Intravesical aminophylline to aid ureteroscopic access in children with distal ureteral stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind trial in children undergoing semi-rigid ureteroscopy for distal ureteral stones. If the initial gentle attempt to pass the ureteroscope fails, participants are randomized to receive intravesical aminophylline or saline placebo for about five minutes before a second access attempt. The primary outcome is successful same-session passage of the ureteroscope without balloon dilation or additional invasive steps. The study aims to determine whether aminophylline improves access and potentially reduces the need for stenting or further maneuvers. Eligible children are between 2 and 18 years old with a single distal stone 5–15 mm, undergoing planned definitive treatment at Beni-Suef University Hospital.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Faculty of medicine BeniSuef University
• Study coordinator: Hany F Badawy, Md
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• L-Citrulline vs Tamsulosin for Helping Distal Ureteral Stones Pass

  This study tests whether L-citrulline helps stones pass from the distal ureter as well as or better than tamsulosin in adults with a single 5–10 mm stone.

  Recruiting Phase 2 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07617909

• Audio consent with human voice or AI-voice added to written consent for ureteroscopy

  This study tests if listening to an audio version of the consent form, read by a real urologist or by an AI-cloned voice, helps adults in Turkey understand their ureteroscopy or RIRS consent better than the written form alone.

  Recruiting at 3 sites Aydin Adnan Menderes University · Aydin, Aydın and 2 other locations · NCT07859436

• Comparing Two Ureteral Stent Designs in Children with Kidney Stones

  This study tests whether two common ureteral stents lead to different comfort and urinary symptoms in kids undergoing stone treatment.

  Recruiting The Hospital for Sick Children · Toronto, Ontario · NCT07742358

• ComfiJ vs. standard double-J stent after ureteroscopy or RIRS

  This trial tests whether a ComfiJ ureteral stent causes fewer urinary symptoms than a conventional double-J stent in adults needing short-term stenting after ureteroscopy or RIRS for stones.

  Recruiting at 3 sites Beni-Suef University · Banī Suwayf, Beni Suweif Governorate and 2 other locations · NCT07627828

• Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones

  This study tests two laser strategies during bladder-stone surgery in children to see which method finishes faster and leaves the bladder stone-free with fewer complications.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07623980

• Aminophylline in the Bladder to Help Place a Ureteral Stent Quickly

  This study tests whether putting aminophylline into the bladder before stenting helps adults with acute kidney blockage due to stones see if a ureteral stent can be placed more easily and quickly.

  Recruiting Phase 2 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07617948

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.