UrosepsisNCT07826325
Effect of Emergency Urinary Drainage on Subsequent PCNL Outcomes in Obstructive Urosepsis
A study testing Retrograde Ureteral Stenting followed by PCNL and Percutaneous Nephrostomy followed by PCNL in people with Urosepsis and Kidney Stone, run by Beni-Suef University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urosepsis, Kidney Stone
- What is being tested?
- Retrograde Ureteral Stenting followed by PCNL and Percutaneous Nephrostomy followed by PCNL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, 62511
doaa mahmoud khalil, assisstant professor, 01152091011, drm_abdallah_88@yahoo.com
About this study
Official title: Effect of Emergency Urinary Drainage Method on Subsequent Percutaneous Nephrolithotomy Outcomes in Patients With Obstructive Urosepsis: A Prospective Comparative Study
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.
Read the detailed description
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.
- Conditions
- Urosepsis, Kidney Stone
- Being tested
- Retrograde Ureteral Stenting followed by PCNL, Percutaneous Nephrostomy followed by PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Ureteral Stenting followed by PCNLProcedure or surgery
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 PCNLProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Percutaneous Nephrostomy followed by PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 to 4 weeks postoperatively
Secondary outcomes (1)
Incidence of Postoperative Fever or Recurrent Sepsis
Percentage of patients developing postoperative fever (body temperature ≥ 38.0°C) or systemic signs of recurrent urosepsis following PCNL.
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrosepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826325
- Sponsor's protocol ID
- FMBSUREC/07072026A/ Abdallah
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No