Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients (ELESDUCCBM)

Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Neurogenic Bladder; Urinary Diversion
• Intervention / Treatment: Other: Data collection; Other: Interview using a validated questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Recruiting
      • Nimes University Hospital
      • Contact: HILAL AL RASHDI, Dr.; Phone Number: +33 4.66.68.32.30; Email: hah24212@hotmail.com
      • Contact: STEPHANE DROUPY, Pr.; Phone Number: +33 4.66.68.32.30; Email: stephane.DROUPY@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017; The study focuses of a population of 70 patients operated between April 2004 and October 2017 au Nîmes University Hospital for Cutaneous Urinary Diversion.

Other: Data collection; For each patient, the following 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, immediate and later complications.; Other: Interview using a validated questionnaire; A telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of continent cutaneous urinary derivation: catheterisation.	The minimum frequency of urinary catheterisation in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.	3 -16 years after their operation
Efficacy of continent cutaneous urinary derivation:leakage	Absence of leakage through the cystostomy in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.	3 -16 years after their operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications and impact on the patient's quality of life: Age at start of care	The patient's age will be noted at the start of care	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Sex	The patient's sex will be noted at the start of care	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Body Mass Index	The patient's Body Mass Index will be noted at the start of care	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASA score	The ASA Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical comorbidities. The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning) it can be helpful in predicting perioperative risks. ASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life ASA V = A moribund patient who is not expected to survive without the operation ASA VI = A declared brain-dead patient whose organs are being removed for donor purposes	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASIA score	The ASIA (American Spinal Injury Association) assessment is the gold standard for assessing and documenting sensory and motor impairments after Spinal Cord Injury. The score ranges from A to E as follows: A = Complete injury. No motor or sensory function is preserved in the sacral segments S4 or S5. B = Sensory incomplete. Sensory but not motor function is preserved below the level of injury, including the sacral segments. C = Motor incomplete. Motor function is preserved below the level of injury, and more than half of muscles tested below the level of injury have a muscle grade less than 3 (see muscle strength scores table). D = Motor incomplete. Motor function is preserved below the level of injury and at least half of the key muscles below the neurological level have a muscle grade of 3 or more. E = Normal. No motor or sensory deficits, but deficits existed in the past. This score will be used to evaluate the patient at the start of care.	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Bladder dysfunction	The type of bladder dysfunction will be evaluated by urodynamic evaluation	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: urinary tract anomalies evaluated via a morphological examination.	Urinary tract anomalies will be evaluated via a morphological examination (using ultrasound and / or tomodensitometry).	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: cytometry	Urinary tract anomalies will be evaluated via cytometry	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: creatinine clearance	Urinary tract anomalies will be evaluated according to the patient's creatinine clearance	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: operative indications	The indications for the initial surgery will be recorded.	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: mictional mode	The patient's initial mictional mode will be recorded.	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: surgical set-up	The patient's surgical set-up will be recorded.	3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: immediate or later complications	All immediate or later complications will be recorded.	3 -16 years after their operation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: intermittent catheterization; Mitrofanoff; Yang-Monti
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: Local 2019/SD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No