Contact information
Type
Scientific
Primary contact
Mr Chris Chapple
ORCID ID
Contact details
Department of Urology
Central Sheffield University Hospitals NHS Trust
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 (0)114 2712559/3047
c.r.chapple@shef.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/04/08
Study information
Scientific title
Acronym
Study hypothesis
50% of men over 60 years will experience symptoms attributable to benign prostatic enlargement (BNE). The traditional treatment of TURP is efficacious but carries a mortality of 0.5-1% rising to 8% in the over 80s. The overall morbidity is around 80% and has significant implications for quality of life following surgery. The proposed RCT will comprehensively compare the four surgical options TURP, LVAP TUNA and MTA in terms of efficacy, morbidity, cost and overall health gain. The evidence will be used to examine the relative efficiency of each alternative. Clinicians and purchasers of health care need the results of such analyses before deciding whether or not to invest finite resources in newer treatments.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Benign prostatic enlargement (BNE)
Intervention
Please note that this trial was terminated due to poor recruitment.
A comparison of the 4 surgical options: TURP, LVAP, TUNA and MTA
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Efficacy, morbidity, cost and overall health gain.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/06/1996
Overall trial end date
31/05/1999
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
Men over 60 years
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/06/1996
Recruitment end date
31/05/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Urology
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary