Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

NCT05738304 | Unknown

• 1 other identifier: Uro_Azhar_11_023
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stone; Retrograde Intrarenal Surgery; Ureteral Stent

Outcome Measures

Primary Outcomes (2)

• Stone free rate

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

  up to 1 month

• Stent-related symptoms

  Irritative lower urinary tract symptoms

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

Secondary Outcomes (3)

• Postoperative renal pain

  up to 1 month

• Rehospitalization rate

  From post RIRS home discharge up to one month

• Reintervention rate

  up to 3 months

Study Arms (2)

External Ureteral Catheter group

EXPERIMENTAL

After RIRS, an external ureteral catheter will be placed for one day.

Procedure: Retrograde intrarenal surgery with external ureteral catheter

Double J group

ACTIVE COMPARATOR

After RIRS, a double J internal ureteral stent will be placed for 2 weeks.

Procedure: Retrograde intrarenal surgery with double J internal ureteral stent

Interventions

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.

External Ureteral Catheter group

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.

Double J group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of either gender in whom RIRS was the primary modality.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abul-fotouh Ahmed, MD

CONTACT

00201001066756; abulfotouhahmed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: February 22, 2023
• Study Start: January 12, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

EG (1)