Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Weekly episodes of fecal incontinence
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)
Sung-Bum Kang, Ph.D.
Seoul National University Bundang Hospital
Korea: Food and Drug Administration