Aminophylline in the Bladder to Help Place a Ureteral Stent Quickly

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind trial conducted at Beni-Suef University Hospital. Adults with acute calculous anuria due to ureteral stone obstruction in a solitary kidney or with bilateral obstruction will be assigned to intravesical aminophylline or placebo before attempting retrograde Double-J stent placement. The primary outcome is technical success of stent placement without needing percutaneous nephrostomy; secondary outcomes include stenting time, intraoperative complications, renal function recovery, and postoperative pain. Blinding is maintained by having a nurse prepare the solution and keeping patients and surgeons unaware of group assignment. The trial aims to determine if intravesical aminophylline can facilitate urgent urinary drainage in this emergency setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18 years or older.
2. Diagnosis of acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney.
3. Obstruction confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract.
4. Clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and serum creatinine \>2 mg/dL.
5. Ability to provide written informed consent.

Exclusion Criteria:

1. Known hypersensitivity to aminophylline, theophylline, or other methylxanthines.
2. Evidence of active urinary tract infection or urosepsis.
3. Previous history of ureteral stricture or major urinary tract reconstructive surgery.
4. Hemodynamic instability requiring immediate life-saving measures before urological intervention.
5. Pregnancy.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Beni-Suef University
• Study coordinator: Hany F Badawy, Md
• Email: Hanyfathy86@gmail.com
• Phone: +201149525028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.