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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles
Island Hospital
George Town, Pulau Pinang, Malaysia
Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)
Time frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in Incontinence Episode Frequency (IEF)
Time frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in 1-hour exercise (stress) pad test
Time frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in Patient Global Impression of Improvement (PGI-I)
Time frame: Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Time frame: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
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