NCT04936217

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-01-01
• Completion: 2023-06-01
• First posted: 2021-06-23
• Last updated: 2022-09-28

Locations

1 site across 1 country: France