A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate(ThuVARP)versus transurethral resection of the prostate(TURP)in the National Health Service(NHS).
A large NHS trial is directly comparing a newer laser prostate surgery against the standard operation to see which is more effective and cheaper for the health service. The problem is that while the standard operation—transurethral resection of the prostate (TURP)—works well for men with an enlarged prostate causing urinary symptoms or retention, it carries risks of bleeding and longer hospital stays. The newer thulium laser technique (ThuVARP) may be safer, but the evidence is weak: only one small randomised trial, conducted in China, has directly compared the two. This UK trial will recruit men across six hospitals, from teaching centres to district generals, to provide robust, real-world data. If ThuVARP proves clinically equivalent to TURP but with fewer complications and lower costs, it could become the new standard procedure in the NHS. That would mean shorter hospital stays, fewer readmissions for bleeding, and quicker recovery for the thousands of men who undergo prostate surgery each year. The trial also measures quality of life and broader societal costs, including time off work, giving funders a clear picture of value for money.
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Design: In this pragmatic study design, centres will use their usual practices, for example, discretionary pressure-flow urodynamics for patient selection, or use of monopolar or bipolar TURP. Follow-up will be at 3 & 12 months (primary endpoint), from the time of surgery (also the time of randomisation) for the patient reported outcome (PRO) of the International Prostate Symptom Score(IPSS) and the maximum urine flow rate (Qmax). Patients will be asked to complete PROs at 6 weeks after surgery (by post) and at 3 & 12 months at clinic visits. To increase compliance with follow-up patients will be reminded by phone to complete their PROs and to attend their appointments. Setting: The study will be conducted in 3 university teaching hospitals (Bristol, Aberdeen, Newcastle) and 3 district general hospitals (Swindon, Cheltenham, Bath). Strategy for reviewing literature: European Urology, the leading urology journal, has recently published a systematic review of laser technology in Urology which recommended ThuVARP as an acceptable alternative to TURP for the treatment of symptomatic BPO. These recommendations were based on 6 studies of ThuVARP: two with a control group but only one randomised controlled trial (RCT). The RCT was conducted in China and randomised 100 consecutive men to ThuVARP or TURP at a single centre. A further case series from a UK centre has been published since the review showing good intermediate-term results. A paper published December 2012 showed that ThuVARP is a safe procedure compared to TURP. Target population: Men who are fit to have prostate surgery for either bothersome lower urinary tract symptoms (LUTS), or urinary retention, secondary to BPO. Measurement of costs and outcomes: The cost-effectiveness analysis will take a societal perspective with NHS costs reported separately. Only resources used in relation to the treatment of LUTS, or urinary retention, secondary to BPO will be measured from randomisation at the time of surgery to 12 months follow-up. Details of initial hospital stay resource use e.g. operation duration, operating staff, consumables, the time spent in recovery, length of stay on different wards, overall length of stay and treatment for complications will be collected on study designed case report forms by the research nurse at the time of the inpatient/day-case stay for the initial surgery. At 12 months follow-up, any subsequent in-patient stays, out-patient visits and procedures occurring in the initial treating hospitals will be abstracted from the patients’ medical records. On discharge from hospital and at 3 months follow-up the patients will be given a study designed Resource Use Log (RUL) to be used as an aide memoire in which to record NHS community based and other NHS hospital health care use, medications, social service resource use in addition to travel, time off work/usual activities and any other expenses resulting from their treatment. These logs will reflect the design of the 3 & 12 month resource use questionnaires. At 3 & 12 months follow-up, self-completed resource use questionnaire will be given to the patients to fill out, using the information from the RUL. The EQ-5D-5L will be used to calculate quality adjusted life years (QALYs). The new 5-level EQ-5D will be used in preference to the 3-level one, owing to its improved discriminatory power. The IPSS and Qmax are internationally accepted and the most frequently used primary outcomes in BPO studies, thereby making results from this study comparable to others. There are no core outcomes measures for BPO listed in the COMET Initiative website. Sample size: This study is powered to establish equivalence in clinical improvement. The Chinese trial observed differences of 0.4 ml/s (95% CI: -2.0 to 2.8) in Qmax and 0.4 units(-0.7 to 1.5) in IPSS between ThuVARP and TURP. Variability(standard deviation;SD) in data at 12 months was approximately 6.0 ml/s (Qmax) and 3.0 units (IPSS), but previous trials of TURP r
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