Tibial Nerve Stimulation for Faecal Incontinence

September 15, 2007 updated by: London North West Healthcare NHS Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W9 3EF
        • Recruiting
        • St Mark's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
14 weeks
The difference in the improvements in the urinary symptoms between placebo and treatment groups.
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (ANTICIPATED)

April 1, 2009

Study Registration Dates

First Submitted

September 15, 2007

First Submitted That Met QC Criteria

September 15, 2007

First Posted (ESTIMATE)

September 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2007

Last Update Submitted That Met QC Criteria

September 15, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/Q0405/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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