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Efficacy of High Intensity Laser for Provoked Vestibulodynia
Sponsor: Université de Sherbrooke
Summary
This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity laser therapy (HILT) (30 minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30 minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).
Official title: Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women with Provoked Vestibulodynia: a Multicenter Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2022-10-26
Completion Date
2025-11-01
Last Updated
2025-02-24
Healthy Volunteers
No
Conditions
Interventions
High Intensity Laser Therapy (HILT)
Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.
Sham High Intensity Laser Therapy
Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.
Locations (4)
Centre Hospitalier Universitaire de Québec - Université Laval
Québec, Quebec, Canada
Kinatex l'Ormière
Québec, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Exogenia
Sherbrooke, Quebec, Canada