Vaginal Photobiomodulation for Chronic Pelvic Pain

NCT06673108 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: SoLaPelvicTherapy
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Pelvic Pain; Chronic Pelvic Pain Syndrome (CPPS)

Outcome Measures

Primary Outcomes (1)

• Overall pelvic pain

  Overall pelvic pain level as measured on a 0-10 numeric rating pain scale (NRPS). On this scale, 0 represents no pain and 10 represents wors pain possible. Pain will be analyzed as median pain levels and % of participants achieving a minimal clinically important difference (MCID) defined as reduction in pain level of 2 or more NRPS points.

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

Secondary Outcomes (8)

• Symptom specific pelvic pain

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

• Pain impact

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

• Quality of life

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

• Global physical and mental health

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

• Satisfaction with treatment.

  At 1-week after completing treatment.

Study Arms (2)

Vaginal photobiomodulation

ACTIVE COMPARATOR

Vaginal photobiomodulation with near-infrared (810-980nm wavelength) energy.

Device: SoLa Pelvic Therapy

Sham-Light without laser energy.

SHAM COMPARATOR

Vaginal light therapy without focused laser energy.

Device: SoLa Pelvic Therapy

Interventions

SoLa Pelvic Therapy DEVICE

SoLa Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 5-8 W for 3-6 minutes and delivers a fluence of 3,000 and 5,000 J/cm2 through a sterile vaginal probe. Specific treatment time is calculated based on vaginal length. Based on a code input, the device can cycle between emitting laser energy or sham which is visible light without focused laser energy.

Also known as: Low level laser therapy

Sham-Light without laser energy.; Vaginal photobiomodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SoLa Pelvic Therapy: lead
• Uroshape LLC: collaborator

Study Sites (5)

Obgyn South

Birmingham, Alabama, 35209, United States

RECRUITING

The Orady Womens Clinic

San Francisco, California, 94109, United States

NOT YET RECRUITING

Urogynecology of Kansas City

Overland Park, Kansas, 66214, United States

RECRUITING

Boston Urogyn

Boston, Massachusetts, 02481, United States

NOT YET RECRUITING

Nurture Women's Health

Frisco, Texas, 75035, United States

RECRUITING

Related Publications (2)

• Zipper R, Pryor B, Lamvu G. Transvaginal Photobiomodulation for the Treatment of Chronic Pelvic Pain: A Pilot Study. Womens Health Rep (New Rochelle). 2021 Nov 23;2(1):518-527. doi: 10.1089/whr.2021.0097. eCollection 2021.

  PMID: 34841398 BACKGROUND

• Zipper R, Pryor B. Evaluation of a novel deep tissue transvaginal near-infrared laser and applicator in an ovine model. Lasers Med Sci. 2022 Feb;37(1):639-643. doi: 10.1007/s10103-021-03315-z. Epub 2021 Apr 14.

  PMID: 33855615 BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Georgine Lamvu, MD, MPH

  SoLá Pelvic Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgine Lamvu, MD, MPH

CONTACT

833-608-6423; georgine@solapelvictherapy.com

Pilar Garcia, MD

CONTACT

pilar@solatherapy.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 4, 2024
• Study Start: October 17, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After analysis and publication is complete and up to a period of 2 years.
• Access Criteria: The study protocol and database will be available after express consent from the study sponsor.

Locations

US (5)