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

Not Applicable

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Device: Electromagnetic stimulation therapy (BIOCON-2000); Device: Electromagnetic stimulation therapy with biofeedback

• Registration Number: NCT02423486
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-22
• Primary Completion: 2019-09-06
• Status Verified: 2019-11
• Study Completion: 2019-11-28
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electromagnetic stimulation therapy	Electromagnetic stimulation therapy (BIOCON-2000)	Electromagnetic stimulation therapy group
Electromagnetic stimulation therapy with biofeedback	Electromagnetic stimulation therapy with biofeedback	Electromagnetic stimulation therapy with biofeedback group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks 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
Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment	12 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of