Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in 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: Vacuum-Assisted Mini-Percutaneous Cystolithotripsy, Transurethral Cystolithotripsy.
- Who it may be relevant to
- Registry conditions: Pediatric Bladder Stones, Bladder Calculi, Pediatric Urolithiasis. Basic parameters: 2 years — 14 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
Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study
Overview
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.
Detailed description
Bladder stones in children remain a relevant urological condition, particularly in settings where nutritional, metabolic, infectious, or hydration-related factors may contribute to stone formation. Minimally invasive endoscopic management has largely replaced open cystolithotomy in many centers. Transurethral cystolithotripsy is commonly used, but in young children the small urethral caliber may make repeated instrumentation and fragment extraction technically challenging and may raise concern about urethral mucosal trauma. Percutaneous cystolithotripsy provides an alternative route that may reduce repeated transurethral fragment extraction.
Vacuum-assisted mini-percutaneous cystolithotripsy uses a suprapubic percutaneous access tract and a suction-assisted sheath to maintain visibility and facilitate evacuation of stone dust and fragments during laser lithotripsy. However, pediatric comparative evidence remains limited.
This study is designed as a prospective randomized controlled pilot study including 40 children with bladder stone(s) measuring 10-30 mm. Eligible patients will be randomized in a 1:1 ratio to vacuum-assisted mini-percutaneous cystolithotripsy or transurethral cystolithotripsy. Both procedures will be performed under general anesthesia using Ho:YAG laser lithotripsy. Patients will be followed postoperatively to assess operative, perioperative, and follow-up outcomes. The study aims to generate preliminary comparative data on operative time, safety, stone clearance, postoperative recovery, and follow-up urinary outcomes to inform future adequately powered trials.
Interventions
- Procedure 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 - Procedure 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
Primary outcome measures
- Total Operative Time [Time frame: Intraoperative]
Secondary outcome measures (4)
- Stone-Free Rate [Time frame: 4 weeks postoperatively]
- Urethral Mucosal Injury [Time frame: Intraoperatively]
- Lithotripsy and Fragment Clearance Time [Time frame: Intraoperative]
- Recurrence or Urethral Stricture-Related Symptoms [Time frame: 6 months postoperatively]
Eligibility criteria
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.
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
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Urology Department - Beni-Suef University Hospitals — Banī Suwayf
Identifiers
NCT: NCT07614880 · FMBSUREC03032026Ahmed · FMBSUREC/03032026/Ahmed