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Recruiting Not applicable

Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria

NCT07627880 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-05-06
Last updated
2026-06-04

Condition(s) studied

Calculous AnuriaUpper Ureteral StoneObstructive UropathyAcute Kidney Injury

Investigational drug(s) / intervention(s)

Initial JJ Ureteral Stent DrainageInitial Percutaneous Nephrostomy Drainage

Initial JJ Ureteral Stent Drainage: Retrograde cystoscopic placement of a 6 Fr JJ ureteral stent for initial upper urinary tract decompression in 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, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.

Initial Percutaneous Nephrostomy Drainage: Ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for initial upper urinary tract decompression in 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, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS — From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS
    Serum creatinine will be measured in mg/dL at 24-48 hours after initial drainage and on postoperative day 1 after definitive tratment of stone by retrograde intrarenal surgery. The primary outcome will compare the change in serum creatinine from the post-drainage value to the post-RIRS value between the JJ ureteral stent drainage group.

Trial sites (3)

FacilityCityRegionStatus
Department of Urology- Beni-Suef University Hospitals Banī Suwayf Beni Suweif Governorate Recruiting
Department of Urology- Minia University Hospitals Minya Minya Governorate Recruiting
Department of Urology- Tanta University Hospitals Tanta Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07627880 on ClinicalTrials.gov ↗ ← All trials in Egypt