Efficacy of High Intensity Laser for Provoked Vestibulodynia

Phase

N/A

Condition

N/A

Treatment

High Intensity Laser Therapy (HILT)

Sham High Intensity Laser Therapy

Clinical Study ID

NCT05597358

MP-31-2023-4770

Ages 18-45
Female

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourseor attempted sexual intercourse for at least 3 months
Provoked vestibulodynia of at least 3 months duration prior to the study anddiagnosed by a standardized gynaecologic exam

Exclusion

Exclusion Criteria:

Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not relatedto sexual intercourse/contact, dermatological condition, herpes, vulvovaginalatrophy)
Post-menopausal state
Current pregnancy or pregnancy in the last year
Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginalinfection active or in the last 3 months)
Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvicorgan 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

Study Design

High Intensity Laser Therapy (HILT)

October 26, 2022

November 01, 2025

Study 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.

Connect with a study center

Centre Hospitalier Universitaire de Québec - Université Laval
Québec, Quebec G1V 4G2
Canada
Site Not Available
Kinatex l'Ormière
Québec, Quebec G2B 3K3
Canada
Site Not Available
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec J1H 5N4
Canada
Site Not Available
Exogenia
Sherbrooke, Quebec J1L 1C6
Canada
Site Not Available

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