Comparison of PTNS and Biofeedback for Fecal Incontinence

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.

Conditions

• Fecal Incontinence

Interventions

PROCEDURE

Posterior tibial nerve stimulation

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.

PROCEDURE

Biofeedback

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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital

  collaborator OTHER

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Seoul National University Boramae Hospital

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Daehang Hospital

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Sung-Bum Kang, Ph.D. · Seoul National University Bundang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2014-06-30

Completion

2014-12-31

Countries

• South Korea

Study Locations