Comparison of PTNS and Biofeedback for Fecal Incontinence
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Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion criteria
- Patient with 2 or more weekly episodes of fecal incontinence
- Patient who understands and accepts to sign the informed consent form
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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