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RECRUITING
NCT07614880
NA

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

Sponsor: Beni-Suef University

View on ClinicalTrials.gov

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.

Official title: Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study

Key Details

Gender

All

Age Range

2 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-04

Completion Date

2028-03

Last Updated

2026-06-01

Healthy Volunteers

No

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

Locations (1)

Urology Department - Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt