Menu
Not yet recruiting NCT07193940

Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy

No phase Interventional Kidney Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flexible Ureteroscopy, extracorporeal shock wave lithotripsy (ESWL).
Who it may be relevant to
Registry conditions: Kidney Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy for Treatment of Lower Calyceal Renal Stones Less Than 15 mm: A Prospective Randomized Comparative Study

Overview

To compare the efficacy and safety of flexible ureterorenoscopy (fURS) versus extracorporeal shock wave lithotripsy (ESWL) in managing lower calyceal renal stones ≤15 mm and \<1000 HU.

Detailed description

Urolithiasis is a common condition with a steadily increasing global prevalence, and lower calyceal stone treatment is particularly challenging. While stones ≤15 mm and \<1000 Hounsfield Units (HU) are generally treatable, lower pole anatomy limits fragment clearance after extracorporeal shock wave lithotripsy (ESWL). Published SFR for ESWL in this location range between 60-80%, which are lower compared to other calyceal sites. Predictive factors such as stone density, size, and skin-to-stone distance are applied to optimize patients selection.

Conversely, flexible ureteroscopy (fURS) with laser lithotripsy achieves more and higher quality SFRs (80-95%) by active fragmentation and retrieval of the stones, thereby bypassing the anatomic barriers. However, It is invasive, requires anesthesia and has complications such as ureteral trauma and infection, including a small but certain risk of sepsis. EAU and AUA guidelines currently recommend either ESWL or URS for stones \<20 mm, but note reduced clearance of lower-pole stones by ESWL.

This creates a therapeutic dilemma: should stones ≤15 mm and \<1000 HU, theoretically ideal for ESWL, nevertheless to be managed non-invasively, or should fURS be given priority because of increased reliability? We anticipate that fURS will provide a higher 3-month stone-free rate than ESWL, though ESWL may remain a suitable first-line treatment in well-selected patients owing to lower morbidity and non-invasive nature.

Interventions

  • Procedure Flexible Ureteroscopy
    Flexible Ureterorenoscopy
  • Procedure extracorporeal shock wave lithotripsy (ESWL)
    extracorporeal shock wave lithotripsy (ESWL)

Primary outcome measures

  • Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately) [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Adults (≥18 y)
  • Lower-calyx stone
  • Less than or equal15 mm
  • Mean Hounsfield (HU) <1000

Exclusion criteria

  • Pregnancy
  • Uncorrected coagulopathy
  • Active UTI/obstruction
  • Anatomical barriers to Flexible Ureteroscopy or extracorporeal shock wave lithotripsy coupling (e.g., prohibitive SSD/BMI).
  • Cardiac devices contraindicating ESWL

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine, Assiut University — Asyut

Publications

  • Ng CF. The effect of stone size, location, and number on the outcome of extracorporeal shock wave lithotripsy. Int Braz J Urol. 2008;34(6):759-66. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684300/
  • Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27. PMID 27238616
  • Sampaio FJ, Aragao AH. Inferior pole collecting system anatomy: its probable role in extracorporeal shock wave lithotripsy. J Urol. 1992 Feb;147(2):322-4. doi: 10.1016/s0022-5347(17)37226-9. PMID 1732584
  • Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28. PMID 22093679
  • Somani BK, Giusti G, Sun Y, Osther PJ, Frank M, De Sio M, Turna B, de la Rosette J. Complications associated with ureterorenoscopy (URS) related to treatment of urolithiasis: the Clinical Research Office of Endourological Society URS Global study. World J Urol. 2017 Apr;35(4):675-681. doi: 10.1007/s00345-016-1909-0. Epub 2016 Aug 4. PMID 27492012
  • Fankhauser CD, Weber D, Muntener M, Poyet C, Sulser T, Hermanns T. Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5-15 mm: Results of a Randomized Controlled Trial. Eur Urol Open Sci. 2021 Feb 2;25:5-10. doi: 10.1016/j.euros.2021.01.001. eCollection 2021 Mar. PMID 34337498

Identifiers

NCT: NCT07193940 · Ureteroscopy VS ESWL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗