Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-14
SponsorBeni-Suef University

About this trial

This prospective randomized pilot study will compare vacuum-assisted mini-percutaneous cystolithotripsy with standard transurethral cystolithotripsy for the treatment of bladder stones in children. Forty children aged 2 to 14 years with bladder stone(s) measuring 10 -30 mm will be randomly assigned to one of two surgical approaches. The vacuum-assisted mini-percutaneous group will undergo suprapubic percutaneous access using a mini sheath with suction-assisted fragment evacuation, while the transurethral group will undergo standard transurethral cystolithotripsy. The primary outcome will be total operative time. Secondary outcomes will include stone-free rate ,lithotripsy time and fragment clearance time, urethral mucosal injury, postoperative hematuria, fever, urinary tract infection, sepsis, urinary retention, urinary leakage from the suprapubic tract, catheterization time, hospital stay, postoperative pain, analgesic requirement, need for auxiliary procedures or conversion, and recurrence or urethral stricture-related symptoms during follow-up.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vacuum-Assisted Mini-Percutaneous Cystolithotripsy
  • Transurethral Cystolithotripsy

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators