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

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

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.

Study Overview

• Status: Terminated
• Conditions: Spina Bifida Aperta; Acquired Traumatic Spinal Cord Injury

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 Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • CHU de Besancon
  • Bordeaux, France, 33000
    • Clinique Saint Augustin
  • Lille, France, 59000
    • CHU de Lille
  • Lyon, France, 69000
    • Urologie CH Lyon Sud et Hôpital Henry Gabrielle
  • Marseille, France, 13005
    • APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale
  • Nantes, France, 44000
    • MPR neurologique CHU de Nantes
  • Paris, France, 75000
    • APHP Raymond Poincare
  • Paris, France, 75000
    • APHP Rothschild
  • Paris, France, 75000
    • Neuro-urologie et explorations périnéales, APHP Tenon
  • Ploemeur, France, 56270
    • Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
  • Rennes, France, 35000
    • CHU de Rennes CR Spina bifida
  • Rennes, France, 35000
    • Hopital Pontchaillou - CHU de Rennes
  • Rennes, France, 35000
    • MPR St Hélier
  • Rouen, France, 76000
    • Urologie, CHU de Rouen
  • Toulouse, France, 31000
    • MPR CHU Rangueuil
  • Toulouse, France, 31000
    • Urologie CHU Rangueuil Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient seen in university hospitals or in rehabilitation clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Spina bifida aperta
Acquired traumatic spinal cord injury

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of depression and anxiety by Hamilton's scale (HAD)	Score range : 0 - 21. High scores indicate a hight level of symptoms.	At day 0, at month 6
Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT)	Battery of test exploring executives functions. High scores indicate high level of executive functions.	At day 0
Rating Scale vesico-sphincter and anorectal function (ISCOS)	High scores indicate high vesico-sphincter and anorectal dysfunction	At day 0, at month 6
Evaluation scale for the achievement of self catheterizing	14 binary items	At day 0, at month 6
Scale functional mobility and transfers (SCIM III)	The 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.	At day 0
Measure of the global self-esteem by the Rosenberg scale (RSES)	Score range : 10 - 40. High scores indicate hight self esteem.	At month 6
Observance of the appointment		At month 6
Observance of holding of the mictionnel catalog		At month 6
Measure of auto-efficiency experienced scale for Medullary Injured (MSES)	16 items ranging from 1 to 7; Range 16 - 112; High scores correspond to low level of percieved auto-efficiency	At Day 0

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Jacques Kerdraon, MD, CHU Rennes; Study Chair: Reymann Jean Michel, PhD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2012
• Primary Completion (Actual): September 11, 2017
• Study Completion (Actual): September 11, 2017

Study Registration Dates

• First Submitted: May 16, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 28, 2012

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Spinal cord injury; Spina Bifida; Self-esteem
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Trauma, Nervous System; Spinal Cord Diseases; Nervous System Malformations; Neural Tube Defects; Wounds and Injuries; Spinal Cord Injuries; Spina Bifida Cystica; Spinal Dysraphism
• Other Study ID Numbers: B110797-30