Vaginal Photobiomodulation for Chronic Pelvic Pain

PHASE2RecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

October 17, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Chronic Pelvic PainChronic Pelvic Pain Syndrome (CPPS)
Interventions
DEVICE

SoLa 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.

Trial Locations (5)

35209

RECRUITING

Obgyn South, Birmingham

66214

RECRUITING

Urogynecology of Kansas City, Overland Park

75035

RECRUITING

Nurture Women's Health, Frisco

94109

NOT_YET_RECRUITING

The Orady Womens Clinic, San Francisco

02481

NOT_YET_RECRUITING

Boston Urogyn, Boston

All Listed Sponsors
collaborator

Uroshape LLC

UNKNOWN

lead

SoLa Pelvic Therapy

INDUSTRY