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

NCT07523074 | Recruiting

• 1 other identifier: FMBSUREC/02122025/Abdallah
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief Summary

Residual renal stone fragments remain a common clinical issue following percutaneous nephrolithotomy (PCNL), with reported incidence ranging from 10% to 30%. These fragments may act as a nidus for recurrent stone formation, infection, or obstruction, necessitating further intervention. Extracorporeal shock wave lithotripsy (ESWL) is widely used as a non-invasive treatment option for such residual stones; however, the optimal timing of ESWL after PCNL remains unclear. Early application of ESWL may enhance stone clearance before fragment embedding or encrustation occurs, but it could be associated with increased risk of bleeding or infection due to incomplete renal healing. Conversely, delayed ESWL allows for better tissue recovery but may permit stone growth or persistence of symptoms. This prospective randomized comparative study aims to evaluate the optimal timing of ESWL after PCNL in patients with residual renal stones ≤15 mm. Eligible patients will be randomized into two groups: early ESWL (within 7-14 days after PCNL) and delayed ESWL (after 3-4 weeks). The primary outcome is the stone-free rate at 3 months, while secondary outcomes include complication rates, pain scores, renal function changes, and the need for additional interventions. The results of this study are expected to provide evidence-based guidance on the ideal timing of ESWL following PCNL to maximize efficacy and minimize complications.

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate at 3 Months

  The proportion of patients who are stone-free, defined as no residual fragments greater than 2 mm on imaging (ultrasound or CT scan) at 3 months after ESWL treatment.

  3 months after ESWL

Secondary Outcomes (1)

• Complication Rate

  Within 4 weeks after ESWL

Study Arms (2)

(Early ESWL): ESWL within 7-14 days after PCNL

EXPERIMENTAL

Patients receive extracorporeal shock wave lithotripsy (ESWL) within 7-14 days after percutaneous nephrolithotomy (PCNL) for treatment of residual renal stones ≤15 mm. Standard ESWL protocol is applied with a maximum of 3 sessions.

Procedure: Extracorporeal shock wave lithotripsy (ESWL)

(Delayed ESWL): ESWL after 3-4 weeks.

EXPERIMENTAL

Patients receive extracorporeal shock wave lithotripsy (ESWL) 3-4 weeks after percutaneous nephrolithotomy (PCNL) for treatment of residual renal stones ≤15 mm. Standard ESWL protocol is applied with a maximum of 3 sessions.

Procedure: Extracorporeal shock wave lithotripsy (ESWL)

Interventions

Extracorporeal shock wave lithotripsy (ESWL) PROCEDURE

Extracorporeal shock wave lithotripsy (ESWL) is performed using a standardized protocol for treatment of residual renal stones ≤15 mm after percutaneous nephrolithotomy (PCNL). All patients are treated using the same lithotripter model with standardized energy settings and shock frequency according to EAU guidelines. Sedation is administered as needed. A maximum of three ESWL sessions is allowed. Follow-up imaging is performed to assess stone clearance.

(Delayed ESWL): ESWL after 3-4 weeks.; (Early ESWL): ESWL within 7-14 days after PCNL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years.
• Single or multiple residual renal stones ≤15 mm after PCNL.
• Normal renal function (serum creatinine \<1.5 mg/dL).
• No active UTI.

You may not qualify if:

• Bleeding disorders or anticoagulant therapy.
• Obstructed drainage or active sepsis.
• Stones \>15 mm or requiring secondary PCNL.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef university hospital

Banī Suwayf, Beni-Suef Governrate, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mahmoud Abdallah Mahmoud, lecturer of urology

CONTACT

+2001155361979; mahmoud.abdalla@med.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology Beni-Suef university hospital

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

EG (1)