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Tibial Nerve Stimulation for Faecal Incontinence

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ClinicalTrials.gov Identifier: NCT00530933
Recruitment Status : Unknown
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was:  Recruiting
First Posted : September 18, 2007
Last Update Posted : September 18, 2007
Sponsor:
Collaborator:
Uroplasty, Inc
Information provided by:
London North West Healthcare NHS Trust

September 15, 2007
September 18, 2007
September 18, 2007
September 2007
Not Provided
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tibial Nerve Stimulation for Faecal Incontinence
Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence
The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Fecal Incontinence
  • 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
  • Sham Comparator: 1
    Sham tibial nerve stimulation
    Intervention: Procedure: Sham transcutaneous tibial nerve stimulation
  • Experimental: 2
    Percutaneous tibial nerve stimulation
    Intervention: Procedure: Percutaneous posterior tibial nerve stimulation
  • Experimental: 3
    Transcutaneous tibial nerve stimulation
    Intervention: Procedure: Transcutaneous tibial nerve stimulation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
66
Same as current
April 2009
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00530933
07/Q0405/13
No
Not Provided
Not Provided
Not Provided
London North West Healthcare NHS Trust
Uroplasty, Inc
Principal Investigator: James Hollingshead, MRCS London North West Healthcare NHS Trust
Study Director: Carolynne Vaizey, MD FRCS FCS London North West Healthcare NHS Trust
London North West Healthcare NHS Trust
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP