High-level Laser for Provoked Vestibulodynia

Study Overview
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Brief Summary
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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.

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

Conditions
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Vulvodynia

Intervention / Treatment
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* Radiation: High-level laser therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity during intercourse | 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) | Baseline to 2-week post-treatment evaluation | 
| Change in sexual function | 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). | Baseline to 2-week post-treatment evaluation | 
| Change in sexual distress | 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). | Baseline to 2-week post-treatment evaluation | 
| Change in pain quality | 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). | Baseline to 2-week post-treatment evaluation | 
| Patient's global impression of change | 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. | Baseline to 2-week post-treatment evaluation | 
| 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 mean worst outcome (higher fear of pain). | Baseline to 2-week post-treatment evaluation | 
| Change in pain catastrophization | To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization) | Baseline to 2-week post-treatment evaluation | 
| Change in vulvar pain sensitivity | To explore changes in vulvar pain sensitivity (algometer) | Baseline to 2-week post-treatment evaluation | 
| Change in vulvar blood circulation | To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs). | Baseline to 2-week post-treatment evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions