Nadya E York1, Michael S Borofsky2, Ben H Chew3, Casey A Dauw4, Ryan F Paterson3, John D Denstedt5, Hassan Razvi5, Robert B Nadler6, Mitchell R Humphreys7, Glenn M Preminger8, Stephen Y Nakada9, Amy E Krambeck1,10, Nicole L Miller11, Colin Terry12, Lori D Rawlings1, James E Lingeman1. 1. 1 Department of Urology, Indiana University School of Medicine , Indianapolis, Indiana. 2. 2 Department of Urology, University of Minnesota , Minneapolis, Minnesota. 3. 3 Urologic Sciences, Faculty of Medicine, University of British Columbia , Vancouver, Canada . 4. 4 Department of Urology, University of Michigan , Ann Arbor, Michigan. 5. 5 Division of Urology, Western University , London, Ontario, Canada . 6. 6 Department of Urology, Northwestern University , Chicago, Illinois. 7. 7 Mayo Clinic , Phoenix, Arizona. 8. 8 Division of Urology, Duke University , Durham, North Carolina. 9. 9 Department of Urology, University of Wisconsin , Madison, Wisconsin. 10. 10 Mayo Clinic , Rochester, Minnesota. 11. 11 Department of Urology, Vanderbilt University , Nashville, Tennessee. 12. 12 Methodist Research Institute , Indianapolis, Indiana.
Abstract
PURPOSE: To compare the efficiency (stone fragmentation and removal time) and complications of three models of intracorporeal lithotripters in percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS: Prospective, randomized controlled trial at nine centers in North America from 2009 to 2016. Patients were randomized to one of three lithotripter devices: the Cyberwand, a dual-probe ultrasonic device; the Swiss Lithoclast Select, a combination pneumatic and ultrasonic device; and the StoneBreaker, a portable pneumatic device powered by CO2 cartridges. Since the StoneBreaker lacks an ultrasonic component, it was used with the LUS-II ultrasonic lithotripter to allow fair comparison with combination devices. RESULTS:Two hundred seventy patients were enrolled, 69 were excluded after randomization. Two hundred one patients completed the study: 71 in the Cyberwand group, 66 in the Lithoclast Select group, and 64 in the StoneBreaker group. The baseline patient characteristics of the three groups were similar. Mean stone surface area was smaller in the StoneBreaker group at 407.8 mm2 vs 577.5 mm2 (Lithoclast Select) and 627.9 mm2 (Cyberwand). The stone clearance rate was slowest in the StoneBreaker group at 24.0 mm2/min vs 28.9 mm2/min and 32.3 mm2/min in the Lithoclast Select and Cyberwand groups, respectively. After statistically adjusting for the smaller mean stone in the StoneBreaker group, there was no difference in the stone clearance rate among the three groups (p = 0.249). Secondary outcomes, including complications and stone-free rates, were similar between the groups. CONCLUSIONS: The Cyberwand, Lithoclast Select, and the StoneBreaker lithotripters have similar adjusted stone clearance rates in PCNL for stones >2 cm. The safety and efficacy of these devices are comparable.
RCT Entities:
PURPOSE: To compare the efficiency (stone fragmentation and removal time) and complications of three models of intracorporeal lithotripters in percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS: Prospective, randomized controlled trial at nine centers in North America from 2009 to 2016. Patients were randomized to one of three lithotripter devices: the Cyberwand, a dual-probe ultrasonic device; the Swiss Lithoclast Select, a combination pneumatic and ultrasonic device; and the StoneBreaker, a portable pneumatic device powered by CO2 cartridges. Since the StoneBreaker lacks an ultrasonic component, it was used with the LUS-II ultrasonic lithotripter to allow fair comparison with combination devices. RESULTS: Two hundred seventy patients were enrolled, 69 were excluded after randomization. Two hundred one patients completed the study: 71 in the Cyberwand group, 66 in the Lithoclast Select group, and 64 in the StoneBreaker group. The baseline patient characteristics of the three groups were similar. Mean stone surface area was smaller in the StoneBreaker group at 407.8 mm2 vs 577.5 mm2 (Lithoclast Select) and 627.9 mm2 (Cyberwand). The stone clearance rate was slowest in the StoneBreaker group at 24.0 mm2/min vs 28.9 mm2/min and 32.3 mm2/min in the Lithoclast Select and Cyberwand groups, respectively. After statistically adjusting for the smaller mean stone in the StoneBreaker group, there was no difference in the stone clearance rate among the three groups (p = 0.249). Secondary outcomes, including complications and stone-free rates, were similar between the groups. CONCLUSIONS: The Cyberwand, Lithoclast Select, and the StoneBreaker lithotripters have similar adjusted stone clearance rates in PCNL for stones >2 cm. The safety and efficacy of these devices are comparable.
Authors: Maximilian Eisel; Markus J Bader; Frank Strittmatter; Udo Nagele; Christian G Stief; Thomas Pongratz; Ronald Sroka Journal: World J Urol Date: 2020-04-10 Impact factor: 4.226
Authors: Brennan Timm; Matthew Farag; Niall F Davis; David Webb; David Angus; Andrew Troy; Damien Bolton; Gregory S Jack Journal: Can Urol Assoc J Date: 2021-01 Impact factor: 1.862
Authors: Tomas Andri Axelsson; Cecilia Cracco; Mahesh Desai; Mudhar Nazar Hasan; Thomas Knoll; Emanuele Montanari; Daniel Pérez-Fentes; Michael Straub; Kay Thomas; James C Williams; Marianne Brehmer; Palle J S Osther Journal: World J Urol Date: 2020-07-29 Impact factor: 4.226
Authors: Charles Joseph O'Connor; Donnacha Hogan; Lee Chien Yap; Louise Lyons; Derek Barry Hennessey Journal: World J Urol Date: 2022-08-24 Impact factor: 3.661