CERPED: Bladder Neck Surgery in Children With Neurogenic Bladder

• Sponsor: University of Lorraine (Other)
• Overall Status: Completed
• CT.gov ID: NCT05861011
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Actual Duration (Months): 37.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Consequences on bladder voiding.

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urinary; Bladder Dysfunction; Spina Bifida; Neurogenic Bladder

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

• Study Type: Observational
• Actual Enrollment: 48 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Feb 28, 2023

Outcome Measures

Primary Outcome Measures

1. Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow [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

2. Number of participants with muscular bladder [Baseline (Before surgery)]

   The muscular bladder has thicker walls, bladder diverticula and trabecules (diagnosed during abdominal ultrasound, urethro-cystogram and cystoscopy)

Secondary Outcome Measures

1. Length of stay [From admission to discharge home, up to 20 days]

   Length of stay

2. The time length between the surgery date and the postoperative consultation date [Through study completion, an average of 2 years]

   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.

3. Surgical complications after bladder neck procedure [Through study completion, an average of 2 years]

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

4. Operating time [Intraoperative]

   Operating time

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ULorraine	Vandœuvre-lès-Nancy	Grand-Est	France	54500

Sponsors and Collaborators

• University of Lorraine

Investigators

• Principal Investigator: Christelle Destinval, MD, University of Lorraine

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine
• ClinicalTrials.gov Identifier: NCT05861011
• Other Study ID Numbers: ULora; 2023PI004
• First Posted: May 16, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine: Bladder Neck Surgery; Children; Surgical Outcomes; Retrospective Study
• Additional relevant MeSH terms: Urinary Bladder, Neurogenic; Spinal Dysraphism; Urinary Incontinence; Enuresis

Study Results

No Results Posted as of May 16, 2023