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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Vestibulodynia Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01455350
Study type Interventional
Source Université de Sherbrooke
Contact
Status Completed
Phase N/A
Start date October 2011
Completion date November 2015
View Details
See also
  Status Clinical Trial Phase
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Terminated NCT01295268 - Study of Emu Oil vs. Placebo for Vulvar Pain in Women. N/A
Terminated NCT03682601 - Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment Phase 2
Withdrawn NCT03390049 - Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia N/A
Completed NCT00496184 - Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis Phase 3
Completed NCT03431779 - Lipofilling as a Treatment for Vestibulodynia N/A