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 |
| Secondary identifying numbers | 941003 r245/02340 |
- 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
Scientific
University of Newcastle
Department of Surgery
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 7067 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 10/01/1994 |
| Completion date | 30/09/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Male |
| Target number of participants | 106 (added 15/01/10; see publication [2]) |
| 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
- England
- United Kingdom
Study participating centre
University of Newcastle
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 |
Study outputs
| Output type | Details | Date created | Date added | 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 | |
| Other publications | economic evaluation | 01/12/2002 | Yes | No | |
| Results article | results | 01/10/2003 | Yes | No |
