Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-18
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Aminophylline
DrugAminophylline 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.
Normal Saline Placebo
DrugA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intravesical AminophyllineExperimental treatment 1 intervention
Group B: Intravesical Normal Saline PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants With Successful Same-Session Semi-Rigid Ureteroscopic Access Without Balloon Dilation
Successful access is defined as passage of the intended semi-rigid ureteroscope through the ureteric orifice and intramural ureter after study solution instillation, without the need for balloon dilation. The outcome will be reported as the proportion of randomized participants achieving successful access in each study arm.
Time frame
Intraoperative, immediately after 5-minute intravesical study solution instillation during the index ureteroscopy procedure.Secondary outcomes
1
Proportion of Participants Requiring Balloon Dilation
This outcome will assess the proportion of randomized participants who require balloon dilation after failure of the second gentle ureteroscopic access attempt following study solution instillation.
Time frame
Intraoperative, during the index ureteroscopy procedure2
Total Operative Time
Total operative time will be measured in minutes from the start of endoscopic instrumentation to completion of the index endoscopic procedure.
Time frame
Intraoperative, during the index ureteroscopy procedure3
Proportion of Participants Requiring Postoperative Ureteral Stenting
This outcome will assess the proportion of randomized participants requiring ureteral stent placement at the end of the index procedure according to predefined clinical criteria, including significant mucosal injury, false passage, perforation, marked ureteric edema, difficult instrumentation, residual stone burden, or surgeon concern regarding safe postoperative drainage.
Time frame
At the end of the index ureteroscopy procedure4
Proportion of Participants With Postoperative Complications
This outcome will assess postoperative complications including hematuria, pain requiring additional analgesia, fever, febrile urinary tract infection, emergency visit, readmission, or any complication graded according to the Clavien-Dindo classification.
Time frame
From the end of surgery up to 3 months after the index procedureSponsors and contacts
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Source ClinicalTrials.gov