The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary Incontinence patient.

Official Title
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The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Device: Electromagnetic stimulation therapy (BIOCON-2000)
* Device: Electromagnetic stimulation therapy with biofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient with Stress Urinary Incontinence, over 20 Leakage over 2g in stress pad test Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits Exclusion Criteria: Mixed Urinary Incontinence which is dominant in urge urinary incontinence. True incontinence Overflow incontinence Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline. Urinary tract infection found In urine test. Patient who had pelvic organ prolapse. Patient who had inserted pacemaker. Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period. Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease . Patient who will participate in other clinical trial during this study. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electromagnetic stimulation therapy<br>Electromagnetic stimulation therapy group | Device: Electromagnetic stimulation therapy (BIOCON-2000)<br> <br> |
| Experimental: Electromagnetic stimulation therapy with biofeedback<br>Electromagnetic stimulation therapy with biofeedback group | Device: Electromagnetic stimulation therapy with biofeedback<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate comparison of complete recovery in stress pad test after 12 weeks of treatment | Complete recovery is defined as urinary leakage below than 2 gram in stress pad test. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment |  | 12 weeks | 
| Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment |  | 12 weeks | 
| Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment |  | 12 weeks | 
| Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment |  | 12 weeks | 
| Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment | Intravaginal pressure, Extracorporeal pelvic floor muscular strength, Oxford Scale at baseline,4weeks,8weeks,12weeks after treatment | 12 weeks |