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ISRCTN
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ISRCTN94747416
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DOI
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10.1186/ISRCTN94747416
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Evaluation of services for urinary dysfunction
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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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G9410491
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Study hypothesis
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The objective of the phase I trial is to compare a new Continence Nurse Practitioner (CNP) led service with existing service provision for individuals with incontinence and lower urinary tract symptoms in terms of symptom severity, associated factors, impact and economic implications. Treatment in the nursing service lasts eight weeks. The new nursing service delivers a package of evidence based interventions for the provision of continence care which are protocol driven.
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Lay summary
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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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Urinary dysfunction
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Participants - inclusion criteria
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Urinary dysfunction measured on a postal questionnaire (incontinence, nocturia, frequent voiding, urinary urgency)
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Participants - exclusion criteria
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1. Pregnancy
2. Malignancy
3. Fistula
4. Those already in receipt of treatment
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Anticipated start date
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01/06/1996
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Anticipated end date
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31/03/2002
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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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6000
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Interventions
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1. Existing service provision: general practitioners and primary health care team
2. Nurse led service provision: new service instituting evidence based assessment and interventions provided by specially trained nurses
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Primary outcome measure(s)
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An independent interview is carried out 13 weeks and 26 weeks after randomisation in both arms of the trial . This measures symptom severity, associated factors, impact (social and psychological) and economic aspects of the condition.
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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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Medical Research Council (UK)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12133054
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Contact name
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Dr
C
McGrother
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Address
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Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
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City/town
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Leicester
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Zip/Postcode
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LE1 2TP
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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12/09/2007
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Date ISRCTN assigned
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25/10/2000
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