Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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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

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flexible Ureteroscopy

Interventional procedure: Flexible Ureteroscopy

Group Type EXPERIMENTAL

Flexible Ureteroscopy

Intervention Type PROCEDURE

Flexible Ureterorenoscopy

Extracorporeal Shock Wave Lithotripsy

Extracorporeal Shock Wave Lithotripsy (ESWL)

Group Type EXPERIMENTAL

extracorporeal shock wave lithotripsy (ESWL)

Intervention Type PROCEDURE

extracorporeal shock wave lithotripsy (ESWL)

Interventions

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Flexible Ureteroscopy

Flexible Ureterorenoscopy

Intervention Type PROCEDURE

extracorporeal shock wave lithotripsy (ESWL)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No