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NCT Number: NCT04502810

High-level Laser for Provoked Vestibulodynia

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.

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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 Sherbroke

Sherbrooke, Quebec, J1H 5N4, Canada

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) 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

Treatment and study plan

High-level laser therapy

Radiation

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

Other names: Nd:Yag laser

Primary outcomes

  1. Adherence rate

    Time frame: 2-week post-treatment evaluation

    To determine acceptability by assessing adherence to treatment sessions

  2. Level of satisfaction with the treatment

    Time frame: 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)

  3. Willingness to recommend the treatment

    Time frame: 2-week post-treatment evaluation

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

  4. Rate of adverse events

    Time frame: 2-week post-treatment evaluation

    To document any adverse events.

  5. Blinding effectiveness

    Time frame: 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? ''

  6. Recruitment rate

    Time frame: 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

  7. Completion and dropout rates

    Time frame: 2-week post-treatment evaluation

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

  8. Completeness of data

    Time frame: Baseline to 2-week post-treatment evaluation

    To examine the percentage of completed outcome measures.

Secondary outcomes

  1. Change in pain intensity during intercourse

    Time frame: 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)

  2. Change in sexual function

    Time frame: 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).

  3. Change in sexual distress

    Time frame: 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).

  4. Change in pain quality

    Time frame: 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).

  5. Patient's global impression of change

    Time frame: 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.

  6. Change in fear of pain

    Time frame: 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).

  7. Change in pain catastrophization

    Time frame: 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)

  8. Change in vulvar pain sensitivity

    Time frame: Baseline to 2-week post-treatment evaluation

    To explore changes in vulvar pain sensitivity (algometer)

  9. Change in vulvar blood circulation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  • Exogenia

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2020
Registry last updated
Feb 10, 2022

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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