High-level Laser for Provoked Vestibulodynia

NCT04502810 | Completed

• 1 other identifier: #2020-3535
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia

Keywords

Laser; Provoked vestibulodynia; Pain; Sexual dysfunctions

Outcome Measures

Primary Outcomes (8)

• Adherence rate

  To determine acceptability by assessing adherence to treatment sessions

  2-week post-treatment evaluation

• Level of satisfaction with the treatment

  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)

  2-week post-treatment evaluation

• Willingness to recommend the treatment

  To determine acceptability by assessing whether the participant would recommend the treatment.

  2-week post-treatment evaluation

• Rate of adverse events

  To document any adverse events.

  2-week post-treatment evaluation

• Blinding effectiveness

  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? ''

  2-week post-treatment evaluation

• Recruitment rate

  To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion

  Baseline to 2-week post-treatment evaluation

• Completion and dropout rates

  To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.

  2-week post-treatment evaluation

• Completeness of data

  To examine the percentage of completed outcome measures.

  Baseline to 2-week post-treatment evaluation

Secondary Outcomes (9)

• Change in pain intensity during intercourse

  Baseline to 2-week post-treatment evaluation

• Change in sexual function

  Baseline to 2-week post-treatment evaluation

• Change in sexual distress

  Baseline to 2-week post-treatment evaluation

• Change in pain quality

  Baseline to 2-week post-treatment evaluation

• Patient's global impression of change

  Baseline to 2-week post-treatment evaluation

Study Arms (2)

High-level laser therapy

EXPERIMENTAL

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

Radiation: High-level laser therapy

Sham High-level laser therapy

SHAM COMPARATOR

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

Radiation: High-level laser therapy

Interventions

High-level laser therapy RADIATION

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

Also known as: Nd:Yag laser

High-level laser therapy; Sham High-level 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) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• Exogenia: collaborator

Study Sites (1)

Centre hospitalier Universitaire de Sherbroke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Vulvodynia; Pain

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Associate Professor

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

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 6, 2020
• Study Start: August 1, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)