Energy Ramping Versus Fixed Dose ESWL

NCT ID: NCT07334236

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-03
• Study Completion Date: 2026-11-01

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.

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.

Conditions

Renal Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal shock wave lithotripsy

Intervention Type: 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

• 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.

Group Type: EXPERIMENTAL

Extracorporeal shock wave lithotripsy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

mohammed Abdelhafez

OTHER

Sponsor Role: lead

Responsible Party

mohammed Abdelhafez

Urology Resident , sohag hospital university

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

mohammed A Abdelhafez

Role: CONTACT

3elwa97@gmail.com

+201143548707

Facility Contacts

ahmed abdelhamed, professor

Role: primary

sharkawiahmed@yahoo.com

+201068056074

Other Identifiers

Soh-med--25-11-18MS

Identifier Type: -

Identifier Source: org_study_id