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Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria

Intravesical Aminophylline-Assisted Urgent Retrograde Ureteral Stenting for Acute Calculous Anuria: A Prospective Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07617948
Enrollment
72
Registered
2026-06-01
Start date
2026-04-08
Completion date
2027-04-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

This is a prospective, randomized, double-blind, controlled trial conducted at the Department of Urology, Beni-Suef University Hospital. The study will include adult patients aged 18 years or older presenting with acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Obstruction will be confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract. Eligible patients will have clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and elevated serum creatinine. After eligibility assessment and informed consent, participants will be randomly allocated in a 1:1 ratio to one of two groups. Participants in the aminophylline group will receive intravesical instillation of 250 mg aminophylline diluted in normal saline to a total volume of 160 mL. Participants in the control group will receive placebo intravesical instillation using normal saline with the same total volume. The study solution will be prepared by a nurse who is not involved in the operation to maintain blinding of the patient and the operating surgeon. Under general or spinal anesthesia, the patient will be placed in the lithotomy position. A cystoscope will be introduced and the bladder will be emptied. The assigned intravesical solution will then be instilled into the bladder and retained for 5 minutes before proceeding with retrograde ureteral stenting. Under fluoroscopic guidance, a guidewire will be advanced through the ureteric orifice in an attempt to bypass the obstructing ureteral stone. If successful, a Double-J ureteral stent will be advanced over the guidewire and positioned across the obstruction. The primary endpoint is technical success of retrograde ureteral stenting, defined as successful placement of the Double-J stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary endpoints include time required for successful stent placement, intraoperative complications, serum creatinine changes at 24, 48, and 72 hours after decompression, postoperative pain score, analgesic requirement, and the need for alternative drainage after failed retrograde stenting.

Interventions

DRUGIntravesical Aminophylline

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 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.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Technical Success of Retrograde Double-J Ureteral Stent PlacementDuring the index urgent retrograde stenting procedureTechnical 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.

Secondary

MeasureTime frameDescription
Retrograde Stenting Attempt TimeDuring the index urgent retrograde stenting procedureTime will be measured in minutes from the start of the retrograde stenting attempt after the 5-minute intravesical dwell time until successful final Double-J stent positioning or the decision to stop the retrograde attempt because of technical failure.
Intraoperative Complication RateDuring the index urgent retrograde stenting procedureProportion of participants who experience intraoperative procedure-related complications, including ureteral mucosal injury, ureteral perforation, bleeding, guidewire false passage, or other procedure-related adverse events.
Serum Creatinine Change During the First 72 Hours After DecompressionBaseline, 24 hours, 48 hours, and 72 hours after decompressionSerum creatinine will be measured before decompression and at 24, 48, and 72 hours after the procedure to assess early renal function recovery.
Postoperative Pain Score During the First 24 HoursEvery 4 hours during the first 24 hours postoperativelyPostoperative pain will be assessed using a 10-point Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded every 4 hours during the first 24 hours after recovery from anesthesia.

Countries

Egypt

Contacts

CONTACTHany F Badawy, Md
Hanyfathy86@gmail.com+201149525028
CONTACTMahmoud Abdallah, MD
Drhanyfathy86@GMAIL.COM+201211874080
PRINCIPAL_INVESTIGATORHany F Badawy, MD

Beni-Suef University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026