A Multicenter Randomized Controlled Trial of Antimicrobial Prophylaxis to Prevent Urinary Tract Infections after Shockwave Lithotripsy for Urolithiasis: The APPEAL Trial
Abstract
BACKGROUND AND OBJECTIVE
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).
METHODS
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.
KEY FINDINGS AND LIMITATIONS
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.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,722 participants or records.
Read the paper
Related studies
- Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study
- Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China
- The Role of the NLR and PLR in Urinary Tract Infection
- Threat of Antimicrobial Resistance among Pilgrims with Infectious Diseases during Hajj: Lessons Learnt from COVID-19 Pandemic
- Leclercia adecarboxylata urinary tract infection in a patient with bladder cancer and recurrent hematuria
- A Case Series of Staphylococcus lugdunensis Infection in Cancer Patients at an Academic Cancer Institute in the United States
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.