RECRUITING

Vaginal Photobiomodulation for Chronic Pelvic Pain

Conditions

Chronic Pelvic Pain Chronic Pelvic Pain Syndrome (CPPS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial

Quick Facts

Study Start:2024-10-17

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06673108

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Georgine Lamvu, MD, MPH

CONTACT

833-608-6423

georgine@solapelvictherapy.com

Pilar Garcia, MD

CONTACT

pilar@solatherapy.com

Principal Investigator

Georgine Lamvu, MD, MPH

PRINCIPAL_INVESTIGATOR

SoLá Pelvic Therapy

Study Locations (Sites)

Obgyn South

Birmingham, Alabama, 35209

United States

The Orady Womens Clinic

San Francisco, California, 94109

United States

Urogynecology of Kansas City

Overland Park, Kansas, 66214

United States

Boston Urogyn

Boston, Massachusetts, 02481

United States

Nurture Women's Health

Frisco, Texas, 75035

United States

Collaborators and Investigators

Sponsor: SoLa Pelvic Therapy

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-10-17

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome (CPPS)