NCT03932370

Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones

Completed Last updated 30 September 2025

What this trial tests

trial testing Flexible ureteroscopy in Stone;Renal in 118 participants. Completed in 27 December 2021.

Timeline

27 May 2019

Primary endpoint
30 July 2021

27 December 2021

Quick facts

Lead sponsor	Assiut University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	118
Start date	27 May 2019
Primary completion	30 July 2021
Estimated completion	27 December 2021
Sites	1 location across Egypt

Drugs / interventions tested

• Flexible ureteroscopy
• mini-Percutaneus nephrolithotomy

Conditions studied

• Stone;Renal — all drugs for Stone;Renal →

Sponsor

Assiut University

Who can join

Adults 16 to 90, any sex, with Stone;Renal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).

Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (\>2cm); stones with high densities (\>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.

Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults.
   Soderberg L, Ergun O, Ding M, Parker R, et al · · 2023 · cited 19× · PMID 37955353 · DOI 10.1002/14651858.cd013445.pub2
2. A randomized comparative study of flexible ureterorenoscopy versus mini-percutaneous nephrolithotomy for treatment of renal stones 2 cm or less.
   Darwish AE, Abdel Moneim AE, Ahmed AI, Hamdy SM, et al · · 2024 · cited 1× · PMID 40256303 · DOI 10.1097/cu9.0000000000000215