Tibial Nerve Stimulation for Faecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00530933
• Other study ID #: 07/Q0405/13
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2007
• Last updated: September 15, 2007
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2007
• Source: London North West Healthcare NHS Trust
• Contact: James Hollingshead, MRCS
• Phone: 020 8235 4081
• Email: james.hollingshead[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18

• Incontinence to solid or liquid faeces

Exclusion Criteria:

• Previous congenital or acquired spinal injury, spinal tumour or spinal surgery

• Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease

• Peripheral vascular disease

• Diabetes mellitus

• Congenital anorectal malformations

• Previous rectal surgery (rectopexy / resection) done < 12 months ago (24 months for cancer)

• Present evidence of external full thickness rectal prolapse

• Chronic bowel diseases such as inflammatory bowel disease

• Chronic diarrhoea, uncontrolled by drugs or diet

• Anatomical limitations that would prevent successful placement of an electrode

• Previous use of transcutaneous electrical nerve stimulation Stoma in situ

Study Design

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Procedure:
• Percutaneous posterior tibial nerve stimulation
Once weekly for 30 minutes
• Transcutaneous tibial nerve stimulation
30 minutes once weekly
• Sham transcutaneous tibial nerve stimulation
Once weekly for 30 minutes

Locations

Country	Name	City	State
United Kingdom	St Mark's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust	Uroplasty, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the percentage of patients with a 20% reduction in episodes of faecal incontinence between the placebo and treatment groups.		14 weeks
Secondary	The difference in the improvements in the St Mark's incontinence score, quality of life scales, and physiological parameters between the treatment and placebo groups.		14 weeks
Secondary	The difference in the improvements in the urinary symptoms between placebo and treatment groups.		14 weeks