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You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024

P2-09 COMPARATIVE EFFECTIVENESS OF URETEROSCOPY AND SHOCKWAVE LITHOTRIPSY FOR CHILDREN WITH NEPHROLITHIASIS: RESULTS OF A MULTICENTER PROSPECTIVE CLINICAL TRIAL

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    BACKGROUND:

    AUA and EAU guidelines recommend ureteroscopy (URS) or shockwave lithotripsy (SWL) for pediatric patients with kidney stones <20 mm and for ureteral stones based on low-level evidence for stone clearance and no evidence on patient reported outcomes (PROs). Despite equal weight of the recommendations, 80% of children have URS for these stones.

    METHODS:

    The Pediatric KIDney Stone (PKIDS) Care Improvement Network embedded a prospective observational trial of patients aged 8-21 years in clinical care at 30 medical centers in North America from 2020-2023 to compare URS and SWL for kidney and ureteral stones. The primary outcome was stone clearance assessed by ultrasound 6 (±2) weeks after surgery considering heterogeneity of treatment effect (HTE) by a priori categories of stone size (<7 mm, 7-10 mm, 10-15 mm, and >15 mm) and location (ureter/UPJ, non-lower pole kidney, and lower pole kidney). Secondary outcomes were PROs measured by PROMIS and urinary symptom scores at 1, 3, 6 and 12 weeks after surgery, assessing HTE by age and sex. Stone clearance and PROs were compared using generalized linear models and ANCOVA, respectively, weighted with inverse propensity scores to balance patient, surgeon, and institutional characteristics across groups.

    RESULTS:

    Among 1142 patients (median age of 15.6 years; 690 were female (60%); 884 were White (77%), 41 were Black (4%), 130 were Hispanic (11%), 1070 and 197 kidneys with a median stone size of 6 mm (IQR 4, 9) were treated with SWL performed by 125 urologists. For all stone sizes, stone clearance was 74.5% for URS (95% CI, 65.7 to 83.3) and 68.6% for SWL (95% CI, 59.7 to 77.7), which was not statistically different (risk difference 5.9; 95% CI -6.6 to 18.5). Compared to URS, SWL resulted in less pain intensity, pain interference, and urinary symptoms one week after surgery, adjusting for pre-operative symptoms (Table). There were no differences between treatments for any PROs from 3 weeks until the last survey 3 months after surgery. In HTE analyses, there were no differences in stone clearance by size or location. Stone clearance could not be compared for stones >15 mm as only 3 patients had SWL for these stones. Patients aged 18-21 years treated with URS had worse urinary symptoms one week after surgery than younger patients. There were no sex differences in PROs between treatments.

    CONCLUSIONS:

    Among pediatric patients with kidney and ureteral stones, SWL resulted in similar stone clearance and better lived experiences than URS. These findings support SWL for children and adolescents with small to medium sized urinary stones.

    Source of Funding:

    This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (CER-2018C3-14778)