Efficacy of High Intensity Laser for Provoked Vestibulodynia

Vulvodynia Clinical Trial

— Laser_RCT  

Official title:

Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597358
• Other study ID #: MP-31-2023-4770
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: March 2024
• Source: Université de Sherbrooke
• Contact: Camille Simard, MSc
• Phone: 819-821-8000
• Email: labomorin[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Vestibulitis
• Vulvodynia

Intervention

Radiation:
• High Intensity Laser Therapy (HILT)
Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.
• Sham High Intensity Laser Therapy
Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Québec - Université Laval	Québec
Canada	Kinatex l'Ormière	Québec
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Exogenia	Sherbrooke	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, CHU de Quebec-Universite Laval, Exogenia, Kinatex l'Ormière

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain quality	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).	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in sexual function	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).	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in sexual distress	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).	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in pain catastrophizing	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).	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in fear of pain	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).	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in cognitions regarding vaginal penetration	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.	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in the life impact of pelvic pain	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.	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Change in intercourse self-efficacy	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.	Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Level of satisfaction with treatment	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).	2-week post-treatment evaluation, 6-months follow-up assessment
Secondary	Patient's global impression of change	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.	2-week post-treatment evaluation, 6-months follow-up assessment