Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of depletive lumbar puncture on overactive bladder symptoms 1
研究概览
简要总结
Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. A harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary.
The investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in iNPH.
The secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.
详细描述
Prospective study interventional but non invasive Bicentric in two universitarian hospitals in France On a cohort of patients presenting at least two out of three symptoms of the classic triad (urinary symptoms, cognitive symptoms and gait disturbance) and enlargement of ventricles non explained by cortical atrophy.
Participants are offered, as routine care, a diagnostic evaluation of the effect of depletive lumbar puncture on these triad symptoms (this exam is part of routine care).
Before the planned lumbar puncture, the participants are requested to participate to the study, with written consent and information given. The participants are requested to fill in a USP (urinary symptoms profile, validated international questionnaire) questionnaire and a micturition calendar. The same urinary evaluation is made 5 days after lumbar puncture. Gait and cognition are evaluated as in routine practice.
Of the participants initially evaluated, some will be proposed shunt surgery (routine care). These participants will be proposed to fill in the same questionnaire and micturition calendar around 3 months after shunt surgery (post operative evaluation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2/3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms
- •Ventricular enlargement non explained by cortical atrophy
排除标准
- •analphabetism or not french speaking
- •Cognitive disability making understanding of study impossible (as informed consent)
研究组 & 干预措施
single cohort
Participants presenting at least 2/3 of symptom triad : gait disturbance, urinary symptoms and cognitive disturbance Ventricular enlargement non explained by cortical atrophy Cognitive capacity to understand the study and give informed consent (mini mental state > 13), speaking and reading french.
干预措施: Urinary symptoms profile questionnaire (Diagnostic Test)
single cohort
Participants presenting at least 2/3 of symptom triad : gait disturbance, urinary symptoms and cognitive disturbance Ventricular enlargement non explained by cortical atrophy Cognitive capacity to understand the study and give informed consent (mini mental state > 13), speaking and reading french.
干预措施: Micturition calendar (Diagnostic Test)
结局指标
主要结局
Effect of depletive lumbar puncture on overactive bladder symptoms 1
时间窗: 5 days after lumbar puncture
evaluation on USP questionnaire, subsection HAV \[0-21\]
Effect of depletive lumbar puncture on overactive bladder symptoms 2
时间窗: 5 days after lumbar puncture
evaluation on micturition calendar on 2 days \[number of mictions/day\]
次要结局
- Effect of shunt surgery on overactive bladder symptoms 1(3 to 4 months after surgery)
- Effect of shunt surgery on overactive bladder symptoms 2(3 to 4 months after surgery)
研究者
EssaiClinique_PL-HPN
Clinical Professor
University Hospital, Grenoble