Urinary Stress Incontinence
Conditions
Brief summary
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.
Interventions
DEVICEElectromagnetic stimulation therapy (BIOCON-2000)
DEVICEElectromagnetic stimulation therapy with biofeedback
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female patient with Stress Urinary Incontinence, over 20 2. Leakage over 2g in stress pad test 3. 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
1. Mixed Urinary Incontinence which is dominant in urge urinary incontinence. 2. True incontinence 3. Overflow incontinence 4. Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline. 5. Urinary tract infection found In urine test. 6. Patient who had pelvic organ prolapse. 7. Patient who had inserted pacemaker. 8. Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period. 9. Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease . 10. Patient who will participate in other clinical trial during this study. 11. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate comparison of complete recovery in stress pad test after 12 weeks of treatment | 12 weeks | Complete recovery is defined as urinary leakage below than 2 gram in stress pad test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | Intravaginal pressure, Extracorporeal pelvic floor muscular strength, Oxford Scale at baseline,4weeks,8weeks,12weeks after treatment |
Countries
South Korea
Outcome results
None listed