Clinical trial NCT05597358: Efficacy of High Intensity Laser for Provoked Vestibulodynia
Official title: Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women with Provoked Vestibulodynia: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vulvodynia
Keywords: Laser
Provoked vestibulodynia
Pain
Sexual dysfunctions
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Exogenia
name: CHU de Quebec-Universite Laval
name: Kinatex l'Ormière
First posted: 2022-10-28
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Baseline evaluation
* Randomization to active laser or sham laser (12 sessions in 6 consecutive weeks) Post-treatment evaluation (2 weeks post-treatment)
* Follow-up evaluation (6 months post-treatment)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity during intercourse
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary outcomes:
measure: Change in pain quality
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in sexual function
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in sexual distress
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in pain catastrophizing
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in fear of pain
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in cognitions regarding vaginal penetration
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in the life impact of pelvic pain
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Change in intercourse self-efficacy
timeFrame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Level of satisfaction with treatment
timeFrame: 2-week post-treatment evaluation, 6-months follow-up assessment
measure: Patient's global impression of change
timeFrame: 2-week post-treatment evaluation, 6-months follow-up assessment
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec - Université Laval
state: Quebec
city: Québec
country: Canada
facility: Kinatex l'Ormière
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Sherbrooke
country: Canada
facility: Exogenia
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Mélanie Morin, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: