A large number of minimally invasive techniques have been developed for the surgical management of male lower urinary tract symptoms (LUTS) presumed to be secondary to benign prostatic obstruction (BPO) over the last 3 decades. Many have not stood the test of time often because they were overpromoted before there were sufficient data.
The scope of this paper is to consider whether new devices, for the treatment of male LUTS/BPO, have been implemented prematurely in the past. We also examine the relative certainty of evidence (CoE) that is currently available for newer developing technologies and make recommendations about the CoE that should be demanded in the future before widespread implementation.
This evidence must provide adequate length of follow-up to allow proper information to be provided for patients before treatment choices are made and to be able to create recommendations in high-quality guidelines such as those of the European Association of Urology. It is not just within the domain of LUTS treatments that this is important, other urological devices, such as mesh devices, have been equally “guilty” and likewise devices in most other (surgical) specialities. We believe that there is a need for a set of requirements built around primary randomised controlled trials (RCTs) looking at both efficacy and safety, and secondary studies to confirm the reproducibility and generalisability of the first pivotal studies. Otherwise, there is a danger that a single pivotal study can be overexploited by device manufacturers. Studies that are needed include (1) proof of concept, (2) RCTs on efficacy and safety, as well as (3) cohort studies with a broad range of inclusion and exclusion criteria to confirm both reproducibility and generalisability of the benefits and harms. It is not the purpose of this paper to make judgements about individual treatments but simply to look at different treatments to provide verification for this debate.
Many new treatment devices have been developed over the last 20–30 yr, often with inadequate medium- to long-term results. Many have not stood the test of time, but were heavily promoted by manufacturers, the press, and some doctors when they were first released, meaning that many patients had unsatisfactory results. This paper proposes minimum standards for the investigation of new treatments before their widespread promotion to patients.