The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Primary Purpose
Urinary Stress Incontinence
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electromagnetic stimulation therapy (BIOCON-2000)
Electromagnetic stimulation therapy with biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Stress Incontinence
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Electromagnetic stimulation therapy
Electromagnetic stimulation therapy with biofeedback
Arm Description
Electromagnetic stimulation therapy group
Electromagnetic stimulation therapy with biofeedback group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment
Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment
Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment
Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment
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
Full Information
NCT ID
NCT02423486
First Posted
March 24, 2015
Last Updated
November 28, 2019
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02423486
Brief Title
The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Official Title
The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
November 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic stimulation therapy
Arm Type
Experimental
Arm Description
Electromagnetic stimulation therapy group
Arm Title
Electromagnetic stimulation therapy with biofeedback
Arm Type
Experimental
Arm Description
Electromagnetic stimulation therapy with biofeedback group
Intervention Type
Device
Intervention Name(s)
Electromagnetic stimulation therapy (BIOCON-2000)
Intervention Type
Device
Intervention Name(s)
Electromagnetic stimulation therapy with biofeedback
Primary Outcome Measure Information:
Title
Rate comparison of complete recovery in stress pad test after 12 weeks of treatment
Description
Complete recovery is defined as urinary leakage below than 2 gram in stress pad test.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment
Time Frame
12 weeks
Title
Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment
Time Frame
12 weeks
Title
Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment
Time Frame
12 weeks
Title
Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment
Time Frame
12 weeks
Title
Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment
Description
Intravaginal pressure, Extracorporeal pelvic floor muscular strength, Oxford Scale at baseline,4weeks,8weeks,12weeks after treatment
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
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The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
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