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

Traumatic Brain Injury Clinical Trial

— TCG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163262
• Other study ID #: APHP211155
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: February 2, 2026

Study information

• Verified date: January 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hélène ROBERT, Doctor
• Phone: 0142161242
• Email: helene.robert[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2, 2026
• Est. primary completion date: February 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The course of sphincter disorders will occur: • By clinical evaluation		less than 3 months, 6 months and 1 year from TC
Secondary	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
Secondary	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
Secondary	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
Secondary	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