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

NCT06970587 | Completed DMC

• 1 other identifier: Cystolithotripsy
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Bladder Stone

Outcome Measures

Primary Outcomes (1)

• Cystolithotripsy treatment

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

  45 minutes after the procedure begin

Secondary Outcomes (2)

• operative time

  45 minutes after the procedure begin

• Hospital stay duration

  24 hours after the Cystolithotripsy operation

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Procedure: percutaneous cystolithotripsy

Group B

ACTIVE COMPARATOR

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

Procedure: percutaneous cystolithotripsy

Interventions

percutaneous cystolithotripsy PROCEDURE

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

Group A; Group B

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University Hospitals

Qina, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Calculi

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Urolithiasis; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Mahmoud Hasan, Assist.Prof.

  Urology Department,Faculty of Medicine,South Valley University,Qena,Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at Urology Department, Faculty of Medicine

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: February 1, 2019
• Primary Completion: February 1, 2024
• Study Completion: February 10, 2024
• Last Updated: May 14, 2025

Record last verified: 2019-02

Locations

EG (1)