Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID07623980

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey: What to Expect

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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