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RECRUITING
NCT07617896
PHASE2

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

Sponsor: Beni-Suef University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-05-09

Completion Date

2027-05

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Aminophylline

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.

DRUG

Normal 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