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
Secondary identifying numbers HTA 94/04/08
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
14/10/2009
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Urological and Genital Diseases
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

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives50% 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) studiedBenign prostatic enlargement (BNE)
InterventionPlease note that this trial was terminated due to poor recruitment.

A comparison of the 4 surgical options: TURP, LVAP, TUNA and MTA
Intervention typeOther
Primary outcome measureEfficacy, morbidity, cost and overall health gain.
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/06/1996
Completion date31/05/1999
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupSenior
SexMale
Target number of participantsNot provided at time of registration.
Key inclusion criteriaMen over 60 years
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/06/1996
Date of final enrolment31/05/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Urology
Sheffield
S10 2JF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan