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

16. Juni 2026 aktualisiert von: Centre Hospitalier Universitaire de Nīmes

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

70

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Frankreich
    • Gard
      • Nîmes, Gard, Frankreich, 30029
        • Nîmes University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

17 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

N/A

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

All patients who have suffered a spinal cord injury, operated on between April 2004 and October 2017 at Nîmes University Hospital.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Retrospektive

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Efficacy of continent cutaneous urinary derivation: catheterisation.
Zeitfenster: 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.
3 -16 years after their operation
Efficacy of continent cutaneous urinary derivation:leakage
Zeitfenster: 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.
3 -16 years after their operation

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Surgical complications and impact on the patient's quality of life: Age at start of care
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 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
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASIA score
Zeitfenster: 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.
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Bladder dysfunction
Zeitfenster: 3 -16 years after their operation
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.
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
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
Zeitfenster: 3 -16 years after their operation
All immediate or later complications will be recorded.
3 -16 years after their operation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2020

Primärer Abschluss (Tatsächlich)

31. Dezember 2022

Studienabschluss (Tatsächlich)

31. Dezember 2022

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2021

Zuerst gepostet (Tatsächlich)

23. Juni 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Local 2019/SD-01

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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