Comparison of PTNS and Biofeedback for Fecal Incontinence

Seoul National University Hospital

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Fecal Incontinence

Interventions

Posterior tibial nerve stimulationPROCEDURE

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.

BiofeedbackPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

Hallym University College of Medicine

Anyang-si, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Outcomes

Primary Outcomes

Weekly episodes of fecal incontinence

Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)

Time frame: 1 week

Secondary Outcomes

Weekly episodes of fecal incontinence

Measured by bowel diary at post-treatment(2, 4, 6 months)

Time frame: 6 months

Severity of fecal incontinence

Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)

Time frame: 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)

Time frame: 6 months

Anal function

Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.