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ISRCTN
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ISRCTN84594746
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ClinicalTrials.gov identifier
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Public title
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Proposal for pilot randomised controlled trial of pelvic floor exercises for premature ejaculation
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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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N0620154903
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Study hypothesis
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Exploring the effectiveness of pelvic floor exercises for premature ejaculation.
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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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Pilot 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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Mental and Behavioural Disorders: Premature ejaculation (PE)
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Participants - inclusion criteria
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Not provided at time of registration
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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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18/10/2004
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Anticipated end date
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28/02/2007
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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15 men in each arm of the trial, total 30
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Interventions
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Treatment group of men with premature ejaculation (PE) receiving pelvic floor exercises and relaxation advice and a non-treatment control group of men with PE receiving only relaxation advice.
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Primary outcome measure(s)
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1. Subjects in both groups to be evaluated for PE initially, and at 3 months by completing a questionnaire.
2. Subjective & objective physiotherapy assessment to include digital anal measurements by clinician.
3. Assessment by Ros Wills, a physiotherapist who is blinded to the subject grouping.
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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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Exeter Primary Care Trust (UK)
Own account
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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Dr
Grace
Dorey
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Address
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Old Hill Farm
Portmore
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City/town
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Barnstaple
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Zip/Postcode
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EX32 0HR
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 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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Fax
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+44 (0)20 7307 2623
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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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30/09/2005
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Last edited
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31/03/2011
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Date ISRCTN assigned
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30/09/2005
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