NCT06830577

Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.

Detailed description

Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries. patients will be divided into 3 groups: 1. Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline 2. Group B (Ureteral Dilator Group): Traditional ureteral dilators 3. Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)

Conditions

• Stones, Kidney
• Ureteric Injury

Interventions

Type	Name	Description
DRUG	Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy	Intraureteric aminophylline installation prior to ureteric dilatation
DEVICE	Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy	traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
OTHER	Aminophylline instillation and Ureteral dilators together	Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-02-17
• Last updated: 2025-06-12

Locations

1 site across 1 country: Egypt