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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

Zhu W 1 , Ann Chai C 2 , Ma J 3 , İlker Gökce M 4 , Gadzhiev N 5 , Kalathia J 6 Show all authors , Jiang K 7 , Duan X 8 , Cao J 9 , Wu R 10 , Song R 11 , Bai S 12 , Li X 13 , Liu S 1 , Zeng G 1

Affiliations 

  • 1 Department of Urology and Guangdong Key Laboratory of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
  • 2 Department of Urology, University Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 3 School of Public Health, Guangzhou Medical University, Guangzhou, China
  • 4 Department of Urology, School of Medicine, Ankara University, Ankara, Turkey
  • 5 Department of Urology, St. Petersburg State University Hospital, St. Petersburg, Russia
  • 6 Department of Urology and Kidney Transplantation, Fortune Urology Clinic, Gujarat, India
  • 7 Department of Urology, Guizhou Provincial People's Hospital, Guizhou, China
  • 8 Department of Urology, Baoshan No. 2 People's Hospital, Baoshan, China
  • 9 Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
  • 10 Department of Urology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
  • 11 Department of Urology, Nanjing Medical University First Affiliated Hospital, Nanjing, China
  • 12 Department of Urology, Shengjing Hospital, China Medical University, Shenyang, China
  • 13 Department of Urology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China
Eur Urol Open Sci, 2024 Dec;70:167-173.
PMID: 39559532 DOI: 10.1016/j.euros.2024.10.014

Abstract

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 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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