Ignite Creation Date:
2024-05-06 @ 1:52 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01924728
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2013-08-14
Brief Title:
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
Sponsor:
QRS Asia Sdn Bhd
Organization:
QRS Asia Sdn Bhd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None