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Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury

Analysis of Psychosocial Determinants of Observance of Monitoring Neuro-urological in Spina-bifida Adult Patients and in Spinal Cord Injury Patients: a Prospective, Comparative, Multicenter With Parallel Groups Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01606618
Acronym
ESTIME
Enrollment
111
Registered
2012-05-28
Start date
2012-03-12
Completion date
2017-09-11
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Traumatic Spinal Cord Injury, Spina Bifida Aperta

Keywords

Self-esteem, Spina Bifida, Spinal cord injury

Brief 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.

Detailed description

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. The risk of developing a terminal renal insufficiency is eight times higher than the risk in the general population and twice as important as in acquired spinal cord injury. This risk continues to evolve with advancing age. 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. However, some studies report that nearly two thirds of these patients are not monitored at regular neuro-urological in the adulthood. Different psychosocial determinants were analyzed as potential markers of the impact of chronic diseases from childhood to adulthood and could account for the disparity of follow-up and access to healthcare. Among these, the self-esteem is a psychological dimension of analysis particularly relevant within the framework of chronic states inherited from the childhood. The investigators formulate the hypothesis that global self-esteem and lower perceived self-efficacy may be a causal predictive factor of a reduced access to the continence and a lower compliance monitoring in adult patients with a spina bifida.

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of the global self-esteem by the Rosenberg scale (RSES)At day 0Score range : 10 - 40. High scores indicate hight self esteem.

Secondary

MeasureTime frameDescription
Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT)At day 0Battery of test exploring executives functions. High scores indicate high level of executive functions.
Rating Scale vesico-sphincter and anorectal function (ISCOS)At day 0, at month 6High scores indicate high vesico-sphincter and anorectal dysfunction
Evaluation scale for the achievement of self catheterizingAt day 0, at month 614 binary items
Scale functional mobility and transfers (SCIM III)At day 0The SCIM is a disability scale in order to describe patients' ability to accomplish activities of daily living and to make functional assessments of this population more sensitive to changes. SCIM-III is comprised of 19 items in 3 subscales, which are: (i) self-care (sub-score 0-20); (ii) respiration and sphincter management (sub-score 0-40); (iii) mobility (sub-score 0-40). The mobility subscale is further sub-divided to assess mobility in room and toilet and for indoors and outdoors, on an even surface. The total score ranges from 0 to 100.
Evaluation of depression and anxiety by Hamilton's scale (HAD)At day 0, at month 6Score range : 0 - 21. High scores indicate a hight level of symptoms.
Observance of the appointmentAt month 6
Observance of holding of the mictionnel catalogAt month 6
Measure of auto-efficiency experienced scale for Medullary Injured (MSES)At Day 0* 16 items ranging from 1 to 7 * Range 16 - 112 * High scores correspond to low level of percieved auto-efficiency
Measure of the global self-esteem by the Rosenberg scale (RSES)At month 6Score range : 10 - 40. High scores indicate hight self esteem.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026