Status:
COMPLETED
High-level Laser for Provoked Vestibulodynia
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Exogenia
Conditions:
Vulvodynia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants w...
Eligibility Criteria
Inclusion
- Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months
- Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
- Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam
Exclusion
- Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Post-menopausal state
- Actual or past pregnancy in the last year
- Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
- Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses surgery)
- Prior use of laser treatments for vulvar pain
- Expected changes of medication that could influence pain perception (e.g. analgesic, antidepressant)
- Other medical conditions that could interfere with the study
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04502810
Start Date
August 1 2020
End Date
May 4 2021
Last Update
February 10 2022
Active Locations (1)
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1
Centre hospitalier Universitaire de Sherbroke
Sherbrooke, Quebec, Canada, J1H 5N4