Title: Prostate Resection versus Minimally Invasive Surgery Evaluation Trial- PREMISE trial
Funder: Department of Health and Social Care

Abstract: Aim: The aim of minimally invasive treatments (MITs) is to shorten hospital stays, decrease costs for the NHS and limit long-term side effects, whilst also treating symptoms for patients. This study aims to assess how well different MITs work for male urinary symptoms compared to standard treatment and see if it is good value for money for the NHS. _x000D_ _x000D_ Background: There are currently about 25,000 bladder outlet procedures per year performed on men in the UK to treat enlarged prostates. These vary from some done under local anaesthetic to more invasive resection or removal procedures. The National Institute for Health and Care Excellence (NICE) supports the use of two minimally invasive procedures but there is little evidence as to which treatment is likely to be of most benefit to particular categories of patients. This study will aim to answer this question. _x000D_ _x000D_ Design and methods:_x000D_ The MITs being investigated are called: water vapour ablation (Rezum), prostatic urethral lift (Urolift) and temporary implanted device (iTind) compared to the current standard treatment of Transurethral resection (cutting away) of prostate (TURP). The trial will randomly assign (by chance) 536 eligible men to receive one of these. As there are three MITs and one traditional standard treatment three men out of four entering the trial will be assigned a newer treatment._x000D_ _x000D_ Following treatment the main outcome will be the patient’s reported lower urinary tract symptoms measured using an existing patient questionnaire and a measure of their flow of urine. These outcomes will be measured twelve months after treatment. Other outcomes will include: sexual function, quality of life, costs and value for money to the NHS and acceptability to participants, long term outcomes and whether men would recommend the treatment to others. These outcomes will be assessed at 6, 12, 24 and 36 months._x000D_ _x000D_ _x000D_ Patient and public involvement: A patient advisory group (PAG) has been involved in the trial from the outset and have given guidance on trial design, interventions and outcomes. Members of the public will be involved with the trial literature and trial delivery including attendance at regular trial steering committee meetings._x000D_ _x000D_ The outcome of the trial will be disseminated and published in the medical and public domains and participants in the trial will be informed of the outcomes. Output from the trial will be incorporated into international guidelines and NICE guidance.

Lay abstract: A randomised trial of minimally invasive Surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service._x000D_ PREMISE Trial_x000D_ Prostate Resection versus Minimally Invasive Surgery Evaluation Trial_x000D_ _x000D_ 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? _x000D_ Design: multi-arm randomised control trial (RCT) trial for men who are being considered for surgical intervention to treat their lower urinary tract symptoms. _x000D_ 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._x000D_ 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._x000D_ 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._x000D_ Comparator: Trans urethral resection of prostate (TURP) is the standard comparator in most major trials assessing interventional treatments for BOO._x000D_ Outcomes: The primary outcome measure for men will be change in International prostate symptom score (IPSS) from baseline to 12 months post-intervention._x000D_ 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._x000D_ 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. _x000D_ 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._x000D_ Exploratory: Assessment of potential carbon cost of each intervention and its associated pathway will be quantified, in line with the NHS carbon reduction strategy._x000D_ 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.

Research activity codes: 6.4 SURGERY
Health categories: RENAL AND UROGENITAL