NCT04502810

High-level Laser for Provoked Vestibulodynia

A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level 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. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.

Conditions

• Vulvodynia

Interventions

Type	Name	Description
RADIATION	High-level laser therapy	Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2020-08-06
• Last updated: 2022-02-10

Locations

1 site across 1 country: Canada