Status:
COMPLETED
Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Conditions:
Vestibulodynia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01455350
Start Date
October 1 2011
End Date
November 1 2015
Last Update
November 4 2016
Active Locations (2)
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1
University of Montreal
Montreal, Quebec, Canada, H3C 3T5
2
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4