Status:
WITHDRAWN
Comparison of PTNS and Biofeedback for Fecal Incontinence
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
National Cancer Center, Korea
Conditions:
Fecal Incontinence
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
Until recently, there is no definite treatment for fecal incontinence that is proven to be effective with low morbidity. The efficacy of biofeedback therapy for incontinence has not been proven on the...
Detailed Description
This prospective randomized controlled trial is designed to compare the efficacy of biofeedback and posterior tibial nerve stimulation for fecal incontinence. Primary endpoint is weekly episodes of fe...
Eligibility Criteria
Inclusion
- Patient with 2 or more weekly episodes of fecal incontinence
- Patient who understands and accepts to sign the informed consent form
Exclusion
- Patient with gas incontinence only
- Major injury in anal sphincter
- Anorectal operation history within 24 months
- Previous spinal injury, tumor or surgery
- Presence of neurological disease
- Peripheral vascular disease
- Severe comorbidity
- Psychiatric disorder
- Legally prohibited for clinical trial
- Pregnancy or breast feeding
- Previous disease or disability expected to influence the assessment of postoperative quality of life
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01882101
Start Date
January 1 2014
End Date
December 1 2014
Last Update
April 27 2017
Active Locations (6)
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1
Hallym University College of Medicine
Anyang-si, Gyeonggi-do, South Korea, 431-070
2
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769
3
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
4
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 110-744