Vaginal Photobiomodulation for Chronic Pelvic Pain

This clinical trial will be a multi-center, triple-masked randomized study comparing vaginal photobiomodulation to sham, for the treatment of chronic pelvic pain in women. The study will include 126 participants, 63 randomized to vaginal photobiomodulation and 63 randomized to vaginal sham treatment. Potential participants will be recruited in communities and clinics where gynecologists are routinely evaluating patients for chronic pelvic pain.

Women who fulfill inclusion criteria will undergo, screening gynecologic evaluation to ensure they can participate. Informed and written consent will be obtained from all study participants prior to enrollment.

After consent, participants will be randomized to 8 treatments with active photobiomodulation or sham administered twice a week. Study subjects will be randomized using blocked 1:1 randomization with random permuted blocks of 4. Participants, study investigators, staff, and statisticians will remain masked throughout the study and unaware of whether sham or active laser is being administered to each participant.

Treatments will be administered using the SoLá Pelvic Therapy laser, which has been modified to emit sham or active photobiomodulation through the vagina using a thin laser wand protected by a sterile plastic covering. Treatments will be administered by a gynecology providers who specialize in evaluation and management of chronic pelvic pain. The SoLá Pelvic Therapy device auto-calculates power and duration of treatment based on vaginal length. The procedure typically lasts 3-6 minutes depending on the vaginal length and the pre-determined dosing selected by the device.

Patient reported pain levels will be assessed prior to each treatment and again at 1-week and 3-months after treatment. Pain levels will be obtained from both groups at baseline and after each treatment, while demographics, pain intensity, pain impact, pain behavior, and quality of life measures (QoL) will be collected at baseline and after treatment. Need for additional therapies, global impression of change, adherence and satisfaction will be assessed after 8 treatments. To assess effect duration, both groups will be followed for an additional 3 months, after which pain levels, QoL, use of additional treatments, global health, global impression of change, and satisfaction with the procedure will be assessed. After the 3-month follow-up, participation will come to an end.

The primary outcome will be to determine the percentage of participants who achieve a minimal clinically important difference (MCID) in overall pelvic pain, defined as a post-treatment decrease of ≥2 points on a 0-10 pain NRS (Numeric Rating Scale) at 3 months compared to baseline. Secondary outcomes include changes from baseline in:

* mean NRS pain levels of overall pelvic pain and symptom specific pelvic pain (pain with exercise, sitting, standing, bowel movements, urination, and intercourse); * percentage of patients achieving MICD for symptom specific pelvic pain * quality of life measured by decrease in pain intensity, impact, and interference, reduced need for additional treatments; * improvement in global health; * global impression of change, * adherence and satisfaction with treatment. The intervention will be considered superior if 30% or higher percentage of participants achieve MCID compared to placebo (e.g., 30% in sham group vs 60%), or the intervention results in ≥1.1 NRS points reduction in mean pain levels compared to sham (e.g., intervention reduces mean pain levels by 2.4 points while sham reduces mean pain levels by 1.2 NRS points).

All patient reported outcomes (PROs) will be recorded using electronic surveys; many are specifically validated to measure pelvic pain, pelvic function, and quality of life.

• Symptom specific pelvic pain [Срок оценки: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.]
• Pain impact [Срок оценки: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.]
• Quality of life [Срок оценки: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.]
• Global physical and mental health [Срок оценки: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.]
• Satisfaction with treatment. [Срок оценки: At 1-week after completing treatment.]
• Adherence with treatment. [Срок оценки: After 5 treatments are completed.]
• Need for additional treatment [Срок оценки: This questionnaire is completed once a week, prior to each treatment through administration of all 8 treatments (which are administered twice a week), and again at 3 months after completing the last treatment.]
• Global impression of change [Срок оценки: At 1-week after completing treatment, and at 3 months after completing treatment.]