Bladder Neck Surgery in Children With Neurogenic Bladder

Neurogenic Bladder Clinical Trial

— CERPED  

Official title:

Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861011
• Other study ID #: ULora
• Secondary ID: 2023PI004
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical outcomes of bladder neck surgery in children with neurogenic bladder.

Consequences on bladder voiding.

Description:

Surgical outcomes of bladder neck surgery in children with neurogenic bladder:

Quality of voiding: spontaneous, need for catheterization, or incontinence.

Other surgical complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bladder Dysfunction
• Enuresis
• Incontinence, Urinary
• Neurogenic Bladder
• Spina Bifida
• Spinal Dysraphism
• Urinary Bladder, Neurogenic
• Urinary Incontinence

Locations

Country	Name	City	State
France	ULorraine	Vandœuvre-lès-Nancy	Grand-Est

Sponsors (1)

Lead Sponsor	Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (Before surgery)
Primary	Number of participants with muscular bladder	The muscular bladder has thicker walls, bladder diverticula and trabecules (diagnosed during abdominal ultrasound, urethro-cystogram and cystoscopy)	Baseline (Before surgery)
Secondary	Length of stay	Length of stay	From admission to discharge home, up to 20 days
Secondary	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.	Through study completion, an average of 2 years
Secondary	Surgical complications after bladder neck procedure	bleeding, bowel obstruction, surgical hernia, urinary stone, urinary infection	Through study completion, an average of 2 years
Secondary	Operating time	Operating time	Intraoperative