Status:
COMPLETED
Feasibility Study for Provoked Vestibulodynia
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Conditions:
Vestibulodynia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The feasibility and acceptability of a somatosensory rehabilitation program and an educational pain management program will be investigated in women with provoked vestibulodynia. Forty-four women will...
Eligibility Criteria
Inclusion
- Diagnosis of provoked vestibulodynia according to a standardized gynaecologic exam
- Moderate to severe pain (≥5/10) located in the vulvar vestibule for at least 90% of vaginal penetrations or attempted vaginal penetrations or activities with pressure on the vagina for at least 3 months
Exclusion
- Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Prior vulvo-vaginal surgery or radiotherapy
- Post-menopausal status
- Participant refusal to not use other treatments for the provoked vestibulodynia during the entire study (until 3 months post-treatment);
- Other urogynecological condition (e.g. pelvic organs prolapse ≥3, current urinary/vaginal infection or in the last 3 months)
- Prior use of Somatosensory Rehabilitation Program or Educational Pain Management Program
- Current or past pregnancy in the last year;
- Changes of medication that could influence pain perception (e.g. analgesic, antidepressant) in the last 3 months
- Major psychological condition (e.g. depressive symptoms, anxiety) which can present a security issue for the participant
- Other medical conditions that could interfere with the study
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05342402
Start Date
May 16 2022
End Date
July 31 2023
Last Update
September 28 2023
Active Locations (1)
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1
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4