Clinical trial NCT00530933: Tibial Nerve Stimulation for Faecal Incontinence
Official title: Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Uroplasty, Inc
First posted: 2007-09-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference in the percentage of patients with a 20% reduction in episodes of faecal incontinence between the placebo and treatment groups.
timeFrame: 14 weeks
Secondary outcomes:
measure: 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.
timeFrame: 14 weeks
measure: The difference in the improvements in the urinary symptoms between placebo and treatment groups.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mark's Hospital
Study officials:
affiliation: London North West Healthcare NHS Trust
name: James Hollingshead, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: London North West Healthcare NHS Trust
name: Carolynne Vaizey, MD FRCS FCS
role: STUDY_DIRECTOR
References:
citation: George AT, Kalmar K, Sala S, Kopanakis K, Panarese A, Dudding TC, Hollingshead JR, Nicholls RJ, Vaizey CJ. Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in faecal incontinence. Br J Surg. 2013 Feb;100(3):330-8. doi: 10.1002/bjs.9000.