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

Expert Rev Med Devices. 2020 Apr;17(4):365-369. doi: 10.1080/17434440.2020.1742699. Epub 2020 Mar 19.

Abstract

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.

Keywords: BPH; lower urinary tract symptoms; prostatic urethral lift; water vapor thermal therapy.

MeSH terms

  • Aged
  • Clinical Trials as Topic*
  • Computer Simulation
  • Humans
  • Hyperthermia, Induced
  • Lower Urinary Tract Symptoms
  • Male
  • Middle Aged
  • Minimally Invasive Surgical Procedures*
  • Monte Carlo Method
  • Prostate / surgery
  • Prostatic Hyperplasia / surgery*
  • Quality of Life
  • Risk Factors
  • Steam
  • Treatment Outcome
  • Urethra / surgery

Substances

  • Steam