Fecal IncontinenceNCT00530933
Tibial Nerve Stimulation for Faecal Incontinence
A study testing Percutaneous posterior tibial nerve stimulation and Transcutaneous tibial nerve stimulation in people with Fecal Incontinence, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Percutaneous posterior tibial nerve stimulation and Transcutaneous tibial nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18
- Incontinence to solid or liquid faeces
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Mark's Hospital
London, W9 3EF
About this study
Official title: 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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Percutaneous posterior tibial nerve stimulation, Transcutaneous tibial nerve stimulation, Sham transcutaneous tibial nerve stimulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous posterior tibial nerve stimulationProcedure or surgery
Once weekly for 30 minutes
Transcutaneous tibial nerve stimulationProcedure or surgery
30 minutes once weekly
Sham transcutaneous tibial nerve stimulationProcedure or surgery
Once weekly for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Sham tibial nerve stimulation Receives: Procedure: Sham transcutaneous tibial nerve stimulation |
| 2 | Experimental | Percutaneous tibial nerve stimulation Receives: Procedure: Percutaneous posterior tibial nerve stimulation |
| 3 | Experimental | Transcutaneous tibial nerve stimulation Receives: Procedure: Transcutaneous tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the percentage of patients with a 20% reduction in episodes of faecal incontinence between the placebo and treatment groups.
Measured: 14 weeks
Secondary outcomes (2)
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.
Measured: 14 weeks
The difference in the improvements in the urinary symptoms between placebo and treatment groups.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startSep 2007
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Uroplasty, Inc
- Investigators
- James Hollingshead, MRCS, Principal investigator, London North West Healthcare NHS TrustCarolynne Vaizey, MD FRCS FCS, Study director, London North West Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530933
- Sponsor's protocol ID
- 07/Q0405/13
- Status last verified
- Sep 2007
- First submitted
- 15 Sep 2007
- Last updated
- 18 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23300071
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence
- ClinicalTrials.gov ID
- NCT00530933
- Acronym / sponsor ID
- 07/Q0405/13
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Uroplasty, Inc
- Study start
- Sep 2007
- Study completion
- Apr 2009 (estimated)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Procedure: Sham transcutaneous tibial nerve stimulationSham tibial nerve stimulation |
| 2 | Experimental | Procedure: Percutaneous posterior tibial nerve stimulationPercutaneous tibial nerve stimulation |
| 3 | Experimental | Procedure: Transcutaneous tibial nerve stimulationTranscutaneous tibial nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18
- Incontinence to solid or liquid faeces
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous posterior tibial nerve stimulationOnce weekly for 30 minutes | Procedure or surgery | 2 |
| Transcutaneous tibial nerve stimulation30 minutes once weekly | Procedure or surgery | 3 |
| Sham transcutaneous tibial nerve stimulationOnce weekly for 30 minutes | Procedure or surgery | 1 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2007.
- Derived from this study: PubMed 23300071George 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hollingshead, MRCS principal investigator
London North West Healthcare NHS Trust
Carolynne Vaizey, MD FRCS FCS study director
London North West Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous posterior tibial nerve stimulation and Transcutaneous tibial nerve stimulation in people with Fecal Incontinence, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Hollingshead, MRCS (020 8235 4081, james.hollingshead@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2007.