Actively Recruiting

Phase Not Applicable
Age: 2Years - 14Years
All Genders
ID07614880

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

Led by Beni-Suef University · Updated on 2026-06-01

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical methods for treating bladder stones in children aged 2 to 14 years. This study compares vacuum-assisted mini-percutaneous cystolithotripsy with the standard transurethral cystolithotripsy, focusing mainly on the total time taken for the operation. The research aims to provide early comparative data on safety, stone removal, recovery, and follow-up outcomes to guide future studies. Participants will be randomly assigned to one of two groups. One group will receive vacuum-assisted mini-percutaneous cystolithotripsy using a small suprapubic access point and suction to remove stone fragments during laser treatment. The other group will have transurethral cystolithotripsy using a small ureteroscope passed through the urethra to break and clear stones with laser assistance. Both procedures are done under general anesthesia. Throughout the study, children will be monitored for surgery duration, stone clearance, injury to the urethra, postoperative complications like infection or urinary leakage, pain, hospital stay, and recovery progress. Follow-up will include checking for stone recurrence or urethral issues up to six months after surgery. The study expects to help understand which method may offer better outcomes for children with bladder stones.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 to 14 years
  • Diagnosis of bladder stone(s) measuring 10 to 30 mm confirmed by ultrasound
  • Normal upper urinary tract
  • Fit for general anesthesia
  • Written informed consent from parents or legal guardians obtained
Not Eligible

You will not qualify if you...

  • 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 precluding safe endoscopic or percutaneous cystolithotripsy as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey: What to Expect

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo either vacuum-assisted mini-percutaneous cystolithotomy or transurethral cystolithotripsy under general anesthesia to fragment and remove bladder stones.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 6 months

Participants are monitored postoperatively to assess stone clearance, recovery, and urinary outcomes.

Follow-up visits at 4 weeks and additional assessments up to 6 months

Trial Site Locations

Total: 1 location

1

Urology Department - Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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