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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sexuality questionnaire
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Sexuality, Sexual disorders, bladder-sphincter dysfunctions, anorectal disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Patient under AME

Sites / Locations

  • Médecine Physique et Réadaptation , Pitié-Salpêtrière HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
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.
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)
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.
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
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

Secondary Outcome Measures

The course of sphincter disorders will occur: • By clinical evaluation
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).
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.
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)
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),

Full Information

First Posted
December 6, 2021
Last Updated
January 16, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05163262
Brief Title
Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
Acronym
TCG
Official Title
Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2, 2025 (Anticipated)
Study Completion Date
February 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Sexuality, Sexual disorders, bladder-sphincter dysfunctions, anorectal disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
Addition of a sexuality questionnaire during patient follow-up within 3 months after inclusion, 6 months after and at one year
Intervention Type
Other
Intervention Name(s)
sexuality questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
3 month after inclusion
Title
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
Description
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.
Time Frame
3 month after inclusion
Title
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
Description
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.
Time Frame
3 month after inclusion
Title
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,
Description
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)
Time Frame
3 month after inclusion
Title
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
Description
the higher the score, the greater the achievement, there is no defined threshold.
Time Frame
3 month after inclusion
Title
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
Description
a score between 0-6 indicates very minimal impairment, 7-9: minimal; 10-13 moderate; ≥ 14 severe
Time Frame
3 month after inclusion
Title
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
Description
overall score ≥ 5 indicates a bladder complaint
Time Frame
3 month after inclusion
Secondary Outcome Measure Information:
Title
The course of sphincter disorders will occur: • By clinical evaluation
Time Frame
less than 3 months, 6 months and 1 year from TC
Title
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
Description
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).
Time Frame
less than 3 months, 6 months and 1 year from TC
Title
The course of sphincter disorders will occur:By self-administered questionaries less than 3 months, 6 months and 1 year from TC.
Description
The self-questionaries are the same as those for the main criterion allowing the diagnosis of sphincter disorders.
Time Frame
less than 3 months, 6 months and 1 year from TC
Title
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.
Description
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)
Time Frame
less than 3 months, 6 months and 1 year from TC
Title
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
Description
Tests evaluating cognitive functions (MOCA / BREF), patients' functional recovery (GOSE / MIF) and thymic state (HADS),
Time Frame
less than 3 months, 6 months and 1 year from TC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène ROBERT, Doctor
Phone
0142161242
Email
helene.robert@aphp.fr
Facility Information:
Facility Name
Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène ROBERT, Doctor
Phone
0142161242
Email
helene.robert@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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