Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus

Conditions
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Normal Pressure Hydrocephalus

Intervention / Treatment
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* Diagnostic Test: Urinary symptoms profile questionnaire
* Diagnostic Test: Micturition calendar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2/3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms Ventricular enlargement non explained by cortical atrophy Exclusion Criteria: analphabetism or not french speaking Cognitive disability making understanding of study impossible (as informed consent)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single cohort<br>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. | Diagnostic Test: Urinary symptoms profile questionnaire<br>* Validated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized<br>Diagnostic Test: Micturition calendar<br>* Micturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of depletive lumbar puncture on overactive bladder symptoms 1 | evaluation on USP questionnaire, subsection HAV [0-21] | 5 days after lumbar puncture | 
| Effect of depletive lumbar puncture on overactive bladder symptoms 2 | evaluation on micturition calendar on 2 days [number of mictions/day] | 5 days after lumbar puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of shunt surgery on overactive bladder symptoms 1 | evaluation on micturition calendar on 2 days [number of mictions/day] | 3 to 4 months after surgery | 
| Effect of shunt surgery on overactive bladder symptoms 2 | evaluation on USP questionnaire, subsection HAV [0-21] | 3 to 4 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower urinary tract dysfunction, urinary incontinence, normal pressure hydrocephalus, overactive bladder