Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/01/2010
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

Dr Jenny Donovan

ORCID ID

Contact details

University of Bristol
Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
+44 (0)117 928 7214
jenny.donovan@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The CLasP Study

Study hypothesis

We assessed the effectiveness of laser therapy versus transurethral prostatic resection in men with symptomatic chronic urinary retention secondary to benign prostatic enlargement.

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

Urological and genital diseases: Lower urinary tract symptoms

Intervention

1. Laser therapy involved neodymium:YAG noncontact visual prostate ablation
2. Transurethral prostatic resection (TURP) was performed by standard electroresection

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

I-PSS quality of life score, maximum urinary flow and post-void residual urine volume.

Secondary outcome measures

Treatment failure, complications, hospital stay and catheterization time.

Overall trial start date

01/10/1994

Overall trial end date

30/05/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Patients reporting moderate to severe lower urinary tract symptoms with an International Prostate Symptom Score (I-PSS) of 8 or more, benign prostatic enlargement and a persistent post-void residual urine volume of more than 300 ml.

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

Added 14/01/10: 82 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1994

Recruitment end date

30/05/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2PR
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 South West (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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10840425

Publication citations

  1. Results

    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.

Additional files

Editorial Notes