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Fankhauser CD. et al., 2021: Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5-15 mm: Results of a Randomized Controlled Trial.

Fankhauser CD, Weber D, Müntener M, Poyet C, Sulser T, Hermanns T.
Department of Urology, University Hospital, University of Zurich, Zurich, Switzerland.

Abstract

Background: Primary flexible ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (SWL) are treatment options in patients with renal calculi of 5-15 mm.

Objective: To compare effectiveness, complication rates, and pain scores between primary URS and SWL.

Design setting and participants: Between 2011 and 2016, patients with renal calculi between 5 and 15 mm were randomized to undergo either primary URS or SWL.

Outcome measurements and statistical analysis: Stone-free rate and size of residual fragments assessed by computed tomography after 3 mo, complications, and pain scores were evaluated.

Results and limitations: The study was prematurely closed after randomizing 44 patients due to poor accrual. The 3-mo stone-free rate and mean residual stone size were, respectively, 61% and 1.8 mm after URS and 48% and 2.4 mm after SWL. Early post-treatment pain scores were significantly higher after URS than after SWL on day 1 (3.3 vs 1.6, p = 0.02) and day 7 (5.2 vs 3.4, p = 0.04), but were no longer detectable after 3 wk and 3 mo, respectively. One Clavien-Dindo grade II complication was observed after URS (5%) and SWL (4%), while one (4%) grade IIIb complication was observed after SWL.

Conclusions: URS appears to be associated with higher early post-treatment discomfort, which could be associated with routine postoperative stenting. Owing to premature closure of this trial, the power was insufficient to formally compare URS and SWL; however, the present data might be informative to counsel patients about treatment outcomes and allow future meta-analyses.

Patient summary: This study was ended prematurely, but it contributes data about efficacy and side effects of different treatment options in patients with renal calculi.
Eur Urol Open Sci. 2021 Feb 2;25:5-10. doi: 10.1016/j.euros.2021.01.001. eCollection 2021 Mar. PMID: 34337498

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Comments 1

Hans-Göran Tiselius on Wednesday, 02 February 2022 09:30

The aim of this study was to compare URS and SWL for removal of stones 5-15 mm and to establish if there were any important differences between the two methods. Unfortunately, the authors decided to terminate the study because of lack of patients who could be included. Obviously, the authors had decided to finish the comparison during a defined period.?
The outcome expressed as SFR was 61% for URS and 48% for SWL. The residual fragments were larger following SWL; in average 2.4 vs 1.8 mm. The authors concluded that it was impossible to draw any conclusions from the study.
It was mentioned that URS was carried out by consultants or residents in training. No information is given on who carried out SWL!

Compared with SWL, the higher stone-free rate following URS should be balanced by longer treatment, more pain and stenting in ALL patients. It is of note that in 13% of the URS-treated patients, access was possible only after pre-stenting!! Nothing is mentioned about which anaesthesia or analgesia that was used.

With reservation that this study was not completed as planned, the results did not indicate superiority of URS compared with SWL. A shorter operation time and no need of stenting were the advantages of SWL. The possibility that repeated sessions might be necessary for SWL is a small price to pay for a non-invasive approach.

Hans-Göran Tiselius

The aim of this study was to compare URS and SWL for removal of stones 5-15 mm and to establish if there were any important differences between the two methods. Unfortunately, the authors decided to terminate the study because of lack of patients who could be included. Obviously, the authors had decided to finish the comparison during a defined period.? The outcome expressed as SFR was 61% for URS and 48% for SWL. The residual fragments were larger following SWL; in average 2.4 vs 1.8 mm. The authors concluded that it was impossible to draw any conclusions from the study. It was mentioned that URS was carried out by consultants or residents in training. No information is given on who carried out SWL! Compared with SWL, the higher stone-free rate following URS should be balanced by longer treatment, more pain and stenting in ALL patients. It is of note that in 13% of the URS-treated patients, access was possible only after pre-stenting!! Nothing is mentioned about which anaesthesia or analgesia that was used. With reservation that this study was not completed as planned, the results did not indicate superiority of URS compared with SWL. A shorter operation time and no need of stenting were the advantages of SWL. The possibility that repeated sessions might be necessary for SWL is a small price to pay for a non-invasive approach. Hans-Göran Tiselius
Monday, 20 May 2024