Clinical trial NCT06970587: Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys
Official title: Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Stone
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Cystolithotripsy treatment
timeFrame: 45 minutes after the procedure begin
Secondary outcomes:
measure: operative time
timeFrame: 45 minutes after the procedure begin
measure: Hospital stay duration
timeFrame: 24 hours after the Cystolithotripsy operation
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University Hospitals
Study officials:
affiliation: Urology Department,Faculty of Medicine,South Valley University,Qena,Egypt
name: Ahmed Mahmoud Hasan, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References: