Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria

Sponsor
Beni-Suef University
Study ID
NCT07627880
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Calculous Anuria
  • Obstructive Uropathy
  • Upper Ureteral Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Initial JJ Ureteral Stent Drainage — PROCEDURE
    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 — PROCEDURE
    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 Details

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.

Key Dates

First listed
Jun 4, 2026
Start date
May 6, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: JJ Ureteral Stent Drainage Group
    Participants randomized to this arm will undergo emergency retrograde placement of a 6 Fr double-J ureteral stent under cystoscopic guidance for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
  • Active Comparator: Percutaneous Nephrostomy Drainage Group
    Participants randomized to this arm will undergo emergency ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.

Primary Outcome Measure

Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS [ Time Frame: From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS ]

Central Contacts

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