Status:
COMPLETED
Efficacy and Safety of Extracorporeal Biofeedback
Lead Sponsor:
KYU-SUNG LEE
Collaborating Sponsors:
Furun Medical
Conditions:
Female Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal prob...
Eligibility Criteria
Inclusion
- Women with stress urinary incontinence
- Standard pad test \> 2gram
Exclusion
- Women with:
- Mixed urinary incontinence of which urgency incontinence is dominant
- True incontinence
- Overflow incontinence
- Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
- Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
- Pelvic organ prolapse which the stage is at least 2
- Proven urinary tract infection during screening period
- Pacemaker
- Pregnant women
- Neurogenic voiding dysfunction
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00910338
Start Date
July 1 2007
End Date
December 1 2009
Last Update
December 2 2019
Active Locations (2)
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1
Samsung Medical Center
Irwon-dong, South Korea, 135-710
2
Asan Medical Center, Ulsan College of Medicine
Seoul, South Korea