Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia (BPH).

ISRCTN	ISRCTN53810731
DOI	https://doi.org/10.1186/ISRCTN53810731
Secondary identifying numbers	HTA 94/04/09

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Christopher Fowler
Scientific

Academic Urological Unit
The Royal London Hospital
4th Floor
Alexandra Wing
Queen Mary and Westfield College
London
E1 1BB
United Kingdom

Phone	+44 (0)20 7377 7226
Email	C.G.Fowler@mds.qmw.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Scientific title	Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia (BPH).
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/1996
Completion date	31/07/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	530
Key inclusion criteria	530 men with BPH causing bladder outflow obstruction will be recruited from four centres: one teaching hospital and three district general hospitals.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/06/1996
Date of final enrolment	31/07/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Urological Unit

London
E1 1BB
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"	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 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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/02/2005		Yes	No

Editorial Notes

08/11/2022: Internal review.