Claudio Maurizio Pacella1, Gianluigi Patelli2, Gennaro Iapicca3, Guglielmo Manenti4, Tommaso Perretta4, Colleen P Ryan4, Renato Esposito5, Giovanni Mauri6,7. 1. Department of Diagnostic Imaging and Interventional Radiology, Regina Apostolorum Hospital, Via San Francesco 50, 00041 Albano Laziale, Rome, Italy. 2. Department of Diagnostic and Interventional Radiology, ASST Bergamoest, via Paderno 21, 24068, Seriate, Italy. 3. Urology Unit, Santa Rita Clinic, Via Appia, 83042 Atripalda, Avellino, Italy. 4. Department of Diagnostic Imaging and Interventional Radiology, Tor Vergata University, Policlinico Tor Vergata, Viale Oxford 81, 00133, Rome, Italy. 5. iGRECO Ospedali Riuniti, Piazza Quintieri 1, 87100, Cosenza, Italy. 6. Division of Interventional Radiology, European Institute of Oncology, IRCCS, Via Ripamonti 435, 20141, Milan, Italy. giovanni.mauri@ieo.it. 7. Department of Oncology and Hemato-Oncology, Faculty of Medicine and Surgery University of Milan, Milan, Italy. giovanni.mauri@ieo.it.
Abstract
PURPOSE: To investigate the effectiveness and safety of SoracteLite™-transperineal percutaneous laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. METHODS: Patients with urinary symptoms secondary to BPH underwent TPLA under local anesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. The primary end-points of this study were change in IPSS, PVR, Qmax, QoL, and prostatic volume at 6 an 12 months from SoracteLiteTM TPLA treatment. Secondary end-point was the assessment of complications. RESULTS: Analysis was performed on data 160 patients (mean age 69.8 ± 9.6 years) with at least 6 months follow and of 83 patients (mean age 67.9 ± 8.7 years) with at least 12 months follow-up. At 6 months, IPSS improved from 22.5 ± 5.1 to 7.7 ± 3.3 (P < 0.001), PVR from 89.5 ± 84.6 to 27.2 ± 44.5 ml (P < 0.001), Qmax from 8.0 ± 3.8 to 14.3 ± 3.9 ml/s (P < 0.001), QoL from 4.5 ± 1.1 to 1.8 ± 1.0 (P < 0.001), volume from 75.0 ± 32.4 to 60.3 ± 24.5 ml (P < 0.001). At 12 months, IPSS improved from 22.5 ± 4.5 to 7.0 ± 2.9 (P < 0.001), PVR from 71.7 ± 93.9 to 17.8 ± 51.0 ml (P < 0.001), Qmax from 8.6 ± 5.2 to 15.0 ± 4.0 ml/s (P < 0.001), QoL from 4.2 ± 0.6 to 1.6 ± 0.9 (P < 0.001), volume from 87.9 ± 31.6 to 58.8 ± 22.9 ml (P < 0.001). 7/160 (4.3%) grade I and 1/160 (0.6%) grade III complication occurred. CONCLUSIONS: SoracteLite™ TPLA allows significant improvement of IPSS, Qol, Qmax, PVR, and reduction of prostatic volume at 6 and 12 months.
PURPOSE: To investigate the effectiveness and safety of SoracteLite™-transperineal percutaneous laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. METHODS:Patients with urinary symptoms secondary to BPH underwent TPLA under local anesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. The primary end-points of this study were change in IPSS, PVR, Qmax, QoL, and prostatic volume at 6 an 12 months from SoracteLiteTM TPLA treatment. Secondary end-point was the assessment of complications. RESULTS: Analysis was performed on data 160 patients (mean age 69.8 ± 9.6 years) with at least 6 months follow and of 83 patients (mean age 67.9 ± 8.7 years) with at least 12 months follow-up. At 6 months, IPSS improved from 22.5 ± 5.1 to 7.7 ± 3.3 (P < 0.001), PVR from 89.5 ± 84.6 to 27.2 ± 44.5 ml (P < 0.001), Qmax from 8.0 ± 3.8 to 14.3 ± 3.9 ml/s (P < 0.001), QoL from 4.5 ± 1.1 to 1.8 ± 1.0 (P < 0.001), volume from 75.0 ± 32.4 to 60.3 ± 24.5 ml (P < 0.001). At 12 months, IPSS improved from 22.5 ± 4.5 to 7.0 ± 2.9 (P < 0.001), PVR from 71.7 ± 93.9 to 17.8 ± 51.0 ml (P < 0.001), Qmax from 8.6 ± 5.2 to 15.0 ± 4.0 ml/s (P < 0.001), QoL from 4.2 ± 0.6 to 1.6 ± 0.9 (P < 0.001), volume from 87.9 ± 31.6 to 58.8 ± 22.9 ml (P < 0.001). 7/160 (4.3%) grade I and 1/160 (0.6%) grade III complication occurred. CONCLUSIONS: SoracteLite™ TPLA allows significant improvement of IPSS, Qol, Qmax, PVR, and reduction of prostatic volume at 6 and 12 months.
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