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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

NCT01455350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2016-11-04

No results posted yet for this study

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).

Conditions

  • Vestibulodynia

Interventions

PROCEDURE

Multimodal physiotherapy

10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.

DRUG

lidocaine

10 weeks of daily topical 5% lidocaine application

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Melanie Morin, Pht, Ph.D. · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455350 on ClinicalTrials.gov