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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05597358
Other study ID # MP-31-2023-4770
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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