Trials / Completed
CompletedNCT01924728
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- QRS Asia Sdn Bhd · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magnetic stimulation | 50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles |
| DEVICE | Sham magnetic stimulation | 50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2013-08-16
- Last updated
- 2016-02-23
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT01924728. Inclusion in this directory is not an endorsement.