Actively Recruiting
International Alliance of Urolithiasis Percutaneous Nephrolithotripsy Study
Led by Foundation Endourology · Updated on 2026-06-03
4000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Foundation Endourology
Lead Sponsor
T
The International Alliance of Urolithiasis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the current use, effectiveness, and safety of percutaneous nephrolithotomy (PCNL) for treating kidney stones. This observational study, led by the International Alliance of Urolithiasis (IAU), aims to evaluate different PCNL techniques, including miniaturized versions, and compare them to standard methods. The study also seeks to identify risk factors for complications during and after surgery, using a standardized classification system to assess outcomes. Participants undergo PCNL procedures according to their clinical center's protocols, which use various imaging methods like ultrasound or fluoroscopy to access the kidney. Techniques include standard and miniaturized PCNL performed in different patient positions, with details recorded on tract dilation methods, lithotripsy energy types, and drainage strategies after surgery. The study collects data over 12 to 18 months at multiple centers worldwide, with oversight by the IAU Scientific Committee and an audit team for quality control. During the study, participants' clinical data are entered securely by local coordinators at each site. Researchers collect detailed preoperative, intraoperative, and postoperative information, including imaging results, stone characteristics, surgical details, complication rates, hospital stay duration, and kidney function changes. The primary outcome is the stone-free rate one month after surgery, with secondary measures including complication rates within 30 days, hemoglobin changes, operative time, and length of hospital stay. The study plans to include up to 10,000 patients to better understand PCNL outcomes and safety.
CONDITIONS
Brief Title
IAU Percutaneous Nephrolithotripsy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years or older at the time of enrollment
- Diagnosed with single or multiple renal calculi or proximal ureteral stones
- Scheduled to undergo any primary or secondary percutaneous surgical stone intervention including standard or miniaturized PCNL
- Provided written informed consent for participation and data use
You will not qualify if you...
- Patient age under 18 years
- Scheduled for alternative primary treatments such as retrograde intrarenal surgery or shockwave lithotripsy alone
- Presence of active, untreated urinary tract infection or clinical urosepsis at surgery
- Uncorrected severe coagulopathy or bleeding disorders
- Missing or incomplete medical records preventing outcome assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo percutaneous nephrolithotomy (PCNL) surgery for treatment of kidney stones. The procedure involves creating a tract to the kidney to remove stones using various techniques and instruments based on clinical practice at each center.
1 surgical visit (in-person)
Duration - Up to 30 days postoperatively
Participants are monitored for up to 30 days after surgery to assess complications, recovery, and stone-free status. This includes hospital stay and postoperative care.
Approximately 1 to 2 visits depending on hospital stay and recovery
Trial Site Locations
Total: 4 locations
1
Foundation Endourology
Sofia, Sofia-Grad, Bulgaria, 1606
Actively Recruiting
2
Foundation Endourology
Sofia, Sofia-Grad, Bulgaria, 1606
Actively Recruiting
3
Foundation Endourology
Sofia, Sofia-Grad, Bulgaria, 1606
Actively Recruiting
4
Military Medical Academy, Department of Urology and Nephrology
Sofia, Sofia-Grad, Bulgaria, 1606
Actively Recruiting
Research Team
I
Iliya P Saltirov, DSc
O
Ognyan H Gatsev, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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