Clinical trial NCT01606618: Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spina Bifida Aperta
Acquired Traumatic Spinal Cord Injury
Keywords: Self-esteem
Spina Bifida
Spinal cord injury
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient seen in university hospitals or in rehabilitation clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure of the global self-esteem by the Rosenberg scale (RSES)
timeFrame: At day 0
Secondary outcomes:
measure: Evaluation of depression and anxiety by Hamilton's scale (HAD)
timeFrame: At day 0, at month 6
measure: Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT)
timeFrame: At day 0
measure: Rating Scale vesico-sphincter and anorectal function (ISCOS)
timeFrame: At day 0, at month 6
measure: Evaluation scale for the achievement of self catheterizing
timeFrame: At day 0, at month 6
measure: Scale functional mobility and transfers (SCIM III)
timeFrame: At day 0
measure: Measure of the global self-esteem by the Rosenberg scale (RSES)
timeFrame: At month 6
measure: Observance of the appointment
timeFrame: At month 6
measure: Observance of holding of the mictionnel catalog
timeFrame: At month 6
measure: Measure of auto-efficiency experienced scale for Medullary Injured (MSES)
timeFrame: At Day 0
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Urologie CH Lyon Sud et Hôpital Henry Gabrielle
city: Marseille
country: France
facility: APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale
city: Nantes
country: France
facility: MPR neurologique CHU de Nantes
city: Paris
country: France
facility: APHP Raymond Poincaré
city: Paris
country: France
facility: APHP Rothschild
city: Paris
country: France
facility: Neuro-urologie et explorations périnéales, APHP Tenon
city: Ploemeur
country: France
facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
city: Rennes
country: France
facility: CHU de Rennes CR Spina bifida
city: Rennes
country: France
facility: Hôpital Pontchaillou - CHU de Rennes
city: Rennes
country: France
facility: MPR St Hélier
city: Rouen
country: France
facility: Urologie, CHU de Rouen
city: Toulouse
country: France
facility: MPR CHU Rangueuil
city: Toulouse
country: France
facility: Urologie CHU Rangueuil Toulouse
Study officials:
affiliation: CHU Rennes
name: Jacques Kerdraon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Reymann Jean Michel, PhD
role: STUDY_CHAIR
References: