Vaginal Photobiomodulation for Chronic Pelvic Pain
This study is looking at whether a treatment called SoLa Pelvic Therapy can help women with chronic pelvic pain. This therapy uses a special laser that shines near-infrared light into the vaginal tissues. Researchers want to see if 8 treatments can reduce overall pelvic pain, and also pain during activities like standing, sitting, urinating, bowel movements, and intercourse. You might be able to join if you are a woman aged 18 or older, have had chronic pelvic pain for at least 3 months, and your pain level is 4 or higher. The study aims to enroll 126 participants. The current status of this study is unclear.
- Study design
- This is a multi-center, triple-masked randomized study comparing vaginal photobiomodulation to a sham treatment. It plans to include 126 participants, with 63 receiving the active treatment and 63 receiving the sham.
- What's involved
- You would undergo a screening gynecologic evaluation, provide informed consent, and then receive 8 treatments twice a week. Specific treatment time is calculated based on vaginal length.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall pelvic pain will be measured at baseline, 1 week after completing treatment, and 3 months after completing treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vaginal Photobiomodulation for Chronic Pelvic Pain
At a glance
Conditions
Where it's being run
11 sites across 9 statesStudy leadership
- Georgine Lamvu, MD, MPH · PRINCIPAL_INVESTIGATOR · SoLá Pelvic Therapy
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Overall pelvic painAt baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Overall pelvic pain level as measured on a 0-10 numeric rating pain scale (NRPS). On this scale, 0 represents no pain and 10 represents wors pain possible. Pain will be analyzed as median pain levels and % of participants achieving a minimal clinically important difference (MCID) defined as reduction in pain level of 2 or more NRPS points.