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

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423486
• Other study ID #: 2013-11-088
• Secondary ID: ksleedr
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: November 28, 2019

Study information

• Verified date: November 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 28, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Device:
• Electromagnetic stimulation therapy (BIOCON-2000)

• Electromagnetic stimulation therapy with biofeedback

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate comparison of complete recovery in stress pad test after 12 weeks of treatment	Complete recovery is defined as urinary leakage below than 2 gram in stress pad test.	12 weeks
Secondary	Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment		12 weeks
Secondary	Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment		12 weeks
Secondary	Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment		12 weeks
Secondary	Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment		12 weeks
Secondary	Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment	Intravaginal pressure, Extracorporeal pelvic floor muscular strength, Oxford Scale at baseline,4weeks,8weeks,12weeks after treatment	12 weeks