A Phase 2 interventional study of Intravesical Aminophylline and Placebo Saline in Acute Calculous Anuria, Ureteral Calculi and Obstructive Uropathy, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Beni-Suef University · Phase 2, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Ureteral Calculi; 14 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 42 interventional studies indexed under Ureteral Calculi.
Browse Ureteral Calculi studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: During the index urgent retrograde stenting procedure
Retrograde Stenting Attempt Time
Time 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.
Time frame: During the index urgent retrograde stenting procedure
Intraoperative Complication Rate
Proportion of participants who experience intraoperative procedure-related complications, including ureteral mucosal injury, ureteral perforation, bleeding, guidewire false passage, or other procedure-related adverse events.
Time frame: During the index urgent retrograde stenting procedure
Serum Creatinine Change During the First 72 Hours After Decompression
Serum creatinine will be measured before decompression and at 24, 48, and 72 hours after the procedure to assess early renal function recovery.
Time frame: Baseline, 24 hours, 48 hours, and 72 hours after decompression
Postoperative Pain Score During the First 24 Hours
Postoperative 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.
Time frame: Every 4 hours during the first 24 hours postoperatively
Plan to share: No — Individual participant data will not be shared. Only aggregated, de-identified study results will be reported. Individual-level data will remain confidential and will be accessible only to the study investigators and authorized regulatory or ethics committee representatives if required.
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Started Apr 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.
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