Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria

NCT07627880 | Recruiting

• 1 other identifier: FMB050526-ANURIA-RIRS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Percutaneous nephrostomy; Double-J ureteral stent; Retrograde intrarenal surgery

Outcome Measures

Primary Outcomes (1)

• Change in Serum Creatinine From After Initial Drainage to 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.

  From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS

Secondary Outcomes (6)

• First-Session Definitive RIRS Success Rate

  During the definitive RIRS procedure

• Stone-Free Rate After Definitive RIRS

  4 weeks after definitive RIRS

• During the definitive RIRS procedure

  During the definitive RIRS procedure

• Need for Ureteral Stenting After Definitive RIRS

  At the end of the definitive RIRS procedure

• Intraoperative Complications During Definitive RIRS

  During the definitive RIRS procedure

Other Outcomes (1)

• Ureteral Access Sheath Insertion Success Rate

  During the definitive RIRS procedure

Study Arms (2)

JJ Ureteral Stent Drainage Group

ACTIVE COMPARATOR

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.

Procedure: Initial JJ Ureteral Stent Drainage

Percutaneous Nephrostomy Drainage Group

ACTIVE COMPARATOR

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.

Procedure: Initial Percutaneous Nephrostomy Drainage

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.

JJ Ureteral Stent Drainage Group

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.

Percutaneous Nephrostomy Drainage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (3)

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

MeSH Terms

Conditions

Ureterolithiasis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Renal Insufficiency; Kidney Diseases

Study Officials

• Hany F Badawy, MD

  Faculty of medicine BeniSuef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors evaluating postoperative laboratory results, imaging-based stone-free status, complications, and microbiological outcomes will be blinded to the initial drainage allocation whenever feasible. Participants, care providers, and operating surgeons cannot be blinded because the assigned drainage method is clinically evident.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1 ratio to one of two emergency drainage strategies: retrograde JJ ureteral stent drainage or percutaneous nephrostomy drainage. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)