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

NCT04936217 | Unknown

• 1 other identifier: Local 2019/SD-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Urinary Diversion; Neurogenic Bladder

Keywords

intermittent catheterization; Mitrofanoff; Yang-Monti

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

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

  3 -16 years after their operation

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

  3 -16 years after their operation

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

  3 -16 years after their operation

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

  3 -16 years after their operation

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

  3 -16 years after their operation

Study Arms (1)

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; Other: Interview using a validated questionnaire

Interventions

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.

Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017

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.

Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• no history of continuous cystostomy in another centre
• a follow-up \> 24 months,
• a continent cutaneous urinary diversion for a spinal cord injury.
• Patient affiliated to or beneficiary of a health insurance scheme.
• Adult patient (≥18 years of age) and under 85 years of age.

You may not qualify if:

• 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.
• Patient for whom it is impossible to give enlightened information.
• Patient under legal protection, guardianship or curatorship.
• Patient unable to express consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 23, 2021
• Study Start: August 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

FR (1)