CompletedNot Applicable

Efficacy of High Intensity Laser for Provoked Vestibulodynia

Canada145 participantsStarted 2022-10-26

Plain-language 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).

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months * Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam Exclusion Criteria: * Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy) * Post-menopausal state * Current pregnancy or pregnancy in the last year * Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months) * Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery) * Prior use of laser treatments for vulvar pain * Expected changes of medication that could influence pain perception (e.g., analgesic, antidepressant) * Other medical conditions that could interfere with the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested high intensity laser as a treatment for provoked vestibulodynia — is this something that's currently available or being offered outside of a research setting, and would it be appropriate to discuss for my situation?
2Since the trial is completed and was measuring changes in pain during intercourse, have the results been published yet, and what do they show about how much pain relief participants actually experienced?
3The trial was listed as 'Phase NA,' which often means it's an exploratory or device study rather than a traditional drug trial — what does that mean for how confident we can be in the safety and effectiveness of this laser treatment based on what's been studied so far?
4Are there standard treatments for provoked vestibulodynia — like pelvic floor physical therapy, topical medications, or other approaches — that I should try first before considering a newer procedure like high intensity laser?
5What would recovery or follow-up look like if I were to pursue a high intensity laser treatment similar to what was studied in this trial, and how many sessions or visits would typically be involved?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain intensity during intercourse

Timeframe: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

Trial details

NCT IDNCT05597358

SponsorUniversité de Sherbrooke

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-16

View on ClinicalTrials.gov More Vulvodynia trials