Actively Recruiting
Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial
Led by Beni-Suef University · Updated on 2026-06-03
110
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different Holmium:YAG laser techniques for treating children with a single bladder stone smaller than 3 cm. This trial compares the dusting method, which breaks the stone into fine particles, with the fragmentation method, which creates larger pieces that may be actively removed. The purpose is to find out which laser strategy results in shorter surgery time and better stone clearance in pediatric patients. Children will be randomly assigned to one of two groups for transurethral laser cystolithotripsy under general anesthesia. In the dusting group, low pulse energy and higher frequency settings (0.5-0.8 J and 10-15 Hz) will be used to reduce stones to tiny fragments with minimal extraction. The fragmentation group will receive higher pulse energy and lower frequency settings (1.0 J and 6-10 Hz) aiming to produce visible fragments sized 2-5 mm that can be removed. Procedures use a pediatric semi-rigid ureteroscope in the lithotomy position with a 550-micron laser fiber. Participants will be monitored during and after the procedure for total operation time, laser time, need for fragment extraction, and stone-free status via endoscopy and ultrasound. Follow-up visits at 1 week, 1 month, and 3 months will assess urinary symptoms, infections, catheter need, and hospital stay length. Safety will be evaluated by tracking complications such as mucosal injury, bleeding, hematuria, and dysuria. The study will last until May 2027.
CONDITIONS
Brief Title
Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged less than 18 years
- Radiologically confirmed single bladder stone less than 3 cm
- Suitable for transurethral cystolithotripsy
- Fit for general anesthesia
- Written informed consent from parents or legal guardians
You will not qualify if you...
- Giant bladder stones more than 3 cm
- Urethral pathology preventing safe transurethral access
- Major lower urinary tract anomaly or neurogenic bladder
- Active untreated urinary tract infection
- Coagulation disorder or contraindication to endoscopic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo transurethral Holmium:YAG laser cystolithotripsy under general anesthesia using either a dusting or fragmentation laser strategy to break down bladder stones.
1 procedure visit (in-person under general anesthesia)
Duration - 3 months
Participants return for clinical assessment and ultrasound to monitor stone clearance and postoperative recovery.
Visits at 1 week, 1 month, and 3 months post-procedure
Trial Site Locations
Total: 1 location
1
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt
Actively Recruiting
Research Team
H
Hany F Badawy, MD
G
Ghada S Etman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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