PREMISE: a surgical trial of minimally invasive treatments of prostate obstruction of the bladder

Not Applicable

• Conditions: Minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate; Surgery

• Registration Number: ISRCTN50571778
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Last Update Posted: 2 September 2024
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 536

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical effectiveness of treatments measured using change in international prostate symptom score (I-PSS) from baseline to 12 months post-intervention<br><br>Primary economic outcome measure:<br>2. Cost-effectiveness of treatments measured using incremental cost per quality-adjusted life year (QALY) gained at 12 months post-intervention.<br>2.1. Cost-effectiveness acceptability curves (CEACs) to assess the probability of each of the interventions being considered cost-effective at different willingness-to-pay (WTP) thresholds for a gained QALY<br>2.2. QALYs will be calculated using responses to the EQ-5D-5L questionnaire<br>