RecruitingPhase 2

Vaginal Photobiomodulation for Chronic Pelvic Pain

United States126 participantsStarted 2024-10-17

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Previous vaginal or vulvar laser therapy;
✕. Receiving concurrent pelvic physical therapy;
✕. Unable to tolerate vaginal/pelvic examination
✕. Taking drugs that have heat- or light- sensitive contraindications;
✕. Subjectively reports abnormal or decreased sensation in the vagina or rectum;
✕. History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;
✕. History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;
✕. History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;

What they're measuring

Overall pelvic pain

Timeframe: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.

Trial details

NCT IDNCT06673108

SponsorSoLa Pelvic Therapy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Georgine Lamvu, MD, MPH

833-608-6423 georgine@solapelvictherapy.com

View on ClinicalTrials.gov More Chronic Pelvic Pain trials