Stress Urinary Incontinence Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Effects of Transpelvic Magnetic Stimulation (Using QRS®-1010 PelviCenter) in Patients With Stress Urinary Incontinence.
The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female
patients with stress urinary incontinence.
Based on the available data on magnetic stimulation, the investigators hypothesize that
magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary
leakage upon exertion as well as improve patients' quality of life.
A total of 120 female patients will be randomly assigned into two treatment groups (active arm and sham arm) in a 1:1 ratio. The standard QRS®-1010 PelviCenter treatment plan involves 16 sessions of 20 minutes each. Each subject will attend 2 sessions per week (total 16 sessions). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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