Tibial Nerve Stimulation for Faecal Incontinence
|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.|
|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
|Condition or disease||Intervention/treatment|
|Fecal Incontinence||Procedure: Percutaneous posterior tibial nerve stimulation Procedure: Transcutaneous tibial nerve stimulation Procedure: Sham transcutaneous tibial nerve stimulation|
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 (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence|
|Study Start Date :||September 2007|
|Estimated Study Completion Date :||April 2009|
Sham Comparator: 1
Sham tibial nerve stimulation
Procedure: Sham transcutaneous tibial nerve stimulation
Once weekly for 30 minutes
Percutaneous tibial nerve stimulation
Procedure: Percutaneous posterior tibial nerve stimulation
Once weekly for 30 minutes
Transcutaneous tibial nerve stimulation
Procedure: Transcutaneous tibial nerve stimulation
30 minutes once weekly
- 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 ]
- 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 ]
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
|Contact: James Hollingshead, MRCS||020 8235 firstname.lastname@example.org|
|St Mark's Hospital||Recruiting|
|London, United Kingdom, W9 3EF|
|Principal Investigator:||James Hollingshead, MRCS||London North West Healthcare NHS Trust|
|Study Director:||Carolynne Vaizey, MD FRCS FCS||London North West Healthcare NHS Trust|