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RECRUITING
NCT07773090
NA

Role of Pre-stenting Before Retrograde Intrarenal Surgery With Miniaturized Flexible Ureteroscopes

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

Summary

This prospective randomized controlled trial will compare retrograde intrarenal surgery performed after routine preoperative ureteral stenting with direct retrograde intrarenal surgery without planned preoperative stenting in adults with unilateral renal calculi measuring 10-20 mm. The study will evaluate stone-free rate, ureteral access, need for rescue stenting, operative outcomes, complications, staged procedures, postoperative recovery, and auxiliary treatment.

Official title: Does Pre-stenting Still Have a Role in Retrograde Intrarenal Surgery in the Era of Miniaturized Flexible Ureteroscopes? Surgical Outcomes From a Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2026-08-19

Completion Date

2028-11-01

Last Updated

2026-08-21

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Preoperative double-J ureteral stenting followed by retrograde intrarenal surgery

Participants randomized to this group will undergo insertion of a 4.8-6 French double-J ureteral stent approximately 7-14 days before definitive RIRS. The stent will be used to provide passive ureteral dilation. Definitive RIRS will then be performed using a miniaturized digital flexible ureteroscope and holmium:YAG laser lithotripsy. The stent size, length, date of insertion, dwell time, technical success, complications, urinary tract infection, and stent-related symptoms will be recorded.

PROCEDURE

Direct retrograde intrarenal surgery without planned preoperative ureteral stenting

Participants randomized to this group will undergo direct RIRS without planned preoperative ureteral stenting. No routine active ureteral dilation will be performed before initial access. Gentle dilation may be performed when clinically necessary and will be documented. If safe access cannot be achieved, the procedure will be discontinued and a double-J ureteral stent will be inserted for passive dilation. Repeat RIRS will be scheduled approximately 7-14 days later.

Locations (1)

Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University

Cairo, Egypt