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Tibial Nerve Stimulation for Faecal Incontinence

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530933
First Posted: September 18, 2007
Last Update Posted: September 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Uroplasty, Inc
Information provided by:
London North West Healthcare NHS Trust
  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 (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence

Resource links provided by NLM:


Further study details as provided by London North West Healthcare NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530933


Contacts
Contact: James Hollingshead, MRCS 020 8235 4081 james.hollingshead@nhs.net

Locations
United Kingdom
St Mark's Hospital Recruiting
London, United Kingdom, W9 3EF
Sponsors and Collaborators
London North West Healthcare NHS Trust
Uroplasty, Inc
Investigators
Principal Investigator: James Hollingshead, MRCS London North West Healthcare NHS Trust
Study Director: Carolynne Vaizey, MD FRCS FCS London North West Healthcare NHS Trust
  More Information

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
First Submitted: September 15, 2007
First Posted: September 18, 2007
Last Update Posted: September 18, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases