Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/01/2010
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

Prof David Neal

ORCID ID

Contact details

University of Newcastle
Department of Surgery
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 7067

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

941003 r245/02340

Study information

Scientific title

Acronym

The CLasP Study

Study hypothesis

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

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

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Treatment failure
2. Hospital stay
3. Major complications.

Overall trial start date

10/01/1994

Overall trial end date

30/09/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Men with uncomplicated lower urinary tract symptom that is not acute or chronic urinary retention.

Participant type

Patient

Age group

Other

Gender

Male

Target number of participants

106 (added 15/01/10; see publication [2])

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

10/01/1994

Recruitment end date

30/09/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Newcastle
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

1. 2000 results for men with chronic urinary retention in http://www.ncbi.nlm.nih.gov/pubmed/10840425
2. 2000 results for men with symptoms associated with benign prostatic enlargement in http://www.ncbi.nlm.nih.gov/pubmed/10840426
3. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11435848
4. 2002 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/12441944
5. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14596755

Publication citations

  1. Results for men with chronic urinary retention

    Gujral S, Abrams P, Donovan JL, Neal DE, Brookes ST, Chacko KN, Wright MJ, Timoney AG, Peters TJ, A prospective randomized trial comparing transurethral resection of the prostate and laser therapy in men with chronic urinary retention: The CLasP study., J. Urol., 2000, 164, 1, 59-64.

  2. Results for men with symptoms associated with benign prostatic enlargement

    Donovan JL, Peters TJ, Neal DE, Brookes ST, Gujral S, Chacko KN, Wright M, Kennedy LG, Abrams P, A randomized trial comparing transurethral resection of the prostate, laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement: The CLasP study., J. Urol., 2000, 164, 1, 65-70.

  3. Results

    Chacko KN, Donovan JL, Abrams P, Peters TJ, Brookes ST, Thorpe AC, Gujral S, Wright M, Kennedy LG, Neal DE, Transurethral prostatic resection or laser therapy for men with acute urinary retention: the ClasP randomized trial., J. Urol., 2001, 166, 1, 166-70; discussion 170-1.

  4. Economic evaluation

    Noble SM, Coast J, Brookes S, Neal DE, Abrams P, Peters TJ, Donovan JL, Transurethral prostate resection, noncontact laser therapy or conservative management in men with symptoms of benign prostatic enlargement? An economic evaluation., J. Urol., 2002, 168, 6, 2476-2482, doi: 10.1097/01.ju.0000035182.81727.be.

  5. Results

    Brookes S, Peters T, Campbell R, Featherstone K, Neal D, Abrams P, Donovan J, Including a 'no active intervention' arm in surgical trials is possible: evidence from the CLasP randomised trial., J Health Serv Res Policy, 2003, 8, 4, 209-214, doi: 10.1258/135581903322403272.

Additional files

Editorial Notes