Renal Calculi
Conditions
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.
Interventions
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.
Sponsors
mohammed Abdelhafez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free rate | 4 weeks | Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT). |
Secondary
| Measure | Time frame |
|---|---|
| Number of ESWL sessions to achieve SFR. | 4 weeks |
Countries
Egypt
Contacts
Primary Contactmohammed A Abdelhafez
Outcome results
None listed