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NCT Number: NCT05738304

Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Retrograde Intrarenal Surgery Ureteral Stent Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology Department, Al-Azhar University Hospital

Cairo, Egypt

Location status: Recruiting

Location contact

Ahmed Fahim, MD

CONTACT

[email protected]

002025107333

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Retrograde intrarenal surgery with external ureteral catheter

Procedure

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

Procedure

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.

Primary outcomes

  1. Stone free rate

    Time frame: up to 1 month

    No stones or residual fragments >3 mm on postoperative imaging study

  2. Stent-related symptoms

    Time frame: from post operative day one till double J removal; an average of 2 weeks

    Irritative lower urinary tract symptoms

Secondary outcomes

  1. Postoperative renal pain

    Time frame: up to 1 month

    Renal pain attacks and severity as evaluated by visual analogue pain scale (VAPS).

    The VAPS is a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  2. Rehospitalization rate

    Time frame: From post RIRS home discharge up to one month

    the need for unscheduled hospital admission

  3. Reintervention rate

    Time frame: up to 3 months

    the need for reoperation

Study contacts

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

Abul-fotouh Ahmed, MD

CONTACT

[email protected]

00201001066756

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

One-Day External Ureteral Catheter Versus Double-J Internal Ureteral Stent After Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 22, 2023
Registry last updated
Aug 24, 2026

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.

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