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Vulvodynia clinical trials

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NCT ID: NCT02881229 Terminated - Vulvodynia Clinical Trials

Vulvar Mucosal Specialty Clinic Chart Review

Start date: April 2016
Phase:
Study type: Observational

This study aims to develop a clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in management of vulvar disease.

NCT ID: NCT02871661 Recruiting - Vulvodynia Clinical Trials

Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial

Start date: July 2016
Phase: Phase 3
Study type: Interventional

INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a negative impact over quality of life in women with this diagnose. The existing treatments, however, are manifold but insufficient. This study aims to verify the effectiveness of kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia. METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline), amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline hydrochloride associated with electrotherapy (interferential current). Exclusion criteria are: presence of infections or genital cancers, chronic degenerative diseases; younger than 18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and being pacemakers use. The parameters analyzed before and after treatment will be: muscle volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound, subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal intercourse, pain referred within vulvar touch on physical examination (swab test from zero to 10) and female sexual function (Female Sexual Function questionnaire - FSFI). There will be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal intercourse obtained by telephone contact with the voluntary on one, six and twelve months after the end of interventions. The data will be analyzed using Chi-square test of Pearson, Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the Wilcoxon test (related samples) and McNemar (effect of the intervention), considering statistical significance level of 5%. The software used is the statistical analysis software (SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical Package for the Social Sciences (SPSS) -Release 17.0.

NCT ID: NCT02858375 Completed - Vestibulodynia Clinical Trials

Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

QUALVESTO
Start date: March 2013
Phase: N/A
Study type: Observational

The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.

NCT ID: NCT02858219 Completed - Vestibulodynia Clinical Trials

A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia

VESTIBULE
Start date: May 4, 2010
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.

NCT ID: NCT02856334 Enrolling by invitation - Pelvic Pain Clinical Trials

Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain

Start date: January 2016
Phase: N/A
Study type: Observational

The purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.

NCT ID: NCT02854670 Terminated - Vestibulodynia Clinical Trials

A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia

CAPSIVU
Start date: January 20, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.

NCT ID: NCT02809612 Completed - Vulvodynia Clinical Trials

An Internet-based Information Platform for Vulvodynia Patients

EMBLA
Start date: March 2016
Phase: N/A
Study type: Interventional

Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.

NCT ID: NCT02773641 Completed - Vulvodynia Clinical Trials

Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

Start date: May 2016
Phase: Phase 3
Study type: Interventional

Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study is that for women with PVD who don't succeed to restore the function of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the high muscle tonus and thus possibly reduce the coital pain.

NCT ID: NCT02733172 Completed - Vulvodynia Clinical Trials

Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes

Vulvodynia
Start date: July 2013
Phase:
Study type: Observational

The investigators plan to extensively phenotype a large sample of Vulvodynia (VD) patients using functional and structural brain imaging together with genetic, physiological, and biological parameters.

NCT ID: NCT02732145 Completed - Vulvodynia Clinical Trials

Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis

DATRIV
Start date: December 2011
Phase: N/A
Study type: Interventional

The objective of the study was to determine sensitivity, specificity and diagnostic accuracy of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.