NCT05597358

Efficacy of High Intensity Laser for Provoked Vestibulodynia

Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women with Provoked Vestibulodynia: a Multicenter Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled trial.

Conditions

• Vulvodynia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-26
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2022-10-28
• Last updated: 2025-02-24

Locations

4 sites across 1 country: Canada