RecruitingPhase 2NCT07617896

Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.

Intravesical Aminophylline to Facilitate Semi-Rigid Ureteroscopic Access in Children With Lower Ureteral Stones: A Prospective Randomized Double-Blind Placebo-Controlled Trial


Sponsor

Beni-Suef University

Enrollment

60 participants

Start Date

May 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate whether intravesical aminophylline can facilitate semi-rigid ureteroscopic access in children with distal ureteral stones when the first gentle attempt to enter the ureter is unsuccessful. Children scheduled for semi-rigid ureteroscopy for distal ureteral stones will first undergo the standard gentle attempt to pass the ureteroscope through the ureteric orifice and intramural ureter. If access is achieved, the child will continue standard treatment and will not be randomized. If access is not achieved, the child will be randomized during the operation to receive either intravesical aminophylline or intravesical normal saline placebo. The study solution will be instilled into the bladder for approximately 5 minutes, then drained, and a second gentle ureteroscopic access attempt will be made. The main outcome is successful same-session passage of the intended semi-rigid ureteroscope without balloon dilation. The study will also assess the need for JJ stenting and deferred ureteroscopy, same-session stone treatment, operative outcomes, complications, and early aminophylline-related safety.


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Aminophylline and a drug called Normal Saline Placebo for people with distal ureteral stone, pediatric urolithiasis, and other related conditions. The study is currently recruiting participants at 1 location.

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

DRUGAminophylline

Aminophylline will be administered intravesically at a dose of 0.5 mg/kg, diluted in 0.9% normal saline to a fixed total volume of 50 mL. The solution will be instilled through a urethral catheter, retained in the bladder for approximately 5 minutes, then drained before a second gentle semi-rigid ureteroscopic access attempt.

DRUGNormal Saline Placebo

A 50 mL volume of 0.9% normal saline placebo will be instilled intravesically through a urethral catheter, retained in the bladder for approximately 5 minutes, then drained before a second gentle semi-rigid ureteroscopic access attempt.


Locations(1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

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NCT07617896


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