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ISRCTN
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ISRCTN28188933
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DOI
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10.1186/ISRCTN28188933
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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 the efficacy of pelvic floor therapies in the management of genuine stress incontinence
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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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To investigate the efficacy of standard pelvic floor therapies designed to strengthen pelvic floor and reduce incontinence in women with sphincteric incontinence.
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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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Incontinence
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Participants - inclusion criteria
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1. Failed conservative therapies for urinary dysfunction (nursing interventions) in women
2. Urodynamically proven genuine stress incontinence
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Participants - exclusion criteria
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1. Pregnancy
2. Malignancy
3. Fistula
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Anticipated start date
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01/06/1997
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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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345
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Interventions
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1. Vaginal cone therapy - the use of vaginal cones to build up pelvic floor contractions and to provide feedback about proper contraction.
2. Pelvic floor therapy - instructions on the contraction of the pelvic floor together with vaginal assessment to confirm proper contraction and bio-feedback.
3. Pelvic floor awareness - simple verbal and written instructions on contraction of the pelvic floor.
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Primary outcome measure(s)
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Clinical assessment using urinary diaries and 24 h home pad test and 1 h ICS pad test. Digital, perineometry and urodynamic evaluation of the pelvic floor and urinary sphincter.
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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 (MRC) (UK)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17034605
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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 6TP
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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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07/10/2009
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Date ISRCTN assigned
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25/10/2000
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