A Prospective Randomised Trial Comparing the Modified HM3 with the MODULITH® SLX-F2 Lithotripter

Background: The relative efficacy of first-versus last-generation lithotripters is unknown. Objectives: To compare the clinical effectiveness and complications of the modified Dornier HM3 lithotripter (Dornier MedTech, Wessling, Germany) to the MODULITH (R) SLX-F2 lithotripter (Storz Medical AG, Tagerwilen, Switzerland) for extracorporeal shock wave lithotripsy (ESWL). Design, setting and participants: We conducted a prospective, randomised, single-institution trial that included elective and emergency patients. Interventions: Shock wave treatments were performed under anaesthesia. Measurements: Stone disintegration, residual fragments, collecting system dilatation, colic pain, and possible kidney haematoma were evaluated 1 d and 3 mo after ESWL. Complications, ESWL retreatments, and adjuvant procedures were documented. Results and limitations: Patients treated with the HM3 lithotripter (n = 405) required fewer shock waves and shorter fluoroscopy times than patients treated with the MODULITH (R) SLX-F2 lithotripter (n = 415). For solitary kidney stones, the HM3 lithotripter produced a slightly higher stone-free rate (p = 0.06) on day 1; stone-free rates were not significantly different at 3 mo (HM3: 74% vs MODULITH (R) SLX-F2: 67%; p = 0.36). For solitary ureteral stones, the stone-free rate was higher at 3 mo with the HM3 lithotripter (HM3: 90% vs MODULITH (R) SLX-F2: 81%; p = 0.05). For solitary lower calyx stones, stone-free rates were equal at 3 mo (63%). In patients with multiple stones, the HM3 lithotripter's stone-free rate was higher at 3 mo(HM3: 64% vs MODULITH (R) SLX-F2: 44%; p = 0.003). Overall, HM3 lithotripter led to fewer secondary treatments (HM3: 11% vs MODULITH (R) SLX-F2: 19%; p = 0.001) and fewer kidney haematomas (HM3: 1% vs. MODULITH (R) SLX-F2: 3%; p = 0.02). Conclusions: The modified HM3 lithotripter required fewer shock waves and shorter fluoroscopy times, showed higher stone-free rates for solitary ureteral stones and multiple stones, and led to fewer kidney haematomas and fewer secondary treatments than the MODULITH (R) SLX-F2 lithotripter. In patients with a solitary kidney and solitary lower calyx stones, results were comparable for both lithotripters. (C) 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.