Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorBeni-Suef University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Children aged less than 18 years.
Radiologically confirmed single bladder stone less than 3 cm.
Suitable for transurethral cystolithotripsy.
Fit for general anesthesia.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dusting Holmium:YAG Laser Cystolithotripsy
Procedure/SurgeryTransurethral 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.
Fragmentation Holmium:YAG Laser Cystolithotripsy
Procedure/SurgeryTransurethral 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: DustingExperimental treatment 1 intervention
Group B: FragmentationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Operative Time
Total operative time will be measured in minutes from insertion of the endoscope into the urethra until completion of bladder stone clearance and termination of the procedure, including active fragment retrieval when required.
Time frame
During the index transurethral cystolithotripsy procedureSecondary outcomes
1
Laser Time
Laser time will be measured in minutes as the cumulative duration of active Holmium:YAG laser firing during the index transurethral cystolithotripsy procedure.
Time frame
During the index transurethral cystolithotripsy procedure2
Need for Active Fragment Extraction
The need for active fragment extraction will be recorded as whether stone fragments required active removal using endoscopic retrieval maneuvers during the index transurethral cystolithotripsy procedure.
Time frame
During the index transurethral cystolithotripsy procedure3
Endoscopic Stone-Free Status at the End of the Procedure
Endoscopic stone-free status will be assessed at the end of the procedure and defined as no visible residual bladder stone fragments on final endoscopic inspection.
Time frame
At the end of the index transurethral cystolithotripsy proced4
Postoperative Hematuria
Postoperative hematuria will be recorded based on clinical observation or patient/guardian report during postoperativ follow-up.
Time frame
From the end of the procedure to 1 month postoperativelySponsors and contacts
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Source ClinicalTrials.gov