An interventional study of Flexible Ureteroscopy and extracorporeal shock wave lithotripsy (ESWL) in Kidney Stones, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Interventional procedure: Flexible Ureteroscopy
Procedure: Flexible Ureteroscopy
Extracorporeal Shock Wave Lithotripsy (ESWL)
Procedure: extracorporeal shock wave lithotripsy (ESWL)
Flexible Ureterorenoscopy
extracorporeal shock wave lithotripsy (ESWL)
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)
Stone-free rate at 1 months on low-dose NCCT (no fragment \>2 mm; report CIRF separately)
Time frame: baseline
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Assiut University