A pilot study for a randomized controlled trial comparing the efficacy, safety and cost‐effectiveness of surgical treatments of the prostate

Abstract

Although more men with benign prostatic disease and lower urinary tract symptoms are being seen in clinics, the reduced proportion of patients continuing to surgical intervention will lead to increasing difficulty in carrying out randomized controlled clinical trials assessing surgical options. With ever more therapeutic options available, patients find it difficult to make decisions in both the clinical situation and when asked to enter a trial. Fully informed decisions by both the surgeon and the patient will only be possible when objective data are available from trials that investigate outcome, cost-efficacy and cost-benefit. This study suggests that when presented with more information and counselling, fewer men decide to undergo prostate surgery for symptomatic BPH.

Who Should Be Treated and How? Evidence-Based Medicine in Symptomatic BPH

“…On the other hand, it becomes increasingly difficult to include patients in the necessary trials: in shared-decision approaches, patients often prefer less invasive nonsurgical treatment options [109]. …”

Unique Methodological Issues Facing Randomized Controlled Trials of Endourologic Procedures

“…This information often biases patients either for or against the new procedure, lessening the likelihood that they will accept randomization, particularly if one alternative is substantially less invasive than the other. A qualitative examination of patients' preferences when participating in three BPH trials 44 demonstrated that patients found the concept of randomization confusing, while another 45 showed that concerns regarding patient preference for a particular treatment option, lack of choice when randomized, and uncertainty about outcome all decreased the likelihood of participation in endourologic trials. These barriers are not insuperable, however.…”

Introduction and Concluding Remarks

“…There is however a need for objective data on the global outcome and cost-effectiveness aspects of the various invasive therapies in order to allow surgeons together with patients to make appropriate treatment decisions [10]. …”

“…Surgery is still considered to be the most effective therapy for treating LUTS suggestive of BPO and there has been a proliferation of minimally invasive therapies available for the treatment of LUTS; despite this, its use has declined considerably [10, 11]. Why has this occurred?…”