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NCT07623980
Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones
Conditions: Bladder Calculi, Pediatric Bladder Stones, Pediatric Urolithiasis
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Beni-Suef University
Location: Department of Urology- Beni-Suef University Hospitals Banī Suwayf Beni Suweif Governorate
Summary
Bladder stones are a clinically relevant pediatric urological condition that may require endoscopic treatment. Transurethral Holmium:YAG laser cystolithotripsy is a minimally invasive option for selected children with bladder stones.
This prospective randomized trial will compare two Holmium:YAG laser strategies during transurethral cystolithotripsy in children with a single bladder stone less than 3 cm: dusting and fragmentation. Children will be randomized to undergo laser dusting or laser fragmentation during transurethral cystolithotripsy.
The primary outcome is total operative time. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status during follow-up, intraoperative complications, postoperative urinary symptoms, urinary tract infection, need for postoperative catheterization, and hospital stay.
Eligibility Criteria
Inclusion Criteria:
1. Children aged less than 18 years.
2. Radiologically confirmed single bladder stone less than 3 cm.
3. Suitable for transurethral cystolithotripsy.
4. Fit for general anesthesia.
5. Written informed consent from parents or legal guardians.
Exclusion Criteria:
1. Giant bladder stones more than 3 cm.
2. Urethral pathology preventing safe transurethral access.
3. Major lower urinary tract anomaly or neurogenic bladder.
4. Active untreated urinary tract infection.
5. Coagulation disorder or contraindication to endoscopic surgery.
Source: ClinicalTrials.gov (NCT07623980). StuddyBuddy aggregates publicly available trial information.
