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(®) SLX-F2 lithotripter (Storz Medical AG, Tägerwilen, 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(®) 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(®) 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(®) 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(®) SLX-F2: 44%; p=0.003). Overall, HM3 lithotripter led to fewer secondary treatments (HM3: 11% vs MODULITH(®) SLX-F2: 19%; p=0.001) and fewer kidney haematomas (HM3: 1% vs. MODULITH(®) 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(®) SLX-F2 lithotripter. In patients with a solitary kidney and solitary lower calyx stones, results were comparable for both lithotripters.