Prostate Resection versus Minimally Invasive Surgery Evaluation Trial- PREMISE trial

A randomised trial of minimally invasive Surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service. PREMISE Trial Prostate Resection versus Minimally Invasive Surgery Evaluation Trial Research question: What is the comparative clinical and cost effectiveness of minimally invasive treatments for the treatment of bladder outlet obstruction in men who would normally be offered surgery? Design: multi-arm randomised control trial (RCT) trial for men who are being considered for surgical intervention to treat their lower urinary tract symptoms. 536 participants will be followed for 3 years post-intervention, recruited from 10 sites across the UK. The trial includes a 6 month internal pilot. Blinding of patients to their treatment is not possible. Population: Men aged 50-85 years, prostate volume up to 80ml who are offered surgery for bladder outlet obstruction (BOO) within an NHS setting. Men with known prostate cancer or any previous minimally invasive or surgical treatment for BOO are excluded. Men who are unfit for spinal or general anaesthesia are ineligible. Interventions: Water vapour ablation (Rezum) vs Prostatic urethral lift (Urolift) vs Temporary Implantable Nitinol Device (iTIND). These Minimally invasive treatments (MITS) are proposed based on NICE guidance and current UK practice. Comparator: Trans urethral resection of prostate (TURP) is the standard comparator in most major trials assessing interventional treatments for BOO. Outcomes: The primary outcome measure for men will be change in International prostate symptom score (IPSS) from baseline to 12 months post-intervention. Primary economic outcome: Incremental cost per quality-adjusted life year (QALY) gained of the interventions at 12 months post-intervention; 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. Secondary Outcomes for all participants: objective measurement of bladder voiding efficiency (BVE) and maximum flow rate (Qmax) at 12 months post-intervention compared to baseline. Adverse events up to 6 months post-intervention. International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) at 6, 12, 24 and 36 months post-intervention. Other PROMs including sexual function, quality of life and general health up to 36 months post-intervention, assessed using validated questionnaires: IPSS-QOL, ICIQMLUTSsex, ICIQ-LUTSqol and EQ-5D-5L. Length of post-intervention hospital stay. Perioperative and post-intervention use of catheters. Number of BPE related hospital attendances. Number of patients requiring blood transfusions. Number of patients experiencing acute urinary retention up to 12 months post-intervention. Secondary economic outcomes: compare costs and quality of life post-intervention using average healthcare costs per participant, utility scores derived from responses to EQ-5D-5L and average QALYs per participant at 12 months post-intervention. QALY gained at 24 and 36 months post-intervention, cost-effectiveness acceptability curves. A longer-term model, extrapolating both costs, quality of life and incremental costs per QALY over a patient’s lifetime. Incremental net benefit of interventions. Exploratory: Assessment of potential carbon cost of each intervention and its associated pathway will be quantified, in line with the NHS carbon reduction strategy. Trial Timelines: The trial will take 71 months to complete. Months 0-9 set-up; months 10-15 pilot; months 16-29 main phase recruitment; months 30-65 follow up; months 66-71 data lock, analysis, trial report and site closedown.