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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000518066
• Date of registration: 23/06/2010
• Prospective Registration: Yes
• Primary sponsor: Philip McCahy
• 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.
• Date of first enrolment: 01/09/2010
• Target sample size: 150
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12610000518066.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mr Philip McCahy

• Name: Mr Philip McCahy

Key inclusion & exclusion criteria

Inclusion criteria: Urinary flow rate < 15mls/sec, IPSS > 12
Exclusion criteria: Prostate cancer, inability to provide informed consent

Age minimum: 50 Years
Age maximum: 85 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Surgery - Surgical techniques

Benign prostate enlargement;
Benign prostate enlargement

Renal and Urogenital - Other renal and urogenital disorders

Intervention(s)

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.

Primary Outcome(s)

Improvement in clinical symptoms assessed with the International prostate symptom score (IPSS)[Pre operation 3 months, 1 year, 5 years following surgery]

The primary end point is urinary flow measured with a flow meter.[Pre operation 3 months, 1 year, 5 years following surgery]

Secondary Outcome(s)

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.[At time of surgery/admission and 5 years post surgery]

Secondary ID(s)

None

Source(s) of Monetary Support

Southern Health

Secondary Sponsor(s)

Department of Urology, Monash Medical Centre

Ethics review

Status: Not approved
Approval date:
Contact:

Southern Health