Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
NCT ID: NCT01924728
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2013-09-30
2016-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Magnetic stimulation
Active magnetic stimulation delivered to the pelvic floor muscles
Magnetic stimulation
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
Sham magnetic stimulation
Sham magnetic stimulation delivered to the pelvic floor muscles
Sham magnetic stimulation
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles
Interventions
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Magnetic stimulation
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
Sham magnetic stimulation
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
FEMALE
No
Sponsors
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Universiti Sains Malaysia
OTHER
Island Hospital
OTHER
Penang Adventist Hospital
UNKNOWN
QRS Asia Sdn Bhd
INDUSTRY
Responsible Party
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Lim Renly
M. Pharm
Principal Investigators
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Liong Men Long, MBBS
Role: PRINCIPAL_INVESTIGATOR
Island Hospital, Penang
Locations
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Island Hospital
George Town, Pulau Pinang, Malaysia
Countries
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References
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Lim R, Liong ML, Leong WS, Khan NA, Yuen KH. Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:279. doi: 10.1186/s13063-015-0803-1.
Other Identifiers
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QRSPelvicenter
Identifier Type: -
Identifier Source: org_study_id
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