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ISRCTN
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ISRCTN75596544
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled cluster trial to evaluate an electronic system for assessing pelvic floor symptomatology in women
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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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N0059132289
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Study hypothesis
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We aim to evaluate the impact of a new electronic pelvic floor symptoms assessment questionnaire (e-PAQ) on the diagnosis and management of pelvic floor disorders, compared with traditional clinical interviewing. We propose to evaluate this system in a randomised, controlled cluster trial in the areas of pelvic floor medicine in which it is likely to be employed; community continence clinics (physiotherapists and continence nurses) and in secondary care (urologists, gynaecologists and colorectal surgeons). The study will focus on detection rates of symptoms, the patient's perspective of the clinical episode and subsequent referral rates and prescribing patterns.
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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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Pelvic floor symptoms
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Participants - inclusion criteria
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Sheffield patients
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/12/2003
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Anticipated end date
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01/10/2005
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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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Target recruitment: 1500
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Interventions
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A randomised controlled cluster trial of a new electronic pelvic floor symptoms assessment questionnaire (e-PAQ), compared with traditional clinical interviewing for the diagnosis and management of pelvic floor disorders
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Primary outcome measure(s)
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Added 28/01/10:
1. Factor analysis
2. Reliability
3. Validity
4. Patient satisfaction
5. Completion times
6. System costs
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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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1. Sheffield Teaching Hospitals NHS Foundation Trust (NHS R&D Support Funding)
2. Urogynaecology research fund
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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16412003
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18553041
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Contact name
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Mr
Steve
Radley
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Address
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STH NHS Trust
OGN & Midwifery
G18
Jessop Wing
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City/town
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Sheffield
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Zip/Postcode
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S10 2SF
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Country
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United Kingdom
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Tel
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+44 (0)114 271 2559
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Fax
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+44 (0)114 271 1901
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Email
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stephen.radley@sth.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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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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30/09/2004
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Last edited
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28/01/2010
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Date ISRCTN assigned
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30/09/2004
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