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Vaginal Photobiomodulation for Chronic Pelvic Pain
Sponsor: SoLa Pelvic Therapy
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.
Official title: Vaginal Photobiomodulation for Chronic Pelvic Pain: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-10-17
Completion Date
2026-06-17
Last Updated
2026-08-25
Healthy Volunteers
No
Interventions
SoLa Pelvic Therapy
SoLá Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 6 W for 3-6 minutes and delivers a fluence of 300-1,600 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.
Sham
Sham red light WITHOUT focused laser energy.
Locations (11)
Obgyn South
Birmingham, Alabama, United States
The Clark Center for Urogynecology
Newport Beach, California, United States
The Orady Womens Clinic
San Francisco, California, United States
IntimMedicine Specialists
Washington D.C., District of Columbia, United States
Urogynecology of Kansas City
Overland Park, Kansas, United States
Boston Urogyn
Boston, Massachusetts, United States
Horizons Health and Wellness
Bridgewater, Massachusetts, United States
Minnesota Women's Care: OBGYN and Urogynecology
Maplewood, Minnesota, United States
The Continence Program-Southeast Urogyn
Flowood, Mississippi, United States
The Thompkins Center
Brentwood, Tennessee, United States
Nurture Women's Health
Frisco, Texas, United States