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ISRCTN
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ISRCTN16113281
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ClinicalTrials.gov identifier
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Public title
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A Randomised Controlled Trial to Assess the Effectiveness and Cost Effectiveness of TURP, Laser and Watchful Waiting in the Treatment of Bladder Outflow Obstruction
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Scientific title
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Acronym
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The CLasP Study
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Serial number at source
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941003 r245/02340
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Study hypothesis
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Ten to fifteen percent of men aged 40 undergo transurethral prostatectomy (TURP) in their lifetime.
About 20% do not achieve satisfactory symptomatic results, 5% to 10% suffer major morbidity and 0.2% to 1% die from the procedure. The annual cost of TURP in the USA is in excess of $3,000,000,000. New, less invasive treatments are now available including laser treatment which may be provided as a day-case procedure. It is unclear how laser treatment compares with TURP or indeed with conservative treatment (watchful waiting - reassurance and advice) in terms of cost, effectiveness, improvement in quality of life and urodynamic outcome. These deficiencies in knowledge are clearly very important to the NHS which cannot afford to take up high cost, high technology treatments unless they are shown to be of clear benefit. We propose carrying out a randomised controlled trial comparing TURP, laser treatment and watchful waiting in men who would normally undergo TURP.
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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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Men with uncomplicated lower urinary tract symptom that is not acute or chronic urinary retention.
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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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10/01/1994
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Anticipated end date
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30/09/1997
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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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Not provided at time of registration
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Interventions
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i. Laser therapy with a noncontact, side firing neodymium:YAG probe
ii. TURP (standard transurethral prostatic resection)
iii. Watchful waiting (conservative management, including monitoring without active intervention)
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Primary outcome measure(s)
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Primary outcomes were International Prostate Symptom Score (I-PSS), maximum urinary flow rate, a composite measure of success based on I-PSS and maximum urinary flow rate categories, I-PSS quality of life score and post-void residual urine volume.
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Secondary outcome measure(s)
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Secondary outcomes included treatment failure, hospital stay and major complications.
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Sources of funding
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NHS Executive Northern and Yorkshire
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Trial website
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Publications
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Contact name
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Prof
David
Neal
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Address
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University of Newcastle
Department of Surgery
Framlington Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Tel
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+44 0191 222 7067/232 5131 ext 24719
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Fax
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+44 0191 222 8514
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Email
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d.e.neal@ncl.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - 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.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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21/11/2005
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Date ISRCTN assigned
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23/01/2004
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