The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
2 other identifiers
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2019
CompletedDecember 2, 2019
November 1, 2019
5.8 years
March 24, 2015
November 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (2)
Electromagnetic stimulation therapy
EXPERIMENTALElectromagnetic stimulation therapy group
Electromagnetic stimulation therapy with biofeedback
EXPERIMENTALElectromagnetic stimulation therapy with biofeedback group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyu-Sung Lee, Ph.D
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 22, 2015
Study Start
November 1, 2013
Primary Completion
September 6, 2019
Study Completion
November 28, 2019
Last Updated
December 2, 2019
Record last verified: 2019-11