A randomised controlled trial comparing the efficacy, safety and cost-effectiveness of transurethral resection (TURP), laser vaporisation (LVAP), transurethral needle ablation (TUNA) and microwave thermoablation (MTA) of the prostate

ISRCTN	ISRCTN23921450
DOI	https://doi.org/10.1186/ISRCTN23921450
Protocol serial number	HTA 94/04/08
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Chris Chapple
Scientific

Department of Urology
Central Sheffield University Hospitals NHS Trust
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Phone	+44 (0)114 2712559/3047
Email	c.r.chapple@shef.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Efficacy, morbidity, cost and overall health gain.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/05/1999
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Senior
Sex	Male
Key inclusion criteria	Men over 60 years
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/06/1996
Date of final enrolment	31/05/1999

Department of Urology

Sheffield
S10 2JF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan