Energy Ramping Versus Fixed Dose ESWL

Energy Ramping Versus Fixed Dose ESWL on Stone-Free Rate (Comparative Study)

This clinical trial compares two techniques of extracorporeal shock wave lithotripsy (ESWL) - energy ramping versus fixed dose - in adult patients with renal stones. The study aims to evaluate stone-free rates, retreatment needs, and safety outcomes across multiple clinical sites in Egypt.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Calculi
• Intervention / Treatment: Procedure: Extracorporeal shock wave lithotripsy

Detailed Description

This multi-center, randomized controlled trial investigates the impact of energy ramping versus fixed-dose ESWL on stone clearance in patients with solitary renal calculi. Participants will be assigned to either a gradually increasing energy protocol or a constant energy protocol using standardized lithotripter settings. The primary outcome is stone-free rate at two weeks post-treatment, assessed via imaging. Secondary outcomes include retreatment rate, pain scores, adverse events, and procedure duration. The study is conducted under IRB approval from Sohag University and follows international ethical standards for human research.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed A Abdelhafez; Phone Number: +201143548707; Email: 3elwa97@gmail.com

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Sohag University Hospital
    • Contact: ahmed abdelhamed, professor; Phone Number: +201068056074; Email: sharkawiahmed@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ≥18 years.
• Radiopaque renal or proximal/mid ureteral stone ≤20 mm.
• eGFR ≥60 mL/min/1.73 m².
• Fit for ESWL.
• Able to give informed consent and complete follow up.

Exclusion Criteria:

• • Pregnancy.

  • Active, untreated UTI.
  • Uncorrected bleeding disorder or anticoagulation that cannot be stopped.
  • Prior ipsilateral renal surgery.
  • Non radio-opaque stone without reliable imaging.
  • Inability to tolerate ESWL or required anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fixed-dose ESWL; Start therapeutic/high energy (e.g., 80-100% device max) from therapeutic phase.; Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks and cumulative energy.	Procedure: Extracorporeal shock wave lithotripsy; Fixed Voltage (experimental): Subjects receive shock wave therapy at a constant energy level (e.g., 20-22 kV) for the entire duration of the session. Standard delivery includes approximately 3,000 shocks at a frequency of 60-90 shocks per minute. Voltage Ramping (control): Subjects receive shock wave therapy starting at a low energy level (e.g., 6-10 kV) for an initial "priming" phase of 100-500 shocks. Energy is then escalated in predefined increments (e.g., 1-2 kV every 250-500 shocks) until reaching the target therapeutic voltage.
Experimental: escalating-dose ESWL; Stepwise escalation: increase energy every 500-1000 shocks (example: 20% → 40% → 60% → 80-100%) until therapeutic energy reached.; Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks per step and cumulative energy.	Procedure: Extracorporeal shock wave lithotripsy; Fixed Voltage (experimental): Subjects receive shock wave therapy at a constant energy level (e.g., 20-22 kV) for the entire duration of the session. Standard delivery includes approximately 3,000 shocks at a frequency of 60-90 shocks per minute. Voltage Ramping (control): Subjects receive shock wave therapy starting at a low energy level (e.g., 6-10 kV) for an initial "priming" phase of 100-500 shocks. Energy is then escalated in predefined increments (e.g., 1-2 kV every 250-500 shocks) until reaching the target therapeutic voltage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of ESWL sessions to achieve SFR.	4 weeks

Collaborators and Investigators

• Sponsor: mohammed Abdelhafez

Study record dates

Study Major Dates

• Study Start (Estimated): January 3, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Therapeutics; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Lithotripsy
• Other Study ID Numbers: Soh-med--25-11-18MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No