Clinical trial NCT04936217: Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
Official title: Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Urinary Diversion
Neurogenic Bladder
Keywords: intermittent catheterization
Mitrofanoff
Yang-Monti
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have suffered a spinal cord injury, operated on between April 2004 and October 2017 at Nîmes University Hospital.

Brief summary: Continent Cutaneous Urinary Deviation (CUD), using the Mitrofanoff, Yang-Monti or Casale principle, is offered to patients with neurological diseases who are unable to perform intermittent catheterisation through the native urethra due to upper limb disability.

There is very little data in the literature examining the long-term efficacy and complications of this technique. The main objective of this study is to evaluate the effectiveness of long-term CUDs in spinal cord injury patients. The secondary objectives are to evaluate the surgical complications and the impact on the patient's quality of life.

For each patient, several data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly and any immediate or late complications. In a second stage, a questionnaire survey will be conducted by telephone.


Eligibility criteria: Inclusion Criteria:

Specific inclusion criteria for the study :

* no history of continuous cystostomy in another centre
* a follow-up \> 24 months,
* a continent cutaneous urinary diversion for a spinal cord injury.

General inclusion criteria :

* Patient affiliated to or beneficiary of a health insurance scheme.
* Adult patient (≥18 years of age) and under 85 years of age.

Exclusion Criteria:

* Criteria for non-inclusion specific to the study :
* All urinary incontinence outside of medullary waiting period.
* A history of continuous cystostomy in another centre.
* A follow-up of less than 24 months,
* a continent cutaneous urinary diversion for a neurological pathology other than spinal cord injury.

General criteria for non-inclusion :

* Patient in a period of exclusion determined by another study.
* Patient for whom it is impossible to give enlightened information.
* Patient under legal protection, guardianship or curatorship.
* Patient unable to express consent

Primary outcomes:
measure: Efficacy of continent cutaneous urinary derivation: catheterisation.
timeFrame: 3 -16 years after their operation
measure: Efficacy of continent cutaneous urinary derivation:leakage
timeFrame: 3 -16 years after their operation
Secondary outcomes:
measure: Surgical complications and impact on the patient's quality of life: Age at start of care
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: Sex
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: Body Mass Index
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: ASA score
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: ASIA score
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: Bladder dysfunction
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: urinary tract anomalies evaluated via a morphological examination.
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: cytometry
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: creatinine clearance
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: operative indications
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: mictional mode
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: surgical set-up
timeFrame: 3 -16 years after their operation
measure: Surgical complications and impact on the patient's quality of life: immediate or later complications
timeFrame: 3 -16 years after their operation
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Gard
Study officials:
References: