Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population

NCT ID: NCT05163262

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2022-05-27

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental

Addition of a sexuality questionnaire during patient follow-up within 3 months after inclusion, 6 months after and at one year

Group Type: EXPERIMENTAL

sexuality questionnaire

Intervention Type: OTHER

Questionnaire evaluating the sexuality of head trauma victims by comparing their sexual focus, the quality of their relationship, their self-esteem, their mood before the trauma to their current situation

Interventions

sexuality questionnaire

Questionnaire evaluating the sexuality of head trauma victims by comparing their sexual focus, the quality of their relationship, their self-esteem, their mood before the trauma to their current situation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital

Paris, , France

Countries

France

Other Identifiers

APHP211155

Identifier Type: -

Identifier Source: org_study_id