NCT05163262: TCG

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

Terminated NA Last updated 22 April 2025

What this trial tests

NA trial testing sexuality questionnaire in Traumatic Brain Injury in 8 participants. Terminated before completion.

Timeline

2 February 2022

Primary endpoint
27 May 2022

27 May 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	8
Start date	2 February 2022
Primary completion	27 May 2022
Estimated completion	27 May 2022
Sites	1 location across France

Drugs / interventions tested

• sexuality questionnaire

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 70, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.