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

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ClinicalTrials.gov Identifier: NCT02423486
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Device: Electromagnetic stimulation therapy (BIOCON-2000) Device: Electromagnetic stimulation therapy with biofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Study Start Date : November 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Electromagnetic stimulation therapy
Electromagnetic stimulation therapy group
Device: Electromagnetic stimulation therapy (BIOCON-2000)
Experimental: Electromagnetic stimulation therapy with biofeedback
Electromagnetic stimulation therapy with biofeedback group
Device: Electromagnetic stimulation therapy with biofeedback



Primary Outcome Measures :
  1. Rate comparison of complete recovery in stress pad test after 12 weeks of treatment [ Time Frame: 12 weeks ]
    Complete recovery is defined as urinary leakage below than 2 gram in stress pad test.


Secondary Outcome Measures :
  1. Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment [ Time Frame: 12 weeks ]
  2. Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment [ Time Frame: 12 weeks ]
  3. Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment [ Time Frame: 12 weeks ]
  4. Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment [ Time Frame: 12 weeks ]
  5. Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment [ Time Frame: 12 weeks ]
    Intravaginal pressure, Extracorporeal pelvic floor muscular strength, Oxford Scale at baseline,4weeks,8weeks,12weeks after treatment



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423486


Contacts
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Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, Ph.D    82-2-3410-3554    ksleedr@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02423486     History of Changes
Other Study ID Numbers: 2013-11-088
ksleedr ( Other Identifier: Samsung Medical Center )
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms