Incontinence, UrinaryCERPEDNCT05861011
Bladder Neck Surgery in Children With Neurogenic Bladder
An observational study of Incontinence, Urinary and Bladder Dysfunction, run by University of Lorraine 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 Up to 17 years
- Conditions the study is for
- Incontinence, Urinary, Bladder Dysfunction, Spina Bifida
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 28 Feb 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 Up 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.
About this study
Official title: Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study
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.
- Keywords
- Bladder Neck Surgery, Children, Surgical Outcomes, Retrospective Study
- Medical subject headings
- Urinary Incontinence, Spinal Dysraphism, Urinary Bladder, Neurogenic
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
Cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck.
delayed or incomplete opening of the bladder neck
Measured: Baseline (Before surgery)
Number of participants with muscular bladder
The muscular bladder has thicker walls, bladder diverticula and trabecules (diagnosed during abdominal ultrasound, urethro-cystogram and cystoscopy)
Measured: Baseline (Before surgery)
Secondary outcomes (4)
Length of stay
Length of stay
Measured: From admission to discharge home, up to 20 days
The time length between the surgery date and the postoperative consultation date
Follow_up represents the time length between the surgery date and the postoperative consultation date in days, months, or years. Generally, there are a-month-follow-up, a three month-follow-up, a six month-follow-up, and a year-follow-up. The surgeon can see the patient if there is any problem between these consultations. After a year of follow-up, it is up to the surgeon to decide if the patient needs to be seen yearly or not. The last follow-up date is crucial because it indicates how the patient is and if other follow-up dates need to be applied.
Measured: Through study completion, an average of 2 years
Surgical complications after bladder neck procedure
bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection
Measured: Through study completion, an average of 2 years
Operating time
Operating time
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion28 Feb 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 Incontinence, UrinaryStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Christelle DESTINVAL, University of Lorraine
- Investigators
- Christelle Destinval, MD, Principal investigator, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861011
- Sponsor's protocol ID
- ULora
- Other IDs
- 2023PI004
- Acronym
- CERPED
- Status last verified
- May 2023
- First submitted
- 13 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study
- ClinicalTrials.gov ID
- NCT05861011
- Acronym / sponsor ID
- CERPED / ULora
- Keywords
- Bladder Neck Surgery, Children, Surgical Outcomes, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 May 2023 (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
- Up 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.
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: Baseline (Before surgery)
Cysto-urethrogram and uroflowmetry help diagnose delayed or incomplete opening of the bladder neck. delayed or incomplete opening of the bladder neck
Number of participants with muscular bladder
Time frame: Baseline (Before surgery)
The muscular bladder has thicker walls, bladder diverticula and trabecules (diagnosed during abdominal ultrasound, urethro-cystogram and cystoscopy)
4 secondary outcomes
Length of stay
Time frame: From admission to discharge home, up to 20 days
The time length between the surgery date and the postoperative consultation date
Time frame: Through study completion, an average of 2 years
Surgical complications after bladder neck procedure
Time frame: Through study completion, an average of 2 years
Operating time
Time frame: Intraoperative
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 May 2023.
- 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.
Christelle Destinval, MD principal investigator
University of Lorraine
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, Urinary and Bladder Dysfunction, run by University of Lorraine 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 May 2023. 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: Baseline (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 NCT05861011, 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 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.