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Completed

NCT Number: NCT04936217

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Diversion Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nîmes University Hospital

Nîmes, Gard, 30029, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Interview using a validated questionnaire

Other

A telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life.

Primary outcomes

  1. Efficacy of continent cutaneous urinary derivation: catheterisation.

    Time frame: 3 -16 years after their operation

    The minimum frequency of urinary catheterisation in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.

  2. Efficacy of continent cutaneous urinary derivation:leakage

    Time frame: 3 -16 years after their operation

    Absence of leakage through the cystostomy in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.

Secondary outcomes

  1. Surgical complications and impact on the patient's quality of life: Age at start of care

    Time frame: 3 -16 years after their operation

    The patient's age will be noted at the start of care

  2. Surgical complications and impact on the patient's quality of life: Sex

    Time frame: 3 -16 years after their operation

    The patient's sex will be noted at the start of care

  3. Surgical complications and impact on the patient's quality of life: Body Mass Index

    Time frame: 3 -16 years after their operation

    The patient's Body Mass Index will be noted at the start of care

  4. Surgical complications and impact on the patient's quality of life: ASA score

    Time frame: 3 -16 years after their operation

    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

  5. Surgical complications and impact on the patient's quality of life: ASIA score

    Time frame: 3 -16 years after their operation

    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.

  6. Surgical complications and impact on the patient's quality of life: Bladder dysfunction

    Time frame: 3 -16 years after their operation

    The type of bladder dysfunction will be evaluated by urodynamic evaluation

  7. Surgical complications and impact on the patient's quality of life: urinary tract anomalies evaluated via a morphological examination.

    Time frame: 3 -16 years after their operation

    Urinary tract anomalies will be evaluated via a morphological examination (using ultrasound and / or tomodensitometry).

  8. Surgical complications and impact on the patient's quality of life: cytometry

    Time frame: 3 -16 years after their operation

    Urinary tract anomalies will be evaluated via cytometry

  9. Surgical complications and impact on the patient's quality of life: creatinine clearance

    Time frame: 3 -16 years after their operation

    Urinary tract anomalies will be evaluated according to the patient's creatinine clearance

  10. Surgical complications and impact on the patient's quality of life: operative indications

    Time frame: 3 -16 years after their operation

    The indications for the initial surgery will be recorded.

  11. Surgical complications and impact on the patient's quality of life: mictional mode

    Time frame: 3 -16 years after their operation

    The patient's initial mictional mode will be recorded.

  12. Surgical complications and impact on the patient's quality of life: surgical set-up

    Time frame: 3 -16 years after their operation

    The patient's surgical set-up will be recorded.

  13. Surgical complications and impact on the patient's quality of life: immediate or later complications

    Time frame: 3 -16 years after their operation

    All immediate or later complications will be recorded.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: ELESDUCCBM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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