Using laser therapy to reduce chronic pelvic pain in women

Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial

This study is testing if a special laser treatment can help women with chronic pelvic pain feel better during everyday activities.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: SoLa Pelvic Therapy (Industry-sponsored)
• Locations: 5 sites (Birmingham, Alabama and 4 other locations)
• Trial ID: NCT06673108 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of vaginal photobiomodulation using near-infrared laser energy in reducing chronic pelvic pain in women. It is a multi-center, triple-masked randomized study involving 126 participants, who will be divided into two groups: one receiving active treatment and the other receiving a sham treatment. Participants will undergo a gynecologic evaluation and will receive eight treatments over four weeks, administered by specialized gynecology providers. The study will assess pain relief during various activities, including sitting, standing, and intercourse.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older who have experienced chronic pelvic pain for at least three months with a severity rating of 4 or higher.

Not a fit: Patients with a history of certain gynecological conditions, recent vaginal trauma, or those currently undergoing pelvic physical therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic pelvic pain and improve the quality of life for affected women.

How similar studies have performed: While the approach of using photobiomodulation for pelvic pain is relatively novel, similar studies in other areas of pain management have shown promising results.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 4 other locations

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

Study contacts

• Principal investigator: Georgine Lamvu, MD, MPH — SoLá Pelvic Therapy
• Study coordinator: Georgine Lamvu, MD, MPH

Conditions Chronic Pelvic Pain; Chronic Pelvic Pain Syndrome