Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 8:04 PM
Study NCT ID:
NCT00530933
Status:
UNKNOWN
Last Update Posted:
2007-09-18
First Post:
2007-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tibial Nerve Stimulation for Faecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-09-15', 'studyFirstSubmitDate': '2007-09-15', 'studyFirstSubmitQcDate': '2007-09-15', 'lastUpdatePostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in the percentage of patients with a 20% reduction in episodes of faecal incontinence between the placebo and treatment groups.', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': "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.", 'timeFrame': '14 weeks'}, {'measure': 'The difference in the improvements in the urinary symptoms between placebo and treatment groups.', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '23300071', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.', 'detailedDescription': '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.\n\nThe 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.\n\nTibial 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 18\n* Incontinence to solid or liquid faeces\n\nExclusion Criteria:\n\n* Previous congenital or acquired spinal injury, spinal tumour or spinal surgery\n* Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease\n* Peripheral vascular disease\n* Diabetes mellitus\n* Congenital anorectal malformations\n* Previous rectal surgery (rectopexy / resection) done \\< 12 months ago (24 months for cancer)\n* Present evidence of external full thickness rectal prolapse\n* Chronic bowel diseases such as inflammatory bowel disease\n* Chronic diarrhoea, uncontrolled by drugs or diet\n* Anatomical limitations that would prevent successful placement of an electrode\n* Previous use of transcutaneous electrical nerve stimulation Stoma in situ"}, 'identificationModule': {'nctId': 'NCT00530933', 'briefTitle': 'Tibial Nerve Stimulation for Faecal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'London North West Healthcare NHS Trust'}, 'officialTitle': 'Prospective Randomised Placebo Controlled Study Into Percutaneous and Transcutaneous Tibial Nerve Stimulation for Faecal Incontinence', 'orgStudyIdInfo': {'id': '07/Q0405/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1', 'description': 'Sham tibial nerve stimulation', 'interventionNames': ['Procedure: Sham transcutaneous tibial nerve stimulation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Percutaneous tibial nerve stimulation', 'interventionNames': ['Procedure: Percutaneous posterior tibial nerve stimulation']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Transcutaneous tibial nerve stimulation', 'interventionNames': ['Procedure: Transcutaneous tibial nerve stimulation']}], 'interventions': [{'name': 'Percutaneous posterior tibial nerve stimulation', 'type': 'PROCEDURE', 'description': 'Once weekly for 30 minutes', 'armGroupLabels': ['2']}, {'name': 'Transcutaneous tibial nerve stimulation', 'type': 'PROCEDURE', 'description': '30 minutes once weekly', 'armGroupLabels': ['3']}, {'name': 'Sham transcutaneous tibial nerve stimulation', 'type': 'PROCEDURE', 'description': 'Once weekly for 30 minutes', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W9 3EF', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "St Mark's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'James Hollingshead, MRCS', 'role': 'CONTACT', 'email': 'james.hollingshead@nhs.net', 'phone': '020 8235 4081'}], 'overallOfficials': [{'name': 'James Hollingshead, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London North West Healthcare NHS Trust'}, {'name': 'Carolynne Vaizey, MD FRCS FCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'London North West Healthcare NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London North West Healthcare NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uroplasty, Inc', 'class': 'INDUSTRY'}]}}}