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

Rambam Health Care Campus125 enrolled

Overview

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.

Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronical files.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

125

Conditions

Exposure Laser

Interventions

CO2 AcuPulse LaserDEVICE

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.

Sham LaserDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Negative urine culture. * Positive cough test. * Normal Papanicolaou (PAP) test from the past 3 years. Exclusion Criteria: * signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence. * Overactive bladder. * Previous bulking injections. * Previous transvaginal mesh implant. * Previous surgery for stress urinary incontinence. * Presence of pelvic organ prolapse. * Presence of an active or recurring genital infection or urinary tract infection. * Previous laser-based or other energy-based treatments for gynecological indications. * Vaginal bleeding of unknown reason. * Pregnancy. * Current pelvic floor physiotherapy. * Current treatment with local or systemic hormone replacement therapy.

Locations (1)

Rambam health care campus

Haifa, Israel