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ISRCTN
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ISRCTN53547889
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ClinicalTrials.gov identifier
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Public title
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Volitional control of the pelvic floor in incomplete spinal cord injury
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0209178291
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Study hypothesis
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This proposal is for a pilot study to determine the extent of residual voluntary control over the pelvic floor muscles and to investigate the training effects of these muscles on changes in strength of the pelvic sphincters and involuntary contractions of the urinary bladder in incomplete spinal cord injury. A positive outcome from this study will be used to establish funding for a broader based programme of research.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and Genital Diseases:
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Participants - inclusion criteria
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Subjects with in incomplete spinal cord injury.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/2005
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Anticipated end date
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01/04/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Single randomised within-subject cross-over study in comparing the interventional effects of volitional pelvic floor muscle training (PFMT) with our standard dorsal penile nerve (DPN) electrical stimulation techniques (neuromodulation) on bladder and sphincter function in male patients with an incomplete spinal cord injury. Randomisation of intervention will help to ensure control of order effect. The principal measures will be the percentage inhibition on neurogenic detrusor overactivity, percentage changes in bladder capacity and percentage changes in sphincter strength and dyssynergia.
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Primary outcome measure(s)
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Extent of residual voluntary control over the pelvic floor muscles.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Royal National Orthopaedic Hospital NHS Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Prof
Michael Duncan
Craggs
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Address
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RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
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City/town
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Stanmore
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Zip/Postcode
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HA7 4LP
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Country
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United Kingdom
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Tel
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+44 x 5343
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Fax
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+44 020 8909 5343
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Email
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michael.craggs@ucl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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29/09/2006
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Date ISRCTN assigned
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29/09/2006
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