NCT07614880 Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones
| NCT ID | NCT07614880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beni-Suef University |
| Condition | Pediatric Bladder Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-03-04 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07614880 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 14 Years, studying Pediatric Bladder Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07614880 currently recruiting?
Yes, NCT07614880 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beni-Suef University to inquire about joining.
Where is the NCT07614880 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07614880 clinical trial?
NCT07614880 is sponsored by Beni-Suef University. The trial plans to enroll 40 participants.