NCT07193940

Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Stones

Interventions

Type	Name	Description
PROCEDURE	Flexible Ureteroscopy	Flexible Ureterorenoscopy
PROCEDURE	extracorporeal shock wave lithotripsy (ESWL)	extracorporeal shock wave lithotripsy (ESWL)

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-04-01
• Completion: 2028-10-01
• First posted: 2025-09-26
• Last updated: 2025-10-02

Locations

1 site across 1 country: Egypt