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| Name | Class |
|---|---|
| Furun Medical | INDUSTRY |
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Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFMT with Extracorporeal Biobeedback | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFMT with Extracorporeal Biofeedback | Device | Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test. | After 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength. | After 12 weeks of treatment | |
| Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW). |
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Inclusion Criteria:
Exclusion Criteria:
Women with:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Irwon-dong | 135-710 | South Korea | |||
| Asan Medical Center, Ulsan College of Medicine |
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| After 12 weeks of treatment |
| Seoul |
| South Korea |