Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients.Reply.

Abstract

To the Editor: In a recent editorial, the senior author of this manuscriptand I shared the view that the urological community must arrive at a consensus for reporting in BPH (benign prostatic hyperplasia)/LUTS (lower urinary tract symptoms) clinical trials, specifically regarding followup procedures and medication usage to treat LUTS, as well as treatments to address complications. We state that the lack of consistent reporting “has led to spurious arguments, confusion and potentially biasing, misinterpretation or manipulation of data.” Perhaps unintentionally this meta-analysis is a salient example of just this problem. The authors propose a new way to determine an annual reintervention rate but apply it only to 1 treatment option, concluding that the prostatic urethral lift (PUL) has a higher reintervention rate than previously reported. Conducting this novel calculation method to only 1 procedure can lead to confusion and misunderstanding, and should be viewed with skepticism and described in context. If we apply the proposed calculations to other BPH treatment options, the reintervention rates are, predictably, much higher than previously reported. The GOLIATH study, a 2-year randomized comparison of laser ablation with transurethral resection of the prostate (TURP), reported retreatment for LUTS/BPH as well as treatment of complications. Applying the proposed calculation method to GOLIATH results in TURP and photoselective vaporization of the prostate having “reintervention rates” of 12% and 11% per year, respectively. Studies of Rez um steam injection would give reintervention rates spanning from 1.1% to 42% per year, the range due largely to treatment of stricture and retention (temporary stenting). These results would suggest that the newly defined reintervention rate described for PUL is certainly within range of the other leading BPH treatment options. Perhaps the most questionable premise of the proposed methodology is that analyzing any number of studies taken out to 1 year can predict an annual recurring reintervention rate. A traditional meta-analysis might appropriately predict that surgical retreatment for LUTS/BPH after PUL might be 5% to 7% at 1 year, but certainly cannot conclude that we should expect that rate to recur every year thereafter. In fact, the only available long-term data refutes the concept of a constant rate. The LIFT randomized study showed retreatment for LUTS that occurred at years 1 through 5 to be 5.0%, 2.1%, 2.9%, 3.6% and 0.0%, respectively. Using treatment of complications to calculate an annual reintervention rate is also problematic, as we must reach consensus on which complications should be counted and review whether they occur 1 time only or at an annual rate. The LIFT study 1-year video cystoscopy found 13 implants misdeployed in the bladder that were then removed. Some of these patients received additional PUL or TURP during removal and were therefore already counted in the reported 13.6% retreatment at 5 years. How does this figure into an annual reintervention rate? These important issues support the need for consensus of definitions to be used in future studies and should lead us to be skeptical of the conclusions and methodology of this paper.