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CompletedNCT06970587Updated May 14, 2025

Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys

An interventional study of percutaneous cystolithotripsy in Bladder Stone, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
1 Year to 6 Years
Sex
All
01

Study summary

Bladder stones are an uncommon condition in children, accounting for only 5% of urolithiasis in developed countries, whereas in developing nations, a greater number of children are affected due to the high incidence of urinary tract infections and inadequate nutrition, primarily a diet lacking in protein and rich in carbohydrates

Read the detailed description

Bladder stones are typically categorized as either primary or secondary. Primary vesical stones are those not linked with urinary tract disease, and are typically found in children who experience episodes of diarrhea, as well as metabolic disorders resulting from inadequate hydration and nutrition.

Secondary bladder stones are linked to various urinary tract issues, such as obstruction at the bladder outlet, persistent infections, the presence of foreign objects, bladder diverticula, and neurological bladder problems.

The incidence of bladder stones is ten times more common in male than in female children, with children aged 1-5 years being more frequently affected, and the peak incidence occurs at 3 years of age.

The traditional treatment for bladder stones in children typically involves open cystolithotomy. The traditional open surgery has several inherent drawbacks, including a lengthy hospital stay, an unsightly suprapubic scar, the need for prolonged catheterization, the necessity for analgesic treatment, and the risk of post-operative wound infection .

Several minimally invasive treatment methods have been outlined, including transurethral cystolithotripsy (TUCL) and percutaneous cystolithotripsy (PCCL), with open cystolithotomy typically reserved for larger stones. In infants and toddlers, transurethral management bypasses abdominal invasion and its associated risks, such as paralytic ileus and fluid leakage.

However, this approach has limitations owing to the narrower urethral diameter compared to the larger diameter of the endoscopic equipment. In the past, percutaneous cystolithotripsy was commonly performed, but it was performed using larger equipment and has been replaced with transurethral cystolithotripsy. The use of mini-perc technology and smaller instruments for percutaneous stone removal is now competing with the transurethral procedure owing to recent advancements and reductions in percutaneous techniques and instruments.

The European guidelines for pediatric urology recommend endoscopy as an initial option for the management of bladder stones in children, with no distinction made between transurethral and percutaneous access methods. Undefined criteria indicate a lack of conclusive evidence to support one approach over the other, the reason for this is the insufficient number of prospective randomized trials which included a large number of patients comparing these techniques especially in this specific age group.

02

Conditions studied

  • Bladder Stone

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03

Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All male preschool-aged patients (ages 1 to 6 years) who had a single bladder calculus measuring ≤ 20 mm in its longest dimensions diagnosed by ultrasonography or KUB.

Exclusion criteria

Exclusion Criteria:

  • Patients with proven bladder dysfunction, such as neurogenic bladder, bladder outlet obstruction, upper urinary tract stones requiring simultaneous ureteroscopy or percutaneous nephrolithotripsy,
  • previous suprapubic procedure,
  • severe skeletal malformation that prevents lithotomy position,
  • bleeding tendency,
  • active urinary tract infection
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Group A

    About 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by percutaneous cystolithotripsy (PCCL)

    Procedure: percutaneous cystolithotripsy

  • Active comparator
    Group B

    About 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by transurethral cystolithotripsy (TUCL)

    Procedure: percutaneous cystolithotripsy

Interventions

  • Procedurepercutaneous cystolithotripsy

    to compare percutaneous cystolithotripsy with transurethral cystolithotripsy as minimally invasive surgical treatments for urinary bladder stones in pre-school age boys, and to assess the safety and the possible complications of both procedures

    Also known as: transurethral cystolithotripsy

05

What researchers measure

Primary outcomes

  1. Cystolithotripsy treatment

    Assessment of the Urinary Bladder condition of the patients after the Cystolithotripsy either successes or complications

    Time frame: 45 minutes after the procedure begin

Secondary outcomes

  1. operative time

    Assessment of the time consumed of the Cystolithotripsy

    Time frame: 45 minutes after the procedure begin

  2. Hospital stay duration

    Assessment of the time required to stay in the hospital after the operation

    Time frame: 24 hours after the Cystolithotripsy operation

06

Study locations

1 site
  • South Valley University Hospitals
    Qinā, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06970587
Lead sponsor
South Valley University
Responsible party
Ahmed Mahmoud Hasan (Assistant Professor at Urology Department, Faculty of Medicine, South Valley University) — Principal investigator
First posted
May 14, 2025
Start date
Feb 1, 2019
Primary completion
Feb 1, 2024
Completion
Feb 10, 2024
Last update
May 14, 2025

Study contacts

Ahmed Mahmoud Hasan, Assist.Prof.
principal investigator · Urology Department,Faculty of Medicine,South Valley University,Qena,Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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