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| Name | Class |
|---|---|
| Universiti Sains Malaysia | OTHER |
| Island Hospital | OTHER |
| Penang Adventist Hospital | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic stimulation | Active Comparator | Active magnetic stimulation delivered to the pelvic floor muscles |
|
| Sham magnetic stimulation | Sham Comparator | Sham magnetic stimulation delivered to the pelvic floor muscles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic stimulation | Device | 50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liong Men Long, MBBS | Island Hospital, Penang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Island Hospital | George Town | Pulau Pinang | 10450 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26093910 | Derived | 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. |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Sham magnetic stimulation | Device | 50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles |
|
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |