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ACTIVE NOT RECRUITING
NCT05597358
NA

Efficacy of High Intensity Laser for Provoked Vestibulodynia

Sponsor: Université de Sherbrooke

View on ClinicalTrials.gov

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

RADIATION

High Intensity Laser Therapy (HILT)

Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.

RADIATION

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