Comparing narrow and wide focus shock wave lithotripsy for kidney stones

Which is Better: Narrow vs. Wide Focus for Shock Wave Lithotripsy of Renal Stones

This study is testing whether using a narrow or wide focus during shock wave treatment for kidney stones helps break them up better and causes less damage to the kidneys.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Benha University (other)
• Locations: 1 site (Banhā, Kalyobiya)
• Trial ID: NCT04759599 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of two different focus sizes in Shock Wave Lithotripsy (SWL) for treating renal stones measuring 1-2 cm. It compares the narrow focus (2mm) against the wide focus (8mm) to determine which is more effective in disintegrating stones and causing less kidney injury. The study will measure the Stone Free Rate (SFR) and assess renal injury through urinary markers. This research is essential to validate previous findings regarding the benefits of smaller focal points in SWL.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a single renal stone between 1-2 cm and normal kidney function.

Not a fit: Patients with conditions such as pregnancy, severe obesity, or active urinary tract infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with renal stones, reducing the need for additional procedures.

How similar studies have performed: Previous studies have suggested that smaller focal points in SWL may enhance stone disintegration, but this specific comparison is novel and requires further validation.

Eligibility criteria

Inclusion Criteria:

1. Adult patients (\>18years old) with 1-2 cm single renal stone.
2. Normal functioning kidney.

Exclusion Criteria:

1. Pregnancy.
2. Bleeding diatheses.
3. Radiolucent stones.
4. Radio-opaque stones with Hounsfield Unit (HU) \> 1200
5. Patients with a pacemaker.
6. Active Urinary Tract Infection (UTI).
7. Severe skeletal malformations.
8. Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2.
9. Renal artery aneurysm at the same site of the stone.
10. Anatomical obstruction distal to the stone.
11. Patients with renal impairment with serum creatinine \> 1.2 mg/dL.

Where this trial is running

Banhā, Kalyobiya

• Faculty of Medicine, Benha University — Banhā, Kalyobiya, Egypt (RECRUITING)

Study contacts

• Principal investigator: Yasser Noureldin, MD, PhD — Benha University
• Study coordinator: Yasser Noureldin, MD, PhD

Conditions: Renal Stone, Treatment Side Effects