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

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Samsung Medical Center

Status

Completed

Conditions

Urinary Stress Incontinence

Treatments

Device: Electromagnetic stimulation therapy (BIOCON-2000)
Device: Electromagnetic stimulation therapy with biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT02423486
ksleedr (Registry Identifier)
2013-11-088

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Electromagnetic stimulation therapy
Experimental group
Description:
Electromagnetic stimulation therapy group
Treatment:
Device: Electromagnetic stimulation therapy (BIOCON-2000)
Electromagnetic stimulation therapy with biofeedback
Experimental group
Description:
Electromagnetic stimulation therapy with biofeedback group
Treatment:
Device: Electromagnetic stimulation therapy with biofeedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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