Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older;
• CPP for 3 months or longer;
• Overall pelvic pain severity ≥4 in the last 7 days;
• Pelvic muscle tenderness pain level ≥4.
Locations
United States
Alabama
Obgyn South
RECRUITING
Birmingham
California
The Orady Womens Clinic
NOT_YET_RECRUITING
San Francisco
Kansas
Urogynecology of Kansas City
RECRUITING
Overland Park
Massachusetts
Boston Urogyn
NOT_YET_RECRUITING
Boston
Texas
Nurture Women's Health
RECRUITING
Frisco
Contact Information
Primary
Georgine Lamvu, MD, MPH
georgine@solapelvictherapy.com
833-608-6423
Backup
Pilar Garcia, MD
pilar@solatherapy.com
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2026-06
Participants
Target number of participants: 126
Treatments
Active_comparator: Vaginal photobiomodulation
Vaginal photobiomodulation with near-infrared (810-980nm wavelength) energy.
Sham_comparator: Sham-Light without laser energy.
Vaginal light therapy without focused laser energy.
Related Therapeutic Areas
Sponsors
Collaborators: Uroshape LLC
Leads: SoLa Pelvic Therapy