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Tibial Nerve Stimulation for Faecal Incontinence

NCT ID: NCT00530933

Last Updated: 2007-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.

Detailed Description

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Sham tibial nerve stimulation

Group Type SHAM_COMPARATOR

Sham transcutaneous tibial nerve stimulation

Intervention Type PROCEDURE

Once weekly for 30 minutes

2

Percutaneous tibial nerve stimulation

Group Type EXPERIMENTAL

Percutaneous posterior tibial nerve stimulation

Intervention Type PROCEDURE

Once weekly for 30 minutes

3

Transcutaneous tibial nerve stimulation

Group Type EXPERIMENTAL

Transcutaneous tibial nerve stimulation

Intervention Type PROCEDURE

30 minutes once weekly

Interventions

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Percutaneous posterior tibial nerve stimulation

Once weekly for 30 minutes

Intervention Type PROCEDURE

Transcutaneous tibial nerve stimulation

30 minutes once weekly

Intervention Type PROCEDURE

Sham transcutaneous tibial nerve stimulation

Once weekly for 30 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uroplasty, Inc

INDUSTRY

Sponsor Role collaborator

London North West Healthcare NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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James Hollingshead, MRCS

Role: PRINCIPAL_INVESTIGATOR

London North West Healthcare NHS Trust

Carolynne Vaizey, MD FRCS FCS

Role: STUDY_DIRECTOR

London North West Healthcare NHS Trust

Locations

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St Mark's Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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James Hollingshead, MRCS

Role: CONTACT

Phone: 020 8235 4081

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 23300071 (View on PubMed)

Other Identifiers

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07/Q0405/13

Identifier Type: -

Identifier Source: org_study_id