Condition category
Urological and Genital Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15698525

Publication citations

  1. 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.

Additional files

Editorial Notes