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ISRCTN
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ISRCTN53810731
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ClinicalTrials.gov identifier
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Public title
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Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia (BPH).
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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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HTA 94/04/09
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Study hypothesis
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Many of the newer means of treating symptomatic BPH require expensive new equipment which requires significant additional capital investment. We consider that before investing in such equipment we should evaluate cheaper electrosurgical methods which may be similarly efficacious.
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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: Other urological and genital disease
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Participants - inclusion criteria
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530 men with BPH causing bladder outflow obstruction will be recruited from four centres: one teaching hospital and three district general hospitals.
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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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01/06/1996
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Anticipated end date
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31/12/2000
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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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530
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Interventions
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1. Transurethral resection of the prostate (TURP)
2. Transurethral diathermy vaporisation of the prostate (TUDVP).
Perioperative complications and time to discharge, determined by strictly defined criteria will be compared.
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Primary outcome measure(s)
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The efficacy of the operation will be assessed by symptom scores, urine flow rate studies at two months and one year after surgery. A questionnaire covering adverse events, quality of life, impact on sexual function and customer satisfaction will be administered preoperatively and at each visit by a trained nurse counsellor. This trial will be coordinated and the results analysed for safety, effectiveness and cost benefit in collaboration with the Prostate trials Office (PROTO) at Bristol.
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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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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15698525
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Contact name
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Mr
Christopher
Fowler
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Address
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Academic Urological Unit
The Royal London Hospital
4th Floor
Alexandra Wing
Queen Mary and Westfield College
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City/town
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London
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Zip/Postcode
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E1 1BB
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Country
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United Kingdom
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Tel
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+44 (0)20 7377 7226
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Fax
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+44 (0)20 7377 8760
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Email
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C.G.Fowler@mds.qmw.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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15/01/2008
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Date ISRCTN assigned
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25/04/2003
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