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

R

Rennes University Hospital

Status

Terminated

Conditions

Acquired Traumatic Spinal Cord Injury
Spina Bifida Aperta

Study type

Observational

Funder types

Other

Identifiers

NCT01606618
B110797-30

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

111 participants in 2 patient groups

Spina bifida aperta
Acquired traumatic spinal cord injury

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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