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RecruitingNCT07826325Updated Sep 17, 2026

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

An interventional study of Retrograde Ureteral Stenting followed by PCNL and Percutaneous Nephrostomy followed by PCNL in Urosepsis and Kidney Stone, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Kidney Calculi with a site in Egypt — 20 open to participants now, 22 under way, none of them phase 3. Kidney Calculi · Egypt.

Planned enrollment
26th of 51
100 · median 100
Started
2026
with 11 others
No phase
48 of 56
19 open now
Primary completion
2028-04
later than 19 of 21 live
Registered
55th of 56
by date

Among the 56 studies in Kidney Calculi with a site in Egypt, this one is the 26th largest by planned enrollment of the 51 interventional ones, is one of 12 that started in 2026, is one of 48 with no phase, reaches primary completion later than 19 of the 21 other live ones, and was the 55th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study48 · 19 open
Observational5 · 1 open
Phase 42 · 0 open
Phase 31 · 0 open

By the year they started

First in 2011; this study’s year is marked. 12 started in 2026.

Size and results

Median enrollment 100 across the 51 interventional studies, 100 across the 5 observational. Of the 24 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

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.

03

Conditions studied

  • Urosepsis
  • Kidney Stone

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 obtained prior to enrollment.

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Group A: Retrograde Ureteral Stent (RUS)

    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

  • Active comparator
    Group B: Percutaneous Nephrostomy (PCN)

    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

  • ProcedureRetrograde Ureteral Stenting followed by PCNL

    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.

  • ProcedurePercutaneous Nephrostomy followed by PCNL

    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.

06

What researchers measure

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.

    Time frame: 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.

    Time frame: Within 30 days postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.

Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 18 months is below that.

Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2026
First posted
Sep 17, 2026
StartEst.
Oct 2026
Primary completionEst.
Apr 2028
CompletionEst.
Jun 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07826325
Responsible party
Mahmoud Abdallah (lecturer of urology, Beni-Suef University) — Principal investigator
First posted
Sep 17, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Mahmoud Abdallah Mahmoud, lecturer
Contact
mahmoud.abdalla@med.bsu.edu.eg
01155361979

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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