RecruitingPhase 2NCT06673108

Vaginal Photobiomodulation for Chronic Pelvic Pain

Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial

Sponsor

SoLa Pelvic Therapy

Enrollment

126 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic pelvic pain Chronic Pelvic Pain Syndrome (CPPS)

Summary

The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SoLa Pelvic Therapy for people with chronic pelvic pain syndrome (cpps) and chronic pelvic pain. The study is currently recruiting participants at 5 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESoLa Pelvic Therapy

SoLa Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 5-8 W for 3-6 minutes and delivers a fluence of 3,000 and 5,000 J/cm2 through a sterile vaginal probe. Specific treatment time is calculated based on vaginal length. Based on a code input, the device can cycle between emitting laser energy or sham which is visible light without focused laser energy.