Bladder Calculi, Pediatric Bladder Stones, Pediatric Urolithiasis
Conditions
Keywords
Pediatric bladder stones, Mini-percutaneous cystolithotripsy, Vacuum-assisted cystolithotripsy, Ho:YAG laser lithotripsy
Brief 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.
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
PROCEDUREVacuum-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
PROCEDURETransurethral 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
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The operating surgeon and patients' guardians will not be masked because of the surgical nature of the interventions. Postoperative imaging assessment for stone-free status will be performed by a radiologist or outcomes assessor masked to treatment allocation.
Intervention model description
Participants will be randomized in a 1:1 ratio to either vacuum-assisted mini-percutaneous cystolithotripsy or transurethral cystolithotripsy.
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate | 4 weeks postoperatively | Stone-free rate will be defined as the proportion of patients with no residual bladder stone fragments on postoperative pelvi abdominl ultrasound. Low-dose non-contrast CT urinary tract will be reserved for equivocal ultrasound findings. Time Frame: 4 weeks postoperatively |
| Urethral Mucosal Injury | Intraoperatively | Occurrence of visible urethral mucosal injury detected intraoperatively. |
| Lithotripsy and Fragment Clearance Time | Intraoperative | Time from initiation of laser lithotripsy to endoscopic confirmation of complete stone clearance, measured in minutes. |
| Recurrence or Urethral Stricture-Related Symptoms | 6 months postoperatively | Occurrence of recurrent bladder stone symptoms, abnormal urinary stream, suspected urethral stricture symptoms, or need for further diagnostic evaluation |
Countries
Egypt
Outcome results
None listed