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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01924728
Study type Interventional
Source QRS Asia Sdn Bhd
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date February 2016

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