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

Condition(s) studied

Investigational drug(s) / intervention(s)

Vacuum-Assisted Mini-Percutaneous Cystolithotripsy: Surgical treatment of pediatric bladder stones using suprapubic mini-percutaneous bladder access, a suction-assisted mini sheath, and Ho:YAG laser lithotripsy for stone fragmentation and evacuation

Transurethral Cystolithotripsy: Standard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation

Study summary

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

Primary outcome measure(s)

• Total Operative Time — Intraoperative
  Total operative time will be defined as the time from insertion of the first endoscopic instrument to completion of stone clearance and urethral catheter placement, measured in minutes.

Trial sites (1)

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