Vaginal Photobiomodulation for Chronic Pelvic Pain

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome (CPPS)

In brief

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 facts

Study ID

NCT06673108

Run by

SoLa Pelvic Therapy

People needed

126

Starts

2024-10-17

Expected to finish

2026-06-01

Last updated by the study team

2024-11-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• Less than 6 months post-partum;
• Actively trying to get pregnant or not willing to use contraception during the trial;
• Positive pregnancy test or planning to get pregnant during the study;
• Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; *
• Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;
• Does not speak, read, or writes English and thus cannot complete surveys;
• Does not have access to smart digital devices or computer, or cannot receive emails.

Where it is running

• Obgyn South — Birmingham, Alabama, United States (enrolling)
• Urogynecology of Kansas City — Overland Park, Kansas, United States (enrolling)
• Nurture Women's Health — Frisco, Texas, United States (enrolling)
• The Orady Womens Clinic — San Francisco, California, United States
• Boston Urogyn — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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