Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000518066
Ethics application status
Not yet submitted
Date submitted
21/06/2010
Date registered
23/06/2010
Date last updated
23/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized trial comparing Transurethral resection of the prostate (TURP) with 120W photoselective vapourization of the prostate (PVP) in men with lower urinary tract symptoms
Scientific title
Laser vapourization of the prostate in men with benign prostate enlargement. Long term results and cost analysis.
Secondary ID [1] 252063 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign prostate enlargement 257601 0
Condition category
Condition code
Surgery 257776 257776 0 0
Surgical techniques
Renal and Urogenital 257805 257805 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laser vapourization of prostate (PVP) compared to TURP. PVP uses a 120W green light laser to vapourize prostate tissue to create an opening to allow an improved urinary flow. The procedure takes between 30 and 80 minutes. There is very little bleeding and saline can be used to washout the bladder.
Intervention code [1] 256689 0
Treatment: Surgery
Comparator / control treatment
TURP is the long established "gold standard" to improve urinary flow blocked by an enlarged prostate. An electrical current is used to remove chips of prostate. Whilst generally quicker than PVP there are risks of bleeding and fluid absorption. Saline cannot be used as an irrigant as it will not allow the passage of an electrical current.
Control group
Active

Outcomes
Primary outcome [1] 258645 0
The primary end point is urinary flow measured with a flow meter.
Timepoint [1] 258645 0
Pre operation 3 months, 1 year, 5 years following surgery
Primary outcome [2] 258670 0
Improvement in clinical symptoms assessed with the International prostate symptom score (IPSS)
Timepoint [2] 258670 0
Pre operation 3 months, 1 year, 5 years following surgery
Secondary outcome [1] 264618 0
Overall procedure costs - staff costs, theatre time, theatre disposables, pathology costs. All timings of cases will be recorded at the time of surgery and costs estimated using data provided by hospitals.
Timepoint [1] 264618 0
At time of surgery/admission and 5 years post surgery

Eligibility
Key inclusion criteria
Urinary flow rate < 15mls/sec, IPSS > 12
Minimum age
50 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prostate cancer, inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients offered access to trial from organisations operation waiting list. Computerized random number allocator with sealed envelopes representing either TURP or PVP
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed envelopes will have numbers on to be selected by random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257156 0
Hospital
Name [1] 257156 0
Southern Health
Country [1] 257156 0
Australia
Primary sponsor type
Individual
Name
Philip McCahy
Address
Department of Urology
Casey Hospital
Kangan Drive
Berwick
Vic 3806
Country
Australia
Secondary sponsor category [1] 256414 0
Hospital
Name [1] 256414 0
Department of Urology, Monash Medical Centre
Address [1] 256414 0
Monash Medical Centre Moorabbin
Centre Road
East Bentleigh
Vic 3165
Country [1] 256414 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259200 0
Southern Health
Ethics committee address [1] 259200 0
Monash Medical Centre
Clayton Road
Clayton
Vic 3168
Ethics committee country [1] 259200 0
Australia
Date submitted for ethics approval [1] 259200 0
01/07/2010
Approval date [1] 259200 0
Ethics approval number [1] 259200 0

Summary
Brief summary
PVP is a new procedure that may one day be able to replace TURP as the main treatment for men with benign prostate enlargement. There has only ever been one randomized controlled trial of PVP with TURP and this was using the now outdated 80W model. Recent advice from the UK National Institute for Health and Clinical Excellence has stated that PVP should only be used in the context of randomized controlled trials. We intend to assess whether the procedure has long term benefits for patients and whether it is cost efective for health providers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31308 0
Address 31308 0
Country 31308 0
Phone 31308 0
Fax 31308 0
Email 31308 0
Contact person for public queries
Name 14555 0
Mr Philip McCahy
Address 14555 0
Department of Urology
Casey Hospital
Kangan Drive
Berwick
Vic 3806
Country 14555 0
Australia
Phone 14555 0
+61 3 99288643
Fax 14555 0
+61 3 99288361
Email 14555 0
[email protected]
Contact person for scientific queries
Name 5483 0
Mr Philip McCahy
Address 5483 0
Department of Urology
Casey Hospital
Kangan Drive
Berwick
Vic 3806
Country 5483 0
Australia
Phone 5483 0
+61 3 99288643
Fax 5483 0
+61 3 99288361
Email 5483 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.