Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms

Rambam Health Care Campus

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: sham laser

Device: carbon dioxide laser

Study type

Interventional

Funder types

Other

Identifiers

NCT05097456

0292-20-RMB

Details and patient eligibility

About

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Full description

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic files.

Enrollment

125 patients

Sex

Female

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Negative urine analysis.
Normal Pap smear test from the recent 3 years.
No previous gynecological laser treatments.
Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion criteria

Active genital infection.
Subject presenting abnormal Pap result from the last three years.
Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
Transvaginal mesh implant.
Serious systemic disease or any chronic condition that could interfere with study compliance.
Any vaginal bleeding of unknown reason.