Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
Sponsor: Centre Hospitalier Universitaire de Nīmes
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.
Official title: Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
Key Details
Gender
All
Age Range
17 Years - Any
Study Type
OBSERVATIONAL
Enrollment
70
Start Date
2020-08-01
Completion Date
2022-12-31
Last Updated
2026-06-17
Healthy Volunteers
Not specified
Interventions
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.
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.
Locations (1)
Nîmes University Hospital
Nîmes, Gard, France