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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07193940
Enrollment
70
Registered
2025-09-26
Start date
2025-10-31
Completion date
2028-10-31
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones

Brief 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.

Interventions

Flexible Ureterorenoscopy

extracorporeal shock wave lithotripsy (ESWL)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)baselineStone-free rate at 1 months on low-dose NCCT (no fragment \>2 mm; report CIRF separately)

Countries

Egypt

Contacts

Primary ContactAhmed A Ahmed Atef Mohamed Abdellatif, MD
aboatef775599@gmail.com+0201069339244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026