ISRCTN50571778
Active, not recruiting
未知
A randomised controlled trial of minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service
ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites536 target enrollmentMay 10, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate
- Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Enrollment
- 536
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men aged 50 years or over
- •2\. Prostate volume up to 80cc (measured by ultrasound or cross\-sectional scan)
- •3\. Eligible for surgery for presumed Bladder Outlet Obstruction with an NHS setting
- •4\. Willing and able to comply with trial procedures, visit schedules, trial restrictions and requirements.
- •5\. Willing and able to provide informed consent.
Exclusion Criteria
- •1\. Any known or suspected prostate cancer treated or untreated; (If known) PSA \> \= 0\.15
- •2\. Known or suspected neuropathic bladder dysfunction
- •3\. Any previous minimally invasive or surgical treatment to the prostate or bladder outlet.
- •4\. Contraindication for both spinal and general anaesthesia
- •5\. Catheterised or self catheterising
- •6\. Predicted life expectancy less than 3 years
- •7\. Participation in any other current interventional trial
Outcomes
Primary Outcomes
Not specified
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