Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial
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.
Description
This clinical trial will be a multi-center, triple-masked randomized study comparing vaginal photobiomodulation to sham, for the treatment of chronic pelvic pain in women. The study will include 126 participants, 63 randomized to vaginal photobiomodulation and 63 randomized to vaginal sham treatment. Potential participants will be recruited in communities and clinics where gynecologists are routinely evaluating patients for chronic pelvic pain. Women who fulfill inclusion criteria will undergo, screening gynecologic evaluation to ensure they can participate. Informed and written consent will…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years or older; 2. CPP for 3 months or longer; 3. Overall pelvic pain severity ≥4 in the last 7 days; 4. Pelvic muscle tenderness pain level ≥4. Exclusion Criteria: 1. Previous vaginal or vulvar laser therapy; 2. Receiving concurrent pelvic physical therapy; 3. Unable to tolerate vaginal/pelvic examination 4. Taking drugs that have heat- or light- sensitive contraindications; 5. Subjectively reports abnormal or decreased sensation in the vagina or rectum; 6. History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or p…
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.
Locations (5)
- Obgyn SouthBirmingham, Alabama
- The Orady Womens ClinicSan Francisco, California
- Urogynecology of Kansas CityOverland Park, Kansas
- Boston UrogynBoston, Massachusetts
- Nurture Women's HealthFrisco, Texas