Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?

NCT04922437 | Unknown

• 1 other identifier: 2020PI311
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty. METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).

Conditions

Neurogenic Bladder; Continent Cutaneous Urinary Diversion; Mitrofanoff

Keywords

native bladder; enterocystoplasty; continent catheterizable channel; neurogenic bladder

Outcome Measures

Primary Outcomes (1)

• Comparison of the long term continence between the two groups

  Continence of the channel at last followup : as being strictly dry day and night between clean intermittent catheterizations (CIC). Patients requirring at leat one pad for leaking and also those with leaks wetting their clothes were considered incontinent as well as those whose interval between CIC was strictly less than 3 hours.

  1 year

Study Arms (2)

Enterocystoplasty (EC)

Patients who had an implantation of the catheterizable continent channel by seromuscular plicature on the anterior wall of the bladder augmentation.

Procedure: Enterocystoplasty implantation

Detrusor (D)

Patients who had an implantation of the catheterizable continent channel in the detruosr of their native bladder (Lich-Gregoir or Cohen).

Procedure: Native bladder implantation

Interventions

Native bladder implantation PROCEDURE

Continent catheterizable channel implanted in the detrusor of the native bladder

Detrusor (D)

Enterocystoplasty implantation PROCEDURE

Continent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation

Enterocystoplasty (EC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric population recruited in the pediatric surgery and urology departments of Nancy University Hospital. Patients with congenital or acquired neurological bladder or malformative uropathies. Surgery performed between 1991 and 2020, followed in the long term in iterative consultation or in hospitalization for evaluation of continence and postoperative complications with or without surgical revision

You may qualify if:

• Adult and pediatric patients who underwent a surgery for creation of a continent catheterizable channel
• Between 1991 and 2020
• In the pediatric surgery or urology department at Nancy University Hospital

You may not qualify if:

• Ghoneim technique used for implantation

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Pierre Lecoanet

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Lecoanet

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 10, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

FR (1)