Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Intravesical Aminophylline
DrugAminophylline 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 Saline
DrugPlacebo 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Intravesical AminophyllineExperimental treatment 1 intervention
Group B: Placebo SalinePlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
During the index urgent retrograde stenting procedureSecondary outcomes
1
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 procedure2
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 procedure3
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 decompression4
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov