Shockwave lithotripsy (SWL) carries a risk of postprocedural infection. Use of antibiotic prophylaxis by clinicians is variable and international guidelines provide conflicting recommendations, reflecting low-certainty evidence. We investigated whether antibiotic prophylaxis reduces bacteriuria and post-SWL urinary tract infections (UTIs).
APPEAL, an international multicenter, blinded trial, randomized adults undergoing SWL for urolithiasis to a single dose of ciprofloxacin or placebo. The primary outcome was the incidence of a composite of bacteriuria or symptomatic UTI after SWL. Other outcomes included the incidence of pyelonephritis or urosepsis.
Of the 1722 randomized patients, 28 underwent postrandomization exclusions (mainly nonvisualizable stones). Among the analysis population (n = 1694; median age 50 yr; 30% female), 74% had kidney stones and 26% had ureteral stones. Bacteriuria (without symptoms) or symptomatic UTI occurred in 20 patients (2.7%) in the ciprofloxacin arm and 30 (3.9%) in the placebo arm (risk ratio [RR] 0.68, 95% confidence interval [CI] 0.41-1.15). Symptomatic UTI occurred in ten patients (1.3%) in the ciprofloxacin arm and 21 (2.7%) in the placebo arm (RR 0.49, 95% CI 0.19-1.23). No patients in the ciprofloxacin arm and nine (1.2%) in the placebo arm developed pyelonephritis (RR 0.05, 95% CI 0.003-0.93). No patients developed urosepsis and no serious adverse events occurred.
A single dose of ciprofloxacin reduced the risk of post-SWL pyelonephritis, with a modest absolute benefit. The patient importance of this reduction depends on individual preferences in weighing a small absolute reduction in risk against the potential harms and resistance-related implications of antibiotic use. Results from the APPEAL trial will inform global practice and support evidence-based decision-making for patients undergoing SWL.
European urology. 2025 Sep 24 [Epub ahead of print]
Kari A O Tikkinen, Borna Tadayon Najafabadi, Sakineh Hajebrahimi, Farhad Tondroanamag, Arto Mikkola, Saana Horstia, Patrick O Richard, Sara V Tornberg, Mohamed Abdelkareem, Le Mai Tu, Thomas Tailly, Farzin Soleimanzadeh, Hanieh Salehi Pourmehr, Mari Saalasti, Jani Ruotsalainen, Hassan Razvi, Negar Pourjamal, Stephen E Pautler, Niko K Nordlund, Sanna Myrskysalo, Andrey O Morozov, Mohsen Mohammadrahimi, Murilo de Almeida Luz, Samuel Lagabrielle, Pauliina Kuutti, Tuomas P Kilpeläinen, Petrus Järvinen, Alex L E Halme, Alireza Farshi Haghro, Salam A Hussain, Agus Rizal A H Hamid, Dmitry Gorelov, Pramila Gaudel, Nariman Gadzhiev, John Denstedt, Kathrin Bausch, Raed A Azhar, APPEAL Trial Investigators
Faculty of Medicine, University of Helsinki, Helsinki, Finland; Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada; Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland. Electronic address: ., Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada; Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada., Department of Urology, Tabriz University of Medical Sciences, Tabriz, Iran; Research Center for Evidence-Based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran., Faculty of Medicine, University of Helsinki, Helsinki, Finland; Department of Urology, Tabriz University of Medical Sciences, Tabriz, Iran; Research Center for Evidence-Based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran., Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Faculty of Medicine, University of Helsinki, Helsinki, Finland., Division of Urology, Department of Surgery, University Hospital of Sherbrooke, Sherbrooke, Canada., Urology Section, Surgery Department, Hazm Mebaireek General Hospital, Hamad Medical Corporation, Doha, Qatar., Department of Urology, University Hospital Ghent, Ghent, Belgium., Department of Urology, Tabriz University of Medical Sciences, Tabriz, Iran., Research Center for Evidence-Based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran., Clinical Trials Unit, HUS Pharmacy, Helsinki University Hospital, Helsinki, Finland., Division of Urology, Schulich School of Medicine and Dentistry, Western University, London, Canada., Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia., Department of Urology, Rede D'Or São Luiz, Sao Paolo, Brazil., Department of Urology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia., Department of Endourology, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russia., Department of Urology, Saint Petersburg State University Hospital, St. Petersburg, Russia., Department of Urology, University Hospital Basel, Basel, Switzerland., Department of Urology, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.