Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non‐inferiority)

Abstract

• To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.