Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones
Official title: Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial
Run by Beni-Suef University · NCT07623980 · Data updated 2026-11-12
This study tests two laser strategies during bladder-stone surgery in children to see which method finishes faster and leaves the bladder stone-free with fewer complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni Suweif Governorate) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07623980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 with a single bladder stone less than 3 cm confirmed by imaging and deemed suitable for transurethral Holmium:YAG laser cystolithotripsy under general anesthesia.
✕Probably not a fit
Children with stones 3 cm or larger, complex urethral anatomy, active urinary infection, or contraindications to endoscopic surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized trial compares two Holmium:YAG laser approaches for transurethral cystolithotripsy in children with a single bladder stone under 3 cm. Participants are randomized to either laser dusting, aiming to pulverize the stone into fine debris, or laser fragmentation, aiming to create extractable fragments for removal. Primary endpoint is total operative time, with secondary outcomes including laser time, need for fragment extraction, stone-free status, imaging-confirmed stone-free follow-up, intraoperative complications, postoperative urinary symptoms and infections, catheterization need, and length of hospital stay. Procedures are performed under general anesthesia in a pediatric setting using standard endoscopic equipment. Conducted at the Department of Urology, Beni-Suef University Hospital, the trial enrolls children meeting specific radiologic and clinical criteria after obtaining parental consent.
Why it matters
Potential benefit: If successful, the trial could identify a more efficient laser approach that reduces operative time and may improve recovery for children undergoing bladder stone removal.
How similar studies have gone: Prior work in adult populations has explored dusting and fragmentation approaches, with mixed results, making this pediatric randomized trial novel in its focus and design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children aged less than 18 years. 2. Radiologically confirmed single bladder stone less than 3 cm. 3. Suitable for transurethral cystolithotripsy. 4. Fit for general anesthesia. 5. Written informed consent from parents or legal guardians. Exclusion Criteria: 1. Giant bladder stones more than 3 cm. 2. Urethral pathology preventing safe transurethral access. 3. Major lower urinary tract anomaly or neurogenic bladder. 4. Active untreated urinary tract infection. 5. Coagulation disorder or contraindication to endoscopic surgery.
Where it's running
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Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Hany F Badawy, MD — Faculty of Medicine, Beni-Suef University hospital
- Study coordinator: Hany F Badawy, MD
- Email: Hanyfathy86@gmail.com
- Phone: +201149525028
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.