Tibial Nerve Stimulation for Faecal Incontinence
Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence
1 other identifier
interventional
66
1 country
1
Brief Summary
The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 15, 2007
CompletedFirst Posted
Study publicly available on registry
September 18, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedSeptember 18, 2007
September 1, 2007
September 15, 2007
September 15, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The difference in the percentage of patients with a 20% reduction in episodes of faecal incontinence between the placebo and treatment groups.
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.
14 weeks
The difference in the improvements in the urinary symptoms between placebo and treatment groups.
14 weeks
Study Arms (3)
1
SHAM COMPARATORSham tibial nerve stimulation
2
EXPERIMENTALPercutaneous tibial nerve stimulation
3
EXPERIMENTALTranscutaneous tibial nerve stimulation
Interventions
Eligibility Criteria
You may qualify if:
- Over 18
- Incontinence to solid or liquid faeces
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London North West Healthcare NHS Trustlead
- Uroplasty, Inccollaborator
Study Sites (1)
St Mark's Hospital
London, W9 3EF, United Kingdom
Related Publications (1)
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.
PMID: 23300071DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hollingshead, MRCS
London North West Healthcare NHS Trust
- STUDY DIRECTOR
Carolynne Vaizey, MD FRCS FCS
London North West Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2007
First Posted
September 18, 2007
Study Start
September 1, 2007
Study Completion
April 1, 2009
Last Updated
September 18, 2007
Record last verified: 2007-09