Traumatic Brain InjuryTCGNCT05163262
Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
A study testing sexuality questionnaire in people with Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- sexuality questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2022to 27 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital
Paris, 75013
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- sexuality questionnaire
- Keywords
- Traumatic Brain Injury, Sexuality, Sexual disorders, bladder-sphincter dysfunctions, anorectal disorders
- Medical subject headings
- Brain Injuries, Traumatic, Sexuality, Sexual Dysfunction, Physiological, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexuality questionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Addition of a sexuality questionnaire during patient follow-up within 3 months after inclusion, 6 months after and at one year Receives: Other: sexuality questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 month after inclusion
Secondary outcomes (5)
The course of sphincter disorders will occur: • By clinical evaluation
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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),
Measured: less than 3 months, 6 months and 1 year from TC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start2 Feb 2022
- Primary completion27 May 2022
- Study completion27 May 2022
Why it stopped: lack of staff to carry out the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163262
- Sponsor's protocol ID
- APHP211155
- Acronym
- TCG
- Status last verified
- Apr 2025
- First submitted
- 6 Dec 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
- ClinicalTrials.gov ID
- NCT05163262
- Acronym / sponsor ID
- TCG / APHP211155
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Sexuality, Sexual disorders, bladder-sphincter dysfunctions, anorectal disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of staff to carry out the study
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: sexuality questionnaireAddition of a sexuality questionnaire during patient follow-up within 3 months after inclusion, 6 months after and at one year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexuality questionnaireQuestionnaire 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 | Other | experimental |
Primary outcome
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
Time frame: 3 month after inclusion
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
Time frame: 3 month after inclusion
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
Time frame: 3 month after inclusion
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,
Time frame: 3 month after inclusion
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
Time frame: 3 month after inclusion
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
Time frame: 3 month after inclusion
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
Time frame: 3 month after inclusion
overall score ≥ 5 indicates a bladder complaint
5 secondary outcomes
The course of sphincter disorders will occur: • By clinical evaluation
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: less than 3 months, 6 months and 1 year from TC
Results and safety
The study was stopped early (reason given: lack of staff to carry out the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexuality questionnaire in people with Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of staff to carry out the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 month after inclusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.