Minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate Surgery
Conditions
Interventions
PREMISE is a multi-arm, multi centre, randomised controlled trial that will take place over 10 different sites/Urology Area Networks.
PREMISE is looking at the clinical and cost effectiveness of diff
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Age
50 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/08/2025: 1. Men aged 50 years or over 2. Prostate volume of between 30 ml (cm³) and up to and including 80 ml (cm³) measured by ultrasound or cross-sectional scan 3. Eligible for surgery for presumed Bladder Outlet Obstruction in 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. _____ Previous 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 in 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
Exclusion criteria: Current key exclusion criteria as of 01/04/2026: 1. Any known or suspected prostate cancer treated or untreated; (If PSA has been performed outside of trial investigations, PSA density =0.15 would be an exclusion unless prostate cancer has been excluded) 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 (only for patients where TURP is among their selected treatment options for randomisation) 5. Catheterised or catheter-dependent self-catheterising patients 6. Predicted life expectancy is less than 3 years 7. Active participation in another interventional urological trial where the ongoing intervention may impact the outcome of this trial _____ Previous exclusion criteria as of 15/08/2025: 1. Any known or suspected prostate cancer treated or untreated; (If PSA has been performed outside of trial investigations, PSA density =0.15 would be an exclusion unless prostate cancer has been excluded) 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 catheter-dependent self-catheterising patients 6. Predicted life expectancy is less than 3 years 7. Active participation in another interventional urological trial where the ongoing intervention may impact the outcome of this trial _____ Previous 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 is less than 3 years 7. Participation in any other current interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical effectiveness of treatments measured using change in international prostate symptom score (I-PSS) from baseline to 12 months post-intervention Primary economic outcome measure: 2. Cost-effectiveness of treatments measured using incremental cost per quality-adjusted life year (QALY) gained at 12 months post-intervention. 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 2.2. QALYs will be calculated using responses to the EQ-5D-5L questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 01/04/2026: 1. Impact on bladder voiding efficiency (BVE) and maximum flow rate (Qmax) measured using change from baseline to 12 months post-intervention in post-void residual and Maximum flow rate (Qmax) 2. Adverse events up to 6 months post-intervention collected via Operative parameters and Adverse event review at 6 weeks and 6 months post-intervention 3. Incontinence measured using International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) at baseline, 6 months, 12 months, 2 and 3 years post-intervention 4. Sexual function measured using ICIQ-MLUTSsex at baseline, 6 months, 12 months, 2 and 3 years post-intervention 5. Quality of life and general health measured using: 5.1. I-PSS-QOL at baseline, 6 months, 12 months, 2 and 3 years post-intervention 5.2. ICIQ-LUTSqol at baseline, 6 months, 12 months, 2 and 3 years post-intervention 5.3. EQ-5D-5L at baseline, 6 weeks post-intervention, 6 months, 12 months, 2 and 3 years post-intervention 6. Establish the most suitable outcome measure for the context of male LUTS intervention by correlation of I-PSS / ICIQ-MLUTS 7. Impact of urinary and sexual symptoms on quality of life measured by correlation of overall QOL (ICIQ-LUTSqol) with symptom scores from ICIQ-MLUTSsex and I-PSS questionnaires 8. Length of post-intervention hospital stay measured using patient records 9. Use of perioperative and post-intervention catheterisation duration and subsequent use of catheters up to 3 years post-intervention, measured using patient records 10. Number of hospital attendances (inpatient or outpatient visits) for events/conditions possibly associated with BPE, condition progression, intervention (including routine follow-up appointments post-intervention) or treatment failure up to 12 months post-intervention 11. Number of patients requiring blood transfusions up to 6 weeks post-intervention measured using patient records 12. Number of patie | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed