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Efficacy of High Intensity Laser for Provoked Vestibulodynia

NCT05597358 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-02-24

No results posted yet for this study

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).

Conditions

  • Vulvodynia

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.

Sponsors & Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    collaborator OTHER

  • Exogenia

    collaborator UNKNOWN

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Kinatex l'Ormière

    collaborator UNKNOWN

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Mélanie Morin, PT, PhD · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2025-11-01
Completion
2025-11-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05597358 on ClinicalTrials.gov