Intravesical Aminophylline to Help Semi-Rigid Ureteroscopic Access in Children with Distal Ureteral Stones A Randomized, Double-Blind, Placebo-Controlled Trial

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 mgkg 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.

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