Provoked Vestibulodynia N1 - No Results Available Behavioral: Group Psychoeducational Treatment|Other: Waitlist control Pain intensity|Long-term pain intensity|Sexual Distress Female Not Applicable 97 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H08-00885 April 2013 PB - Available from: https://ClinicalTrials.gov/show/NCT01704443 PY - 2008 ST - improved TI - Integrated Mindfulness for Provoked Vestibulodynia ID - 55 ER - TY - JOUR AB - Provoked vestibulodynia (PVD) is the most common cause of painful intercourse in women of reproductive age and research supports psychological approaches in the management of chronic pain. We developed a four-session group treatment for women with PVD that relied mostly on mindfulness meditation skills along with education and some discussion of cognitive theory. A total of 85 women were assigned either to immediate treatment (n = 62; mean age, 39 years) or to a 3-month wait-list condition followed by treatment (n = 23; mean age, 40 years). Questionnaires and a genital pain assessment were administered at pre- and post-treatment, and at 6 months follow-up. Women assigned to the two groups did not significantly differ on any measure at baseline. During the pretreatment wait-list period, there were significant improvements in pain self-efficacy, and non-significant improvements in feelings of helplessness, and sex-related distress. Pain self-efficacy, pain catastrophizing, genital pain induced by a cotton swab exam, pain hypervigilance, and sex-related distress all improved with treatment. There was no change in pain with intercourse. Pretreatment genital pain was the best predictor of post-treatment genital pain. Genital pain at 6-month follow-up was predicted by pretreatment genital pain, change in pain self-efficacy, and number of comorbid chronic pain conditions. Taken together, these findings support the use of a brief mindfulness-based program as a promising treatment for distressing genital pain. (PsycINFO Database Record (c) 2018 APA, all rights reserved) AN - 2014-01235-001 AU - Brotto, Lori A. AU - Basson, Rosemary AU - Smith, Kelly B. AU - Driscoll, Miriam AU - Sadownik, Leslie DO - 10.1007/s12671-013-0273-z IS - 3 KW - Provoked vestibulodynia Genital pain Dyspareunia Mindfulness Cognitive behavior therapy Female Sexual Dysfunction Genital Disorders Chronic Pain Group Psychotherapy Meditation Pain Management Mind Body Therapy L1 - internal-pdf://2480672943/53-Brotto-2015.pdf N1 - Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, Canada. Release Date: 20140113. Correction Date: 20180517. Publication Type: Journal (0100), Peer Reviewed Journal (0110). Format Covered: Electronic. Document Type: Journal Article. Language: English. Grant Information: Brotto, Lori A. Major Descriptor: Cognitive Behavior Therapy; Dyspareunia; Female Sexual Dysfunction; Genital Disorders; Mindfulness. Minor Descriptor: Chronic Pain; Group Psychotherapy; Meditation; Pain Management; Mind Body Therapy. Classification: Cognitive Therapy (3311). Population: Human (10); Female (40). Location: Canada. Age Group: Adulthood (18 yrs & older) (300). Tests & Measures: Painful Intercourse Self-Efficacy Scale; Five Factor Mindfulness Questionnaire; Pain Vigilance and Awareness Questionnaire DOI: 10.1037/t14777-000; Female Sexual Function Index DOI: 10.1037/t28568-000; Arthritis Self-Efficacy Scale DOI: 10.1037/t11979-000; Female Sexual Distress Scale DOI: 10.1037/t64236-000; State Trait Anxiety Inventory; Beck Depression Inventory DOI: 10.1037/t00741-000; Pain Catastrophizing Scale DOI: 10.1037/t01304-000. Methodology: Empirical Study; Quantitative Study. References Available: Y. Page Count: 16. Issue Publication Date: Jun, 2015. Publication History: First Posted Date: Jan 10, 2014. Copyright Statement: Springer Science+Business Media New York. 2014. Sponsor: Women’s Health Research Institute, Canada. Recipients: Brotto, Lori A. Sponsor: Michael Smith Foundation for Health Research, Canada. Recipients: Smith, Kelly B. Sponsor: Canadian Pain Society, Canada. Recipients: Smith, Kelly B. RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2015 SN - 1868-8527 1868-8535 SP - 417-432 ST - Mindfulness-based group therapy for women with provoked vestibulodynia T2 - Mindfulness TI - Mindfulness-based group therapy for women with provoked vestibulodynia UR - http://search.ebscohost.com/login.aspx?direct=true&db=psyh&AN=2014-01235-001&site=ehost-live Lori.Brotto@vch.ca VL - 6 ID - 31 ER - TY - JOUR AB - OBJECTIVE: Provoked vestibulodynia (PVD) is a chronic vulvo-vaginal pain condition affecting 8% of premenopausal women. Cognitive-behavioral therapy (CBT) is effective in managing pain and associated sexual and psychological symptoms, and a recent study found group mindfulness-based cognitive therapy (MBCT) to be equivalent. Our goal was to examine the long-term outcomes of these treatments and to explore mediators of change. METHOD: Participants were 130 women diagnosed with PVD who had participated in a clinical trial comparing 8 weeks of group CBT to 8 weeks of group MBCT. Data were collected at pretreatment, posttreatment, and at 6- and 12-month follow-up periods. Outcomes focused on (a) pain with vaginal penetration, (b) pain elicited with a vulvalgesiometer, and (c) sex-related distress. Mediators of interest included pain acceptance (both pain willingness and activities engagement), self-compassion, self-criticism, mindfulness, decentering, and pain catastrophizing. RESULTS: All improvements in the 3 outcomes were retained at 12-month follow-up, with no group differences. Pain catastrophizing, decentering, and chronic pain acceptance (both scales) were mediators of improvement common to both MBCT and CBT. Changes in mindfulness, self-criticism, and self-compassion mediated improvements only in the MBCT group. CONCLUSIONS: Both MBCT and CBT are effective for improving symptoms in women with PVD when assessed 12 months later. The findings have implications for understanding common and potentially distinct pathways by which CBT and MBCT improve pain and sex-related distress in women with PVD. (PsycINFO Database Record (c) 2019 APA, all rights reserved). AN - 31841023 AU - Brotto, L. A. AU - Bergeron, S. AU - Zdaniuk, B. AU - Basson, R. DO - 10.1037/ccp0000473 IS - 1 KW - Adult Catastrophization/px [Psychology] Catastrophization/th [Therapy] *Cognitive Behavioral Therapy/mt [Methods] Female Follow-Up Studies Humans *Mindfulness/mt [Methods] *Psychotherapy, Group/mt [Methods] Sexual Behavior/px [Psychology] Treatment Outcome *Vulvodynia/px [Psychology] *Vulvodynia/th [Therapy] Behavior Therapy Cognitive Therapy L1 - internal-pdf://4123594880/91 Brotto 2020.pdf N1 - Brotto, Lori A Bergeron, Sophie Zdaniuk, Bozena Basson, Rosemary RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2020 SN - 1939-2117 SP - 48-64 ST - Mindfulness and cognitive behavior therapy for provoked vestibulodynia: Mediators of treatment outcome and long-term effects T2 - J Consult Clin Psychol TI - Mindfulness and cognitive behavior therapy for provoked vestibulodynia: Mediators of treatment outcome and long-term effects UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medl&AN=31841023http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:31841023&id=doi:10.1037%2Fccp0000473&issn=0022-006X&isbn=&volume=88&issue=1&spage=48&pages=48-64&date=2020&title=Journal+of+Consulting+%26+Clinical+Psychology&atitle=Mindfulness+and+cognitive+behavior+therapy+for+provoked+vestibulodynia%3A+Mediators+of+treatment+outcome+and+long-term+effects.&aulast=Brotto VL - 88 ID - 17 ER - TY - JOUR AB - INTRODUCTION: Chronic and distressing genito-pelvic pain associated with vaginal penetration is most frequently due to provoked vestibulodynia (PVD). Cognitive behavioral therapy (CBT) significantly reduces genital pain intensity and improves psychological and sexual well-being. In general chronic pain populations, mindfulness-based approaches may be as effective for improving pain intensity as CBT. AIM: To compare mindfulness-based cognitive therapy (MBCT) with CBT in the treatment of PVD. METHODS: To ensure power of 0.95 to find medium effect size or larger in this longitudinal design, we enrolled 130 participants. Of these, 63 were assigned to CBT (mean age 31.2 years), and 67 to MBCT (mean age 33.7 years). Data from all participants who completed baseline measures were analyzed, with intent-to-treat analyses controlling for years since diagnosis. MAIN OUTCOME MEASURES: Our primary outcome was self-reported pain during vaginal penetration at immediate post-treatment and at 6 months' follow-up. Secondary endpoints included pain ratings with a vulvalgesiometer, pain catastrophizing, pain hypervigilance, pain acceptance, sexual function, and sexual distress. RESULTS: There was a significant interaction between group and time for self-reported pain, such that improvements with MBCT were greater than those with CBT. For all other endpoints, both groups led to similar significant improvements, and benefits were maintained at 6 months. CLINICAL IMPLICATIONS: Mindfulness is a promising approach to improving self-reported pain from vaginal penetration and is as effective as CBT for several psychological endpoints. STRENGTH & LIMITATIONS: A strength of the present study was the robust sample size (n = 130 women) who had received confirmed clinical diagnoses of PVD. CONCLUSION: The present study showed mindfulness to be as effective for most pain- and sexuality-related endpoints in the treatment of PVD. Brotto LA, Bergeron S, Zdaniuk B, et al. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med 2019;16:909-923. AN - 31103481 AU - Brotto, L. A. AU - Bergeron, S. AU - Zdaniuk, B. AU - Driscoll, M. AU - Grabovac, A. AU - Sadownik, L. A. AU - Smith, K. B. AU - Basson, R. DO - 10.1016/j.jsxm.2019.04.002 IS - 6 KW - Cognitive Therapy Behavior Therapy L1 - internal-pdf://2111180959/4 Brotto 2019.pdf N1 - Brotto, Lori A Bergeron, Sophie Zdaniuk, Bozena Driscoll, Miriam Grabovac, Andrea Sadownik, Leslie A Smith, Kelly B Basson, Rosemary S1743-6095(19)31109-9 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2019 SN - 1743-6109 SP - 909-923 ST - A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting T2 - J Sex Med TI - A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=prem&AN=31103481http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:31103481&id=doi:10.1016%2Fj.jsxm.2019.04.002&issn=1743-6095&isbn=&volume=16&issue=6&spage=909&pages=909-923&date=2019&title=Journal+of+Sexual+Medicine&atitle=A+Comparison+of+Mindfulness-Based+Cognitive+Therapy+Vs+Cognitive+Behavioral+Therapy+for+the+Treatment+of+Provoked+Vestibulodynia+in+a+Hospital+Clinic+Setting.&aulast=Brotto https://www.jsm.jsexmed.org/article/S1743-6095(19)31109-9/fulltext VL - 16 ID - 24 ER - TY - JOUR AB - BACKGROUND AND AIM: The goal was to evaluate the moderators of mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) to improve dyspareunia, reduce pain catastrophizing, and improve overall sexual function in women with provoked vestibulodynia (PVD). Both treatments effectively reduced self-reported pain, sexual dysfunction, and pain catastrophizing in women with PVD. METHODS: A total of 130 women with PVD were assigned to CBT or MBCT. OUTCOMES: Potential moderators included (i) PVD subtype (primary or secondary), (ii) baseline pain intensity, (iii) trait mindfulness, (iv) treatment credibility, (v) relationship duration, and (vi) age. Outcomes were pain intensity, sexual function, and pain catastrophizing at 4 time points: before and after treatment and 6- and 12-month follow-up. Moderation was tested using multilevel models, nesting 4 time points within participants. The interaction of the moderator, time effect, and treatment group was evaluated for significance, and a simple slope analysis of significant interactions was performed. RESULTS: Pain reduction across 4 time points was the greatest in women who were younger, in relationships of shorter duration, and with greater baseline pain. Treatment credibility moderated pain intensity outcomes (B = 0.305, P < .01) where those with higher treatment credibility ratings (for that particular treatment) improved more in MBCT than CBT. PVD subtype moderated pain catastrophizing (B = 3.150, P < .05). Those with primary PVD improved more in the CBT condition, whereas women with secondary PVD improved more in the MBCT condition. Relationship length moderated sexual function (B = 0.195, P < .01). Women in shorter relationships improved more with MBCT, whereas women in longer relationships improved more on sexual function with CBT. No other tested variables moderated outcomes differentially across both treatment conditions. CLINICAL IMPLICATIONS: Women who present with high credibility about mindfulness, in shorter relationships, and with secondary PVD might respond better to MBCT whereas those with primary PVD and longer relationships might respond better to CBT. STRENGTHS & LIMITATIONS: Clinical sample. Half the women who were not sexually active were omitted from analyses of sexual function. CONCLUSION: Overall, treatment credibility, relationship length, and PVD subtype were found to moderate improvements differently in MBCT and CBT. These findings may assist clinicians in individualizing psychological treatment for women with PVD. CLINICAL TRIAL REGISTRATION: This clinical trial was registered with clinicaltrials.gov, NCT01704456. Brotto LA, Zdaniuk B, Rietchel L, et al. Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia. J Sex Med 2020;17:2247-2259. AN - 32843320 AU - Brotto, L. A. AU - Zdaniuk, B. AU - Rietchel, L. AU - Basson, R. AU - Bergeron, S. CN - UPPDAT Medline 20210129 DA - Nov DO - https://dx.doi.org/10.1016/j.jsxm.2020.07.080 IS - 11 L1 - internal-pdf://1829638303/171-Brotto-2020.pdf N1 - Brotto, Lori A Zdaniuk, Bozena Rietchel, Lauren Basson, Rosemary Bergeron, Sophie S1743-6095(20)30831-6 PY - 2020 SN - 1743-6109 SP - 2247-2259 ST - Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia T2 - J Sex Med TI - Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=prem6&AN=32843320http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:32843320&id=doi:10.1016%2Fj.jsxm.2020.07.080&issn=1743-6095&isbn=&volume=17&issue=11&spage=2247&pages=2247-2259&date=2020&title=Journal+of+Sexual+Medicine&atitle=Moderators+of+Improvement+From+Mindfulness-Based+vs+Traditional+Cognitive+Behavioral+Therapy+for+the+Treatment+of+Provoked+Vestibulodynia.&aulast=Brotto https://www.jsm.jsexmed.org/article/S1743-6095(20)30831-6/pdf VL - 17 ID - 25 ER - TY - JOUR AB - OBJECTIVE: To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia. METHODS: In a multicenter double-blind, placebo-controlled randomized crossover trial, gabapentin (1,200-3,000 mg/d) was compared with a placebo. The primary outcome was mean pain intensity (0, no pain at all to 10, worst pain ever) on the tampon test (a standardized tampon insertion and removal test used as a surrogate marker for dyspareunia) during the last 7 days of the maintenance phase. Secondary outcomes included sexual intercourse pain and daily pain. A sample size of 53 provided 90% power to detect a 1-point reduction on the tampon test (.05 level, two-sided) between the two treatment phases. RESULTS: From August 2012 to January 2016, 230 women were screened at three academic institutions and 89 (mean age 37 years; 65% black) were randomized: 45 to gabapentin first and then placebo and 44 to placebo first and then gabapentin. Tampon test pain with gabapentin was not different compared with the placebo (adjusted mean 4.0, 95% CI 3.0-4.9 vs 4.3, 95% CI 3.4-5.2, difference -0.3, 95% CI -0.7 to 0.0; P=.07). Gabapentin also did not improve pain over placebo for sexual intercourse pain (adjusted mean 3.9, 95% CI 2.4-5.3 vs 4.0, 95% CI 2.5-5.4, difference -0.1, 95% CI -0.9 to 0.6; P=.76) and daily pain (adjusted mean 2.7, 95% CI 1.8-3.6 vs 2.9, 95% CI 2.0-3.8, difference -0.2, 95% CI -0.5 to -0.2; P=.36). Subset analyses found that longer pain duration and oral contraceptive nonuse were associated with minimal improvement in tampon test pain with gabapentin. CONCLUSION: In this cohort, extended-release gabapentin, as compared with a placebo, did not reduce tampon test pain. These data do not support the recommendation of gabapentin alone as treatment for vulvodynia. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01301001. AN - 29742655 AU - Brown, C. S. AU - Bachmann, G. A. AU - Wan, J. AU - Foster, D. C. AU - Gabapentin Study, G. DO - 10.1097/AOG.0000000000002617 IS - 6 KW - Adult *Analgesics/ad [Administration & Dosage] Cross-Over Studies Delayed-Action Preparations Diagnostic Techniques, Obstetrical and Gynecological Double-Blind Method Dyspareunia/dt [Drug Therapy] Dyspareunia/px [Psychology] Female *Gabapentin/ad [Administration & Dosage] Humans Middle Aged *Pain/dt [Drug Therapy] Pain/et [Etiology] Pain Measurement Treatment Outcome *Vulvodynia/dt [Drug Therapy] Vulvodynia/px [Psychology] 0 (Analgesics) 0 (Delayed-Action Preparations) 6CW7F3G59X (Gabapentin) L1 - internal-pdf://1429606513/63 Brown 2018.pdf N1 - (GABA) Brown, Candace S Bachmann, Gloria A Wan, Jim Foster, David C Gabapentin (GABA) Study Group Comment in (CIN) RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2018 SN - 1873-233X SP - 1000-1007 ST - Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial T2 - Obstet Gynecol TI - Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med15&AN=29742655http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:29742655&id=doi:10.1097%2FAOG.0000000000002617&issn=0029-7844&isbn=&volume=131&issue=6&spage=1000&pages=1000-1007&date=2018&title=Obstetrics+%26+Gynecology&atitle=Gabapentin+for+the+Treatment+of+Vulvodynia%3A+A+Randomized+Controlled+Trial.&aulast=Brown VL - 131 ID - 11 ER - TY - GEN AN - NCT04045041 AU - Buhrman, M. CY - Uppsala University DA - January 20 KW - Provoked Vestibulodynia|Vulvodynia, Generalized N1 - No Results Available Behavioral: Acceptance and commitment therapy Female sexual function index|Female sexual distress-scale|Brunnsviken Brief Quality of Life Inventory (BBQ)|Pain severity scale in Multidimensional Pain Inventory (MPI)|Montgomery Åsberg Depression Rating Scale (MADRS-S)|Generalised Anxiety Disorder 7-item scale (GAD-7)|Vaginal penetration cognition questionnaire (VPCQ)|Chronic pain acceptance questionnaire (CPAQ)|Committed Action Questionnaire-8 (CAQ-8)|Mindful Attention Awareness Scale (MAAS)|Treatment credibility scale (TCS)|CHAMP Sexual Pain Coping Scale (CSPCS),|Quality of dyadic relationship (QDR-36) Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20180501 June 30, 2021 PB - Available from: https://ClinicalTrials.gov/show/NCT04045041 PY - 2019 ST - Internet-based Treatment for Provoked Vestibulodynia TI - Internet-based Treatment for Provoked Vestibulodynia Y2 - March 14 2023 ID - 61 ER - TY - GEN AN - NCT01295268 AU - Carrico, D.J. CY - William Beaumont Hospitals DA - February KW - Vulvodynia|Vestibulodynia N1 - No Results Available Other: Emu Oil|Other: Inert oil The change in the Global Response Assessment (GRA) for vulvar pain.|The change in vulvar pain levels Female Not Applicable 1 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2011-019 August 2011 PB - Available from: https://ClinicalTrials.gov/show/NCT01295268 PY - 2011 ST - Study of Emu Oil vs. Placebo for Vulvar Pain in Women TI - Study of Emu Oil vs. Placebo for Vulvar Pain in Women ID - 56 ER - TY - JOUR AB - BACKGROUND: To evaluate the efficacy of electromyographic biofeedback and topical lidocaine treatment for women with vulvar vestibulitis. METHODS: A prospective randomized study where 46 women with vulvar vestibulitis were randomized to receive either electromyographic biofeedback or topical lidocaine treatment for four months. Assessments with vulvar pressure pain thresholds and questionnaires regarding quality of life, psychosocial adjustments, and sexual functioning were made before treatment, after treatment, and at six- and 12-month follow-ups. Nonparametric statistical methods were used to analyze differences in outcomes. RESULTS: Nine women (9/46) dropped out during the treatment period. Both treatments showed significantly improved values for vestibular pressure pain thresholds, quality of life measurements, and sexual functioning at the 12-month follow-up. No differences were found between the two treatment groups. No severe side effects were reported. CONCLUSIONS: Four months' treatment with electromyographic biofeedback and topical lidocaine gave statistically significant improvements on vestibular pain measurements, sexual functioning, and psychosocial adjustments at the 12-month follow-up. No differences in outcome between the two treatments were observed but a larger sample may be needed to obtain significance. The treatments were well tolerated but the compliance to the electromyographic biofeedback training program was low. A combination of both treatments could potentially benefit many women with vulvar vestibulitis. AN - 17091418 AU - Danielsson, I. AU - Torstensson, T. AU - Brodda-Jansen, G. AU - Bohm-Starke, N. DO - 10.1080/00016340600883401 IS - 11 KW - Adaptation, Psychological Administration, Topical Adolescent Adult *Anesthetics, Local/tu [Therapeutic Use] *Biofeedback, Psychology Dyspareunia/th [Therapy] *Electromyography Female Humans *Lidocaine/tu [Therapeutic Use] Pain Measurement Quality of Life Sexual Behavior Social Adjustment *Vulvitis/th [Therapy] 0 (Anesthetics, Local) 98PI200987 (Lidocaine) Lidocaine Biofeedback, Psychology Gels L1 - internal-pdf://4191752258/12 Danielsson 2006.pdf N1 - Danielsson, Ingela Torstensson, Thomas Brodda-Jansen, Gunilla Bohm-Starke, Nina RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2006 SN - 0001-6349 SP - 1360-1367 ST - EMG biofeedback versus topical lidocaine gel: a randomized study for the treatment of women with vulvar vestibulitis T2 - Acta Obstet Gynecol Scand TI - EMG biofeedback versus topical lidocaine gel: a randomized study for the treatment of women with vulvar vestibulitis UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med6&AN=17091418http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:17091418&id=doi:10.1080%2F00016340600883401&issn=0001-6349&isbn=&volume=85&issue=11&spage=1360&pages=1360-7&date=2006&title=Acta+Obstetricia+et+Gynecologica+Scandinavica&atitle=EMG+biofeedback+versus+topical+lidocaine+gel%3A+a+randomized+study+for+the+treatment+of+women+with+vulvar+vestibulitis.&aulast=Danielsson https://obgyn.onlinelibrary.wiley.com/doi/full/10.1080/00016340600883401 VL - 85 ID - 1 ER - TY - GEN AN - NCT03431779 AU - Depypere, B. CY - University Hospital, Ghent DA - April 17 KW - Vestibulodynia N1 - No Results Available Procedure: Adipose derived stem cell transplantation via lipofilling|Procedure: Surgical excision Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery Female Not Applicable 9 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment B670201734071 May 2023 PB - Available from: https://ClinicalTrials.gov/show/NCT03431779 PY - 2018 ST - Lipofilling as a Treatment for Vestibulodynia TI - Lipofilling as a Treatment for Vestibulodynia ID - 48 ER - TY - JOUR AB - BACKGROUND: Previous studies using botulinum toxin type A (BT) to treat provoked vestibulodynia (PVD) reported conflicting findings, possibly attributable to singular injections or low doses. We assessed PVD treatment effectiveness with high-dose single injections of BT (50 or 100 units) versus placebo, and then repeat BT 100 U injections over 6 months. METHODS: This was a randomized, double-blind, three-arm, placebo-controlled study with 33 PVD patients. BT 50 U (arm A), 100 U (arm B) or saline (arm C) were injected subcutaneously into the dorsal vulvar vestibulum and pain was assessed after 3 months. The investigation proceeded as an unblinded exploratory analysis, in which symptomatic patients received a BT 100 U injection. Symptomatic patients in arm C received a second BT 100 U injection at the 6-month visit. Symptoms were measured at 3-month cycles using: (1) cotton swab-provoked visual analogue scale (VAS), (2) von Frey filaments, and (3) Marinoff dyspareunia scale. RESULTS: The three groups were comparable in terms of demographics and baseline clinical characteristics. Three months after the initial injection, no significant differences in pain were observed among the study arms, yet significant improvements occurred within all groups using the von Frey filaments test. Results from the exploratory analyses showed repeat injections of 100 U BT over 6 months led to significant pain reduction (VAS and von Frey filaments). Fifty-eight percent (7/12) of patients assessable after repeat injections were symptom-free or had >= 2 VAS reduction. Adverse events were minor and no serious adverse events occurred during the RCT or exploratory analysis. CONCLUSIONS: PVD symptoms after one subcutaneous injection of BT (50 or 100 units) did not significantly differ compared to placebo, yet all three study arms experienced a reduction in pain 3 months after a single injection. Exploratory analyses indicated that repeat high-dose BT injections may significantly reduce pain over 6 months. TRIAL REGISTRATION: This trial was registered with the Swiss Medical Agency (reference number: 2007DR2102) in 2007. AN - 30707361 AU - Diomande, I. AU - Gabriel, N. AU - Kashiwagi, M. AU - Ghisu, G. P. AU - Welter, J. AU - Fink, D. AU - Fehr, M. K. AU - Betschart, C. DO - 10.1007/s00404-019-05043-w IS - 4 KW - Adult Botulinum Toxins, Type A/pd [Pharmacology] *Botulinum Toxins, Type A/tu [Therapeutic Use] *Dyspareunia/dt [Drug Therapy] Female Humans Male Treatment Outcome *Vulvodynia/dt [Drug Therapy] Vulvodynia/pa [Pathology] Young Adult Botulinum Toxins Botulinum Toxins, Type A L1 - internal-pdf://1094783089/28 Diomande 2019.pdf N1 - Diomande, Inessa Gabriel, Natalie Kashiwagi, Maki Ghisu, Gian-Piero Welter, JoEllen Fink, Daniel Fehr, Mathias K Betschart, Cornelia RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2019 SN - 1432-0711 SP - 993-1000 ST - Subcutaneous botulinum toxin type A injections for provoked vestibulodynia: a randomized placebo-controlled trial and exploratory subanalysis T2 - Arch Gynecol Obstet TI - Subcutaneous botulinum toxin type A injections for provoked vestibulodynia: a randomized placebo-controlled trial and exploratory subanalysis UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medl&AN=30707361http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:30707361&id=doi:10.1007%2Fs00404-019-05043-w&issn=0932-0067&isbn=&volume=299&issue=4&spage=993&pages=993-1000&date=2019&title=Archives+of+Gynecology+%26+Obstetrics&atitle=Subcutaneous+botulinum+toxin+type+A+injections+for+provoked+vestibulodynia%3A+a+randomized+placebo-controlled+trial+and+exploratory+subanalysis.&aulast=Diomande https://link.springer.com/article/10.1007/s00404-019-05043-w VL - 299 ID - 7 ER - TY - JOUR AB - OBJECTIVE: Is treatment of provoked localized vulvodynia with cutaneous lysate skin cream containing human cytokines effective? METHODS: This is a double-blind placebo-controlled randomized crossover trial with a study and a placebo cream applied twice daily for 3 months, 1-week washout, followed by a 3-month crossover medication in 30 patients experiencing provoked localized vulvodynia with visible vulvar erythema. Tolerability of the product, sexual functioning, and clinical findings were the main outcomes. A linear model for repeated measures was used for all visits. Effect after 4 weeks of treatment, effect after 12 weeks of treatment, and, finally, carryover effects of first and second order were estimated. A Wilcoxon signed rank test was used to evaluate 4- and 12-week changes within a group, and Mann-Whitney U test was used to evaluate 4- and 12-week changes between groups. RESULTS: Tolerability of the cream was excellent and not different from that of placebo. During the first 12 weeks, use of the active cream resulted in a significant reduction in pain during sexual activity after 4 and 12 weeks (p < .05); however, use of the placebo cream did not. When analyzing the entire pain data with the statistical model for crossover clinical study design, the active cream resulted in a decrease of 1.1 points (95% confidence interval = -0.6 to 2.8, p = .20) and 1.3 points (95% confidence interval = 0.1 to 2.5, p = .037) in the visual analog scale score compared with that of placebo after 4 and 12 weeks of treatment, respectively. There was evidence for a second-order carryover effect (p = .024). The pain reduction was most evident for women with secondary dyspareunia. Erythema was reduced after use of the cream at 4 (p = .03) and 12 (p = .01) weeks but not after placebo. CONCLUSIONS: As opposed to placebo, use of cutaneous lysate cream was more effective in reducing focal redness and pain while having intercourse in patients with provoked localized vulvodynia with erythema. AN - 22968058 AU - Donders, G. G. AU - Bellen, G. DO - 10.1097/LGT.0b013e31825a2274 IS - 4 KW - Adult *Cell Extracts/ad [Administration & Dosage] Cross-Over Studies Double-Blind Method Female *Fibroblasts/ch [Chemistry] Humans Middle Aged Placebos/ad [Administration & Dosage] *Vaginal Creams, Foams, and Jellies/ad [Administration & Dosage] *Vulvodynia/th [Therapy] Young Adult 0 (Cell Extracts) 0 (Placebos) 0 (Vaginal Creams, Foams, and Jellies) Fibroblasts L1 - internal-pdf://4287893617/65 Donders 2012.pdf N1 - Donders, Gilbert G Bellen, Gert RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2012 SN - 1526-0976 SP - 427-436 ST - Cream with cutaneous fibroblast lysate for the treatment of provoked vestibulodynia: a double-blind randomized placebo-controlled crossover study T2 - J Low Genit Tract Dis TI - Cream with cutaneous fibroblast lysate for the treatment of provoked vestibulodynia: a double-blind randomized placebo-controlled crossover study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med9&AN=22968058http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:22968058&id=doi:10.1097%2FLGT.0b013e31825a2274&issn=1089-2591&isbn=&volume=16&issue=4&spage=427&pages=427-36&date=2012&title=Journal+of+Lower+Genital+Tract+Disease&atitle=Cream+with+cutaneous+fibroblast+lysate+for+the+treatment+of+provoked+vestibulodynia%3A+a+double-blind+randomized+placebo-controlled+crossover+study.&aulast=Donders VL - 16 ID - 12 ER - TY - GEN AN - NCT03481621 AU - Fan, A.Y. CY - McLean Center for Complementary Alternative Medicine, PLC DA - January 1 KW - Vulvodynia|Vulvodynia, Generalized|Vulvar Vestibulitis|Vulvar Pain N1 - No Results Available Device: Acupuncture|Other: Standard care Pain Score (objective)|Pain Score (Subjective)|Pain duration|Intercourse pain Female Not Applicable 51 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment McLeanCCAM01 December 31, 2021 PB - Available from: https://ClinicalTrials.gov/show/NCT03481621 PY - 2018 ST - Acu/Vul-pain TI - Effect of Two Acupuncture Protocols on Vulvodynia ID - 47 ER - TY - JOUR AB - OBJECTIVE: To estimate the effectiveness of enoxaparin-a low-molecular-weight heparin with antiheparanase properties-in treating localized provoked vulvodynia. METHODS: Forty women with severe localized provoked vulvodynia were randomly and blindly assigned to self-administer either 40 mg enoxaparin or saline subcutaneously for 90 days. Dyspareunia and local sensitivity were evaluated before, at the end, and 90 days after treatment. The most painful focus was biopsied at the beginning of the study and a parallel site at the end of study for mast cells, PGP 9.5 nerve fiber staining, and heparanase quantification. RESULTS: The enoxaparin-treated women showed a greater reduction in vestibular sensitivity at the end of treatment and 3 months later (29.6% compared with 11.2%, P=.004). Seventy-five percent (15 of 20) of them reported more than 20% pain reduction compared with 27.8% (five of 18) in the placebo group (P=.004). Seven enoxaparin-treated women compared with three in the placebo group had almost painless intercourse at the end of the study. In women who had improvement of sensitivity at the site parallel to the original biopsy site, there was a histologically documented reduction in the number of intraepithelial-free nerve fibers in the enoxaparin group. CONCLUSION: Enoxaparin reduced the vestibular sensitivity and dyspareunia, concomitant with a reduction in intraepithelial free nerve fibers, in women with localized provoked vulvodynia. AN - 22914465 AU - Farajun, Y. AU - Zarfati, D. AU - Abramov, L. AU - Livoff, A. AU - Bornstein, J. DO - 10.1097/AOG.0b013e3182657de6 IS - 3 KW - Adolescent Adult Biopsy Double-Blind Method Drug Administration Schedule Dyspareunia/et [Etiology] *Enoxaparin/tu [Therapeutic Use] *Enzyme Inhibitors/tu [Therapeutic Use] Female Humans Middle Aged Pain Measurement Treatment Outcome Vulva/pa [Pathology] Vulvodynia/co [Complications] *Vulvodynia/dt [Drug Therapy] Vulvodynia/pa [Pathology] Young Adult 0 (Enoxaparin) 0 (Enzyme Inhibitors) Enoxaparin L1 - internal-pdf://0913838177/13 Farajun 2012.pdf N1 - Farajun, Yaniv Zarfati, Doron Abramov, Liora Livoff, Alejandro Bornstein, Jacob RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2012 SN - 1873-233X SP - 565-572 ST - Enoxaparin treatment for vulvodynia: a randomized controlled trial T2 - Obstet Gynecol TI - Enoxaparin treatment for vulvodynia: a randomized controlled trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med9&AN=22914465http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:22914465&id=doi:10.1097%2FAOG.0b013e3182657de6&issn=0029-7844&isbn=&volume=120&issue=3&spage=565&pages=565-72&date=2012&title=Obstetrics+%26+Gynecology&atitle=Enoxaparin+treatment+for+vulvodynia%3A+a+randomized+controlled+trial.&aulast=Farajun VL - 120 ID - 2 ER - TY - GEN AN - NCT03640624 AU - Forsmo, S. CY - Norwegian University of Science Technology St. Olavs Hospital DA - September 18 KW - Vulvodynia|Chronic Pain N1 - No Results Available Combination Product: Multidisciplinary treatment|Combination Product: Treatment as usual Pain intensity with Brief pain inventory (BPI)|Pain intensity with tampon test|Vulvar pressure pain threshold with vulvalgesiometer|Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)|Sexual distress with Female Sexual Distress Scale - revised (FSDS)|Affective symptoms with Hospital Anxiety and Depression Scale (HADS)|Illness perception with Brief Illness Perception Questionnaire (BIPQ)|Pain catastrophizing with Pain Catastrophizing Scale (PCS)|Levator hiatal area Female Not Applicable 110 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 2016/2150 June 2024 PB - Available from: https://ClinicalTrials.gov/show/NCT03640624 PY - 2018 ST - Multidisciplinary Treatment of Chronic Vulvar Pain TI - Multidisciplinary Treatment of Chronic Vulvar Pain ID - 44 ER - TY - JOUR AB - OBJECTIVE: To estimate the efficacy of common treatments for vulvodynia: topical lidocaine monotherapy, oral desipramine monotherapy, and lidocaine-desipramine combined therapy. METHODS: A 12-week randomized, double-blinded, placebo-controlled trial was conducted on 133 vulvodynia-afflicted women assigned to four treatment arms: placebo tablets-placebo cream, desipramine tablets-placebo cream, placebo tablets-lidocaine cream, and desipramine tablets-lidocaine cream. The tampon test was selected as primary end point using a modified intention-to-treat analysis. Twelve secondary end points were also examined. At completion of the 12-week randomized phase, women were examined "open label" through 52 weeks postrandomization. RESULTS: All treatment arms reported substantial tampon-test pain reduction: 33% reduction placebo cream-placebo tablet, 20% reduction lidocaine cream-placebo tablet, 24% reduction placebo cream-desipramine tablet, and 36% reduction lidocaine cream-desipramine tablet. Compared with placebo, we found no significant difference in tampon-test pain reduction with desipramine (t=0.90; P=.37) or lidocaine (t=1.27; P=.21). Of the remaining 12 outcome measures, only the Index of Sexual Satisfaction, improved with desipramine compared with placebo (t=-2.81; P=.006). During the open-label phase, women undergoing vestibulectomy surgery reported significantly improved pain as measured by cotton swab test and the McGill Pain Scale compared with nonsurgical alternatives. CONCLUSION: Oral desipramine and topical lidocaine, as monotherapy or in combination, failed to reduce vulvodynia pain more than placebo. Placebo or placebo-independent effects are behind the substantial pain improvement seen in all treatment allocations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068. Level of evidence: I. AN - 20733439 AU - Foster, D. C. AU - Kotok, M. B. AU - Huang, L. S. AU - Watts, A. AU - Oakes, D. AU - Howard, F. M. AU - Poleshuck, E. L. AU - Stodgell, C. J. AU - Dworkin, R. H. DO - 10.1097/AOG.0b013e3181e9e0ab IS - 3 KW - Administration, Intravaginal Administration, Oral Adult *Anesthetics, Local/ad [Administration & Dosage] *Antidepressive Agents, Tricyclic/ad [Administration & Dosage] *Desipramine/ad [Administration & Dosage] Double-Blind Method Female Humans *Lidocaine/ad [Administration & Dosage] Treatment Outcome *Vulvodynia/dt [Drug Therapy] Young Adult 0 (Anesthetics, Local) 0 (Antidepressive Agents, Tricyclic) 98PI200987 (Lidocaine) TG537D343B (Desipramine) Desipramine Lidocaine L1 - internal-pdf://1231622272/66 Foster 2010.pdf N1 - Foster, David C Kotok, Merrill Beth Huang, Li-Shan Watts, Arthur Oakes, David Howard, Fred M Poleshuck, Ellen L Stodgell, Chris J Dworkin, Robert H RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2010 SN - 1873-233X SP - 583-593 ST - Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial T2 - Obstet Gynecol TI - Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med8&AN=20733439http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:20733439&id=doi:10.1097%2FAOG.0b013e3181e9e0ab&issn=0029-7844&isbn=&volume=116&issue=3&spage=583&pages=583-93&date=2010&title=Obstetrics+%26+Gynecology&atitle=Oral+desipramine+and+topical+lidocaine+for+vulvodynia%3A+a+randomized+controlled+trial.&aulast=Foster VL - 116 ID - 13 ER - TY - JOUR AB - INTRODUCTION: Non-medical and non-surgical treatments for provoked vestibulodynia target psychological, sexual, and pelvic floor muscle factors that maintain the condition. AIM: The goal of the study was to compare the effects of cognitive-behavioral therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia. METHODS: In a clinical trial, 20 women with provoked vestibulodynia were randomly assigned to receive CBT or comprehensive PT. Participants were assessed before treatment, after treatment, and at 6-month follow-up by gynecologic examination, structured interviews, and standardized questionnaires measuring pain, psychological, and sexual variables. MAIN OUTCOME MEASURES: Outcome measurements were based on an adaptation of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations. The primary outcome was change in intercourse pain intensity. Secondary outcomes included pain during the cotton swab test, pain with various sexual and non-sexual activities, and sexual functioning and negative pain cognitions. RESULTS: The two treatment groups demonstrated significant decreases in vulvar pain during sexual intercourse, with 70% and 80% of participants in the CBT and PT groups demonstrating a moderate clinically important decrease in pain (>=30%) after treatment. Participants in the two groups also had significant improvements in pain during the gynecologic examination, the percentage of painful intercourse attempts, the percentage of activities resulting in pain, and the ability to continue intercourse without stopping because of pain. Psychological outcomes, including pain catastrophizing and perceived control over pain, also showed improvement in the two groups. Significant improvements in sexual functioning were observed only in participants who completed CBT. Few between-group differences were identified other than the PT group showing earlier improvements in some outcomes. Nearly all improvements were maintained at the 6-month follow-up. CONCLUSION: The results of the study suggest that CBT and PT can lead to clinically meaningful improvements in pain and areas of psychosexual functioning. AN - 26755091 AU - Goldfinger, C. AU - Pukall, C. F. AU - Thibault-Gagnon, S. AU - McLean, L. AU - Chamberlain, S. DO - 10.1016/j.jsxm.2015.12.003 IS - 1 KW - Adult *Cognitive Behavioral Therapy *Coitus/px [Psychology] Female Follow-Up Studies Humans Middle Aged Pain Measurement Pelvic Pain Physical Therapy Modalities Pilot Projects Surveys and Questionnaires Treatment Outcome Vulvodynia/et [Etiology] Vulvodynia/pp [Physiopathology] Vulvodynia/px [Psychology] *Vulvodynia/th [Therapy] Young Adult Behavior Therapy Cognitive Therapy L1 - internal-pdf://3523023007/9 Goldfinger 2016.pdf N1 - Goldfinger, Corrie Pukall, Caroline F Thibault-Gagnon, Stephanie McLean, Linda Chamberlain, Susan S1743-6095(15)00012-0 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2016 SN - 1743-6109 SP - 88-94 ST - Effectiveness of Cognitive-Behavioral Therapy and Physical Therapy for Provoked Vestibulodynia: A Randomized Pilot Study T2 - J Sex Med TI - Effectiveness of Cognitive-Behavioral Therapy and Physical Therapy for Provoked Vestibulodynia: A Randomized Pilot Study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med13&AN=26755091http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:26755091&id=doi:10.1016%2Fj.jsxm.2015.12.003&issn=1743-6095&isbn=&volume=13&issue=1&spage=88&pages=88-94&date=2016&title=Journal+of+Sexual+Medicine&atitle=Effectiveness+of+Cognitive-Behavioral+Therapy+and+Physical+Therapy+for+Provoked+Vestibulodynia%3A+A+Randomized+Pilot+Study.&aulast=Goldfinger https://www.jsm.jsexmed.org/article/S1743-6095(15)00012-0/fulltext VL - 13 ID - 26 ER - TY - JOUR AB - BACKGROUND: Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life and consequently negatively affects quality of life. Low-intensity shock wave therapy produces physical forces that lead to pain relief. AIM: The aim of this study was to evaluate the feasibility, safety, and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. METHODS: This is a double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJmm2) using the Medispec, ED-1000 shockwave generator or sham. Participants were assessed at the baseline, and at 1 and 3 months after completing all treatments. OUTCOMES: Pain was assessed by both subjective and objective measures. The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point visual analog scale. Secondary outcome measures were changes in pain threshold and tolerance, assessed by a quantitative validated algometer test, the Wong-Baker pain FACES scale, the Female Sexual Function Index and the Patients' Global Impression of Change scale. RESULTS: From the baseline to 1 month and 3 months after completion of treatment, visual analog scale scores for dyspareunia decreased (8.0 +/- 1.4, 5.7 +/- 2.3, and 4.4 +/- 2.5, respectively, P < .005). For these respective time points, Wong-Baker scores decreased (4.0 +/- 0.6, 2.9 +/- 1.2, 2.5 +/- 1.3, respectively, P < .05); and total Female Sexual Function Index increased (17.9 +/- 6.3, 20.9 +/- 6.2, 22.5 +/- 8, respectively, P < .002). Pain threshold and tolerance measured by the algometer were increased 3 months after completion of the treatment compared with the baseline (69.8 mmHg +/- 11.8 vs 22.9 mmHg +/- 9.0, P < .01 and 87.7 mmHg +/- 35.7 vs 43.3 mmHg +/- 14.7, P < .0001, respectively). No changes were observed in any of the measures assessed in the sham group. CLINICAL IMPLICATIONS: We found a new effective treatment for alleviating the most bothersome symptom in PVD, pain during penetration and intercourse. This resulted in improved sexual function. STRENGTHS & LIMITATIONS: The strengths of this study are the randomized controlled design, the correlated subjective questionnaires, and the use of semiquantitative algometer methodology. The limitations are the relative low number of participants in a single center. CONCLUSION: For women with PVD, low-intensity shockwave therapy applied at the introitus is a feasible, safe, and effective treatment option that may have a beneficial effect in pain relief and in sexual function. I Gruenwald, O Gutzeit, A Petruseva, et al. Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial. J Sex Med 2020;XX:XXX-XXX. AN - 33419704 AU - Gruenwald, I. AU - Gutzeit, O. AU - Petruseva, A. AU - Gartman, I. AU - Lowenstein, L. CN - UPPDAT Medline 20210129 DA - Jan 05 DO - https://dx.doi.org/10.1016/j.jsxm.2020.11.006 L1 - internal-pdf://4058583184/202-Gruenwald-2021.pdf N1 - Using Smart Source Parsing Jan Gruenwald, Ilan Gutzeit, Ola Petruseva, Anna Gartman, Irena Lowenstein, Lior S1743-6095(20)31050-X PY - 2021 SN - 1743-6109 SP - 05 ST - Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial T2 - J Sex Med TI - Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medp&AN=33419704http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:33419704&id=doi:10.1016%2Fj.jsxm.2020.11.006&issn=1743-6095&isbn=&volume=&issue=&spage=&pages=&date=2021&title=Journal+of+Sexual+Medicine&atitle=Low-Intensity+Shockwave+for+Treatment+of+Vestibulodynia%3A+A+Randomized+Controlled+Therapy+Trial.&aulast=Gruenwald https://www.jsm.jsexmed.org/article/S1743-6095(20)31050-X/fulltext VL - 05 ID - 21 ER - TY - JOUR AB - OBJECTIVE: The aim of the study was to compare the effectiveness of mindfulness-based group cognitive behavior therapy (M-gCBT) versus education support group therapy for the pain and distress associated with provoked localized vulvodynia. MATERIALS AND METHODS: Participants were randomized to M-gCBT or education support group therapy. Mindfulness-based group cognitive behavior participants attended 8 weekly sessions. Education support group participants received 8 weeks of online education with 3 in-person group visits. Vaginal insertion pain (tampon test) was the primary outcome. Secondary outcomes (Generalized Anxiety Disorder 7, Beck's Depression Index, Female Sexual Distress Scale, Female Sexual Function Index, and Pain Catastrophizing) were administered before intervention and at the completion of the study period, 3 months, and 6 months. Sample size was based on the ideal number for group dynamics of 6 to 12 participants per group. RESULTS: Participants were enrolled from August 1, 2016, to January 30, 2017. Thirty-two participants were enrolled and 31 were randomized: 14 to M-gCBT and 17 to education support. Baseline characteristics did not differ significantly. Vaginal insertion pain decreased in both groups but was not statistically different between groups (difference of 1.23; 95% CI = -0.52 to 2.98). At 6 months, participants in the M-gCBT group showed statistically significant improvement in the Female Sexual Function Index, Generalized Anxiety Disorder 7, and Beck's Depression Index compared with the education support group. CONCLUSIONS: Mindfulness-based group cognitive behavior and education support group therapy are effective in reducing pain and distress. However, women in the M-gCBT program showed greater improvement in certain secondary outcomes, indicating that M-gCBT may offer some advantages in reducing distress associated with provoked localized vulvodynia. AN - 30688760 AU - Guillet, A. D. AU - Cirino, N. H. AU - Hart, K. D. AU - Leclair, C. M. DO - 10.1097/LGT.0000000000000456 IS - 2 KW - Adolescent Adult *Cognitive Behavioral Therapy/mt [Methods] Female Humans Middle Aged *Psychotherapy, Group/mt [Methods] Treatment Outcome *Vulvodynia/pa [Pathology] *Vulvodynia/th [Therapy] Young Adult Behavior Therapy Cognitive Therapy L1 - internal-pdf://2733117537/17 Guillet 2019.pdf N1 - Guillet, Alyson D Cirino, Nicole H Hart, Kyle D Leclair, Catherine M RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2019 SN - 1526-0976 SP - 170-175 ST - Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial T2 - J Low Genit Tract Dis TI - Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med16&AN=30688760http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:30688760&id=doi:10.1097%2FLGT.0000000000000456&issn=1089-2591&isbn=&volume=23&issue=2&spage=170&pages=170-175&date=2019&title=Journal+of+Lower+Genital+Tract+Disease&atitle=Mindfulness-Based+Group+Cognitive+Behavior+Therapy+for+Provoked+Localized+Vulvodynia%3A+A+Randomized+Controlled+Trial.&aulast=Guillet VL - 23 ID - 4 ER - TY - GEN AN - NCT02362763 AU - Hamani, Y. CY - Hadassah Medical Organization DA - June KW - Vestibulodynia N1 - No Results Available Procedure: Acupuncture Female Sexual Function Index (FSFI) questionnaire|Clinical examination Female Not Applicable 42 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment VESTIB-HMO-CTIL June 2007 PB - Available from: https://ClinicalTrials.gov/show/NCT02362763 PY - 2006 ST - The Use of Acupuncture for the Treatment of Vulvar Vestibulitis TI - The Use of Acupuncture for the Treatment of Vulvar Vestibulitis ID - 53 ER - TY - JOUR AB - OBJECTIVE: To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia. METHODS: We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76+/-31 SD). RESULTS: Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported. CONCLUSION: Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02773641. AD - Department of Clinical Sciences, Division of Obstetrics and Gynecology, Karolinska Institutet Danderyd Hospital, Stockholm, and the Center for Clinical Research, Uppsala University, County Council of Vastmanland Central Hospital, and the School of Health, Care and Social Welfare, Malardalen University, Vasteras, Sweden. AN - 32769643 AU - Haraldson, P. AU - Muhlrad, H. AU - Heddini, U. AU - Nilsson, K. AU - Bohm-Starke, N. DA - Sep DO - 10.1097/AOG.0000000000004008 ET - 2020/08/10 IS - 3 L1 - internal-pdf://2911768720/147 Haraldson 2020.pdf N1 - Haraldson, Philip Muhlrad, Hanna Heddini, Ulrika Nilsson, Kent Bohm-Starke, Nina eng Obstet Gynecol. 2020 Sep;136(3):524-532. doi: 10.1097/AOG.0000000000004008. PY - 2020 SN - 1873-233X (Electronic) 0029-7844 (Linking) SP - 524-532 ST - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial T2 - Obstet Gynecol TI - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial UR - https://www.ncbi.nlm.nih.gov/pubmed/32769643 VL - 136 ID - 20 ER - TY - JOUR AB - BACKGROUND: Internet-based ACT (Acceptance and commitment therapy) treatment may improve accessibility and reduce stigma related to seeking health care, but there are a lack of studies investigating internet-based treatment using ACT principles for women with vulvodynia. AIM: The aim of this study was to investigate the effects of an internet-based treatment of pain during intercourse for women with provoked vulvodynia compared with no intervention during the waiting period before clinical treatment. METHODS: A multicenter randomized controlled trial was conducted during 2016 to 2020, in which 99 participants were included. Participants were randomized to either a 6 week guided internet-based treatment using ACT principles or usual care. Data were collected at baseline, 6 weeks after baseline, and approximately 10 months after baseline. OUTCOMES: Pain-related (pain during intercourse, tampon test, impact of pain on sexual function) and pain behavior-related outcomes (attempts at intercourse, sexual activities besides intercourse, willingness to perform the tampon test, chronic pain acceptance questionnaire) were used as outcomes. RESULTS: Treatment was efficacious in what concerns pain during intercourse and pain acceptance. Less pain during intercourse among women in the intervention group was observed at both post-treatment (primary endpoint, P = .01, Cohen's d = 1.4, 95% CI = 0.33, 2.4), and follow-up (P = .04). Absolut mean difference between groups for pain during intercourse at post-treatment was -2.84, (95 % CI = -4.91, -0.78), and -1.58 at follow-up, (95 % CI = -3.17, 0.02), where the intervention group rated less pain than controls. No differences between groups over time were found for tampon test measures or impact of pain on sexual function. There was a significant difference between groups at all timepoints indicating fewer attempts at intercourse among participants in the intervention group. At post-treatment, women who underwent internet-based treatment reported higher pain acceptance and a rise in activity engagement compared with the control group. CLINICAL IMPLICATIONS: There is an indication that internet-based treatment could be incorporated into clinical practice as a complement to clinical treatment. STRENGTHS & LIMITATIONS: Study strengths included using several forms of recruitment and an intervention built by different professions with long experience of treating patients with vulvodynia. High dropout rate was a limitation of this study. CONCLUSION: Internet-based treatment may have an impact on pain during intercourse and positive effects on pain acceptance. However, conclusions must be drawn with caution due to the small sample size. Engstrom AH, Bohm-Starke N, Kullinger M, et al. Internet-based Treatment for Vulvodynia (EMBLA) - A Randomized Controlled Study. J Sex Med 2022;19:319-330. AD - Uppsala University, Center for Clinical Research, Vastmanland County Hospital, Vasteras, Sweden; Uppsala University, Department of Women's and Children's Health, Uppsala, Sweden. Electronic address: andrea.hess.engstrom@regionvastmanland.se. Karolinska Institute, Department of Clinical Sciences, Division of Obstetrics and Gynecology, Solna, Sweden; Danderyd Hospital, Stockholm, Sweden. Uppsala University, Center for Clinical Research, Vastmanland County Hospital, Vasteras, Sweden; Uppsala University, Department of Women's and Children's Health, Uppsala, Sweden. Uppsala University, Department of Women's and Children's Health, Uppsala, Sweden; Uppsala University, Center for Clinical Research, Falun, Sweden. Uppsala University, Department of Women's and Children's Health, Uppsala, Sweden; Umea University, Department of Epidemiology and Global Health, Umea, Sweden. Uppsala University, Department of Psychology, Division of Clinical Psychology, Uppsala, Sweden. Uppsala University, Department of Women's and Children's Health, Uppsala, Sweden. Electronic address: https://twitter.com/ASkalkidou. AN - 34972640 AU - Hess Engström, A. AU - Bohm-Starke, N. AU - Kullinger, M. AU - Hesselman, S. AU - Hogberg, U. AU - Buhrman, M. AU - Skalkidou, A. DA - Feb DO - 10.1016/j.jsxm.2021.11.019 ET - 20211228 IS - 2 KW - *Acceptance and Commitment Therapy *Chronic Pain Coitus Female Humans Internet Surveys and Questionnaires *Vulvodynia/therapy *cbt *Internet-based treatment *Mindfulness *Vestibulodynia *Vulvodynia L1 - internal-pdf://0487788735/60-Hess Engstrom-2022.pdf internal-pdf://2400063679/60-Hess Engstrom-20221.pdf N1 - Hess Engstrom, Andrea Bohm-Starke, Nina Kullinger, Merit Hesselman, Susanne Hogberg, Ulf Buhrman, Monica Skalkidou, Alkistis eng Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Netherlands 2022/01/02 J Sex Med. 2022 Feb;19(2):319-330. doi: 10.1016/j.jsxm.2021.11.019. Epub 2021 Dec 28. PY - 2022 SN - 1743-6109 (Electronic) 1743-6095 (Linking) SP - 319-330 ST - Internet-based Treatment for Vulvodynia (EMBLA) - A Randomized Controlled Study T2 - J Sex Med TI - Internet-based Treatment for Vulvodynia (EMBLA) - A Randomized Controlled Study UR - https://www.ncbi.nlm.nih.gov/pubmed/34972640 https://www.jsm.jsexmed.org/article/S1743-6095(21)00795-5/pdf VL - 19 ID - 36 ER - TY - JOUR AB - OBJECTIVE: The aim of the study was to assess the feasibility and acceptability of acupuncture's augmentation of lidocaine therapy in the treatment of provoked localized vulvodynia (PLV). MATERIALS AND METHODS: For 12 weeks, women with moderate to severe PLV were randomized to either 18 sessions of traditional acupuncture (TA) or non-TA (NTA). All participants applied lidocaine 5% cream 4 times daily to the vestibule. Feasibility was assessed by recruitment, enrollment, assessment completion, and blinding. Acceptability was assessed by study visit attendance and satisfaction. The primary outcome was change in tampon test scores from baseline to week 12 and follow-up at week 24. RESULTS: Nineteen women enrolled and 14 completed the study. Five withdrew because of lidocaine reaction (n = 2), inability to insert tampon (n = 1), starting a new medication (n = 1), or change in vulvar diagnosis (n = 1). Participants in both groups reported pain reduction for 12 weeks. There was no statistically significant difference between groups. Women in the TA group (n = 7) experienced less pain from baseline to 12 weeks (mean difference [MD] = 42.4 +/- 19.4 and MD = 35.7 +/- 17.8 at week 24). In the non-TA group (n = 7), women experienced a within-group MD of 28.7 +/- 28.5 at 12 weeks and an MD of 36.7 +/- 17.7. CONCLUSIONS: In this early-phase research, acupuncture augmentation of lidocaine was acceptable. The study procedures, with modifications, may be feasible for future investigation. Both acupuncture techniques showed a favorable effect; however, the contribution to pain relief is undetermined. AN - 31592976 AU - Hullender Rubin, L. E. AU - Mist, S. D. AU - Schnyer, R. N. AU - Chao, M. T. AU - Leclair, C. M. DO - 10.1097/LGT.0000000000000489 IS - 4 KW - *Acupuncture/mt [Methods] Adolescent Adult *Anesthetics, Local/ad [Administration & Dosage] Female Humans *Lidocaine/ad [Administration & Dosage] Middle Aged Patient Acceptance of Health Care Treatment Outcome *Vulvodynia/th [Therapy] Young Adult 0 (Anesthetics, Local) 98PI200987 (Lidocaine) Lidocaine L1 - internal-pdf://4200992896/72 Hullender Rubin 2019.pdf N1 - Hullender Rubin, Lee E Mist, Scott D Schnyer, Rosa N Chao, Maria T Leclair, Catherine M RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2019 SN - 1526-0976 SP - 279-286 ST - Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study T2 - J Low Genit Tract Dis TI - Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medl&AN=31592976http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:31592976&id=doi:10.1097%2FLGT.0000000000000489&issn=1089-2591&isbn=&volume=23&issue=4&spage=279&pages=279-286&date=2019&title=Journal+of+Lower+Genital+Tract+Disease&atitle=Acupuncture+Augmentation+of+Lidocaine+for+Provoked%2C+Localized+Vulvodynia%3A+A+Feasibility+and+Acceptability+Study.&aulast=Hullender+Rubin VL - 23 ID - 14 ER - TY - JOUR AB - OBJECTIVE: To determine if montelukast treatment improves symptoms in patients with vulvar vestibulitis. STUDY DESIGN: We administered montelukast to a series of patients with vestibulitis seen at the Pennsylvania State University Vulvodynia Clinic over a period of 2.5 years. We reviewed outcomes using a scoring scheme to quantify signs and symptoms, before and after treatment, in 29 montelukast-treated subjects and 18 subjects in a comparison group treated with standard therapies. RESULTS: Subjects treated with montelukast showed an average of 52% in improvement in symptoms as compared to a 15% improvement in the controls (p < 0.0001). CONCLUSION: Montelukast is a viable treatment option for women with vulvar vestibulitis. This finding implies that leukotrienes have a role in the pathophysiology of vulvar vestibulitis. AN - 17977165 AU - Kamdar, N. AU - Fisher, L. AU - MacNeill, C. IS - 10 KW - *Acetates/tu [Therapeutic Use] Adult Female Humans *Leukotriene Antagonists/tu [Therapeutic Use] Middle Aged *Quinolines/tu [Therapeutic Use] Retrospective Studies Treatment Outcome *Vulvar Vestibulitis/dt [Drug Therapy] 0 (Acetates) 0 (Leukotriene Antagonists) 0 (Quinolines) MHM278SD3E (montelukast) L1 - internal-pdf://3032682671/54-Kamdar-2007.pdf N1 - Kamdar, Neha Fisher, Laura MacNeill, Colin RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} | RAYYAN-LABELS: retrospective PY - 2007 SN - 0024-7758 SP - 912-916 ST - Improvement in vulvar vestibulitis with montelukast T2 - J Reprod Med TI - Improvement in vulvar vestibulitis with montelukast UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med6&AN=17977165http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:17977165&id=doi:&issn=0024-7758&isbn=&volume=52&issue=10&spage=912&pages=912-6&date=2007&title=Journal+of+Reproductive+Medicine&atitle=Improvement+in+vulvar+vestibulitis+with+montelukast.&aulast=Kamdar VL - 52 ID - 32 ER - TY - JOUR AB - OBJECTIVE: To assess the efficacy of conjugated equine estrogen cream in reducing dyspareunia associated with secondary provoked vestibulodynia. METHODS: We conducted a randomized, double-blind, placebo-controlled trial that included women with secondary provoked vestibulodynia. Participants were randomly allocated to daily application of conjugated equine estrogen cream on the vulvar vestibule (estrogen group) or daily application of a similar placebo cream (placebo group). All patients were evaluated before and after eight weeks of treatment, using a visual analogue scale for superficial dyspareunia (primary outcome), the McGill Pain Questionnaire for superficial dyspareunia, the Female Sexual Function Index for sexual satisfaction, and vulvoscopy for vestibular erythema. RESULTS: The targeted recruitment for this study was 44 women, but because of funding shortfalls recruitment was limited to 20 women. These 20 participants were randomly assigned to two groups of 10. Improvement of superficial dyspareunia on the visual analogue scale was not significantly different between the two groups (estrogen group: 27% improvement vs. placebo group: 3% improvement, P = 0.29). However, the use of conjugated equine estrogen cream was associated with a significant post-treatment improvement in superficial dyspareunia and in all three secondary outcomes (P < 0.05), whereas this was not the case with the use of placebo. CONCLUSION: Daily application of conjugated equine estrogen cream to the vulvar vestibule could potentially reduce superficial dyspareunia in women with secondary provoked vestibulodynia, but a randomized trial with adequate statistical power will be required to demonstrate this. AN - 28342741 AU - Langlais, E. L. AU - Lefebvre, J. AU - Maheux-Lacroix, S. AU - Bujold, E. AU - Fortier, M. AU - Bouchard, C. DO - 10.1016/j.jogc.2016.10.011 IS - 6 KW - Adolescent Adult Double-Blind Method Estrogens/ad [Administration & Dosage] Estrogens/tu [Therapeutic Use] *Estrogens Estrogens, Conjugated (USP)/ad [Administration & Dosage] Estrogens, Conjugated (USP)/tu [Therapeutic Use] *Estrogens, Conjugated (USP) Female Humans Pelvic Pain Pilot Projects Placebos Quebec Sexual Behavior Vaginal Creams, Foams, and Jellies *Vulvodynia/dt [Drug Therapy] Young Adult 0 (Estrogens) 0 (Estrogens, Conjugated (USP)) 0 (Placebos) 0 (Vaginal Creams, Foams, and Jellies) Estrogens L1 - internal-pdf://2679574641/31 Langlais 2017.pdf N1 - Langlais, Eve-Lyne Lefebvre, Jessica Maheux-Lacroix, Sarah Bujold, Emmanuel Fortier, Michel Bouchard, Celine S1701-2163(16)39061-2 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2017 SN - 1701-2163 SP - 453-458 ST - Treatment of Secondary Vestibulodynia with Conjugated Estrogen Cream: A Pilot, Double-Blind, Randomized Placebo-Controlled Trial T2 - J Obstet Gynaecol Can TI - Treatment of Secondary Vestibulodynia with Conjugated Estrogen Cream: A Pilot, Double-Blind, Randomized Placebo-Controlled Trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med14&AN=28342741http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:28342741&id=doi:10.1016%2Fj.jogc.2016.10.011&issn=1701-2163&isbn=&volume=39&issue=6&spage=453&pages=453-458&date=2017&title=Journal+of+Obstetrics+%26+Gynaecology+Canada%3A+JOGC&atitle=Treatment+of+Secondary+Vestibulodynia+with+Conjugated+Estrogen+Cream%3A+A+Pilot%2C+Double-Blind%2C+Randomized+Placebo-Controlled+Trial.&aulast=Langlais VL - 39 ID - 8 ER - TY - GEN AN - NCT03541512 AU - Leclair, C. CY - Oregon Health Science University DA - May 1 KW - Provoked Localized Vulvodynia N1 - No Results Available Behavioral: Mindfulness + Education|Behavioral: Education Change in Female Sexual Distress Scale (FSDS) at 8 weeks|Change in Tampon Test Pain Scores at 8 weeks Female Not Applicable 46 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care 18191 September 2024 PB - Available from: https://ClinicalTrials.gov/show/NCT03541512 PY - 2018 ST - Remote Mindfulness Education PLV TI - Remote Mindfulness Education PLV ID - 46 ER - TY - GEN AN - NCT01149031 AU - Lev-Sagie, A. CY - Hadassah Medical Organization DA - June KW - Provoked Vestibulodynia N1 - No Results Available Device: LOW LEVEL LASER SYSTEM Change in vestibular pain level(as measured by variable parameters) Female Not Applicable 34 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment ahinoam110-HMO-CTIL December 2013 PB - Available from: https://ClinicalTrials.gov/show/NCT01149031 PY - 2010 ST - lllt TI - Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia ID - 57 ER - TY - JOUR AB - BACKGROUND: Low-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure. AIM: To investigate the effectiveness of LLLT for PVD in a randomized, placebo-controlled, double-blinded trial. METHODS: Patients with PVD were randomly assigned to receive treatment with LLLT or sham treatment. Patients were treated twice weekly for 6 weeks, for a total of 12 LLLT or placebo sessions. Patients who showed improvement after LLLT were followed for 1 year by clinical pain report and Q-tip examination. OUTCOMES: Change in pain scores obtained in response to the Q-tip test, clinical pain report, visual analog scale score, pain with tampon insertion, daily pain intensity, intercourse pain intensity, frequency of intercourse, and a battery of quality-of-life measures. RESULTS: Thirty-four patients with PVD participated, 18 received LLLT and 16 received placebo. In the clinical pain report at study completion, 14 of 18 patients (78%) receiving LLLT reported improvement compared with 7 of 16 (44%) in the placebo group (P = .042). This effect was not apparent in other outcome measurements. None of the patients reported side effects during the study. At 1-year follow-up, eight patients (57%) reported lasting improvement. CLINICAL IMPLICATIONS: Larger studies with various treatment protocols are needed to define which patients can benefit from LLLT therapy. STRENGTHS AND LIMITATIONS: Strengths include a placebo-controlled, double-blinded design, measurement of a large number of multidimensional end points, and a follow-up period of 1 year. Limitations include the small number of patients recruited, no improvement in measurable parameters, a high improvement rate in the placebo group, the absence of use of validated questionnaires, and the lack of evaluation of psychological and interpersonal factors that might have influenced the results. CONCLUSIONS: Given the results of this pilot study, LLLT cannot currently be recommended as a treatment for PVD. Further studies with a larger population, various treatment protocols, and evaluation of LLLT in different subgroups of PVD are needed to define which patients can benefit from this therapy. Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med 2017;14:1403-1411. AN - 28970071 AU - Lev-Sagie, A. AU - Kopitman, A. AU - Brzezinski, A. DO - 10.1016/j.jsxm.2017.09.004 IS - 11 KW - Adult Clinical Protocols *Coitus/px [Psychology] Female Humans *Low-Level Light Therapy Male Middle Aged Pain Measurement Pilot Projects *Sexual Behavior/px [Psychology] Surveys and Questionnaires Treatment Outcome Vulvodynia/px [Psychology] *Vulvodynia/th [Therapy] Laser Therapy L1 - internal-pdf://0964104289/15 Lev-Sagie 2017.pdf N1 - Lev-Sagie, Ahinoam Kopitman, Asia Brzezinski, Amnon S1743-6095(17)31414-5 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2017 SN - 1743-6109 SP - 1403-1411 ST - Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial T2 - J Sex Med TI - Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med14&AN=28970071http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:28970071&id=doi:10.1016%2Fj.jsxm.2017.09.004&issn=1743-6095&isbn=&volume=14&issue=11&spage=1403&pages=1403-1411&date=2017&title=Journal+of+Sexual+Medicine&atitle=Low-Level+Laser+Therapy+for+the+Treatment+of+Provoked+Vestibulodynia-A+Randomized%2C+Placebo-Controlled+Pilot+Trial.&aulast=Lev-Sagie https://www.jsm.jsexmed.org/article/S1743-6095(17)31414-5/fulltext VL - 14 ID - 3 ER - TY - GEN AN - NCT00607490 AU - Masheb, R. M. CY - Eunice Kennedy Shriver National Institute of Child Health Human Development DA - September KW - Vulvodynia N1 - No Results Available Behavioral: Cognitive-Behavioral Therapy|Behavioral: Supportive Psychotherapy Pain Severity|Sexual Functioning|Emotional Functioning Female Not Applicable 50 NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment R01HD038493 March 2005 PB - Available from: https://ClinicalTrials.gov/show/NCT00607490 PY - 2000 ST - A Randomized Clinical Trial for Women With Vulvodynia TI - A Randomized Clinical Trial for Women With Vulvodynia ID - 59 ER - TY - GEN AN - NCT03390049 AU - Matthews, C.A. CY - Wake Forest University Health Sciences DA - August KW - Vestibulodynia N1 - No Results Available Device: Fractional CO2 Laser Treatment|Device: Sham Laser Treatment Mean change from baseline in subjects' vulvar pain NRS scores|Mean change from baseline in subjects' scores on pain severity subscale VPAQ|Mean change from baseline in subjects' scores on pain severity subscale SF-MPQ|Mean change from baseline in subjects' scores on pain descriptors subscale VPAQ|Mean change from baseline in subjects' scores on the SF-36|Mean change from baseline in subjects' scores on the pain interference subscale of the BPI|Mean change from baseline in subjects' scores on the life interference subscale of the VPAQ|Mean change from baseline in subjects' scores on the life interference subscale of the FSFI|Mean change from baseline in subjects' scores on the sexual function interference subscale of the VPAQ|Mean change from baseline in subjects' scores on the sexual function interference subscale of the PHQ-9|Comparison of percentages of subjects in each treatment arm endorsing improvement in symptoms on the PGIC scale All Not Applicable 0 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment IRB00043442 November 2019 PB - Available from: https://ClinicalTrials.gov/show/NCT03390049 PY - 2018 ST - Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia TI - Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia ID - 49 ER - TY - GEN AN - NCT04234542 AU - McLean, L. CY - University of Ottawa BioFlexTM Laser Therapy DA - February 18 KW - Provoked Vestibulodynia N1 - No Results Available Other: Low Level Laser Therapy|Other: Sham Low Level Laser Therapy Global perception of improvement|The Vulvar Pain Assessment Questionnaire (VPAQ)Inventory:COMPREHENSIVE (FULL) VERSION|The Vulvar Pain Assessment Questionnaire (VPAQ) Inventory:COMPREHENSIVE (FULL) VERSION|Pain rating during the tampon test|Pressure pain threshold (PPT) at the posterior vaginal fourchette|Temporal summation of pain|Global Patient satisfaction with treatment|Female Sexual Function Index (FSFI)|Motor evoked potential (MEP) peak to peak amplitude (µV)|Cortical silent period (ms)|Pain Catastrophizing Scale|Depression Anxiety Stress Scale (DASS)|Central sensitization index|The Vulvar Pain Assessment Questionnaire - Supplemental Domains Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment H-01-19-2367 December 20, 2023 PB - Available from: https://ClinicalTrials.gov/show/NCT04234542 PY - 2021 ST - Is Low Level Laser Therapy (LLLT) Effective for Reducing Pain Experienced by Women With Provoked Vestibulodynia? TI - Is Low Level Laser Therapy (LLLT) Effective for Reducing Pain Experienced by Women With Provoked Vestibulodynia? ID - 40 ER - TY - JOUR AB - BACKGROUND: Provoked vestibulodynia is a highly prevalent condition characterized by acute recurrent pain located at the vaginal entrance in response to pressure application or attempted vaginal penetration. Despite a wide variety of treatments offered to women with provoked vestibulodynia, a high proportion of women are refractory to conventional treatment. Transcranial direct-current stimulation is a noninvasive brain stimulation technique that has been shown effective for improving various chronic pain conditions. Growing evidence suggests that the central nervous system could play a key role in provoked vestibulodynia. Targeting the central nervous system could therefore be a promising treatment for women with provoked vestibulodynia. OBJECTIVE: The purpose of this study was to evaluate and compare the efficacy of active and sham transcranial direct-current stimulation in reducing pain intensity during intercourse in patients with provoked vestibulodynia. STUDY DESIGN: We conducted a triple-blind, parallel-group, randomized controlled trial. Women aged 17-45 years diagnosed with provoked vestibulodynia by a gynecologist using a validated protocol were randomized to 10 sessions of either active transcranial direct-current stimulation (intensity = 2 mA) or 10 sessions of sham transcranial direct-current stimulation, over a 2-week period. Both active and sham transcranial direct-current stimulation were applied for 20 minutes, with the anode positioned over the primary motor cortex, and the cathode over the contralateral supraorbital area. Outcome measures were collected at baseline, 2 weeks after treatment, and at 3-month follow-up by an evaluator blinded to group assignment. The primary objective was to assess pain intensity during intercourse, using a numerical rating scale. Secondary outcomes focused on sexual function and distress, vestibular sensitivity, psychological distress, treatment satisfaction, and patient impression of change. Statistical analyses were conducted on the intention-to-treat basis, and treatment effects were evaluated using a mixed linear model for repeated measures. RESULTS: A total of 40 patients were randomly assigned to receive either active (n = 20) or sham (n = 20) transcranial direct-current stimulation treatments from November 2014 through February 2016. Baseline characteristics were similar between the active and sham transcranial direct-current stimulation groups. In full compliance with the study protocol, every participant followed all courses of the study treatment, including assessments at 2-week and 3-month follow-up. Pain during sexual intercourse was not significantly different between active and sham treatment groups 2 weeks after treatment (P = .84) and at follow-up (P = .09). Mean baseline and 2-week assessment pain intensity were, respectively, 6.8 (95% confidence interval, 5.9-7.7) and 5.6 (95% confidence interval, 4.7-6.5) for active transcranial direct-current stimulation (P = .03) vs 7.5 (95% confidence interval, 6.6-8.4) and 5.7 (95% confidence interval, 4.8-6.6) for sham transcranial direct-current stimulation (P = .001). Nonsignificant differences between the 2 groups were also found in their sexual function and distress after treatment (P > .20) and at follow-up (P > .10). Overall, at 2-week assessment 68% assigned to active transcranial direct-current stimulation reported being very much, much, or slightly improved compared to 65% assigned to sham transcranial direct-current stimulation (P = .82), and still comparable at follow-up: 42% vs 65%, respectively (P = .15). CONCLUSION: Findings suggest that active transcranial direct-current stimulation is not more effective than sham transcranial direct-current stimulation for reducing pain in women with provoked vestibulodynia. Likewise, no significant effects were found on sexual function, vestibular sensitivity, or psychological distress. AN - 28302387 AU - Morin, A. AU - Leonard, G. AU - Gougeon, V. AU - Cyr, M. P. AU - Waddell, G. AU - Bureau, Y. A. AU - Girard, I. AU - Morin, M. DO - 10.1016/j.ajog.2017.02.049 IS - 6 KW - Adolescent Adult *Coitus/ph [Physiology] Coitus/px [Psychology] Female Humans Middle Aged Pain Measurement Stress, Psychological/px [Psychology] *Transcranial Direct Current Stimulation Treatment Outcome Vulvodynia/px [Psychology] *Vulvodynia/th [Therapy] Young Adult L1 - internal-pdf://1046614175/11 Morin 2017.pdf N1 - Morin, Annie Leonard, Guillaume Gougeon, Veronique Cyr, Marie-Pierre Waddell, Guy Bureau, Yves-Andre Girard, Isabelle Morin, Melanie Comment in (CIN) S0002-9378(17)30381-2 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2017 SN - 1097-6868 SP - 584.e581-584.e511 ST - Efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia T2 - Am J Obstet Gynecol TI - Efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med14&AN=28302387http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:28302387&id=doi:10.1016%2Fj.ajog.2017.02.049&issn=0002-9378&isbn=&volume=216&issue=6&spage=584.e1&pages=584.e1-584.e11&date=2017&title=American+Journal+of+Obstetrics+%26+Gynecology&atitle=Efficacy+of+transcranial+direct-current+stimulation+in+women+with+provoked+vestibulodynia.&aulast=Morin VL - 216 ID - 27 ER - TY - GEN AN - NCT04502810 AU - Morin, M. CY - Université de Sherbrooke Centre de recherche du Centre hospitalier universitaire de Sherbrooke Exogenia DA - August 1 KW - Vulvodynia N1 - No Results Available Radiation: High-level laser therapy Adherence rate|Level of satisfaction with the treatment|Willingness to recommend the treatment|Rate of adverse events|Blinding effectiveness|Recruitment rate|Completion and dropout rates|Completeness of data|Change in pain intensity during intercourse|Change in sexual function|Change in sexual distress|Change in pain quality|Patient's global impression of change|Change in fear of pain|Change in pain catastrophization|Change in vulvar pain sensitivity|Change in vulvar blood circulation Female Not Applicable 41 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment #2020-3535 May 4, 2021 PB - Available from: https://ClinicalTrials.gov/show/NCT04502810 PY - 2020 ST - High-level Laser for Provoked Vestibulodynia TI - High-level Laser for Provoked Vestibulodynia ID - 39 ER - TY - JOUR AB - BACKGROUND: Provoked vestibulodynia is the most common subtype of chronic vulvar pain. This highly prevalent and debilitating condition is characterized by acute recurrent pain located at the entry of the vagina in response to pressure application or attempted vaginal penetration. Although physical therapy is advocated as a first-line treatment for provoked vestibulodynia, evidence supporting its efficacy is scarce. OBJECTIVE: The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment. STUDY DESIGN: We conducted a prospective, multicenter, parallel-group, randomized clinical trial in women diagnosed as having provoked vestibulodynia recruited from the community and 4 Canadian university hospitals. Women were randomly assigned (1:1) to receive either weekly sessions of physical therapy or overnight topical lidocaine (5% ointment) for 10 weeks. Randomization was stratified by center using random permuted blocks from a computer-generated list managed by an independent individual. Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy, and dilation. Assessments were conducted at baseline, posttreatment, and 6-month follow-up. Outcome assessors, investigators, and data analysts were masked to allocation. The primary outcome was pain intensity during intercourse evaluated with the numeric rating scale (0-10). Secondary outcomes included pain quality (McGill-Melzack Pain Questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (numeric rating scale of 0-10), and participants' impression of change (Patient Global Impression of Change). Intention-to-treat analyses were conducted using piecewise linear-growth models. RESULTS: Among 212 women who were recruited and randomized, 201 (95%) completed the posttreatment assessment and 195 (92%) completed the 6-month follow-up. Multimodal physical therapy was more effective than lidocaine for reducing pain intensity during intercourse (between-group pre-post slope difference, P<.001; mean group postdifference, 1.8; 95% confidence interval, 1.2-2.3), and results were maintained at 6-month follow-up (mean group difference, 1.8; 95% confidence interval, 1.2-2.5). The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction, and participants' impression of change) at posttreatment and 6-month follow-up. Moreover, the changes observed after physical therapy were shown to be clinically meaningful. Regarding participants' impression of change, 79% of women in the physical therapy group reported being very much or much improved compared with 39% in the lidocaine group (P<.001). CONCLUSION: The findings provide strong evidence that physical therapy is effective for pain, sexual function, and sexual distress and support its recommendation as the first-line treatment of choice for provoked vestibulodynia. AN - 32818475 AU - Morin, M. AU - Dumoulin, C. AU - Bergeron, S. AU - Mayrand, M. H. AU - Khalife, S. AU - Waddell, G. AU - Dubois, M. F. AU - Group, P. V. D. S. CN - UPPDAT Medline 20210129 DA - Aug 18 DO - https://dx.doi.org/10.1016/j.ajog.2020.08.038 L1 - internal-pdf://3028357279/50-Morin-2020.pdf N1 - Using Smart Source Parsing Aug Morin, Melanie Dumoulin, Chantale Bergeron, Sophie Mayrand, Marie-Helene Khalife, Samir Waddell, Guy Dubois, Marie-France PVD Study Group Girard I Bureau YA Ouellet S Reichetzer B Simard-Emond L Brochu I S0002-9378(20)30866-8 PY - 2020 SN - 1097-6868 SP - 18 ST - Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a prospective, multicenter, randomized trial T2 - Am J Obstet Gynecol TI - Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a prospective, multicenter, randomized trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medp&AN=32818475http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:32818475&id=doi:10.1016%2Fj.ajog.2020.08.038&issn=0002-9378&isbn=&volume=&issue=&spage=&pages=&date=2020&title=American+Journal+of+Obstetrics+%26+Gynecology&atitle=Multimodal+physical+therapy+versus+topical+lidocaine+for+provoked+vestibulodynia%3A+a+prospective%2C+multicenter%2C+randomized+trial.&aulast=Morin VL - 18 ID - 28 ER - TY - JOUR AB - OBJECTIVE: To assess the efficacy of transcutaneous electrical nerve stimulation (TENS) in the treatment of vestibulodynia. DESIGN: Double-arm randomised placebo-controlled trial. SETTING: An outpatient department for vulval disease. POPULATION: Forty women with vestibulodynia, a vestibular discomfort mostly reported as a burning pain, occurring in the absence of relevant visible findings or a specific, clinically identifiable, neurological disorder. METHODS: Twice a week active TENS or sham treatment were delivered through a vaginal probe via a calibrated dual channel YSY-EST device. Women of both groups underwent 20 treatment sessions. MAIN OUTCOME MEASURES: Visual analogue scale (VAS), the short form of the McGill-Melzack Pain Questionnaire (SF-MPQ), the Marinoff Scale for dyspareunia and the Female Sexual Function Index questionnaire (FSFI) were assessed at baseline, at the end of treatment and at follow up 3 months after the end of treatment. RESULTS: The VAS and SF-MPQ scores (6.2 +/- 1.9 and 19.5 +/- 11.9 before treatment, respectively) improved significantly in the active TENS group (2.1 +/- 2.7, P= 0.004 and 8.5 +/- 10.7, P= 0.001, respectively), but not in the placebo group. The Marinoff dyspareunia scale and the FSFI also showed a significant improvement. CONCLUSIONS: TENS is a simple, effective and safe short-term (3 months) treatment for the management of vestibulodynia. AN - 18715435 AU - Murina, F. AU - Bianco, V. AU - Radici, G. AU - Felice, R. AU - Di Martino, M. AU - Nicolini, U. DO - 10.1111/j.1471-0528.2008.01803.x IS - 9 KW - Adult Female Humans *Pain Management Pain Measurement Surveys and Questionnaires *Transcutaneous Electric Nerve Stimulation Treatment Outcome *Vulvar Vestibulitis/th [Therapy] L1 - internal-pdf://2298155136/78 Murina 2008.pdf N1 - Murina, F Bianco, V Radici, G Felice, R Di Martino, M Nicolini, U RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2008 SN - 1471-0528 SP - 1165-1170 ST - Transcutaneous electrical nerve stimulation to treat vestibulodynia: a randomised controlled trial T2 - BJOG TI - Transcutaneous electrical nerve stimulation to treat vestibulodynia: a randomised controlled trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med7&AN=18715435http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:18715435&id=doi:10.1111%2Fj.1471-0528.2008.01803.x&issn=1470-0328&isbn=&volume=115&issue=9&spage=1165&pages=1165-70&date=2008&title=BJOG%3A+An+International+Journal+of+Obstetrics+%26+Gynaecology&atitle=Transcutaneous+electrical+nerve+stimulation+to+treat+vestibulodynia%3A+a+randomised+controlled+trial.&aulast=Murina https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/j.1471-0528.2008.01803.x?sid=vendor%3Adatabase VL - 115 ID - 15 ER - TY - JOUR AB - OBJECTIVE: To assess the effectiveness of vaginal diazepam in addition to transcutaneous electrical nerve stimulation (TENS) in the treatment of vestibulodynia (VBD). STUDY DESIGN: This study was a randomized, double-blind, placebo-controlled trial. Forty-two patients with VBD were randomized, 21 underwent diazepam and TENS (diazepam group) and 21 received placebo and TENS (placebo group). Vulvar pain was assessed on a on a 10-cm visual analogue scale (VAS) and dyspareunia according to the Marinoff dyspareunia scale. Vaginal surface electromyography (EMG) and vestibular current perception threshold (CPT) testing were performed at baseline and 60 days after treatment. The primary endpoints included the change in pain and dyspareunia from baseline to 60 days of pain and dyspareunia. The secondary endpoints was the variation in objectivity of pelvic floor muscle (PFM) function and vestibular nerve fiber current perception threshold (CPT). RESULTS: The VAS scores for pain from basal values of 7.5 and 7.2 for the diazepam and placebo, respectively, showed significant (p0.01) decreases from 4.7 to 4.3, but this difference was not statistically significant. The Marinoff dyspareunia scores in the diazepam group showed a significant difference (p 0.05) from values measured in the placebo group. The ability to relax the PFM after contraction (difference between maximal contraction and rest tone) was significantly greater for the diazepam group versus the placebo group (3.8 muv and 2.4 muv, respectively, p0.01). The CPT values for all of the nerve fibers increased after the treatment, but this increase was significant in the diazepam group only for the values at a 5-Hz stimulation (C fibers) with a change of 47.8% vs 26.9% (p<0.05). Only two patients reported a mild drowsiness in the diazepam group. CONCLUSIONS: The present study provided indications that vaginal diazepam plus TENS is useful to improve pain and PFM instability in women with VBD. AN - 29960200 AU - Murina, F. AU - Felice, R. AU - Di Francesco, S. AU - Oneda, S. DO - 10.1016/j.ejogrb.2018.06.026 KW - Administration, Intravaginal Adult Combined Modality Therapy *Diazepam/ad [Administration & Dosage] Double-Blind Method Female Humans *Muscle Relaxants, Central/ad [Administration & Dosage] Pregnancy *Transcutaneous Electric Nerve Stimulation *Vulvodynia/th [Therapy] Young Adult 0 (Muscle Relaxants, Central) Q3JTX2Q7TU (Diazepam) Diazepam L1 - internal-pdf://2851147920/104 Murina 2018.pdf N1 - Murina, Filippo Felice, Raffaele Di Francesco, Stefania Oneda, Silvia S0301-2115(18)30313-0 RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2018 SN - 1872-7654 SP - 148-153 ST - Vaginal diazepam plus transcutaneous electrical nerve stimulation to treat vestibulodynia: A randomized controlled trial T2 - Eur J Obstet Gynecol Reprod Biol TI - Vaginal diazepam plus transcutaneous electrical nerve stimulation to treat vestibulodynia: A randomized controlled trial UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med15&AN=29960200http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:29960200&id=doi:10.1016%2Fj.ejogrb.2018.06.026&issn=0301-2115&isbn=&volume=228&issue=&spage=148&pages=148-153&date=2018&title=European+Journal+of+Obstetrics%2C+Gynecology%2C+%26+Reproductive+Biology&atitle=Vaginal+diazepam+plus+transcutaneous+electrical+nerve+stimulation+to+treat+vestibulodynia%3A+A+randomized+controlled+trial.&aulast=Murina VL - 228 ID - 18 ER - TY - JOUR AB - OBJECTIVE: The study aimed to assess the effect of palmitoylethanolamide + transpolydatin combination in patients with vestibulodynia undergoing transcutaneous electrical nerve stimulation (TENS) therapy and to confirm the effectiveness of TENS also in a domiciliary protocol. The study is based on the premise that palmitoylethanolamide + transpolydatin combination may contribute to a down-regulation of mast cell hyperactivity, which is believed to be responsible for the proliferation and sprouting of vestibular pain fibers and the associated hyperalgesia and allodynia. MATERIALS AND METHODS: Twenty women with vestibulodynia were randomly assigned to receive oral palmitoylethanolamide (PEA) 400 mg and transpolydatin 40 mg or placebo, twice daily for 60 days. All patients underwent TENS therapy in a self-administered home protocol. Visual analogue scale (VAS), Marinoff score for dyspareunia, and current perception threshold obtained from the vulvar vestibule were assessed at baseline and at the end of treatment. RESULTS: The patients received a mean of 26.7 TENS sessions. All scores in the 2 groups improved significantly, although the level of improvement was similar between the groups (VAS, p < .57; dyspareunia, p < .38). Nevertheless, the analysis of regression of symptoms related to the duration of disease revealed the therapy to be more effective when PEA + transpolydatin is included in cases with more recent disease onset, as compared with the placebo group (PEA: VAS, p < .01; dyspareunia, p < .01) (placebo: VAS, p = nonsignificant; dyspareunia, p = nonsignificant). CONCLUSIONS: This study confirms that TENS is of significant benefit in the management of vestibulodynia, also in a home environment. PEA + transpolydatin can be a value-added treatment adjunct when the onset of vestibulodynia is more recent or when the disease relapses. AN - 23343704 AU - Murina, F. AU - Graziottin, A. AU - Felice, R. AU - Radici, G. AU - Tognocchi, C. DO - 10.1097/LGT.0b013e3182652316 IS - 2 KW - Administration, Oral Adolescent Adult *Analgesics/ad [Administration & Dosage] *Drug Synergism *Endocannabinoids/ad [Administration & Dosage] *Ethanolamines/ad [Administration & Dosage] Female *Glucosides/ad [Administration & Dosage] Humans Middle Aged *Palmitic Acids/ad [Administration & Dosage] Placebos/ad [Administration & Dosage] *Stilbenes/ad [Administration & Dosage] *Transcutaneous Electric Nerve Stimulation/mt [Methods] Treatment Outcome *Vulvodynia/dt [Drug Therapy] Young Adult 0 (Analgesics) 0 (Endocannabinoids) 0 (Ethanolamines) 0 (Glucosides) 0 (Palmitic Acids) 0 (Placebos) 0 (Stilbenes) 6R8T1UDM3V (palmidrol) XM261C37CQ (polydatin) L1 - internal-pdf://0712380560/105 Murina 2013.pdf N1 - Murina, Filippo Graziottin, Alessandra Felice, Raffaele Radici, Gianluigi Tognocchi, Cinzia RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} | RAYYAN-LABELS: ? PY - 2013 SN - 1526-0976 SP - 111-116 ST - Vestibulodynia: synergy between palmitoylethanolamide + transpolydatin and transcutaneous electrical nerve stimulation T2 - J Low Genit Tract Dis TI - Vestibulodynia: synergy between palmitoylethanolamide + transpolydatin and transcutaneous electrical nerve stimulation UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med10&AN=23343704http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:23343704&id=doi:10.1097%2FLGT.0b013e3182652316&issn=1089-2591&isbn=&volume=17&issue=2&spage=111&pages=111-6&date=2013&title=Journal+of+Lower+Genital+Tract+Disease&atitle=Vestibulodynia%3A+synergy+between+palmitoylethanolamide+%2B+transpolydatin+and+transcutaneous+electrical+nerve+stimulation.&aulast=Murina VL - 17 ID - 19 ER - TY - GEN AN - NCT03844412 AU - Nackley, A. CY - Duke University Eunice Kennedy Shriver National Institute of Child Health Human Development DA - November 4 KW - Vestibulodynia|Temporomandibular Disorder|Fibromyalgia Syndrome|Irritable Bowel Syndrome|Migraines|Tension Headache|Endometriosis|Interstitial Cystitis|Back Pain|Chronic Fatigue Syndrome N1 - No Results Available Drug: 5% lidocaine/5 mg/ml 0.02% estradiol compound cream|Drug: Nortriptyline|Drug: Placebo cream|Drug: Placebo pill Change in pain score during the tampon test|Change in self-reported pain via the Short Form- McGill Pain Questionnaire (SF-MPQ)|Change in self-reported physical/mental health via SF-12 Health Survey (SF12v2)|Change in sexual health via Patient-Reported Outcomes Measurement Information System (PROMIS)|Change in inflammation as measured by cytokine expression levels|Change in regulators of pro-pain and pro-inflammatory genes, as measured by microRNA expression levels|Change in pain level as measured by Vaginal Vestibule Pressure Pain Intensities (PPI)|Levator Muscle Complex Pressure Pain Thresholds (PPTs)|Change in pain level as measured by Remote Bodily PPTs|Change in degree of overlapping pain, as measured by COPC follow-up survey|Change in mood as measured by the Symptom Checklist-27 (SCL-27)|Change in somatic awareness via Pennebaker Index of Limbic Languidness (PILL)|Change in perceived stress via Perceived Stress Scale (PSS)|Change in sleep as measured by the sleep scale|Change in in pain score during the tampon test at other time points|Change in in pain score via the SF-MPQ at other time points|Change in self-reported health on the SF12v2 at other time points|Change in self-reported health on the PROMIS at other time points|Change in cytokine biomarkers at other time points|Change in microRNA biomarkers at other time points Female Phase 2 400 Other|NIH Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment Pro00100678|1R01HD096331-01 December 1, 2023 PB - Available from: https://ClinicalTrials.gov/show/NCT03844412 PY - 2019 ST - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments TI - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments ID - 43 ER - TY - GEN AN - NCT04016467 AU - Nelson, P. CY - University of Mary Hardin-Baylor Integrity Rehab Home Health DA - May 10 KW - Vulvodynia|Perineal Pain|Vulvar Pain N1 - No Results Available Other: Thoracic manipulation|Other: Sham thoracic treatment Change in Numeric Pain Rating Scale (NPRS) (0=none to 10=worst) report to cotton swab test in clock pattern|Change in peak pressure algometer Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Basic Science 6.7.2018 June 2021 PB - Available from: https://ClinicalTrials.gov/show/NCT04016467 PY - 2019 ST - SpManipPP TI - Effect of Spinal Manipulation on Vulvar Pain ID - 42 ER - TY - JOUR AB - OBJECTIVE: Patients with chronic idiopathic vulvar vestibulitis have increased mast cells when biopsied, and cromolyn has been suggested as a treatment. The purpose of this study was to assess the efficacy of 4% cromolyn cream in women with vulvar vestibulitis. METHODS: A prospective, double blind, randomised, placebo controlled study was initiated at two centres. Patients with vulvar vestibulitis were assigned to apply cromolyn or placebo cream to the vestibule. Symptoms (burning, irritation) and signs (erythema, extent of erythema, tenderness) were recorded on a 0-3 scale. In the sexually active patient subgroup, dyspareunia was also evaluated. RESULTS: 13 of the 26 evaluable patients received cromolyn. Patients in the cromolyn arm were more likely to have failed therapy with amitriptyline (p = 0.05), but the two groups were otherwise similar upon study entry. Overall, scores decreased from a median of 9 to 5 (p = 0.001) during the study, but the level of improvement was similar between both groups. Improvement was unrelated to duration of symptoms, fluconazole use, or sexual activity. Five patients (38%) taking cromolyn and six (46%) taking placebo felt they had a 50% or greater reduction in symptoms. In the 21 sexually active patients, the total score decreased from a mean of 12 to 8 (p = 0.005), but there was no statistically significant difference between study arms. CONCLUSIONS: Cromolyn cream did not confer a significant benefit in patients with vulvar vestibulitis. The large placebo response suggests the need for large well controlled studies of other treatment modalities. AN - 11158692 AU - Nyirjesy, P. AU - Sobel, J. D. AU - Weitz, M. V. AU - Leaman, D. J. AU - Small, M. J. AU - Gelone, S. P. DO - 10.1136/sti.77.1.53 IS - 1 KW - Adult Chronic Disease *Cromolyn Sodium/tu [Therapeutic Use] Double-Blind Method Female Humans Mast Cells/de [Drug Effects] Middle Aged Prospective Studies Treatment Failure *Vulvitis/dt [Drug Therapy] Vulvitis/im [Immunology] Q2WXR1I0PK (Cromolyn Sodium) Cromolyn Sodium L1 - internal-pdf://3686600879/Nyirjesy-2001-Cromolyn cream for recalcitrant.pdf N1 - Nyirjesy, P Sobel, J D Weitz, M V Leaman, D J Small, M J Gelone, S P RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2001 SN - 1368-4973 SP - 53-57 ST - Cromolyn cream for recalcitrant idiopathic vulvar vestibulitis: results of a placebo controlled study T2 - Sex Transm Infect TI - Cromolyn cream for recalcitrant idiopathic vulvar vestibulitis: results of a placebo controlled study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med4&AN=11158692http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:11158692&id=doi:10.1136%2Fsti.77.1.53&issn=1368-4973&isbn=&volume=77&issue=1&spage=53&pages=53-7&date=2001&title=Sexually+Transmitted+Infections&atitle=Cromolyn+cream+for+recalcitrant+idiopathic+vulvar+vestibulitis%3A+results+of+a+placebo+controlled+study.&aulast=Nyirjesy https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1758319/pdf/v077p00053.pdf VL - 77 ID - 29 ER - TY - GEN AN - NCT02858219 AU - Pelletier, F. CY - Centre Hospitalier Universitaire de Besancon DA - May 4 KW - Vestibulodynia N1 - No Results Available Drug: Botulinum Toxin Type A|Other: Saline solution|Other: Indexes Pain improvement Female Phase 3 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment API/2011/20 February 11, 2019 PB - Available from: https://ClinicalTrials.gov/show/NCT02858219 PY - 2010 ST - vestibule TI - A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia ID - 51 ER - TY - JOUR AB - INTRODUCTION: Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat. AIM: This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia. METHODS: Sixty-four women were randomized to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline. MAIN OUTCOME MEASURES: Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36). RESULTS: Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly pain reduction (P < 0.001). There was no significant difference in the median VAS score between the groups at 6 months follow up (P = 0.984). An improvement on the FSFI full score from baseline until 6 months was not significantly different between the groups (P = 0.635). In the placebo group a statistical significant larger reduction in sexual distress was observed from baseline until 6 months follow up compared to the Botox group (P = 0.044). No statistical significant differences were observed between the B- and P-groups in regard to the SF-36 scores. CONCLUSION: Injection of 20 I.E. Botox in the vestibule of women diagnosed with vestibulodynia does not reduce pain, improve sexual functioning, or impact the quality of life compared to placebo and evaluated at 3 and 6 moths follow up. Both the Botox group and the placebo groups experienced a reduction in pain on the VAS Likert scale at 6 months follow up. Women with vestibulodynia have difficulty with sexual function and present with sexual distress, which has to be addressed in conjunction with pain to eliminate the disorder. AN - 19619148 AU - Petersen, C. D. AU - Giraldi, A. AU - Lundvall, L. AU - Kristensen, E. DO - 10.1111/j.1743-6109.2009.01378.x IS - 9 KW - Adaptation, Psychological Adult *Botulinum Toxins, Type A/tu [Therapeutic Use] Double-Blind Method Female Health Status Indicators Humans Logistic Models Multivariate Analysis *Neurotoxins/tu [Therapeutic Use] Pain Measurement Psychometrics Risk Factors *Sexual Dysfunction, Physiological/dt [Drug Therapy] Sexuality Stress, Psychological Surveys and Questionnaires *Vulvodynia/dt [Drug Therapy] 0 (Neurotoxins) Botulinum Toxins, Type A Botulinum Toxins L1 - internal-pdf://0599068800/79 Petersen 2009.pdf N1 - Petersen, Christina Damsted Giraldi, Annamaria Lundvall, Lene Kristensen, Ellids RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 2009 SN - 1743-6109 SP - 2523-2537 ST - Botulinum toxin type A-a novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study T2 - J Sex Med TI - Botulinum toxin type A-a novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med7&AN=19619148http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:19619148&id=doi:10.1111%2Fj.1743-6109.2009.01378.x&issn=1743-6095&isbn=&volume=6&issue=9&spage=2523&pages=2523-37&date=2009&title=Journal+of+Sexual+Medicine&atitle=Botulinum+toxin+type+A-a+novel+treatment+for+provoked+vestibulodynia%3F+Results+from+a+randomized%2C+placebo+controlled%2C+double+blinded+study.&aulast=Petersen https://www.jsm.jsexmed.org/article/S1743-6095(15)32637-0/fulltext VL - 6 ID - 16 ER - TY - GEN AN - NCT00853229 AU - Ridgeway, B.M. CY - The Cleveland Clinic DA - February KW - Vulvodynia|Vulvar Vestibulitis N1 - Has Results Drug: pregabalin Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)|Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10) Female Phase 2 16 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment CCF 08-195 April 2013 PB - Available from: https://ClinicalTrials.gov/show/NCT00853229 PY - 2009 ST - Pregabalin for the Treatment of Vulvodynia TI - Pregabalin for the Treatment of Vulvodynia ID - 58 ER - TY - GEN AN - NCT00450242 AU - Rohl, J. CY - University of North Carolina, Chapel Hill DA - December KW - Vulvar Vestibulitis N1 - Has Results Drug: 5% topical lidocaine ointment|Drug: Placebo cream Number of Participants Who Report the Ability to Have Intercourse|Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8|SF-12 Quality of Life Scores|Modified Gracely Pain Scale Female Phase 2 14 Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 05-2332 January 2009 PB - Available from: https://ClinicalTrials.gov/show/NCT00450242 PY - 2006 ST - 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis TI - 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis ID - 60 ER - TY - GEN AN - NCT03364127 AU - Schlaeger, J. M. CY - University of Illinois at Chicago University of Florida DA - February 23 KW - Vulvodynia|Vulvodynia, Generalized|Vulvar Vestibulitis N1 - No Results Available Other: Active Acupuncture|Other: Placebo Acupuncture Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS).|Dyspareunia Subscale of the Female Sexual Function Index (FSFI)|Total score of the Female Sexual Function Index (FSFI) Female Not Applicable 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2017-0885 November 7, 2022 PB - Available from: https://ClinicalTrials.gov/show/NCT03364127 PY - 2018 ST - Effect of Acupuncture on Patient Vulvodynia Outcomes TI - Effect of Acupuncture on Patient Vulvodynia Outcomes ID - 50 ER - TY - GEN AN - NCT03598777 AU - Simon, J.A. CY - Ipsen DA - June 11 KW - Vulvodynia N1 - Has Results Biological: Botulinum toxin type A|Drug: Placebo Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)|Mean Change From Baseline in Vaginal Dilator Induced Pain During the DB Treatment Period at Week 6 (Stage 2)|Mean Change From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point Numeric Rating Scale (NRS) During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 50% Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 30% Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 2-point Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in the Composite Score for the Vaginal Dilator Induced Pain and Dilator Size During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 50% Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 30% Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 2-point Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in Pain During Intercourse as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in the Number of Intercourse Instances in Participants With Partners During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 Female Phase 2 60 Industry Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment D-FR-52120-236 January 21, 2021 PB - Available from: https://ClinicalTrials.gov/show/NCT03598777 PY - 2018 ST - dyvinia TI - Dysport in Vulvodynia Phase II Study ID - 45 ER - TY - GEN AN - NCT04711369 AU - Trutnovsk, G. CY - Medical University of Graz DA - January 15 KW - Vulvodynia N1 - No Results Available Device: Erbium:Yag laser|Device: Sham Erbium:Yag laser Change of Vestibular pain index|Change of pelvic floor muscle (PFM) function- PFM contraction strength|Change of pelvic floor muscle (PFM) function- PFM tone|Change of levator hiatal dimensions at rest|Change of levator hiatal dimensions at maximal voluntary contraction|Change of levator hiatal dimensions at maximal Valsalva maneuver|Change of Vaginal health score index (VHSI)|Change of Sexual activity|Change of Sexual Function|Change in Endometriosis Health Profile (EHP-30)|Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)|Change in Patient Health Questionnaire (PHQ-D)|Change in Pain sensitivity questionnaire (PSQ)|Change in Patient Global Impression of Improvement (PGI-I)|Change in Patient treatment satisfaction|Change in Treatment discomfort|Change in Treatment pain Female Not Applicable 92 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 32-187 ex 19/20 December 30, 2023 PB - Available from: https://ClinicalTrials.gov/show/NCT04711369 PY - 2021 ST - Lydia TI - Lasertherapy for Vulvodynia ID - 37 ER - TY - JOUR AB - This article describes the outcome of a behavioral approach with or without preceding surgical intervention in 48 women with the vulvar vestibulitis syndrome. In the first part of the study, 14 women with the vulvar vestibulitis syndrome were randomly assigned to one of two treatment programs: either a behavioral approach or a behavioral approach preceded by surgery. In the second part of the study, 34 women and their partners were given a choice of treatment. Follow-up data were gathered a mean of 3 and 2 1/2 years after treatment, respectively. In the randomized patient population, the intervention had a positive effect on all of them: the complaints disappeared, diminished or did not change but formed less of a problem. The difference in outcome between the two different treatments, a behavioral approach with or without preceding surgery, was not statistically significant. In the second non-randomized part of the study, 28 out of the 34 women (82%) chose the behavioral approach without preceding surgery. The difference in outcome between the two treatments was not statistically significant. Two out of the 28 women who chose behavioral treatment without preceding surgery had to be referred for psychiatric consultation because of serious psycho-sexual problems. In one woman, psychiatric treatment was successful. Three other women, whose behavioral treatment failed, underwent additional surgery, which clearly helped them to overcome the deadlock in the behavioral approach. The behavioral approach should be the first choice of treatment for the vulvar vestibulitis syndrome. Surgical intervention should be considered as an additional form of treatment in some cases with the vulvar vestibulitis syndrome to facilitate breaking the vicious circle of irritation, pelvic floor muscle hypertonia and sexual maladaptive behavior. AN - 8892160 AU - Weijmar Schultz, W. C. AU - Gianotten, W. L. AU - van der Meijden, W. I. AU - van de Wiel, H. B. AU - Blindeman, L. AU - Chadha, S. AU - Drogendijk, A. C. DO - 10.3109/01674829609025675 IS - 3 KW - Adolescent Adult *Behavior Therapy/mt [Methods] Choice Behavior Dyspareunia/px [Psychology] *Dyspareunia/th [Therapy] Female Humans Male Prospective Studies Spouses/px [Psychology] Syndrome Treatment Outcome Vulvitis/px [Psychology] *Vulvitis/th [Therapy] L1 - internal-pdf://3971748015/56-Weijmar Schultz-1996.pdf N1 - Weijmar Schultz, W C Gianotten, W L van der Meijden, W I van de Wiel, H B Blindeman, L Chadha, S Drogendijk, A C RAYYAN-INCLUSION: {"Per "=>"Included", "Karin"=>"Included"} PY - 1996 SN - 0167-482X SP - 143-148 ST - Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome: a prospective randomized and non-randomized study T2 - J Psychosom Obstet Gynaecol TI - Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome: a prospective randomized and non-randomized study UR - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med4&AN=8892160http://sfxeu06.hosted.exlibrisgroup.com/sbu?sid=OVID:medline&id=pmid:8892160&id=doi:10.3109%2F01674829609025675&issn=0167-482X&isbn=&volume=17&issue=3&spage=143&pages=143-8&date=1996&title=Journal+of+Psychosomatic+Obstetrics+%26+Gynecology&atitle=Behavioral+approach+with+or+without+surgical+intervention+to+the+vulvar+vestibulitis+syndrome%3A+a+prospective+randomized+and+non-randomized+study.&aulast=Weijmar+Schultz VL - 17 ID - 33 ER - TY - GEN AN - NCT01747161 AU - Weyers, S. CY - University Hospital, Ghent DA - December 17 KW - Localized Provoked Vulvodynia N1 - No Results Available Drug: Botulin toxin|Drug: physiological water to evaluate the efficacy and safety of botulin toxin in alleviating dyspareunia associated with localized provoked vulvodynia. Female Phase 2 5 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2012/445 June 19, 2018 PB - Available from: https://ClinicalTrials.gov/show/NCT01747161 PY - 2013 ST - vvs-01 TI - Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia ID - 54 ER - TY - GEN AN - NCT04613713 AU - Wojniusz, S. CY - Oslo Metropolitan University DA - January 1 KW - Vulvodynia|Vestibulodynia N1 - No Results Available Other: Somatocognitive physiotherapy|Other: Treatment as usual Change in female sexual function index (FSFI) (Rosen et al. 2000)|Change in Participant Perceived Improvement (PGIC) (Dworkin et al. 2005)|Change in the tampon test (Foster et al. 2009)|Change in recalled pain intensity during intercourse|Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - life interference|Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - coping strategies|Change in vulvodynia related self-efficacy|Change in pain catastrophizing scale (Fernandes et al. 2012)|Change in Rumination Response Scale (RRS-10) (Parola et al. 2017)|Change in Hopkins Symptoms Check List (HSCL-25) (Derogatis et al.1974)|Change in EQ-5D-5L (Herdman et al. 2011) Female Not Applicable 128 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 29295 December 31, 2025 PB - Available from: https://ClinicalTrials.gov/show/NCT04613713 PY - 2021 ST - ProLoVe TI - Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study) ID - 38 ER -