Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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 Urinary Symptom Profile questionary
时间窗: 3 month after inclusion
overall score ≥ 5 indicates a bladder complaint
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,
时间窗: 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 sexuality questionary
时间窗: 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
时间窗: 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 Neurogenic Bowel Dysfunction if constipation
时间窗: 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 Wexner score if diarrhea
时间窗: 3 month after inclusion
the higher the score, the greater the achievement, there is no defined threshold.
次要结局
- 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: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)
- 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)
- 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)