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Recruiting Not applicable

Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

NCT05738304 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2021-01-12
Last updated
2026-08-24

Condition(s) studied

Kidney StoneRetrograde Intrarenal SurgeryUreteral Stent

Investigational drug(s) / intervention(s)

Retrograde intrarenal surgery with external ureteral catheterRetrograde intrarenal surgery with double J internal ureteral stent

Retrograde intrarenal surgery with external ureteral catheter: The retrograde fURS sheathless technique will be used in all cases, including (a) cystourethroscopy with the introduction of a guidewire into the ipsilateral ureter up to the collecting system; (b) Semi-rigid ureteroscopy (using 9.5 Fr, Karl Storz, semi-rigid ureteroscope) for visualization of the ureter for any abnormalities, the introduction of the second guidewire and hydrophilic ureteral dilation; (c) introduction of the flexible ureteroscope (8.6 Fr, single-use digital flexible ureteroscope, OUT Medical Inc.) over the guidewire up to the kidney; (d) removal of the working guidewire after visualization of the stone; and (e) fragmentation of the stone using a holmium YAG laser device. All procedure steps will be performed under direct visualization and fluoroscopy guidance. At the end of the procedure, an external ureteral catheter will be placed for 24 hours.

Retrograde intrarenal surgery with double J internal ureteral stent: The retrograde fURS sheathless technique will be used in all cases, including (a) cystourethroscopy with the introduction of a guidewire into the ipsilateral ureter up to the collecting system; (b) Semi-rigid ureteroscopy (using 9.5 Fr, Karl Storz, semi-rigid ureteroscope) for visualization of the ureter for any abnormalities, the introduction of the second guidewire and hydrophilic ureteral dilation; (c) introduction of the flexible ureteroscope (8.6 Fr, single-use digital flexible ureteroscope, OUT Medical Inc.) over the guidewire up to the kidney; (d) removal of the working guidewire after visualization of the stone; and (e) fragmentation of the stone using a holmium YAG laser device. All procedure steps will be performed under direct visualization and fluoroscopy guidance. At the end of the procedure, a double-J internal ureteric stent will be placed for 2 weeks.

Study summary

Several studies evaluated the benefit of a short-term external ureteral catheter (UC) compared to double-J (DJ) ureteral stent after flexible ureteroscopy (URS); the results were controversial. These studies had combined analyses of ureteral and renal stones with a high risk of selection bias. Studies comparing external UC and DJ stent after flexible URS for isolated renal stones are lacking.

In the present study, the investigators will compare the outcomes of using a one-day external UC versus a DJ internal ureteral stent for ureteral drainage after retrograde flexible URS (retrograde intrarenal surgery "RIRS") for renal stones. The investigators aim to identify the best ureteral drainage method after RIRS regarding stone clearance, complications, and stent-related symptoms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: • Adult patients of either gender in whom RIRS was the primary modality. Exclusion Criteria: * Pregnant women * Active urinary tract infection * solitary kidney * Concomitant pathology that need intervention in the same setting * Patients with surgical incidents that indicate double-J stenting (Residual sizable fragments, ureteral false passage, ureteral mucosal laceration, ureteral perforation, and calyceal rupture).

Primary outcome measure(s)

  • Stone free rate — up to 1 month
    No stones or residual fragments \>3 mm on postoperative imaging study
  • Stent-related symptoms — from post operative day one till double J removal; an average of 2 weeks
    Irritative lower urinary tract symptoms

Trial sites (1)

FacilityCityRegionStatus
Urology Department, Al-Azhar University Hospital Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05738304 on ClinicalTrials.gov ↗ ← All trials in Egypt