Condition category
Urological and Genital Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

Publication citations

Additional files

Editorial Notes