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Completed

NCT Number: NCT05597358

Efficacy of High Intensity Laser for Provoked Vestibulodynia

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).

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Vulvar Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Laser Therapy (HILT)

Radiation

Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.

Other names: Nd:Yag laser

Sham High Intensity Laser Therapy

Radiation

Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.

Other names: Sham, Control, Deactivated probe

Primary outcomes

  1. Change in pain intensity during intercourse

    Time frame: 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 outcomes

  1. Change in pain quality

    Time frame: 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).

  2. Change in sexual function

    Time frame: 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).

  3. Change in sexual distress

    Time frame: 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).

  4. Change in pain catastrophizing

    Time frame: 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).

  5. Change in fear of pain

    Time frame: 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).

  6. Change in cognitions regarding vaginal penetration

    Time frame: 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.

  7. Change in the life impact of pelvic pain

    Time frame: 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.

  8. Change in intercourse self-efficacy

    Time frame: 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.

  9. Level of satisfaction with treatment

    Time frame: 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).

  10. Patient's global impression of change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • CHU de Quebec-Universite Laval
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  • Exogenia
  • Kinatex l'Ormière

Registry information

Official study title

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

Acronym: Laser_RCT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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