Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07523074

Optimal Timing of Extracorporeal Shock Wave Lithotripsy for Residual Stones After Percutaneous Nephrolithotomy: A Prospective Randomized Study

Led by Beni-Suef University · Updated on 2026-04-13

476

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the best timing for extracorporeal shock wave lithotripsy (ESWL) after percutaneous nephrolithotomy (PCNL) in patients with residual kidney stones measuring 15 mm or less. Residual stone fragments after PCNL are common and can lead to recurrent stones, infections, or blockages, often requiring further treatment. This randomized study aims to compare early ESWL (within 7-14 days post-PCNL) versus delayed ESWL (after 3-4 weeks) to find the optimal approach that balances stone clearance and complication risks. Participants are divided into two groups: one receives ESWL treatment early, within 7-14 days after PCNL, and the other receives it later, after 3-4 weeks. Both groups use the same type of lithotripter and follow standardized treatment settings per European Association of Urology guidelines. Up to three ESWL sessions are allowed per patient with sedation or pain relief as needed. The study monitors patients clinically and with imaging to evaluate stone clearance. During the study, patients will undergo imaging tests such as ultrasound or non-contrast CT scans after ESWL to check for remaining stones. The main measure of success is the stone-free rate at 3 months. Secondary measures include rates of complications like bleeding or infection, pain levels, changes in kidney function, and the need for further procedures. Follow-up includes clinical and radiological assessments to guide treatment evaluation and patient safety over the course of the study.

CONDITIONS

Brief Title

Early vs Delayed Extracorporeal Shock Wave Lithotripsy for Residual Stones After Percutaneous Nephrolithotomy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Presence of single or multiple residual kidney stones 15 mm or smaller after PCNL
  • Normal kidney function with serum creatinine less than 1.5 mg/dL
  • No active urinary tract infection at the time of enrollment
Not Eligible

You will not qualify if you...

  • Bleeding disorders or current use of anticoagulant therapy
  • Obstructed urinary drainage or active sepsis
  • Kidney stones larger than 15 mm or requiring a second PCNL procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Up to 3 ESWL sessions within 4 weeks after PCNL

Participants undergo extracorporeal shock wave lithotripsy (ESWL) to treat residual kidney stones after percutaneous nephrolithotomy (PCNL). Early ESWL occurs within 7-14 days after PCNL, and delayed ESWL occurs 3-4 weeks after PCNL. Up to 3 ESWL sessions are provided as needed with sedation or analgesia.

1 to 3 visits for ESWL sessions depending on treatment needs

Follow-up

Duration - 3 months after completion of ESWL

Participants are followed clinically and radiologically to assess stone clearance and monitor for any procedure-related complications.

1 imaging visit for assessment and additional clinical follow-up visits as needed

Trial Site Locations

Total: 1 location

1

Beni-Suef university hospital

Banī Suwayf, Beni-Suef Governrate, Egypt, 62511

Actively Recruiting

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Research Team

M

Mahmoud Abdallah Mahmoud, lecturer of urology

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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