Efficacy of High Intensity Laser for Provoked Vestibulodynia (Laser_RCT)

Université de Sherbrooke

Status: Active, not recruiting

Conditions: Vulvodynia

Treatments: Radiation: Sham High Intensity Laser Therapy; Radiation: High Intensity Laser Therapy (HILT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05597358

MP-31-2023-4770

Details and patient eligibility

About

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).

Full 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.

Enrollment: 142 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups

High Intensity Laser Therapy (HILT)

Active Comparator group

Description:

Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Treatment:

Radiation: High Intensity Laser Therapy (HILT)

Sham High Intensity Laser Therapy

Sham Comparator group

Description:

Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Treatment:

Radiation: Sham High Intensity Laser Therapy