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Vaginal Photobiomodulation for Chronic Pelvic Pain

NCT06673108 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-11-04

No results posted yet for this study

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)

Interventions

DEVICE

SoLa Pelvic Therapy

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.

Sponsors & Collaborators

  • Uroshape LLC

    collaborator UNKNOWN

  • SoLa Pelvic Therapy

    lead INDUSTRY

Principal Investigators

  • Georgine Lamvu, MD, MPH · SoLá Pelvic Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2025-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673108 on ClinicalTrials.gov