Acute Calculous AnuriaPhase 2NCT07617948
Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria
A Phase 2 study testing Intravesical Aminophylline in people with Acute Calculous Anuria and Ureteral Calculi, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Calculous Anuria, Ureteral Calculi, Obstructive Uropathy
- What is being tested?
- Intravesical Aminophylline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Apr 2026to Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate
Hany F Badawy, MD, +201149525028, Hanyfathy86@gmail.com
Mahmoud Abdallah, Md, +201211874080, Drhanyfathy86@GMAIL.COM
About this study
Official title: Intravesical Aminophylline-Assisted Urgent Retrograde Ureteral Stenting for Acute Calculous Anuria: A Prospective Randomized Controlled 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.
Read the 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.
- Being tested
- Intravesical Aminophylline, Placebo Saline
- Keywords
- Intravesical aminophylline, Retrograde ureteral stenting, Acute calculous anuria, Emergency urinary drainage, Double-J stent
- Medical subject headings
- Ureteral Calculi, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical AminophyllineDrug
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 SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the index urgent retrograde stenting procedure
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every 4 hours during the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start8 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Calculous AnuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617948
- Sponsor's protocol ID
- FMBSUREC07042026Ahmed
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.