Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury (NCT01606618) | Clinical Trial Compass
TerminatedNot Applicable
Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury
Stopped: Sponsor and investigator's decision
France111 participantsStarted 2012-03-12
Plain-language summary
With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder.
The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.
Who can participate
Age range
18 Years – 60 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:
* Patients with a spina bifida aperta or an acquired traumatic spinal cord injury dating more than two years, the level of injury being below D12 and higher S1 (Score ASIA A).
* Age between 18 and 60
* Knowing how to read, write, count
* Having given their free, informed and in writing consent (an information is also given to the reliable person when it exists)
* Affiliated to the National Health Service
Exclusion Criteria:
* Psychiatric history requiring an hospitalization in a specialized unit during more than two months
* Score MMS lower than 27 ( GRECO version)
* Serious associated pathology or associated pathology which could interfer with the management of vesico-sphincteral disorders
* Neurosurgery, dating from less than one year
* Symptoms of dysfunction of ventricular bypass valve at the time of inclusion
* Clinical epileptic attack within six months prior to inclusion
* Pregnancy or breastfeeding
* Simultaneous inclusion in an another therapeutic protocol or period of exclusion from an another protocol
* Traumatic spinal cord injury acquired before age 16
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
1
Measure of the global self-esteem by the Rosenberg scale (RSES)