CompletedNot Applicable

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

France70 participantsStarted 2020-08-01

Plain-language 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.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of continent cutaneous urinary derivation: catheterisation.

Timeframe: 3 -16 years after their operation

Efficacy of continent cutaneous urinary derivation:leakage

Timeframe: 3 -16 years after their operation

Trial details

NCT IDNCT04936217

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Spinal Cord Injuries trials