Iñigo Insausti1, Ana Sáez de Ocáriz2, Arkaitz Galbete3, Ferran Capdevila4, Saioa Solchaga2, Pedro Giral5, Tiago Bilhim6, Ari Isaacson7, Fermin Urtasun2, Saturnino Napal5. 1. Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: insausti00@hotmail.com. 2. Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain. 3. Navarrabiomed, Complejo Hospitalario de Navarra-Universidad Pública de Navarra, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Pamplona, Spain. 4. Department of Pharmacy, Complejo Hospitalario de Navarra, Pamplona, Spain. 5. Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain. 6. Department of Interventional Radiology, Hospital St. Louis, Lisbon, Portugal; Department of Radiology, NOVA Medical School, Lisbon, Portugal; Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal. 7. Division of Vascular and Interventional Radiology, Department of Radiology, University of North Carolina Medical Center, Chapel Hill, North Carolina.
Abstract
PURPOSE: To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-μm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Qmax) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification. RESULTS:Mean Qmax increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURPpatients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001). CONCLUSIONS:Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.
RCT Entities:
PURPOSE: To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-μm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Qmax) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification. RESULTS: Mean Qmax increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURP patients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001). CONCLUSIONS: Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.
Authors: Marco Pandolfi; Alessandro Liguori; Martina Gurgitano; Antonio Arrichiello; Letizia Di Meglio; Giovanni Maria Rodà; Alice Guadagni; Salvatore Alessio Angileri; Anna Maria Ierardi; Giorgio Buccimazza; Daniela Donat; Aldo Paolucci; Gianpaolo Carrafiello Journal: Acta Biomed Date: 2020-09-23