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

Sponsor

Rennes University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01606618

Collaborator

(none)

111

Enrollment

Locations

Actual Duration (Months)

6.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

111 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 12, 2012

Actual Primary Completion Date :

Sep 11, 2017

Actual Study Completion Date :

Sep 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Spina bifida aperta
Acquired traumatic spinal cord injury

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of depression and anxiety by Hamilton's scale (HAD) [At day 0, at month 6]
Score range : 0 - 21. High scores indicate a hight level of symptoms.
Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT) [At day 0]
Battery 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 6]
High scores indicate high vesico-sphincter and anorectal dysfunction
Evaluation scale for the achievement of self catheterizing [At day 0, at month 6]
14 binary items
Scale functional mobility and transfers (SCIM III) [At day 0]
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.
Measure of the global self-esteem by the Rosenberg scale (RSES) [At month 6]
Score range : 10 - 40. High scores indicate hight self esteem.
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) [At Day 0]
16 items ranging from 1 to 7 Range 16 - 112 High scores correspond to low level of percieved auto-efficiency

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Besançon	Besançon	France	25000
2	Clinique Saint Augustin	Bordeaux	France	33000
3	CHU de Lille	Lille	France	59000
4	Urologie CH Lyon Sud et Hôpital Henry Gabrielle	Lyon	France	69000
5	APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale	Marseille	France	13005
6	MPR neurologique CHU de Nantes	Nantes	France	44000
7	APHP Raymond Poincaré	Paris	France	75000
8	APHP Rothschild	Paris	France	75000
9	Neuro-urologie et explorations périnéales, APHP Tenon	Paris	France	75000
10	Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE	Ploemeur	France	56270
11	CHU de Rennes CR Spina bifida	Rennes	France	35000
12	Hôpital Pontchaillou - CHU de Rennes	Rennes	France	35000
13	MPR St Hélier	Rennes	France	35000
14	Urologie, CHU de Rouen	Rouen	France	76000
15	MPR CHU Rangueuil	Toulouse	France	31000
16	Urologie CHU Rangueuil Toulouse	Toulouse	France	31000