Efficacy of High Intensity Laser for Provoked Vestibulodynia

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Vulvodynia

Intervention / Treatment
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* Radiation: High Intensity Laser Therapy (HILT)
* Radiation: Sham High Intensity Laser Therapy


Participation Criteria
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Eligibility Criteria
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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

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 active laser or sham laser (12 sessions in 6 consecutive weeks) Post-treatment evaluation (2 weeks post-treatment) Follow-up evaluation (6 months post-treatment)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Intensity Laser Therapy (HILT)<br>Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments) | Radiation: High Intensity Laser Therapy (HILT)<br>* Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.<br>* Other names: Nd:Yag laser;|
| Sham Comparator: Sham High Intensity Laser Therapy<br>Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments) | Radiation: Sham High Intensity Laser Therapy<br>* Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.<br>* Other names: Deactivated probe;|

What is the study measuring?
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Primary 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 (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever) | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain quality | 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). | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Change in sexual function | 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). | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Change in sexual distress | 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). | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Change in pain catastrophizing | 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). | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| 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 indicate a worse outcome (higher fear of pain). | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Change in cognitions regarding vaginal penetration | 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. | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Change in the life impact of pelvic pain | 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. | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Change in intercourse self-efficacy | 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. | Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Level of satisfaction with treatment | 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). | 2-week post-treatment evaluation, 6-months follow-up assessment | 
| Patient's global impression of change | 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. | 2-week post-treatment evaluation, 6-months follow-up assessment | 

 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