Bladder StoneNCT06970587
Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys
A study testing percutaneous cystolithotripsy in people with Bladder Stone, run by South Valley University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Bladder Stone
- What is being tested?
- percutaneous cystolithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys: Prospective Randomized Study
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.
- Conditions
- Bladder Stone
- Being tested
- percutaneous cystolithotripsy
- Medical subject headings
- Urinary Bladder Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous cystolithotripsyProcedure or surgery
Also called transurethral 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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by percutaneous cystolithotripsy (PCCL) Receives: 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) Receives: Procedure: percutaneous cystolithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystolithotripsy treatment
Assessment of the Urinary Bladder condition of the patients after the Cystolithotripsy either successes or complications
Measured: 45 minutes after the procedure begin
Secondary outcomes (2)
operative time
Assessment of the time consumed of the Cystolithotripsy
Measured: 45 minutes after the procedure begin
Hospital stay duration
Assessment of the time required to stay in the hospital after the operation
Measured: 24 hours after the Cystolithotripsy operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Feb 2019
- Primary completion1 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Hasan, South Valley University
- Investigators
- Ahmed Mahmoud Hasan, Assist.Prof., Principal investigator, Urology Department,Faculty of Medicine,South Valley University,Qena,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970587
- Sponsor's protocol ID
- Cystolithotripsy
- Status last verified
- Feb 2019
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hasan AM, Mohammed AA, Abdel-Kader MS, Abdelhamid AM, Abdeldayem AM, Ahmed MA. Percutaneous versus transurethral cystolithotripsy for the management of bladder calculi in the pre-school boys: Prospective randomized study. J Pediatr Urol. 2025 Dec;21(6):1411-1417. doi: 10.1016/j.jpurol.2025.07.016. Epub 2025 Jul 17.
PubMed 40701892
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Versus Transurethral Cystolithotripsy For The Management Of Bladder Calculi In The Pre-school Boys: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06970587
- Acronym / sponsor ID
- Cystolithotripsy
- Conditions
- Bladder Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: percutaneous cystolithotripsyAbout 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by percutaneous cystolithotripsy (PCCL) |
| Group B | Active comparator | Procedure: percutaneous cystolithotripsyAbout 75 children suffering from bladder stone with a single bladder calculus ≤ 20 mm and managed by transurethral cystolithotripsy (TUCL) |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous cystolithotripsyAlso: transurethral cystolithotripsyto 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 | Procedure or surgery | Group A, Group B |
Primary outcome
Cystolithotripsy treatment
Time frame: 45 minutes after the procedure begin
Assessment of the Urinary Bladder condition of the patients after the Cystolithotripsy either successes or complications
2 secondary outcomes
operative time
Time frame: 45 minutes after the procedure begin
Hospital stay duration
Time frame: 24 hours after the Cystolithotripsy operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 40701892Hasan AM, Mohammed AA, Abdel-Kader MS, Abdelhamid AM, Abdeldayem AM, Ahmed MA. Percutaneous versus transurethral cystolithotripsy for the management of bladder calculi in the pre-school boys: Prospective randomized study. J Pediatr Urol. 2025 Dec;21(6):1411-1417. doi: 10.1016/j.jpurol.2025.07.016. Epub 2025 Jul 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mahmoud Hasan, Assist.Prof. principal investigator
Urology Department,Faculty of Medicine,South Valley University,Qena,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous cystolithotripsy in people with Bladder Stone, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystolithotripsy treatment (time frame: 45 minutes after the procedure begin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06970587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.