Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria

Sponsor
Beni-Suef University
Study ID
NCT07617948
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Calculous Anuria
  • Acute Kidney Injury
  • Obstructive Uropathy
  • Ureteral Calculi

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravesical Aminophylline — DRUG
    Aminophylline 250 mg diluted with normal saline to a total intravesical instillation volume of 160 mL. The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.
  • Placebo Saline — DRUG
    Placebo intravesical instillation using normal saline to a total volume of 160 mL. The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Apr 8, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravesical Aminophylline
    Participants will receive intravesical instillation of 250 mg aminophylline diluted with normal saline to a total volume of 160 mL. The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
  • Placebo Comparator: Placebo Saline
    Participants will receive intravesical placebo instillation using normal saline to a total volume of 160 mL. The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.

Primary Outcome Measure

Technical Success of Retrograde Double-J Ureteral Stent Placement [ Time Frame: During the index urgent retrograde stenting procedure ]

Central Contacts

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