Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria

NCT07617948 | Recruiting Phase 2

• 1 other identifier: FMBSUREC07042026Ahmed
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Intravesical aminophylline; Retrograde ureteral stenting; Acute calculous anuria; Emergency urinary drainage; Double-J stent

Outcome Measures

Primary Outcomes (1)

• Technical Success of Retrograde Double-J Ureteral Stent Placement

  Technical success will be defined as successful placement of a Double-J ureteral stent across the obstructing ureteral stone during the initial urgent retrograde stenting procedure without the need for percutaneous nephrostomy.

  During the index urgent retrograde stenting procedure

Secondary Outcomes (4)

• Retrograde Stenting Attempt Time

  During the index urgent retrograde stenting procedure

• Intraoperative Complication Rate

  During the index urgent retrograde stenting procedure

• Serum Creatinine Change During the First 72 Hours After Decompression

  Baseline, 24 hours, 48 hours, and 72 hours after decompression

• Postoperative Pain Score During the First 24 Hours

  Every 4 hours during the first 24 hours postoperatively

Study Arms (2)

Intravesical Aminophylline

EXPERIMENTAL

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.

Drug: Intravesical Aminophylline

Placebo Saline

PLACEBO COMPARATOR

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.

Drug: Placebo Saline

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.

Intravesical Aminophylline

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.

Placebo Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Ureteral Calculi; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases

Study Officials

• Hany F Badawy, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, Md

CONTACT

+201149525028; Hanyfathy86@gmail.com

Mahmoud Abdallah, MD

CONTACT

+201211874080; Drhanyfathy86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intravesical study solution will be prepared by a nurse not involved in the procedure. Participants, care providers, investigators, and outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1 ratio to receive either intravesical aminophylline or placebo normal saline before urgent retrograde Double-J ureteral stent placement.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)