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 |
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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
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 |
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c.r.chapple@shef.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | Efficacy, morbidity, cost and overall health gain. |
Secondary outcome measures | Not provided at time of registration. |
Overall study start date | 01/06/1996 |
Completion date | 31/05/1999 |
Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Male |
Target number of participants | Not provided at time of registration. |
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
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Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |