Energy Ramping Versus Fixed Dose ESWL

mohammed Abdelhafez

Status: Not yet enrolling

Conditions: Renal Calculi

Treatments: Procedure: Extracorporeal shock wave lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07334236

Soh-med--25-11-18MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

fixed-dose ESWL

Active Comparator group

Description:

* 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.

Treatment:

Procedure: Extracorporeal shock wave lithotripsy

escalating-dose ESWL

Experimental group

Description:

* 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.

Treatment:

Procedure: Extracorporeal shock wave lithotripsy