Vaginal Photobiomodulation for Chronic Pelvic Pain

Description

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.

Conditions

Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome (CPPS)

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Study Overview

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Study Details

Study overview

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.

Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial

Vaginal Photobiomodulation for Chronic Pelvic Pain

Condition
Chronic Pelvic Pain
Intervention / Treatment

-

Contacts and Locations

Birmingham

Obgyn South, Birmingham, Alabama, United States, 35209

San Francisco

The Orady Womens Clinic, San Francisco, California, United States, 94109

Overland Park

Urogynecology of Kansas City, Overland Park, Kansas, United States, 66214

Boston

Boston Urogyn, Boston, Massachusetts, United States, 02481

Frisco

Nurture Women's Health, Frisco, Texas, United States, 75035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

SoLa Pelvic Therapy,

Georgine Lamvu, MD, MPH, PRINCIPAL_INVESTIGATOR, SoLá Pelvic Therapy

Study Record Dates

2026-06