High-level Laser for Provoked Vestibulodynia

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT04502810

Collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other), Exogenia (Other)

Enrollment

Location

Arms

9.1

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvodynia	Radiation: High-level laser therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluationBaseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

May 4, 2021

Actual Study Completion Date :

May 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-level laser therapy Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)	Radiation: High-level laser therapy Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area. Other Names: Nd:Yag laser
Sham Comparator: Sham High-level laser therapy Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)	Radiation: High-level laser therapy Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area. Other Names: Nd:Yag laser

Arm

Intervention/Treatment

Experimental: High-level laser therapy

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

Radiation: High-level laser therapy

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

Other Names:

Nd:Yag laser

Sham Comparator: Sham High-level laser therapy

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

Radiation: High-level laser therapy

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

Other Names:

Nd:Yag laser

Outcome Measures

Primary Outcome Measures

Adherence rate [2-week post-treatment evaluation]
To determine acceptability by assessing adherence to treatment sessions
Level of satisfaction with the treatment [2-week post-treatment evaluation]
To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
Willingness to recommend the treatment [2-week post-treatment evaluation]
To determine acceptability by assessing whether the participant would recommend the treatment.
Rate of adverse events [2-week post-treatment evaluation]
To document any adverse events.
Blinding effectiveness [2-week post-treatment evaluation]
To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''
Recruitment rate [Baseline to 2-week post-treatment evaluation]
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Completion and dropout rates [2-week post-treatment evaluation]
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Completeness of data [Baseline to 2-week post-treatment evaluation]
To examine the percentage of completed outcome measures.

Secondary Outcome Measures

Change in pain intensity during intercourse [Baseline to 2-week post-treatment evaluation]
To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
Change in sexual function [Baseline to 2-week post-treatment evaluation]
To explore changes in sexual function (Female Sexual Function Index). Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function).
Change in sexual distress [Baseline to 2-week post-treatment evaluation]
To explore changes in sexual distress (Female Sexual Distress Scale ). Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress).
Change in pain quality [Baseline to 2-week post-treatment evaluation]
To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain).
Patient's global impression of change [Baseline to 2-week post-treatment evaluation]
To examine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
Change in fear of pain [Baseline to 2-week post-treatment evaluation]
To explore changes in fear of pain (Pain Anxiety Symptoms Scale (PASS-20)). Minimum value: 0, Maximum value: 100, higher scores mean worst outcome (higher fear of pain).
Change in pain catastrophization [Baseline to 2-week post-treatment evaluation]
To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)
Change in vulvar pain sensitivity [Baseline to 2-week post-treatment evaluation]
To explore changes in vulvar pain sensitivity (algometer)
Change in vulvar blood circulation [Baseline to 2-week post-treatment evaluation]
To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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