High-level Laser for Provoked Vestibulodynia

Université de Sherbrooke

Status: Completed

Conditions: Vulvodynia

Treatments: Radiation: High-level laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04502810

#2020-3535

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups

High-level laser therapy

Experimental group

Description:

Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Treatment:

Radiation: High-level laser therapy

Sham High-level laser therapy

Sham Comparator group

Description:

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

Treatment:

Radiation: High-level laser therapy