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

NCT07617896 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Pediatric Urolithiasis
  • Distal Ureteral Stone
  • Ureteral Calculi

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Hany F Badawy, MD · Faculty of medicine BeniSuef University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-09
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617896 on ClinicalTrials.gov