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OpenTrials
Completed

NCT Number: NCT02423486

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electromagnetic stimulation therapy (BIOCON-2000)

Device

Electromagnetic stimulation therapy with biofeedback

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2015
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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