High-level Laser for Provoked Vestibulodynia

NCT ID: NCT04502810

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-05-04

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.

Conditions

Vulvodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High-level laser therapy

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

Group Type: EXPERIMENTAL

High-level laser therapy

Intervention Type: RADIATION

Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.

Sham High-level laser therapy

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

Group Type: SHAM_COMPARATOR

High-level laser therapy

Intervention Type: RADIATION

Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.

Interventions

High-level laser therapy

Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.

Intervention Type: RADIATION

Other Intervention Names

Nd:Yag laser

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: collaborator

Exogenia

UNKNOWN

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Mélanie Morin

Researcher and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mélanie Morin, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre hospitalier Universitaire de Sherbroke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

#2020-3535

Identifier Type: -

Identifier Source: org_study_id