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

16. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

70

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
    • Gard
      • Nîmes, Gard, Francie, 30029
        • Nîmes University Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

17 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

N/A

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Kohorta
  • Časové perspektivy: Retrospektivní

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Jiný: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Efficacy of continent cutaneous urinary derivation: catheterisation.
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Surgical complications and impact on the patient's quality of life: Age at start of care
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 3 -16 years after their operation
All immediate or later complications will be recorded.
3 -16 years after their operation

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Centre Hospitalier Universitaire de Nīmes

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. srpna 2020

Primární dokončení (Aktuální)

31. prosince 2022

Dokončení studie (Aktuální)

31. prosince 2022

Termíny zápisu do studia

První předloženo

18. června 2021

První předloženo, které splnilo kritéria kontroly kvality

18. června 2021

První zveřejněno (Aktuální)

23. června 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Local 2019/SD-01

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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