A novel metric for treatment durability in clinical trials of minimally invasive treatments for benign prostatic hyperplasia
| Autor: | Sean Lilienfeld, Alexis E. Te, Larry E. Miller, Ryan Dornbier, Kevin T. McVary, Samir Bhattacharyya |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty education Biomedical Engineering Urology Prostatic Hyperplasia 030204 cardiovascular system & hematology urologic and male genital diseases 03 medical and health sciences 0302 clinical medicine Lower Urinary Tract Symptoms Urethra Lower urinary tract symptoms Risk Factors medicine Humans Minimally Invasive Surgical Procedures Computer Simulation Prostatic urethral lift Aged Clinical Trials as Topic business.industry Invasive treatments Minimal clinically important difference Prostate General Medicine Hyperthermia Induced Hyperplasia Middle Aged medicine.disease humanities Clinical trial Steam Treatment Outcome Quality of Life Surgery International Prostate Symptom Score Metric (unit) business Monte Carlo Method 030217 neurology & neurosurgery |
| Zdroj: | Expert review of medical devices. 17(4) |
| ISSN: | 1745-2422 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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