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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
125
carbon dioxide laser
sham laser
Rambam health care campus
Haifa, Israel
Pad weight test
Change in pad weight
Time frame: From treatment up to 12 months post treatment
Cough test
Positive cough test
Time frame: From treatment up to 12 months post treatment
Urinary distress index questionnaire
Change in urinary distress index questionnaire scores
Time frame: From treatment up to 12 months post treatment
International consultation on incontinence questionnaire-urinary incontinence
Change in international consultation on incontinence questionnaire-urinary incontinence scores
Time frame: From treatment up to 12 months post treatment
Pelvic organ prolapse/urinary incontinence sexual questionnaire
Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores
Time frame: From treatment up to 12 months post treatment
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