NCT00530933

Tibial Nerve Stimulation for Faecal Incontinence

Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: London North West Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
PROCEDURE	Percutaneous posterior tibial nerve stimulation	Once weekly for 30 minutes
PROCEDURE	Transcutaneous tibial nerve stimulation	30 minutes once weekly
PROCEDURE	Sham transcutaneous tibial nerve stimulation	Once weekly for 30 minutes

Timeline

• Start date: 2007-09-01
• Completion: 2009-04-01
• First posted: 2007-09-18
• Last updated: 2007-09-18

Locations

1 site across 1 country: United Kingdom