RecruitingPhase 2

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

Egypt60 participantsStarted 2026-05-09

Plain-language 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.

Who can participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children older than 2 years and younger than 18 years. * Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy. * Stone size 5 to 15 mm. * Candidate for definitive treatment by semi-rigid ureteroscopy. * Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention. * Intraoperative failed initial gentle negotiation of the ureteric orifice/intramural ureter according to the study definition. * Written informed consent from the parent or legal guardian, with child assent when appropriate. Exclusion Criteria: * Known hypersensitivity to aminophylline, theophylline, or ethylenediamine. * Use of oral or intravenous aminophylline or theophylline within the previous 24 hours. * Pre-existing ipsilateral JJ ureteral stent. * Stone peeping at the ureteric orifice. * Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or previous ipsilateral ureteral reconstruction. * Known bladder dysfunction or conditions likely to affect normal bladder capacity. * Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or a ureteral access sheath strategy. * Febrile urinary tract infection, pyonephrosis, sepsis, or any case requiring urgent decompression instead of definitiv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants With Successful Same-Session Semi-Rigid Ureteroscopic Access Without Balloon Dilation

Timeframe: Intraoperative, immediately after 5-minute intravesical study solution instillation during the index ureteroscopy procedure.

Trial details

NCT IDNCT07617896

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Hany F Badawy, Md

+201149525028 HANYFATHY86@GMAIL.COM

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