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

NCT05163262 | Terminated

• 1 other identifier: APHP211155
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Sexuality; Sexual disorders; bladder-sphincter dysfunctions; anorectal disorders

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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

  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.

  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.

  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

  less than 3 months, 6 months and 1 year from TC

Study Arms (1)

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

Interventions

sexuality questionnaire 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

experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient information and not opposition

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Sexuality; Sexual Dysfunction, Physiological; Rectal Diseases

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sexual Behavior; Behavior; Genital Diseases; Urogenital Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: February 2, 2022
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)