ClinicalTrials.gg
CompletedNCT06734390CERPEDUpdated Dec 16, 2024

Bladder Neck Surgery in Children with Neurogenic Bladder

An observational study in Incontinence, Bladder Dysfunction and Spina Bifida, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
46
Ages
0 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Incontinence
  • Bladder Dysfunction
  • Spina Bifida
  • Neurogenic Bladder Disorder
  • Child, Only

Keywords

  • Bladder Neck Surgery
  • Surgical Outcomes
  • Child
  • Retrospective Study
03

In context

Spinal Dysraphism

142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.

This study's enrollment of 46 is below the median of 105 across 48 observational studies indexed under Spinal Dysraphism.

Browse Spinal Dysraphism studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with neurogenic bladder

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with neurogenic bladder and younger than 18 years old , who underwent a bladder neck procedure

Exclusion criteria

Exclusion Criteria:

  • Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
46 participants (actual)
Patient registry
No

Interventions

  • OtherBladder Neck Surgery

    Bladder Neck Surgery regroups many surgical procedures to cure urinary incontinence.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before surgery

  2. Long-term urinary continence

    Reporting if the patients are dry or need catheterizations or protections

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Length of stay

    Length of stay

    Time frame: From admission to discharge home, up to 20 days

  2. Complications after bladder neck procedure

    bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection

    Time frame: Through study completion, an average of 2 years

  3. 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.

    Time frame: Through study completion, an average of 2 years

07

Study locations

1 site
  • University Hospital, Clermont-Ferrand
    Clermont-Ferrand, Auvergne 63003, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No — In the name of anonymization, the investigators won't share individual participant data

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Dec 2020, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2024
First posted
Dec 16, 2024
StartActual
Jan 1, 2020
Primary completionActual
Dec 31, 2020
CompletionActual
Jan 1, 2023
Last update
Dec 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06734390
Responsible party
Destinval Christelle (M.D., University Hospital, Clermont-Ferrand) — Principal investigator
First posted
Dec 16, 2024
Start date
Jan 1, 2020
Primary completion
Dec 31, 2020
Completion
Jan 1, 2023
Last update
Dec 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion