NCT06734390

Brief Summary

Surgical outcomes of bladder neck surgery in children with neurogenic bladder. Consequences on bladder voiding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 10, 2024

Last Update Submit

December 11, 2024

Conditions

Keywords

Bladder Neck SurgerySurgical OutcomesChildRetrospective Study

Outcome Measures

Primary Outcomes (2)

  • 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.

    Before surgery

  • Long-term urinary continence

    Reporting if the patients are dry or need catheterizations or protections

    Through study completion, an average of 2 years

Secondary Outcomes (3)

  • Length of stay

    From admission to discharge home, up to 20 days

  • Complications after bladder neck procedure

    Through study completion, an average of 2 years

  • Follow-up

    Through study completion, an average of 2 years

Interventions

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

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients with neurogenic bladder

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 31794087BACKGROUND

MeSH Terms

Conditions

Spinal DysraphismUrinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 16, 2024

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

January 1, 2023

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

In the name of anonymization, the investigators won't share individual participant data

Locations