PREMISE
Research type
Research Study
Full title
A randomised controlled trial of minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service
IRAS ID
318198
Contact name
Tobias Page
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN50571778
Duration of Study in the UK
4 years, 6 months, 31 days
Research summary
Benign prostate enlargement (BPE) with ageing causes increasing bladder outlet obstruction (BOO), a situation known as benign prostatic obstruction (BPO). BPO is a major contributor to the emergence of lower urinary tract symptoms (LUTS). Voiding symptoms (e.g. slow stream, intermittency, hesitancy, straining, dribbling) and post voiding symptoms (e.g. post-micturition dribble) reflect problems occurring when passing urine or immediately after. Many men also experience storage symptoms (e.g. increased daytime urinary frequency, nocturia, urgency, incontinence). The most severe situation as BOO progresses is acute urinary retention, when a man becomes unable to pass urine at all, leading to painful bladder distension which requires emergency treatment with an indwelling catheter (IDC) to relieve the physical blockage until definitive treatment can be undertaken.
There are several types of surgery currently available for treatment of benign prostate enlargement. They all have different benefits and negatives, so we currently don’t know which type of surgery is best.
Transurethral resection of the prostate (TURP) has been the main surgery performed for treatment of benign prostate enlargement for a number of years, it is known to be effective and is a widespread and standardised procedure. This surgery requires a general anaesthetic and usually a 1 to 3 day hospital stay. More recently, a number of alternative minimally invasive surgeries have become available. These usually require a shorter time in hospital and potentially a lower risk of complications.
PREMISE will compare TURP with three other minimally invasive surgeries currently used in NHS practice (Rezum Water Vapour Therapy, Prostatic Urethral Lift and iTIND) to see which is most effective at treating symptoms caused by benign prostate enlargement, in order to inform future care within the NHS.REC name
North West - Preston Research Ethics Committee
REC reference
23/NW/0053
Date of REC Opinion
31 Mar 2023
REC opinion
Further Information Favourable Opinion