A Randomised Controlled Trial to Assess the Effectiveness and Cost Effectiveness of TURP, Laser and Watchful Waiting in the Treatment of Bladder Outflow Obstruction

ISRCTN	ISRCTN16113281
DOI	https://doi.org/10.1186/ISRCTN16113281
Protocol serial number	941003 r245/02340
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 18/01/2010

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

Prof David Neal
Scientific

University of Newcastle
Department of Surgery
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 7067

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The CLasP Study
Study objectives	Ten to fifteen percent of men aged 40 undergo transurethral prostatectomy (TURP) in their lifetime. About 20% do not achieve satisfactory symptomatic results, 5% to 10% suffer major morbidity and 0.2% to 1% die from the procedure. The annual cost of TURP in the USA is in excess of $3,000,000,000. New, less invasive treatments are now available including laser treatment which may be provided as a day-case procedure. It is unclear how laser treatment compares with TURP or indeed with conservative treatment (watchful waiting - reassurance and advice) in terms of cost, effectiveness, improvement in quality of life and urodynamic outcome. These deficiencies in knowledge are clearly very important to the NHS which cannot afford to take up high cost, high technology treatments unless they are shown to be of clear benefit. We propose carrying out a randomised controlled trial comparing TURP, laser treatment and watchful waiting in men who would normally undergo TURP.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bladder outflow obstruction in men
Intervention	1. Laser therapy with a noncontact, side firing neodymium:YAG probe 2. TURP (standard transurethral prostatic resection) 3. Watchful waiting (conservative management, including monitoring without active intervention)
Intervention type	Other
Primary outcome measure(s)	1. International Prostate Symptom Score (I-PSS) 2. Maximum urinary flow rate 3. A composite measure of success based on I-PSS and maximum urinary flow rate categories 4. I-PSS quality of life score 5. Post-void residual urine volume
Key secondary outcome measure(s)	1. Treatment failure 2. Hospital stay 3. Major complications.
Completion date	30/09/1997

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Male
Target sample size at registration	106
Key inclusion criteria	Men with uncomplicated lower urinary tract symptom that is not acute or chronic urinary retention.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	10/01/1994
Date of final enrolment	30/09/1997

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Newcastle

Newcastle upon Tyne
NE2 4HH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results for men with chronic urinary retention	01/07/2000	Yes	No
Results article	results for men with symptoms associated with benign prostatic enlargement	01/07/2000	Yes	No
Results article	results	01/07/2001	Yes	No
Results article	results	01/10/2003	Yes	No
Other publications	economic evaluation	01/12/2002	Yes	No