Comparison of PTNS and Biofeedback for Fecal Incontinence

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: Posterior tibial nerve stimulation
* Procedure: Biofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior tibial nerve stimulation<br> | Procedure: Posterior tibial nerve stimulation<br>* 34G needle is introduced percutaneously three finger-breadths superior to the medial malleolus and an electrode is attached to the ipsilateral foot. Electrical stimulation is applied monitoring motor and sensory response. The treatment lasts for 30 minutes, and will be repeated twice a week for 6 weeks.<br>* Other names: PTNS;|
| Experimental: Biofeedback<br> | Procedure: Biofeedback<br>* Electrodes are attached to the lower abdomen and acryl plug is inserted into the anal canal. The patients perform pelvic muscle exercise watching EMG activity of themselves. The treatment lasts over 30 minutes, and will be repeated twice a week for 6 weeks.<br>* Other names: Pelvic floor muscle exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly episodes of fecal incontinence | Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week) | 1 week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, posterior tibial nerve stimulation, biofeedback, quality of life