Vaginal Photobiomodulation for Chronic Pelvic Pain
CompletedPhase 2NCT06673108
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Vaginal Photobiomodulation for Chronic Pelvic Pain: A Randomized Controlled Trial
- Conditions
- Chronic Pelvic Pain
- Chronic Pelvic Pain Syndrome (CPPS)
- Interventions
- Device: SoLa Pelvic Therapy
- Device: Sham
- Sponsor
- SoLa Pelvic Therapy
- Collaborators
- Uroshape LLC
- Start date
- 2024-10-17
- Primary completion
- 2026-06-17
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 11
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 pre-cancerous lesions; 7. History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses; 8. History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown; 9. Less than 6 months post-partum; 10. Actively trying to get pregnant or not willing to use contraception during the trial; 11. Positive pregnancy test or planning to get pregnant during the study; 12. Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; \* 13. Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain; 14. Does not speak, read, or writes English and thus cannot complete surveys; 15. Does not have access to smart digital devices or computer, or cannot receive emails.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06673108