Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Pad weight test
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Laser treatment
carbon dioxide treatment
Intervention: carbon dioxide laser (Device)
Sham treatment
sham treatment
Intervention: sham laser (Device)
Outcomes
Primary Outcomes
Pad weight test
Time Frame: From treatment up to 12 months post treatment
Change in pad weight
Secondary Outcomes
- Urinary distress index questionnaire(From treatment up to 12 months post treatment)
- Cough test(From treatment up to 12 months post treatment)
- International consultation on incontinence questionnaire-urinary incontinence(From treatment up to 12 months post treatment)
- Pelvic organ prolapse/urinary incontinence sexual questionnaire(From treatment up to 12 months post treatment)
Investigators
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus