Energy Ramping Versus Fixed Dose ESWL

NCT07334236 | Not Yet Recruiting

• 1 other identifier: Soh-med--25-11-18MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Calculi

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).

  4 weeks

Secondary Outcomes (1)

• Number of ESWL sessions to achieve SFR.

  4 weeks

Study Arms (2)

fixed-dose ESWL

ACTIVE COMPARATOR

* 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

escalating-dose ESWL

EXPERIMENTAL

* 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

Interventions

Extracorporeal shock wave lithotripsy PROCEDURE

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.

escalating-dose ESWL; fixed-dose ESWL

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• mohammed Abdelhafez: lead

Study Sites (1)

Sohag university Hospital

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

mohammed A Abdelhafez

CONTACT

+201143548707; 3elwa97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urology Resident , sohag hospital university

Model Details: Randomized Parallel Assignment Randomized, two-arm parallel assignment comparing energy-ramping ESWL versus fixed-dose ESWL; participants randomized 1:1. Treatment allocation is stratified by stone size (\<10 mm vs ≥10 mm). Primary outcomes assessed at 3 months post-treatment.

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 12, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

EG (1)