Initial drainage method for a solitary kidney stone causing kidney failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with calculous anuria from a single upper ureteral stone, this multicenter randomized trial compares two emergency drainage methods before performing definitive flexible ureteroscopy/retrograde intrarenal surgery. Participants are randomized to emergency retrograde JJ ureteral stent drainage or emergency percutaneous nephrostomy drainage, then reassessed after renal function improves for the standardized definitive procedure. Outcomes include renal function recovery, urinary output, stabilization, and intraoperative details of the final endoscopic procedure. The study uses computer-generated randomization with allocation concealment and adheres to a predefined operative strategy for the definitive surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting
• Department of Urology- Minia University Hospitals
  Minya, Minya Governorate, Egypt Recruiting
• Department of Urology- Tanta University Hospitals
  Tanta, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Faculty of medicine BeniSuef University
• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.