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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

Tracking Information
First Submitted Date  ICMJE March 24, 2015
First Posted Date  ICMJE April 22, 2015
Last Update Posted Date March 5, 2019
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02423486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2015)
  • Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment [ Time Frame: 12 weeks ]
  • Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment [ Time Frame: 12 weeks ]
  • Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment [ Time Frame: 12 weeks ]
  • Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment [ Time Frame: 12 weeks ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Official Title  ICMJE The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Stress Incontinence
Intervention  ICMJE
  • Device: Electromagnetic stimulation therapy (BIOCON-2000)
  • Device: Electromagnetic stimulation therapy with biofeedback
Study Arms  ICMJE
  • Experimental: Electromagnetic stimulation therapy
    Electromagnetic stimulation therapy group
    Intervention: Device: Electromagnetic stimulation therapy (BIOCON-2000)
  • Experimental: Electromagnetic stimulation therapy with biofeedback
    Electromagnetic stimulation therapy with biofeedback group
    Intervention: Device: Electromagnetic stimulation therapy with biofeedback
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02423486
Other Study ID Numbers  ICMJE 2013-11-088
ksleedr ( Other Identifier: Samsung Medical Center )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP