Tibial Nerve Stimulation for Faecal Incontinence
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.
| Condition | Intervention |
|---|---|
|
Fecal Incontinence |
Procedure: Percutaneous posterior tibial nerve stimulation Procedure: Transcutaneous tibial nerve stimulation Procedure: Sham transcutaneous tibial nerve stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence |
- The difference in the percentage of patients with a 20% reduction in episodes of faecal incontinence between the placebo and treatment groups. [ Time Frame: 14 weeks ]
- 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. [ Time Frame: 14 weeks ]
- The difference in the improvements in the urinary symptoms between placebo and treatment groups. [ Time Frame: 14 weeks ]
| Estimated Enrollment: | 66 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | April 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: 1
Sham tibial nerve stimulation
|
Procedure: Sham transcutaneous tibial nerve stimulation
Once weekly for 30 minutes
|
|
Experimental: 2
Percutaneous tibial nerve stimulation
|
Procedure: Percutaneous posterior tibial nerve stimulation
Once weekly for 30 minutes
|
|
Experimental: 3
Transcutaneous tibial nerve stimulation
|
Procedure: Transcutaneous tibial nerve stimulation
30 minutes once weekly
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: James Hollingshead, MRCS | 020 8235 4081 | james.hollingshead@nhs.net |
| United Kingdom | |
| St Mark's Hospital | Recruiting |
| London, United Kingdom, W9 3EF | |
| Principal Investigator: | James Hollingshead, MRCS | North West London Hospitals NHS Trust |
| Study Director: | Carolynne Vaizey, MD FRCS FCS | North West London Hospitals NHS Trust |
More Information
No publications provided by North West London Hospitals NHS Trust
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00530933 History of Changes |
| Other Study ID Numbers: | 07/Q0405/13 |
| Study First Received: | September 15, 2007 |
| Last Updated: | September 15, 2007 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013