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Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy

A

Assiut University

Status

Not yet enrolling

Conditions

Kidney Stones

Treatments

Procedure: Flexible Ureteroscopy
Procedure: extracorporeal shock wave lithotripsy (ESWL)

Study type

Interventional

Funder types

Other

Identifiers

NCT07193940
Ureteroscopy VS ESWL

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Flexible Ureteroscopy
Experimental group
Description:
Interventional procedure: Flexible Ureteroscopy
Treatment:
Procedure: Flexible Ureteroscopy
Extracorporeal Shock Wave Lithotripsy
Experimental group
Description:
Extracorporeal Shock Wave Lithotripsy (ESWL)
Treatment:
Procedure: extracorporeal shock wave lithotripsy (ESWL)

Trial contacts and locations

1

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Central trial contact

Ahmed A Ahmed Atef Mohamed Abdellatif, MD

Data sourced from clinicaltrials.gov

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