Viewing Study NCT01606618


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Study NCT ID: NCT01606618
Status: TERMINATED
Last Update Posted: 2021-04-15
First Post: 2012-05-16
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury
Sponsor: Rennes University Hospital
Organization:

Study Overview

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
Status: TERMINATED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Sponsor and investigator's decision
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ESTIME
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: