Neurogenic Bladder DisorderSUAPEDNCT06734429
Urinary Artificial Sphincter in Children
An observational study of Neurogenic Bladder Disorder and Bladder Dysfunction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Retrospective monocentric study of the outcomes of patients with neurogenic bladder who had a urinary artificial sphincter before the age of 18 years old. Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient? Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Neurogenic Bladder Disorder, Bladder Dysfunction, Spina Bifida
- What is being tested?
- Urinary Artificial Sphincter
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2022to 31 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 younger than 18 years old who have neurogenic bladders
Who may be able to join
- Patients who were younger than 18 years old when they had an urinary artificial sphincter
Who cannot join
- Patients who were 18 years old or older when they had an urinary artificial sphincter
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 Who Had an Artificial Urethral Sphincter by Laparotomy in Childhood
Retrospective monocentric study of the outcomes of patients with neurogenic bladder who had a urinary artificial sphincter before the age of 18 years old. Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient?
Read the detailed description
The management of patients with neurogenic bladder is complex. Several patients have been operated multiple times. Surgical procedures such as Mitrofanoff's, bladder neck surgery, bladder augmentation, and urinary artificial sphincter are common. The investigators wanted to analyze the participants' data, which led to the indication of a urinary artificial sphincter and its outcomes.
- Conditions
- Neurogenic Bladder Disorder, Bladder Dysfunction, Spina Bifida, Urinary Incontinence Due to Urethral Sphincter Incompetence, Child, Only
- Being tested
- Urinary Artificial Sphincter
- Keywords
- Urinary Artificial Sphincter, Neurogenic Bladder, Child, Outcomes, Retrospective Study
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary Artificial SphincterOther
Urinary Artificial Sphincter is a device used for patients with urethral sphincter incompetence
| Study group | Role | What they receive |
|---|---|---|
| Urinary Artificial Sphincter (UAS) in Children | Patients aged under 18 years old with UAS Receives: Other: Urinary Artificial Sphincter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with urinary sphincter incomptetence
Participants with urinary incontinence caused by urinary sphincter incomptetence
Measured: Before surgery
Impact of urinary artificial sphincter on the participants' incontinence
Three outcomes are possible: the participant is continent (with or without a few leaks), the participant is continent with catheterization, the patient is incontinent.
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Impact of bladder augmentation on participants' incontinence
Analysing the presence of bladder augmentation in participants with urinary artificial sphincter. Three outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.
Measured: Through study completion, an average of 2 years
Impact of Mitrofanoff procedure on participants' incontinence
Analysing the presence of Mitrofanoff procedure in participants with urinary artificial sphincter. Three outcomes are possible: the participant is continent, the participant is continent with catheterization, or the patient is incontinent.
Measured: Through study completion, an average of 2 years
Impact of bladder neck surgery on participants' incontinence
Analysing the presence of bladder neck surgery in participants with urinary artificial sphincter. hree outcomes are possible: the participant is continent, the participant is continent with catheterization or the patient is incontinent.
Measured: Through study completion, an average of 2 years
Last follow-up
Follow-up represents the time between the surgery and postoperative consultation dates 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]
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 start20 Nov 2022
- Primary completion31 Jan 2023
- Study completion31 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 Neurogenic Bladder DisorderStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Principal investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734429
- Sponsor's protocol ID
- M24DC1105
- Acronym
- SUAPED
- Status last verified
- Dec 2024
- First submitted
- 11 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
Delgado-Miguel C, Munoz-Serrano A, Amesty V, Rivas S, Lobato R, Martinez-Urrutia MJ, Lopez-Pereira P. Artificial urinary sphincter in congenital neuropathic bladder: Very long-term outcomes. Int J Urol. 2022 Jul;29(7):692-697. doi: 10.1111/iju.14874. Epub 2022 Mar 26.
PubMed 35340070
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 Who Had an Artificial Urethral Sphincter by Laparotomy in Childhood
- ClinicalTrials.gov ID
- NCT06734429
- Acronym / sponsor ID
- SUAPED / M24DC1105
- Conditions
- Neurogenic Bladder Disorder, Bladder Dysfunction, Spina Bifida, Urinary Incontinence Due to Urethral Sphincter Incompetence, Child, Only
- Keywords
- Urinary Artificial Sphincter, Neurogenic Bladder, Child, Outcomes, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 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.
Retrospective monocentric study of the outcomes of patients with neurogenic bladder who had a urinary artificial sphincter before the age of 18 years old. Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient?
Detailed description
The management of patients with neurogenic bladder is complex. Several patients have been operated multiple times. Surgical procedures such as Mitrofanoff's, bladder neck surgery, bladder augmentation, and urinary artificial sphincter are common. The investigators wanted to analyze the participants' data, which led to the indication of a urinary artificial sphincter and its outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary Artificial Sphincter (UAS) in Children | – | Other: Urinary Artificial SphincterPatients aged under 18 years old with UAS |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients younger than 18 years old who have neurogenic bladders
Key inclusion criteria (1 listed)
- Patients who were younger than 18 years old when they had an urinary artificial sphincter
Key exclusion criteria (1 listed)
- Patients who were 18 years old or older when they had an urinary artificial sphincter
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 |
|---|---|---|
| Urinary Artificial SphincterUrinary Artificial Sphincter is a device used for patients with urethral sphincter incompetence | Other | Urinary Artificial Sphincter (UAS) in Children |
Primary outcome
Number of participants with urinary sphincter incomptetence
Time frame: Before surgery
Participants with urinary incontinence caused by urinary sphincter incomptetence
Impact of urinary artificial sphincter on the participants' incontinence
Time frame: Through study completion, an average of 2 years
Three outcomes are possible: the participant is continent (with or without a few leaks), the participant is continent with catheterization, the patient is incontinent.
4 secondary outcomes
Impact of bladder augmentation on participants' incontinence
Time frame: Through study completion, an average of 2 years
Impact of Mitrofanoff procedure on participants' incontinence
Time frame: Through study completion, an average of 2 years
Impact of bladder neck surgery on participants' incontinence
Time frame: Through study completion, an average of 2 years
Last 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 35340070Delgado-Miguel C, Munoz-Serrano A, Amesty V, Rivas S, Lobato R, Martinez-Urrutia MJ, Lopez-Pereira P. Artificial urinary sphincter in congenital neuropathic bladder: Very long-term outcomes. Int J Urol. 2022 Jul;29(7):692-697. doi: 10.1111/iju.14874. Epub 2022 Mar 26.
- 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 Neurogenic Bladder Disorder 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 urinary sphincter incomptetence (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 NCT06734429, 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.