Actively Recruiting
Intravesical Aminophylline-Assisted Urgent Retrograde Ureteral Stenting for Acute Calculous Anuria: A Prospective Randomized Controlled Trial
Led by Beni-Suef University · Updated on 2026-06-02
72
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying acute calculous anuria, a serious urological emergency caused by blockage of urine flow due to ureteral stones in a solitary functioning kidney or both ureters. This trial evaluates whether using intravesical aminophylline can help make urgent retrograde ureteral stenting easier and more successful in adult patients with this condition. The study is a prospective, randomized, double-blind controlled trial aiming to improve urine drainage and prevent kidney damage. Participants will be randomly assigned to receive either intravesical aminophylline diluted in normal saline or a placebo saline solution before undergoing retrograde ureteral stenting. Under anesthesia, the assigned solution is instilled into the bladder and retained for 5 minutes before attempting to place a Double-J ureteral stent through the ureter to bypass the obstructing stone. The procedure is done under fluoroscopic guidance, and success is defined as placing the stent without needing a more invasive drainage method. During the trial, researchers will monitor technical success, time taken to place the stent, any complications during the procedure, changes in kidney function over 72 hours, pain levels, pain medication use, and whether alternative drainage is needed. The study involves clinical evaluations, imaging confirmation, laboratory tests for kidney function, and pain assessments to understand how well the treatment works and its effects after stenting.
CONDITIONS
Brief Title
Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosis of acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney
- Obstruction confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract
- Clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and serum creatinine >2 mg/dL
- Ability to provide written informed consent
You will not qualify if you...
- Known hypersensitivity to aminophylline, theophylline, or other methylxanthines
- Evidence of active urinary tract infection or urosepsis
- Previous history of ureteral stricture or major urinary tract reconstructive surgery
- Hemodynamic instability requiring immediate life-saving measures before urological intervention
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm diagnosis and eligibility
Duration - Single procedure day
Participants receive intravesical instillation of either aminophylline or placebo retained in the bladder for 5 minutes, followed by urgent retrograde ureteral stenting under anesthesia.
1 visit (in-person) for the instillation and stenting procedure
Duration - 72 hours after the procedure
Participants are monitored for postoperative outcomes including serum creatinine levels and pain scores.
Several assessments including serum creatinine measurements at baseline, 24, 48, and 72 hours and pain scores every 4 hours during the first 24 hours
Trial Site Locations
Total: 1 location
1
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt
Actively Recruiting
Research Team
H
Hany F Badawy, Md
M
Mahmoud Abdallah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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