A novel metric for treatment durability in clinical trials of minimally invasive treatments for benign prostatic hyperplasia.

Introduction: Clinical trial manuscripts commonly report results of individual endpoints. However, durability of a medical treatment may be difficult to determine when evaluating endpoint outcomes individually. We reviewed pivotal trial manuscripts of two minimally invasive benign prostatic hyperplasia (BPH) treatments and estimated the rate of treatment durability using a composite, symptom-centric metric.Methods: Data were derived from published pivotal trial reports of two minimally invasive BPH treatments - water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL). We estimated the risk of medical or surgical retreatment using life-table methods, and the number of patients achieving the minimal clinically important difference (MCID) for the International Prostate Symptom Score (IPSS) using z-score methods. Treatment durability was defined as a MCID on the IPSS at the 4-year follow-up visit while free from medical or surgical retreatment.Results: Comparing WVTT to PUL, the rate of medical or surgical retreatment was 10.6% vs. 31.8%, the IPSS MCID was achieved in 82.2% vs. 79.5%, and treatment durability rates were 71.8% vs. 51.7%.Conclusions: Utilization of a composite treatment durability metric derived from endpoints commonly reported in the BPH literature may allow patients and their providers to make better informed treatment decisions.

Expert review of medical devices. 2020 Mar 19 [Epub ahead of print]

Larry E Miller, Alexis E Te, Samir K Bhattacharyya, Sean Lilienfeld, Ryan A Dornbier, Kevin T McVary

Miller Scientific, Johnson City, TN, USA., Brady Prostate Center & Urodynamic Laboratory, Urology Program, Iris Cantor Men's Health Center, Weill Medical College of Cornell University, New York, NY, USA., Boston Scientific, Marlborough, MA, USA., Center for Male Health, Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA.