Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2–3-cm Renal Stones: Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial

• Published in: European urology open science (Online) Vol. 70; pp. 167 - 173
• Main Authors: Zhu, Wei, Ann Chai, Chu, Ma, Jinxiang, İlker Gökce, Mehmet, Gadzhiev, Nariman, Kalathia, Jaisukh, Jiang, Kehua, Duan, Xianzhong, Cao, Jianwei, Wu, Rongpei, Song, Rijin, Bai, Song, Li, Xuedong, Liu, Shusheng, Zeng, Guohua
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01-12-2024; Elsevier
• Subjects: Flexible urteroscopy; Percutaneous nephrolithotomy; Retrograde intrarenal surgery; Tip bandable suction ureteral access sheath; Trial Protocol; Ureteral access sheath; Urolithiasis; Retrograde intrarenal surgery; Flexible urteroscopy; Urolithiasis; Tip bandable suction ureteral access sheath; Percutaneous nephrolithotomy; Ureteral access sheath
• ISSN: 2666-1683; 2666-1691; 2666-1683
• DOI: 10.1016/j.euros.2024.10.014

The aim of our study is to assess whether flexible ureteroscopy with a suction bendable ureteral access sheath is comparable to mini-percutaneous nephrolithotomy in terms of the stone-free rate and perioperative outcomes.
Guidelines recommend percutaneous nephrolithotomy (PCNL) for larger renal stones, but advances in flexible ureteroscopy (f-URS) with a tip-bendable suction ureteral access sheath (S-UAS) have prompted further investigation. Our multicenter, international, randomized controlled trial is investigating whether f-URS with S-UAS is noninferior to mini-PCNL (mPCNL) for renal stones of 2–3 cm. The primary objective is the immediate stone-free rate (SFR). Secondary outcomes include the 3-mo SFR, complication rates, surgical time, hospital stay, auxiliary procedures, and improvements in quality of life. A total of 720 patients from 12 urological centers will be randomized to either f-URS with S-UAS or PCNL. Statistical analyses will include intention-to-treat and per-protocol approaches, with specific methods for normally and non-normally distributed data. Subgroup analyses will focus on stone location and lithotripter types. The significance threshold will be set at p < 0.05. The aim of this trial is to generate high-level evidence regarding the noninferiority of f-URS with S-UAS compared to mPCNL for medium-sized renal stones.
The trial is registered on ClinicalTrials.gov as NCT06526390.