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

NCT05163262 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-22

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2022-05-27
Completion
2022-05-27

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163262 on ClinicalTrials.gov