Spina Bifida ApertaESTIMENCT01606618
Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury
An observational study of Spina Bifida Aperta and Acquired Traumatic Spinal Cord Injury, run by Rennes University Hospital at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spina Bifida Aperta, Acquired Traumatic Spinal Cord Injury
- How many people
- 111 participants
- Where
- 16 sitesFrance
- Study dates
- 12 Mar 2012to 11 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient seen in university hospitals or in rehabilitation clinic
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CHU de Besançon
Besançon, 25000
Clinique Saint Augustin
Bordeaux, 33000
CHU de Lille
Lille, 59000
Urologie CH Lyon Sud et Hôpital Henry Gabrielle
Lyon, 69000
APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale
Marseille, 13005
MPR neurologique CHU de Nantes
Nantes, 44000
APHP Raymond Poincaré
Paris, 75000
APHP Rothschild
Paris, 75000
Neuro-urologie et explorations périnéales, APHP Tenon
Paris, 75000
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
Ploemeur, 56270
CHU de Rennes CR Spina bifida
Rennes, 35000
Hôpital Pontchaillou - CHU de Rennes
Rennes, 35000
MPR St Hélier
Rennes, 35000
Urologie, CHU de Rouen
Rouen, 76000
MPR CHU Rangueuil
Toulouse, 31000
Urologie CHU Rangueuil Toulouse
Toulouse, 31000
About this study
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
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.
Read the 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.
- Keywords
- Self-esteem, Spina Bifida, Spinal cord injury
- Medical subject headings
- Spina Bifida Cystica, Spinal Dysraphism, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spina bifida aperta | Not described | |
| Acquired traumatic spinal cord injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the global self-esteem by the Rosenberg scale (RSES)
Score range : 10 - 40. High scores indicate hight self esteem.
Measured: At day 0
Secondary outcomes (9)
Evaluation of depression and anxiety by Hamilton's scale (HAD)
Score range : 0 - 21. High scores indicate a hight level of symptoms.
Measured: 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.
Measured: At day 0
Rating Scale vesico-sphincter and anorectal function (ISCOS)
High scores indicate high vesico-sphincter and anorectal dysfunction
Measured: At day 0, at month 6
Evaluation scale for the achievement of self catheterizing
14 binary items
Measured: 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.
Measured: At day 0
Measure of the global self-esteem by the Rosenberg scale (RSES)
Score range : 10 - 40. High scores indicate hight self esteem.
Measured: At month 6
Observance of the appointment
Measured: At month 6
Observance of holding of the mictionnel catalog
Measured: 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
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study start12 Mar 2012
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
Why it stopped: Sponsor and investigator's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina Bifida ApertaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Kerdraon, MD, Principal investigator, Rennes University HospitalReymann Jean Michel, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606618
- Sponsor's protocol ID
- B110797-30
- Acronym
- ESTIME
- Status last verified
- Apr 2021
- First submitted
- 16 May 2012
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01606618
- Acronym / sponsor ID
- ESTIME / B110797-30
- Keywords
- Self-esteem, Spina Bifida, Spinal cord injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor and investigator's decision
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2012 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 28 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spina bifida aperta | – | – |
| Acquired traumatic spinal cord injury | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient seen in university hospitals or in rehabilitation clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of the global self-esteem by the Rosenberg scale (RSES)
Time frame: At day 0
Score range : 10 - 40. High scores indicate hight self esteem.
9 secondary outcomes
Evaluation of depression and anxiety by Hamilton's scale (HAD)
Time frame: At day 0, at month 6
Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT)
Time frame: At day 0
Rating Scale vesico-sphincter and anorectal function (ISCOS)
Time frame: At day 0, at month 6
Evaluation scale for the achievement of self catheterizing
Time frame: At day 0, at month 6
Scale functional mobility and transfers (SCIM III)
Time frame: At day 0
Measure of the global self-esteem by the Rosenberg scale (RSES)
Time frame: At month 6
Observance of the appointment
Time frame: At month 6
Observance of holding of the mictionnel catalog
Time frame: At month 6
Measure of auto-efficiency experienced scale for Medullary Injured (MSES)
Time frame: At Day 0
Results and safety
The study was stopped early (reason given: Sponsor and investigator's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Related trials for Spina Bifida Aperta
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Fetoscopic Robotic Open Spina Bifida Treatment
Fetal Congenital Abnormalities, Fetoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Kerdraon, MD principal investigator
Rennes University Hospital
Reymann Jean Michel, PhD study chair
Rennes University Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida Aperta and Acquired Traumatic Spinal Cord Injury, run by Rennes University Hospital at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor and investigator's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the global self-esteem by the Rosenberg scale (RSES) (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.