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Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.

NCT02861391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-01-17

No results posted yet for this study

Summary

The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Conditions

  • Exposure Laser

Interventions

DEVICE

CO2 AcuPulse Laser

Each subject will receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

DEVICE

Sham Laser

Each subject will receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Lior Lowenstein, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2021-11-01
Completion
2022-01-30

Countries

  • Israel

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 NCT02861391 on ClinicalTrials.gov