Actively Recruiting
Intravesical Aminophylline to Facilitate Semi-Rigid Ureteroscopic Access in Children With Lower Ureteral Stones: A Prospective Randomized Double-Blind Placebo-Controlled Trial
Led by Beni-Suef University · Updated on 2026-06-01
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether intravesical aminophylline can help children with distal ureteral stones gain access for semi-rigid ureteroscopy when the first gentle attempt to enter the ureter is unsuccessful. The study is a prospective, randomized, double-blind, placebo-controlled trial involving children aged 2 to 18 years with symptomatic distal ureteral stones scheduled for semi-rigid ureteroscopy. The trial compares aminophylline against a saline placebo to assess its effect on ureteroscopic access without balloon dilation and monitors safety outcomes related to aminophylline use. During surgery, children first undergo a gentle attempt to pass a semi-rigid ureteroscope through the ureter. If unsuccessful, they are randomized to receive either intravesical aminophylline at 0.5 mg/kg diluted in saline or a saline placebo instilled into the bladder for about 5 minutes. After drainage, a second gentle ureteroscopic attempt is made. If access is obtained, stone treatment continues in the same session; otherwise, a rescue plan including balloon dilation or stenting may be followed. The study is designed to keep surgeons, families, and outcome assessors blinded to treatment. Participants will have preoperative evaluations and postoperative monitoring including cardiorespiratory checks and serum theophylline levels in treated cases. Follow-up visits occur immediately after surgery and at intervals up to three months to assess recovery, complications, stone status, and any additional procedures needed. The primary measure is successful ureteroscopic access without balloon dilation immediately after study solution instillation, with secondary outcomes tracking operative details, stenting, complications, and stone clearance.
CONDITIONS
Brief Title
Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children older than 2 years and younger than 18 years
- Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography
- Stone size between 5 and 15 mm
- Candidate for definitive treatment by semi-rigid ureteroscopy
- Sterile urine culture before surgery, or previously positive urine culture treated before intervention
- Intraoperative failed initial gentle negotiation of the ureteric orifice/intramural ureter
- Written informed consent from parent or legal guardian, with child assent when appropriate
You will not qualify if you...
- 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 abnormalities affecting distal ureteric access such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or ipsilateral ureteral reconstruction
- Known bladder dysfunction or conditions affecting normal bladder capacity
- Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or ureteral access sheath
- Febrile urinary tract infection, pyonephrosis, sepsis, or any urgent decompression case
- Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, significant hepatic impairment
- Inability to complete follow-up
AI-Screening
AI-Powered Screening
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Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical session
Participants undergo semi-rigid ureteroscopy. If the initial gentle ureteroscopic access fails, they are randomized to receive either intravesical aminophylline or placebo instilled through a catheter. After a 5-minute dwell time, a second gentle ureteroscopic attempt is made to facilitate access and continue stone treatment if successful.
1 intraoperative procedure
Duration - Approximately 3 months
Participants are monitored after surgery to assess recovery, postoperative complications, stone-free status, and any need for additional interventions, including assessments of pain, infection, and stent-related symptoms if applicable.
4 visits: immediate postoperative, 1 to 2 weeks, 4 weeks, and 3 months after surgery
Trial Site Locations
Total: 1 location
1
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt
Actively Recruiting
Research Team
H
Hany F Badawy, Md
A
Ahmed Gmal, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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