Efficacy of Magnetic Stimulation for Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Magnetic stimulation
* Device: Sham magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged at least 21 years old Demonstration of stress urinary incontinence by vaginal examination with half full bladder (200 to 250ml) ICIQ UI SF score ≥ 6 points Able and agree to carry out one hour pad test Exclusion Criteria: Acute severe infections Urinary tract infections and hematuria, active vaginal lesions or infections Pelvic organ prolapse stage III and IV, severe urethral sphincter weakness/defect, suspected fistula Severe cardiac arrhythmia Cardiac pacemaker or other implanted metallic devices History of pelvic irradiation Pregnant, or actively trying to conceive. Neurologic conditions such as epilepsy, Parkinson disease, multiple sclerosis Patient who has been treated with electromagnetic stimulation Concurrent medications with alpha-adrenergic antagonists (e.g. terazosin, tamsulosin, doxazosin), diuretics, serotonin/norepinephrine reuptake inhibitors (SNRIs) or any other medications known to worsen incontinence. Post void residual volume of ≥ 200ml Random blood sugar >10 mmol/L Patient who had pelvic or gynaecological surgery for less than three weeks Patient scheduled for pelvic or gynaecological surgery in the next eight weeks

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnetic stimulation<br>Active magnetic stimulation delivered to the pelvic floor muscles | Device: Magnetic stimulation<br>* 50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles<br>|
| Sham Comparator: Sham magnetic stimulation<br>Sham magnetic stimulation delivered to the pelvic floor muscles | Device: Sham magnetic stimulation<br>* 50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF) |  | Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incontinence Episode Frequency (IEF) |  | Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment | 
| Change in 1-hour exercise (stress) pad test |  | Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment | 
| Change in Patient Global Impression of Improvement (PGI-I) |  | 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) |  | Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment |