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NCT Number: NCT07826325

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location status: Recruiting

Location contact

doaa mahmoud khalil, assisstant professor

CONTACT

[email protected]

01152091011

About this study

Patients presenting to the emergency department with obstructive upper urinary tract stones and urosepsis will be prospectively enrolled. Initial emergency management includes hemodynamic resuscitation, broad-spectrum intravenous antibiotic therapy, and emergency decompression of the collecting system using either retrograde ureteral stent (RUS) insertion or percutaneous nephrostomy (PCN) based on surgeon judgment and clinical feasibility.

Following complete clinical resolution of sepsis, normalization of inflammatory markers, and confirmation of a sterile urine culture, patients will undergo definitive percutaneous nephrolithotomy (PCNL) under general anesthesia. Operative parameters including access technique, dilation, fragmentation method, operative time, and hemoglobin drop will be recorded. Postoperatively, complications will be graded according to the Clavien-Dindo classification system. Stone-free status (defined as the absence of residual fragments or fragments ≤ 4 mm) will be assessed at 2-4 weeks postoperatively using non-contrast computed tomography (NCCT) or ultrasonography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Stone-Free Rate (SFR) after PCNL

    Time frame: 2 to 4 weeks postoperatively

    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.

Secondary outcomes

  1. Incidence of Postoperative Fever or Recurrent Sepsis

    Time frame: Within 30 days postoperatively

    Percentage of patients developing postoperative fever (body temperature ≥ 38.0°C) or systemic signs of recurrent urosepsis following PCNL.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Abdallah Mahmoud, lecturer

CONTACT

[email protected]

01155361979

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Emergency Urinary Drainage Method on Subsequent Percutaneous Nephrolithotomy Outcomes in Patients With Obstructive Urosepsis: A Prospective Comparative Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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