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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-11-28

Brief Summary

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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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Detailed Description

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Conditions

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Urinary Stress Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electromagnetic stimulation therapy

Electromagnetic stimulation therapy group

Group Type EXPERIMENTAL

Electromagnetic stimulation therapy (BIOCON-2000)

Intervention Type DEVICE

Electromagnetic stimulation therapy with biofeedback

Electromagnetic stimulation therapy with biofeedback group

Group Type EXPERIMENTAL

Electromagnetic stimulation therapy with biofeedback

Intervention Type DEVICE

Interventions

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Electromagnetic stimulation therapy (BIOCON-2000)

Intervention Type DEVICE

Electromagnetic stimulation therapy with biofeedback

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No