drugset / Trial / NCT07617948

Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria

NCT07617948

Phase 2 Recruiting 72 enrolled Beni-Suef University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Acute calculous anuria is a urological emergency caused by ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Urgent decompression of the upper urinary tract is required to restore urine drainage and prevent further renal impairment. This prospective randomized double-blind controlled trial will evaluate whether intravesical aminophylline can facilitate urgent retrograde ureteral stenting in adult patients with acute calculous anuria due to ureteral stones. Eligible patients will be randomly assigned to receive either intravesical aminophylline diluted in normal saline or placebo saline before attempted retrograde Double-J ureteral stent placement. The primary outcome is technical success, defined as successful placement of a Double-J ureteral stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary outcomes include stenting time, intraoperative complications, renal function recovery, postoperative pain, analgesic requirement, and the need for alternative drainage.

Timeline

Start
2026-04-08
Primary completion
2027-03
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminophylline Small molecule 250 mg Other