A randomised controlled trial of minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service
Minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate
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 different treatments in patients with bladder outlet obstruction due to enlarged prostate. 536 participants will be randomised to receive one of the 4 treatment options: Prostatic urethral lift (Urolift) vs Temporary Implantable Nitinol Device (iTIND) vs Water vapour ablation (Rezum) vs Transurethral resection of prostate (TURP). Potential patients within secondary care will be identified through dedicated Lower Urinary Tract Symptoms (LUTS) clinics and general urology clinics, as well as through database searches for patients already waiting to receive standard of care treatment. Potential patients will be screened and if eligible and willing to take part, they will be consented onto the trial. Trial participants will then be randomised to receive either TURP or one of the 3 minimally invasive procedures. As part of the trial the participant will have a number of clinical procedures performed and will complete questionnaires at various timepoints throughout the study. Participants will be given the option of completing the study questionnaires on paper and returning them in a pre-paid, addressed envelope, or completing them electronically. Consent will be sought from participants to be contacted by post, telephone, email and text message for the purposes of trial communication and completion of the study questionnaires. At the screening visit, following the participant giving consent to take part in the trial, demographic and medical history information will be taken, along with details of medications that the participant is currently taking. The following procedures may also be performed if they have not previously been performed as part of standard of care within the defined time period stated in the protocol; Prostate Ultrasound, Digital Rectal Exam and Flow test an
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.
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