RecruitingNot ApplicableNCT07773090

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

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


Sponsor

Al-Azhar University

Enrollment

270 participants

Start Date

Aug 19, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Direct retrograde intrarenal surgery without planned preoperative ureteral stenting and a procedure called Preoperative double-J ureteral stenting followed by retrograde intrarenal surgery for people with renal calculi. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPreoperative 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.

PROCEDUREDirect 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

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NCT07773090


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