Energy Ramping Versus Fixed Dose ESWL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extracorporeal shock wave lithotripsy.
- Who it may be relevant to
- Registry conditions: Renal Calculi. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Energy Ramping Versus Fixed Dose ESWL on Stone-Free Rate (Comparative Study)
Overview
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.
Interventions
- 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
Primary outcome measures
- Stone free rate [Time frame: 4 weeks]
Secondary outcome measures (1)
- Number of ESWL sessions to achieve SFR. [Time frame: 4 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Sohag university Hospital — Sohag
Identifiers
NCT: NCT07334236 · Soh-med--25-11-18MS