Vacuum-assisted Mini-percutaneous vs Transurethral Cystolithotripsy for Pediatric Bladder Stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized pilot trial enrolling 40 children with bladder stones 10–30 mm. Participants will be assigned to vacuum-assisted mini-percutaneous cystolithotripsy or conventional transurethral cystolithotripsy under general anesthesia with Ho:YAG laser lithotripsy. The primary outcome is total operative time, with secondary outcomes including stone-free rate, lithotripsy and fragment clearance times, perioperative safety measures, postoperative pain and analgesic use, catheterization and hospital stay, and need for additional procedures. The aim is to generate preliminary comparative data on safety, efficiency, and outcomes to guide future research. Eligible children must have normal upper urinary tracts and be fit for anesthesia; exclusion criteria include urethral abnormalities, active infection, bleeding disorders, prior open bladder surgery, or conditions precluding safe endoscopic or percutaneous access.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 2 to 14 years.
* Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.
* Normal upper urinary tract.
* Fit for general anesthesia.
* Written informed consent obtained from parents or legal guardians.

Exclusion Criteria:

* Known urethral stricture or posterior urethral valves.
* Active urinary tract infection at the time of surgery.
* Coagulopathy or uncorrected bleeding disorder.
* Previous open bladder surgery.
* Any anatomical or clinical condition that, in the investigator's judgment, precludes safe endoscopic or percutaneous cystolithotripsy.

Where it's running

• Urology Department - Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.