Contact information
Type
Scientific
Primary contact
Mr Christopher Fowler
ORCID ID
Contact details
Academic Urological Unit
The Royal London Hospital
4th Floor
Alexandra Wing
Queen Mary and Westfield College
London
E1 1BB
United Kingdom
+44 (0)20 7377 7226
C.G.Fowler@mds.qmw.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/04/09
Study information
Scientific title
Acronym
Study hypothesis
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.
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
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Urological and genital diseases: Other urological and genital disease
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/06/1996
Overall trial end date
31/07/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
530 men with BPH causing bladder outflow obstruction will be recruited from four centres: one teaching hospital and three district general hospitals.
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
530
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/06/1996
Recruitment end date
31/07/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Urological Unit
London
E1 1BB
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
Basic results (scientific)
Publication list
2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15698525
Publication citations
-
HTA monograph
Fowler C, McAllister W, Plail R, Karim O, Yang Q, Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia., Health Technol Assess, 2005, 9, 4, iii-iv, 1-30.