Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dusting Holmium:YAG Laser Cystolithotripsy, Fragmentation Holmium:YAG Laser Cystolithotripsy.
- Who it may be relevant to
- Registry conditions: Bladder Calculi, Pediatric Bladder Stones, Pediatric Urolithiasis. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial
Overview
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.
Detailed description
This is a prospective randomized controlled trial conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University Hospital.
The study will include children with radiologically confirmed single bladder stones less than 3 cm who are planned for transurethral Holmium:YAG laser cystolithotripsy and are suitable for transurethral endoscopic management under general anesthesia. Written informed consent will be obtained from parents or legal guardians before enrollment.
Eligible children will be randomized in a 1:1 ratio into two groups. Participants in the dusting group will undergo transurethral Holmium:YAG laser cystolithotripsy using low pulse energy and higher pulse frequency settings, with the aim of reducing the stone into fine particulate debris and tiny fragments with minimal need for active extraction. Participants in the fragmentation group will undergo transurethral Holmium:YAG laser cystolithotripsy using higher pulse energy and lower pulse frequency settings, with the aim of producing visible extractable fragments that can be actively removed when needed.
All procedures will be performed under general anesthesia in the lithotomy position using a pediatric semi-rigid ureteroscope. A Holmium:YAG laser will be used in both groups. The planned settings are 0.5-0.8 J and 10-15 Hz in the dusting group, and 1.0 J and 6-10 Hz in the fragmentation group. A 550-micron end-firing laser fiber will be preferred when compatible with the available endoscope.
The primary outcome is total operative time, defined as the time in minutes from insertion of the endoscope into the urethra until completion of stone clearance and termination of the procedure, including fragment retrieval when required. 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 at follow-up, intraoperative mucosal injury or bleeding, need for postoperative catheterization, postoperative hematuria, dysuria, urinary tract infection, and hospital stay. Follow-up will be scheduled at 1 week, 1 month, and 3 months with clinical assessment and ultrasonography.
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.
Primary outcome measures
- Total Operative Time [Time frame: During the index transurethral cystolithotripsy procedure]
Secondary outcome measures (4)
- Laser Time [Time frame: During the index transurethral cystolithotripsy procedure]
- Need for Active Fragment Extraction [Time frame: During the index transurethral cystolithotripsy procedure]
- Endoscopic Stone-Free Status at the End of the Procedure [Time frame: At the end of the index transurethral cystolithotripsy proced]
- Postoperative Hematuria [Time frame: From the end of the procedure to 1 month postoperatively]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Department of Urology- Beni-Suef University Hospitals — Banī Suwayf
Identifiers
NCT: NCT07623980 · FMBSUREC05052026BadawyDF · FMBSUREC/05052026/Badawy