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Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones

NCT07623980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Bladder Calculi
  • Pediatric Bladder Stones
  • Pediatric Urolithiasis

Interventions

PROCEDURE

Dusting Holmium:YAG Laser Cystolithotripsy

Transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with planned laser settings of 0.5-0.8 J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.

PROCEDURE

Fragmentation Holmium:YAG Laser Cystolithotripsy

Transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with planned laser settings of 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments of approximately 2-5 mm, with active fragment removal when needed.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Hany F Badawy, MD · Faculty of Medicine, Beni-Suef University hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623980 on ClinicalTrials.gov