Back to resultsEfficacy of Magnetic Stimulation for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Magnetic stimulation
Sham magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Magnetic stimulation
Sham magnetic stimulation
Arm Description
Active magnetic stimulation delivered to the pelvic floor muscles
Sham magnetic stimulation delivered to the pelvic floor muscles
Outcomes
Primary Outcome Measures
Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)
Secondary Outcome Measures
Change in Incontinence Episode Frequency (IEF)
Change in 1-hour exercise (stress) pad test
Change in Patient Global Impression of Improvement (PGI-I)
Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Full Information
NCT ID
NCT01924728
First Posted
August 14, 2013
Last Updated
February 19, 2016
Sponsor
QRS Asia Sdn Bhd
Collaborators
Universiti Sains Malaysia, Island Hospital, Penang Adventist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01924728
Brief Title
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
QRS Asia Sdn Bhd
Collaborators
Universiti Sains Malaysia, Island Hospital, Penang Adventist Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic stimulation
Arm Type
Active Comparator
Arm Description
Active magnetic stimulation delivered to the pelvic floor muscles
Arm Title
Sham magnetic stimulation
Arm Type
Sham Comparator
Arm Description
Sham magnetic stimulation delivered to the pelvic floor muscles
Intervention Type
Device
Intervention Name(s)
Magnetic stimulation
Intervention Description
50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
Intervention Type
Device
Intervention Name(s)
Sham magnetic stimulation
Intervention Description
50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in Incontinence Episode Frequency (IEF)
Time Frame
Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Title
Change in 1-hour exercise (stress) pad test
Time Frame
Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Title
Change in Patient Global Impression of Improvement (PGI-I)
Time Frame
Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liong Men Long, MBBS
Organizational Affiliation
Island Hospital, Penang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Island Hospital
City
Penang
ZIP/Postal Code
10450
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
26093910
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
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