Clinical trial NCT05163262: Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
Official title: Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Sexuality
Sexual disorders
bladder-sphincter dysfunctions
anorectal disorders
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Severe traumatic brain injury (TCI), defined by an initial GCS of ≤ 8 and/or admitted to a neurosurgical intensive care unit, are responsible for diffuse brain lesions that can lead to multiple deficits, including impairment of sphincter functions: bladder, rectal and sexual.

Bladder-sphincter disorders are very common after a TBI. Urinary incontinence predominates, with a prevalence varying from 50 to 100% in the acute period following a TBI.

The variability of the clinical data is explained by the heterogeneity of the populations studied (severity of TBI, duration of coma, time to care) and the tools used to objectify sphincter disorders. The interest of this study is to make an evaluation and a prospective follow-up of sphincter disorders in this population during one year.

Detailed description: A first visit, planned as part of the care, within 3 months of TBI with a clinical examination and 8 to 11 questionnaires, depending on your sex and your transit, to assess cognitive functions, the sphincter sphere, the autonomy and mood achieved as part of your usual care. These questionnaires will be taken with the doctor during consultation, As part of the research, patient will be asked to additionally answer the sexuality questionnaire consisting of 23 questions.

The same visit will be carried out at 6 months and at 1 year, also planned as part of the usual care.

If beyond 6 months vesico-sphincter complaints persist, a urodynamic examination will be realised in order to compare subjective complaints with a urodynamic examination (flowmeter, cystomanometry with +/- pressure / flow rate curve, sphincterometry).

This is a single-center research. The patients will be included in the neurosurgical intensive care unit of the Pitié Salpêtrière hospital and will be followed in the Physical Medicine and Rehabilitation unit of the same hospital.

Eligibility criteria: Inclusion Criteria:

* Have been the victim of a serious head trauma (initial glasgow ≤ 8 and / or admitted to neurosurgical resuscitation for less than 3 months
* Admitted to Neurosurgical Resuscitation at Pitié-Salpêtrière
* Aged 18 to 70
* Good written and oral comprehension of the French language
* Glasgow score = 15 at the time of inclusion and able to say no to opposition
* Patient information and not opposition

Exclusion Criteria:

* Severe comprehension disorders
* History of vesico-sphincteric disorders before TC
* Neurological and psychiatric history
* Patient not affiliated to a social security scheme or entitled
* Patient under guardianship / curators

Primary outcomes:
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through the sexuality questionary
timeFrame: 3 month after inclusion
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through the Female sexual function Index
timeFrame: 3 month after inclusion
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through the Premature Ejaculation Profile
timeFrame: 3 month after inclusion
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through the abridged IIEF-5 questionary,
timeFrame: 3 month after inclusion
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through the Wexner score if diarrhea
timeFrame: 3 month after inclusion
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through The Neurogenic Bowel Dysfunction if constipation
timeFrame: 3 month after inclusion
measure: evaluate the prevalence and typology of sphincter disorders in patients presenting a TCG of less than 3 months and admitted to the neurosurgical unit of the Pitié-Salpêtrière through the Urinary Symptom Profile questionary
timeFrame: 3 month after inclusion
Secondary outcomes:
measure: The course of sphincter disorders will occur: • By clinical evaluation
timeFrame: less than 3 months, 6 months and 1 year from TC
measure: The course of sphincter disorders will occur: The subjective complaints will be compared with a urodynamic examination (flowmeter, cystomanometry with +/- pressure / flow rate curve, sphincterometry in order to objectify the disorders if they persist
timeFrame: less than 3 months, 6 months and 1 year from TC
measure: The course of sphincter disorders will occur:By self-administered questionaries less than 3 months, 6 months and 1 year from TC.
timeFrame: less than 3 months, 6 months and 1 year from TC
measure: The results of the TBI sexuality questionary will be compared with the reference questionaries that are not specific to head trauma in order to assess the correlation between these questionaries.
timeFrame: less than 3 months, 6 months and 1 year from TC
measure: correlate whether the patients who have the most vesicosphincter complaints are the patients with the most more severe and / or the most depressed or vice versa
timeFrame: less than 3 months, 6 months and 1 year from TC
Other outcomes:
Locations:
city: Paris
country: France
facility: Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital
Study officials:
References: