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

November 28, 2019 updated by: Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment
Time Frame: 12 weeks
12 weeks
Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment
Time Frame: 12 weeks
12 weeks
Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment
Time Frame: 12 weeks
12 weeks
Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment
Time Frame: 12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

September 6, 2019

Study Completion (Actual)

November 28, 2019

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-11-088
  • ksleedr (Other Identifier: Samsung Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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