Comparison of PTNS and Biofeedback for Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title: Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT01882101
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2014
• Completion date: December 2014