Clinical trial NCT04502810: High-level Laser for Provoked Vestibulodynia
Official title: A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
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
First posted: 2020-08-06
Enrollment: 41
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 real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months
* Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
* Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam

Exclusion Criteria:

* Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
* Post-menopausal state
* Actual or past pregnancy in the last year
* Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
* Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses 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: Adherence rate
timeFrame: 2-week post-treatment evaluation
measure: Level of satisfaction with the treatment
timeFrame: 2-week post-treatment evaluation
measure: Willingness to recommend the treatment
timeFrame: 2-week post-treatment evaluation
measure: Rate of adverse events
timeFrame: 2-week post-treatment evaluation
measure: Blinding effectiveness
timeFrame: 2-week post-treatment evaluation
measure: Recruitment rate
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Completion and dropout rates
timeFrame: 2-week post-treatment evaluation
measure: Completeness of data
timeFrame: Baseline to 2-week post-treatment evaluation
Secondary outcomes:
measure: Change in pain intensity during intercourse
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in sexual function
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in sexual distress
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in pain quality
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Patient's global impression of change
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in fear of pain
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in pain catastrophization
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in vulvar pain sensitivity
timeFrame: Baseline to 2-week post-treatment evaluation
measure: Change in vulvar blood circulation
timeFrame: Baseline to 2-week post-treatment evaluation
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier Universitaire de Sherbroke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Mélanie Morin, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: