Clinical Trial: Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Short Term Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence:Randomized Controlled Study

Brief Summary:

Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal incontinence patients without significant sphincteric lesions or rectal prolapse. However, the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the patients can develop a resistance to the SNS only a few months following the definite implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a new perspective. It consists in stimulating the same metameric area as the sacral nerves. It is regularly used for the treatment of urinary incontinence caused by overactive bladder. It is a non-invasive technique, causing but a few side effects. A preliminary study showed that 7 in 10 incontinent patients saw an improvement when treated with PTNS.

Purpose:

The aim of this study is to analyse and evaluate the PTNS technique in the short term as a treatment of anal incontinence. It is done through the means of a multi-centric prospective randomized study.

Patients:

Will be included: all patients followed for anal incontinence (either with liquid or solid stools) having at least one accident a month for 3months, and who are not diagnosed with colorectal lesions and who are without anal or rectal significant anatomic anomalies, without rectal prolapse, and who have failed to respond to medical treatment (such as medicine or perineal reeducation). The main criterium to analyze the efficiency will be the number of fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144 patients, tha

Detailed Summary:
Sponsor: University Hospital, Rouen

Current Primary Outcome: fecal incontinence episode per week [ Time Frame: three months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: cleveland clinic score FIQL score analogic visual scale urinary score and anorectal manometry [ Time Frame: 3 months ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: September 15, 2009
Date Started: October 2009
Date Completion:
Last Updated: August 22, 2011
Last Verified: August 2011