Efficacy of High Intensity Laser for Provoked Vestibulodynia

Not Applicable

Recruiting

• Conditions: Vulvodynia
• Interventions: Radiation: High Intensity Laser Therapy (HILT); Radiation: Sham High Intensity Laser Therapy

• Registration Number: NCT05597358
• Lead Sponsor: Université de Sherbrooke

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study Start: 2022-10-26
• Study First Posted: 2022-10-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 142

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Laser Therapy (HILT)	High Intensity Laser Therapy (HILT)	Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Sham High Intensity Laser Therapy	Sham High Intensity Laser Therapy	Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Primary Outcome Measures

Name	Time	Method
Change in pain intensity during intercourse	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	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)

Secondary Outcome Measures

Name	Time	Method
Change in pain quality	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore changes in the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores indicate a worse outcome (higher pain).
Change in the life impact of pelvic pain	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore the change in the life impact of pelvic pain (Pelvic Pain Impact Questionnaire). Minimum value: 0, Maximum value: 32, higher scores indicate that the pelvic pain of the participants has a strong impact on their life.
Level of satisfaction with treatment	2-week post-treatment evaluation, 6-months follow-up assessment	To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
Patient's global impression of change	2-week post-treatment evaluation, 6-months follow-up assessment	To examine patient self-reported improvement (Patient's Global Impression of Change - PGIC) ranging from "very much worse" to "very much improved" on a 7-point scale.
Change in sexual distress	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher sexually-related distress).
Change in fear of pain	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore changes in fear of pain (Pain Anxiety Symptoms Scale - PASS-20). Minimum value: 0, Maximum value: 100, higher scores indicate a worse outcome (higher fear of pain).
Change in pain catastrophizing	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore changes in pain catastrophizing (Pain Catastrophizing Scale - PCS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher pain catastrophizing).
Change in sexual function	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore changes in sexual function (Female Sexual Function Index - FSFI). Minimum value: 2, Maximum value: 36, lower scores indicate a worse outcome (low sexual function).
Change in intercourse self-efficacy	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore the change self-efficacy regarding painful intercourse (Painful Intercourse Self-Efficacy Scale). Minimum value: 20, Maximum value: 100, higher scores indicate higher self-efficacy.
Change in cognitions regarding vaginal penetration	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment	To explore the cognitions of women towards vaginal penetration (Vaginal penetration cognition questionnaire (VPCQ)). Minimum value: 0, Maximum value: 240, higher scores show higher levels of perceived penetration control.

Trial Locations

Locations (4)

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Exogenia; 🇨🇦 Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Québec - Université Laval; 🇨🇦 Québec, Canada

Kinatex l'Ormière; 🇨🇦 Québec, Canada