Tibial Nerve Stimulation for Faecal Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Uroplasty, Inc
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00530933
First received: September 15, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by North West London Hospitals 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
North West London Hospitals NHS Trust
Uroplasty, Inc
Investigators
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 September 18, 2014