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Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Department of Urology- Beni-Suef University Hospitals
RECRUITING
Banī Suwayf
Contact Information
Primary
Hany F Badawy, MD
Hanyfathy86@gmail.com
+201149525028
Backup
Ghada S Etman, MD
DrhanYFATHY86@GMAIL.COM
+2010 07913852
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2027-05
Participants
Target number of participants: 110
Treatments
Experimental: Dusting
Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with low pulse energy . The planned settings are 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.
Active_comparator: Fragmentation
Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with higher pulse energy. The planned settings are 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments, approximately 2-5 mm, with active fragment removal when needed.
Sponsors
Leads: Beni-Suef University

This content was sourced from clinicaltrials.gov