Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Study Overview
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Brief Summary
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Chronic gynaecological pain is a major medical problem that affects 20-30% of women at different moments of their life. This largely neglected issue has a significant impact on the sexual and conjugal life of women suffering from it as well as on their psychological health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally ignored. Also, treatment is limited and not extensively studied. This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital, Royal-Victoria Hospital, CHUM St-Luc).

Detailed Description
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This is a randomised controlled trial comparing the impact of multimodal physiotherapy treatments to topical lidocaine in women suffering from provoked vestibulodyina. The first treatment consists of 10 sixty minutes weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises. The second treatment is a night time application of lidocaine to the vulva for 10 weeks. Physiotherapists will then evaluate women's pain and sexual function right after the treatment and 6 months later.

Official Title
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Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine

Conditions
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Vestibulodynia

Intervention / Treatment
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* Procedure: Multimodal physiotherapy
* Drug: lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe pain in at least 90% of sexual intercourses. Moderate to severe pain during the cotton-swab test at one of more vestibule regions (5/10 minimum pain evaluation on the verbal pain intensity scale). Pain limited to the vestibule during vaginal penetrations and during activities applying pressure on the vestibule. Provoked vestibulodynia lasting at least 6 months prior to the study and diagnosed by a standardised gynaecologic exam protocol by one of our collaborator. Exclusion Criteria: Major psychiatric condition or pelvic pathology associated with a genital pain problem (e.g.: dyspareunia). Use of medication that could influence pain perception. Actual or past pregnancy. Vulvar or vaginal surgery Post-menopausal state Unwillingness to restrain from other treatments till the 6 months post-treatment evaluation. Urogynaecologic symptoms (urinary/anal incontinence, pelvic organs prolapsus, urinary/vaginal infection active or during the last 3 months). Incapacity to have sexual intercourse including vaginal penetration during the last 6 months. Physiotherapy treatments or lidocaine application prior to the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>10 week treatment of daily application of topical lidocaine | Drug: lidocaine<br>* 10 weeks of daily topical 5% lidocaine application<br>* Other names: Xylocaine;|
| Experimental: Multimodal physiotherapy<br>10 weeks of weekly multimodal physiotherapy treatments | Procedure: Multimodal physiotherapy<br>* 10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain during intercourse | evaluated with a visual analog scale | before treatment, after treatment, 6 months after treatment | 
| Change in global sexual function | evaluated with the female sexual function index (FSFI) | before treatment, after treatment, 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain catastrophizing | evaluated using the pain catastrophizing scale | before treatment, after treatment, 6 months after treatment | 
| Change in psychologic distress | evaluated using the State-trait Anxiety Inventory (STAI) | before treatment, after treatment, 6 months after treatment | 
| Change in fear of pain | evaluated using the Pain Anxiety Symptoms Scale (PASS-20) | before treatment, after treatment, 6 months after treatment | 
| Change in vulvar blood circulation | evaluated using a doppler laser | before treatment, after treatment, 6 months after treatment | 
| Change in pelvic floor muscles function | evaluated using transperineal ultrasound and dynamometry | before treatment, after treatment, 6 months after treatment | 
| Change in pain sensitivity (pressure pain) | evaluated using a vulvagesiometer | before treatment, after treatment, 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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provoked vestibulodynia, multimodal physiotherapy, lidocaine