Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria (NCT07627880) | Clinical Trial Compass
RecruitingNot Applicable
Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria
Egypt90 participantsStarted 2026-05-06
Plain-language summary
Calculous anuria caused by obstructing upper ureteral stones in a solitary functioning kidney is a urological emergency requiring urgent decompression. Both retrograde JJ ureteral stenting and percutaneous nephrostomy are commonly used emergency drainage methods. However, limited evidence is available regarding whether the initial drainage method affects subsequent definitive flexible ureteroscopy/retrograde intrarenal surgery outcomes.
This multicenter prospective randomized controlled trial will compare emergency JJ ureteral stent drainage versus percutaneous nephrostomy drainage in adult patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery. The study will assess renal functional recovery, first-session surgical success, stone-free rate, operative parameters, complications, and microbiological outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older.
* Calculous anuria secondary to a single upper ureteral stone.
* Solitary functioning kidney, whether anatomical or functional.
* Single upper ureteral stone confirmed by non-contrast computed tomography.
* Stone size from 6 mm to 20 mm in maximum diameter.
* Patient considered suitable for either initial JJ ureteral stent drainage or percutaneous nephrostomy drainage.
* Candidate for definitive treatment by flexible ureteroscopy/retrograde intrarenal surgery.
* Documented renal functional improvement and clinical stabilization before definitive RIRS.
* Negative or appropriately treated urine culture before definitive RIRS.
* Ability and willingness to provide written informed consent.
Exclusion Criteria:
* Multiple stones or bilateral stones not fitting the solitary-kidney study design.
* Renal pelvic, distal ureteral, or multiple ipsilateral stones.
* Stone burden greater than 20 mm.
* Septic shock, hemodynamic instability, or need for emergency dialysis at presentation.
* Pyonephrosis requiring a non-randomized drainage decision.
* Anatomical abnormalities affecting endoscopic access, such as horseshoe kidney, pelvic kidney, ureterocele, or ureteral stricture.
* Previous ipsilateral ureteral reconstructive surgery.
* Uncorrected coagulopathy.
* Pregnancy.
* Genitourinary malignancy.
* Inability to complete follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS
Timeframe: From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS