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

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.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: sexuality questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; Addition of a sexuality questionnaire during patient follow-up within 3 months after inclusion, 6 months after and at one year	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Overall score from 15 to 75, threshold 45; Sexual functioning (8 questions): score from 8 to 40, threshold 24; Quality of Relationship and Self-Esteem (5 questions): score from 5 to 25, threshold 15; Mood (2 questions): score from 2 to 10, threshold 6	3 month after inclusion
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	The presence of these disorders will be reported subjectively by patients the lower the score, the more complaints the patient has, there is no pathological threshold.	3 month after inclusion
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	The presence of these disorders will be reported subjectively by patients the lower the score, the more complaints the patient has, there is no pathological threshold.	3 month after inclusion
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,	referred to as the Sexual Health Inventory of Men (SHIM) = SHIM-IIEF 5: Erectile dysfunction severe (score of 5 to 10), moderate (11 to 15), mild (16 to 20), normal erectile function (21 to 25) and not interpretable (1 to 4)	3 month after inclusion
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	the higher the score, the greater the achievement, there is no defined threshold.	3 month after inclusion
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	a score between 0-6 indicates very minimal impairment, 7-9: minimal; 10-13 moderate; ≥ 14 severe	3 month after inclusion
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	overall score ≥ 5 indicates a bladder complaint	3 month after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The course of sphincter disorders will occur: • By clinical evaluation		less than 3 months, 6 months and 1 year from TC
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	The urodynamic examination allows if there is a neurological bladder (detrusor hyperactivity, hypocontractility, vesico-sphincteric dyssynergy) to corroborate the patient's complaints and therefore to guide the therapeutic management (anticholinergics, alphablocker, auto- surveys, transcutaneous neurostimulation).	less than 3 months, 6 months and 1 year from TC
The course of sphincter disorders will occur:By self-administered questionaries less than 3 months, 6 months and 1 year from TC.	The self-questionaries are the same as those for the main criterion allowing the diagnosis of sphincter disorders.	less than 3 months, 6 months and 1 year from TC
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.	in men: ▪ the abridged IIEF-5questionaries, referred to as the Sexual Health Inventory of Men (SHIM) = SHIM-IIEF 5 and Premature Ejaculation Profile (PEP) • in women Female sexual function Index (FSFI)	less than 3 months, 6 months and 1 year from TC
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	Tests evaluating cognitive functions (MOCA / BREF), patients' functional recovery (GOSE / MIF) and thymic state (HADS),	less than 3 months, 6 months and 1 year from TC

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Sexuality; Sexual disorders; bladder-sphincter dysfunctions; anorectal disorders
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: APHP211155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No