Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?

Neurogenic Bladder Clinical Trial

— ICODE  

Official title:

Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04922437
• Other study ID #: 2020PI311
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: June 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

This is a monocentric and retrospective study involving adult and pediatric population who underwent the creation of a CCC between June 1991 and January 2020. Two different surgical techniques were performed: on the first hand, the implantation of the channel in the native bladder's detrusor (D group), on the other hand the implantation of the channel by seromuscular plicature on the anterior wall of the enterocystoplasty (EC group).

The CCC were made from the appendix, an ileal or sigmoid segment, an ureter or a skin flap. Bladder augmentation and cervicoplasty (Kropp, Kurzrock, Young-Dees, artificial urinary sphincter, sling suspension of the bladder neck, closure of the bladder neck) were frequently associated.

The following informations were obtained in all included patients by charts reviews: age at surgery, gender, main underlying pathology, details of operative reports with the type of channel, bladder augmentation and/or associated cervicoplasty, early postoperative complications, complications appearing during the follow up period and the requirement of surgical or non-surgical revision, finally the channel continence at the last follow up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: June 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Ghoneim technique used for implantation

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Procedure:
• Native bladder implantation
Continent catheterizable channel implanted in the detrusor of the native bladder
• Enterocystoplasty implantation
Continent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation

Locations

Country	Name	City	State
France	Pierre Lecoanet	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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