Spinal Cord InjuriesELESDUCCBMNCT04936217
Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
An observational study of Spinal Cord Injuries and Urinary Diversion, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Spinal Cord Injuries, Urinary Diversion, Neurogenic Bladder
- What is being tested?
- Data collection and Interview using a validated questionnaire
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients who have suffered a spinal cord injury, operated on between April 2004 and October 2017 at Nîmes University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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 :
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries, Urinary Diversion, Neurogenic Bladder
- Being tested
- Data collection, Interview using a validated questionnaire
- Keywords
- intermittent catheterization, Mitrofanoff, Yang-Monti
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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 questionnaireOther
A telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection; Other: Interview using a validated questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The patient's age will be noted at the start of care
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Sex
The patient's sex will be noted at the start of care
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Body Mass Index
The patient's Body Mass Index will be noted at the start of care
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASA score
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
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASIA score
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.
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Bladder dysfunction
The type of bladder dysfunction will be evaluated by urodynamic evaluation
Measured: 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.
Urinary tract anomalies will be evaluated via a morphological examination (using ultrasound and / or tomodensitometry).
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: cytometry
Urinary tract anomalies will be evaluated via cytometry
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: creatinine clearance
Urinary tract anomalies will be evaluated according to the patient's creatinine clearance
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: operative indications
The indications for the initial surgery will be recorded.
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: mictional mode
The patient's initial mictional mode will be recorded.
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: surgical set-up
The patient's surgical set-up will be recorded.
Measured: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: immediate or later complications
All immediate or later complications will be recorded.
Measured: 3 -16 years after their operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936217
- Sponsor's protocol ID
- Local 2019/SD-01
- Acronym
- ELESDUCCBM
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT04936217
- Acronym / sponsor ID
- ELESDUCCBM / Local 2019/SD-01
- Conditions
- Spinal Cord Injuries, Urinary Diversion, Neurogenic Bladder
- Keywords
- intermittent catheterization, Mitrofanoff, Yang-Monti
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017 | – | Other: Data collection, Other: Interview using a validated questionnaireThe study focuses of a population of 70 patients operated between April 2004 and October 2017 au Nîmes University Hospital for Cutaneous Urinary Diversion. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have suffered a spinal cord injury, operated on between April 2004 and October 2017 at Nîmes University Hospital.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionFor 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 | Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017 |
| Interview using a validated questionnaireA telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life. | Other | Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017 |
Primary outcome
Efficacy of continent cutaneous urinary derivation: catheterisation.
Time frame: 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.
Efficacy of continent cutaneous urinary derivation:leakage
Time frame: 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.
13 secondary outcomes
Surgical complications and impact on the patient's quality of life: Age at start of care
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Sex
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Body Mass Index
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASA score
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASIA score
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Bladder dysfunction
Time frame: 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.
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: cytometry
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: creatinine clearance
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: operative indications
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: mictional mode
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: surgical set-up
Time frame: 3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: immediate or later complications
Time frame: 3 -16 years after their operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Urinary Diversion, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of continent cutaneous urinary derivation: catheterisation. (time frame: 3 -16 years after their operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.