Tibial Nerve Stimulation for Faecal Incontinence

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.

Clinical Trial Description

Faecal incontinence is a common problem, affecting approximately 2% of the adult general population. Initial management involves dietary advice, anti−diarrhoeal medication, and behavioural therapy. In those who have not benefited from these conservative techniques sacral nerve stimulation is an established and effective treatment for faecal incontinence. This treatment involves using electrical pulses to stimulate the S3 nerve root − a nerve at the bottom of the back. These are the nerves which supply the lower end of the bowel, and the anal sphincter. It is believed that it is stimulation of the sensory fibres heading back towards the spinal cord at this level which is important for the therapeutic effect. To stimulate the sacral nerves however requires two operations under general anaesthetic, and surgical implantation of an expensive nerve stimulator.

The tibial nerve also contains fibres that arise from the S3 part of the spinal cord. Electrical stimulation of the tibial nerve will therefore send sensory information back to the same region of the spinal cord as sacral nerve stimulation. The tibial nerve is much more easily accessible on the inside of the ankle, and this allows stimulation to be carried out as an outpatient and without the need for surgery. It can be performed either percutaneously (with a fine needle placed through the skin to sit next to the nerve), or transcutaneously.

Tibial nerve stimulation has been successfully used for patients with urinary incontinence. There are small studies looking at tibial nerve stimulation for faecal incontinence which both show a benefit, but these studies are not controlled. We aim to determine in a randomised controlled trial whether either percutaneous or transcutaneous tibial nerve stimulation is an effective treatment for faecal incontinence. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Fecal Incontinence

Clinical Trial Details

NCT number	NCT00530933
Study type	Interventional
Source	London North West Healthcare NHS Trust
Contact	James Hollingshead, MRCS
Phone	020 8235 4081
Email	james.hollingshead@nhs.net
Status	Recruiting
Phase	N/A
Start date	September 2007
Completion date	April 2009

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.