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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Pediatric Urolithiasis, Distal Ureteral Stone, Ureteral Calculi

In brief

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.

Key facts

Study ID

NCT07617896

Run by

Beni-Suef University

People needed

60

Starts

2026-05-09

Expected to finish

2027-05-01

Last updated by the study team

2026-06-01

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 definitive ureteroscopy.
• Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, or significant hepatic impairment.
• Inability to complete follow-up.

Where it is running

• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf, Beni Suweif Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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