IncontinenceCERPEDNCT06734390
Bladder Neck Surgery in Children with Neurogenic Bladder
An observational study of Incontinence and Bladder Dysfunction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Incontinence, Bladder Dysfunction, Spina Bifida
- What is being tested?
- Bladder Neck Surgery
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jan 2023
- Phase
- Observational
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with neurogenic bladder
Who may be able to join
- Patients with neurogenic bladder and younger than 18 years old , who underwent a bladder neck procedure
Who cannot join
- Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
About this study
Official title: Management of Patients Under 18 Years of Age Who Have Had Bladder Neck Procedures
Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.
Read the detailed description
Surgical outcomes of bladder neck surgery in children with neurogenic bladder:
Quality of voiding: spontaneous, need for catheterization, or incontinence. Other surgical complications.
- Being tested
- Bladder Neck Surgery
- Keywords
- Bladder Neck Surgery, Surgical Outcomes, Child, Retrospective Study
- Medical subject headings
- Spinal Dysraphism, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder Neck SurgeryOther
Bladder Neck Surgery regroups many surgical procedures to cure urinary incontinence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow
Abdominal ultrasound, cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck.
Measured: Before surgery
Long-term urinary continence
Reporting if the patients are dry or need catheterizations or protections
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Length of stay
Length of stay
Measured: From admission to discharge home, up to 20 days
Complications after bladder neck procedure
bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection
Measured: Through study completion, an average of 2 years
Follow-up
The time length between the surgery date and the postoperative consultation date.
Follow-up represents the time between the surgery and postoperative consultation dates in days, months, or years.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion1 Jan 2023
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 IncontinenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734390
- Sponsor's protocol ID
- M24DC1103
- Acronym
- CERPED
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the name of anonymization, the investigators won't share individual participant data
Publications
Stein R, Bogaert G, Dogan HS, Hoen L, Kocvara R, Nijman RJM, Quaedackers J, Rawashdeh YF, Silay MS, Tekgul S, Radmayr C. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part II operative management. Neurourol Urodyn. 2020 Feb;39(2):498-506. doi: 10.1002/nau.24248. Epub 2019 Dec 3.
PubMed 31794087
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients Under 18 Years of Age Who Have Had Bladder Neck Procedures
- ClinicalTrials.gov ID
- NCT06734390
- Acronym / sponsor ID
- CERPED / M24DC1103
- Keywords
- Bladder Neck Surgery, Surgical Outcomes, Child, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Dec 2024 (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.
Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.
Detailed description
Surgical outcomes of bladder neck surgery in children with neurogenic bladder:
Quality of voiding: spontaneous, need for catheterization, or incontinence. Other surgical complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with neurogenic bladder
Key inclusion criteria (1 listed)
- Patients with neurogenic bladder and younger than 18 years old , who underwent a bladder neck procedure
Key exclusion criteria (1 listed)
- Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure
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 |
|---|---|---|
| Bladder Neck SurgeryBladder Neck Surgery regroups many surgical procedures to cure urinary incontinence. | Other | – |
Primary outcome
Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow
Time frame: Before surgery
Abdominal ultrasound, cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck.
Long-term urinary continence
Time frame: Through study completion, an average of 2 years
Reporting if the patients are dry or need catheterizations or protections
3 secondary outcomes
Length of stay
Time frame: From admission to discharge home, up to 20 days
Complications after bladder neck procedure
Time frame: Through study completion, an average of 2 years
Follow-up
Time frame: Through study completion, an average of 2 years
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 16 Dec 2024.
- Background: PubMed 31794087Stein R, Bogaert G, Dogan HS, Hoen L, Kocvara R, Nijman RJM, Quaedackers J, Rawashdeh YF, Silay MS, Tekgul S, Radmayr C. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part II operative management. Neurourol Urodyn. 2020 Feb;39(2):498-506. doi: 10.1002/nau.24248. Epub 2019 Dec 3.
- Individual participant dataSharing planned: No. In the name of anonymization, the investigators won't share individual participant data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incontinence and Bladder Dysfunction, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 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 16 Dec 2024. 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 France. 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?
Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow (time frame: Before surgery). The study lists 2 primary outcomes in all. 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 NCT06734390, 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 16 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.