Comparison of PTNS and Biofeedback for Fecal Incontinence

Phase 3

Withdrawn

• Conditions: Fecal Incontinence
• Interventions: Procedure: Posterior tibial nerve stimulation; Procedure: Biofeedback

• Registration Number: NCT01882101
• Lead Sponsor: Seoul National University Hospital

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 randomized controlled trials. Sacral nerve stimulation is too expensive although some prospective studies showed the therapeutic potential. Recently, posterior tibial nerve stimulation has been reported to be effective with lower cost in comparison with sacral nerve stimulation. This study is designed to show the efficacy of posterior tibial nerve stimulation compared with biofeedback therapy for fecal incontinence.

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 fecal incontinence at 1 week after each treatment. Sample size was calculated as 50 patients. Outcomes include weekly episodes and severity of fecal incontinence, quality of life and anal function. Outcomes will be assessed using bowel diary, FISI questionnaire, FIQL questionnaire and anorectal manometry at 1,8,16 and 24 weeks after each treatment for 6 weeks.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-20
• Study Start: 2014-01
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient with 2 or more weekly episodes of fecal incontinence
• Patient who understands and accepts to sign the informed consent form

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior tibial nerve stimulation	Posterior tibial nerve stimulation	-
Biofeedback	Biofeedback	-

Primary Outcome Measures

Name	Time	Method
Weekly episodes of fecal incontinence	1 week	Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)

Secondary Outcome Measures

Name	Time	Method
Weekly episodes of fecal incontinence	6 months	Measured by bowel diary at post-treatment(2, 4, 6 months)
Severity of fecal incontinence	6 months	Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Quality of life associated with fecal incontinence	6 months	Measured by FIQL questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Anal function	6 months	Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)

Trial Locations

Locations (6)

Daehang Hospital; 🇰🇷 Seoul, Korea, Republic of

Hallym University College of Medicine; 🇰🇷 Anyang, Gyeong-gi, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 SeongNam, GyeongGi, Korea, Republic of

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of