Vaginal Photobiomodulation for Chronic Pelvic Pain

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
SoLa Pelvic Therapy
Study ID
NCT06673108
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pelvic Pain
  • Chronic Pelvic Pain Syndrome (CPPS)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SoLa Pelvic Therapy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 17, 2024
Status verified
Nov 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall pelvic pain [ Time Frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Obgyn SouthBirminghamAlabama35209
Alexander Childs, MD
[email protected]
(205) 397-9000
Georgine Lamvu, MD
[email protected]
407-461-1189
Alexander Childs, MD
The Orady Womens ClinicSan FranciscoCalifornia94109
Mona Orady, MD
[email protected]
(415)500-8133
Georgine Lamvu, MD
[email protected]
407-461-1189
Mona Orady, MD
Urogynecology of Kansas CityOverland ParkKansas66214
Charles Butrick, MD
[email protected]
(913)262-3000
Georgine Lamvu, MD
[email protected]
407-461-1189
Charles Butrick, MD
Boston UrogynBostonMassachusetts02481
Neeraj Kohli, MD
[email protected]
Georgine Lamvu, MD
[email protected]
407-461-1189
Neeraj Kholi, MD
Nurture Women's HealthFriscoTexas75035
Angela Stoehr, MD
[email protected]
(972) 406-9911
Georgine Lamvu, MD
[email protected]
407-461-1189
Angela Stoehr, MD

Find similar trials in Birmingham, AL

By research site
Obgyn South· Birmingham, ALThe Orady Womens Clinic· San Francisco, CAUrogynecology of Kansas City· Overland Park, KSBoston Urogyn· Boston, MANurture Women's Health· Frisco, TX

Related Studies