Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07193940

Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flexible ureteroscopy

Procedure

Flexible Ureterorenoscopy

Extracorporeal shock wave lithotripsy (ESWL)

Procedure

extracorporeal shock wave lithotripsy (ESWL)

Primary outcomes

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

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Ahmed Atef Mohamed Abdellatif, MD

CONTACT

[email protected]

+0201069339244

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 26, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.