Effect of Emergency Urinary Drainage on Subsequent PCNL Outcomes in Obstructive Urosepsis

NCT07826325 | Recruiting

• 1 other identifier: FMBSUREC/07072026A/ Abdallah
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive urolithiasis complicated by urosepsis is a life-threatening medical emergency requiring urgent urinary tract decompression. Emergency drainage is typically achieved by either retrograde ureteral stent (RUS) insertion or percutaneous nephrostomy (PCN). Following clinical stabilization and resolution of infection, percutaneous nephrolithotomy (PCNL) is commonly performed as definitive stone treatment. This prospective comparative study aims to evaluate and compare the outcomes of subsequent PCNL between patients who underwent emergency drainage via retrograde ureteral stent and those who underwent percutaneous nephrostomy. The main outcomes to be compared include stone-free rates, operative time, blood loss, postoperative complications, length of hospital stay, and the need for auxiliary procedures.

Conditions

Urosepsis; Kidney Stone

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate (SFR) after PCNL

  Percentage of patients achieving stone-free status, defined as the complete absence of residual stone fragments or presence of clinically insignificant residual fragments ≤ 2 mm, assessed via non-contrast CT or ultrasound.

  2 to 4 weeks postoperatively

Secondary Outcomes (1)

• Incidence of Postoperative Fever or Recurrent Sepsis

  Within 30 days postoperatively

Study Arms (2)

Group A: Retrograde Ureteral Stent (RUS)

ACTIVE COMPARATOR

Patients presenting with obstructive urosepsis who undergo initial emergency urinary decompression via retrograde ureteral stent (RUS / Double J stent) insertion, followed by definitive percutaneous nephrolithotomy (PCNL) after sepsis resolution and urine culture sterilization.

Procedure: Retrograde Ureteral Stenting followed by PCNL

Group B: Percutaneous Nephrostomy (PCN)

ACTIVE COMPARATOR

Patients presenting with obstructive urosepsis who undergo initial emergency urinary decompression via percutaneous nephrostomy (PCN) tube insertion, followed by definitive percutaneous nephrolithotomy (PCNL) after sepsis resolution and urine culture sterilization.

Procedure: Percutaneous Nephrostomy followed by PCNL

Interventions

Retrograde Ureteral Stenting followed by PCNL PROCEDURE

Emergency decompression via retrograde ureteral stent (Double-J stent) placement under fluoroscopic guidance, along with intravenous antibiotic therapy and resuscitation. Once sepsis resolves, inflammatory markers normalize, and urine culture becomes sterile, definitive percutaneous nephrolithotomy (PCNL) is performed.

Group A: Retrograde Ureteral Stent (RUS)

Percutaneous Nephrostomy followed by PCNL PROCEDURE

Emergency decompression via ultrasound- and/or fluoroscopy-guided percutaneous nephrostomy (PCN) tube insertion, combined with intravenous antibiotics and resuscitation. After complete resolution of sepsis, normalization of inflammatory parameters, and confirmation of sterile urine, definitive percutaneous nephrolithotomy (PCNL) is performed.

Group B: Percutaneous Nephrostomy (PCN)

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Presence of renal or proximal ureteral stones.
• Presentation with urosepsis secondary to obstructive urolithiasis.
• Emergency urinary decompression performed by either retrograde ureteral stent (Double-J stent) or percutaneous nephrostomy (PCN).
• Patients scheduled for definitive stone management via percutaneous nephrolithotomy (PCNL) after clinical stabilization and infection resolution.
• Written informed consent obtained prior to enrollment.

You may not qualify if:

• Congenital renal anomalies (e.g., horseshoe kidney, ectopic kidney).
• Pregnancy.
• Uncorrectable coagulopathy or bleeding disorders.
• Active, uncontrolled urinary tract infection at the time of definitive PCNL.
• Severe cardiopulmonary comorbidities rendering the patient unfit for surgery or general anesthesia.
• Patients managed definitively by other modalities (e.g., ureteroscopy or ESWL alone).

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of Medicine, Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mahmoud Abdallah Mahmoud, lecturer

CONTACT

01155361979; mahmoud.abdalla@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)