Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results
Daniele Amparore, Sabrina De Cillis, Claude Schulman, Gregor Kadner, Cristian Fiori, Francesco Porpiglia
Abstract
BACKGROUND: ) in men with benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS). METHODS: device, per study protocol. Due to COVID-19, follow-up was amended. Each patient was assessed once during 50-79 months postoperatively for IPSS and IPSS-quality of life (IPSS-QoL), change in medication, need for surgical re-treatment and adverse events telephonically. RESULTS: device treatment showed significant improvement in symptoms (IPSS: -45.3%, P<0.0001 and IPSS-QoL: -45.1%, P<0.0001) from baseline to 79 months post-procedure; mean±SD of 11.26±7.67 and 2.10±1.41 points, respectively. No complications were recorded between 36 up to 79 months; no patient required additional medication. CONCLUSIONS: device provided significant and durable symptom reduction and improved IPSS-QoL for >48 months post treatment. No late postoperative complications were reported beyond 36 months of follow-up. Surgical re-treatment rate for >36 months was 4%.