Efficacy of High Intensity Laser for Provoked Vestibulodynia

NCT05597358 | Active Not Recruiting DMC

• 1 other identifier: MP-31-2023-4770
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 4

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).

Conditions

Vulvodynia

Keywords

Laser; Provoked vestibulodynia; Pain; Sexual dysfunctions

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity during intercourse

  To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)

  Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

Secondary Outcomes (10)

• Change in pain quality

  Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

• Change in sexual function

  Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

• Change in sexual distress

  Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

• Change in pain catastrophizing

  Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

• Change in fear of pain

  Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

Study Arms (2)

High Intensity Laser Therapy (HILT)

ACTIVE COMPARATOR

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

Radiation: High Intensity Laser Therapy (HILT)

Sham High Intensity Laser Therapy

SHAM COMPARATOR

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

Radiation: Sham High Intensity Laser Therapy

Interventions

High Intensity Laser Therapy (HILT) RADIATION

Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.

Also known as: Nd:Yag laser

High Intensity Laser Therapy (HILT)

Sham High Intensity Laser Therapy RADIATION

Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.

Also known as: Sham, Control, Deactivated probe

Sham High Intensity Laser Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• Exogenia: collaborator
• CHU de Quebec-Universite Laval: collaborator
• Kinatex l'Ormière: collaborator

Study Sites (4)

Centre Hospitalier Universitaire de Québec - Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Kinatex l'Ormière

Québec, Quebec, G2B 3K3, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Exogenia

Sherbrooke, Quebec, J1L 1C6, Canada

Location

MeSH Terms

Conditions

Vulvodynia; Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mélanie Morin, PT, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, outcomes assessors and data analysts will be masked to group assignation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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)

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 28, 2022
• Study Start: October 26, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CA (4)