Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03877107
Status:
UNKNOWN
Last Update Posted:
2019-03-19
First Post:
2019-03-13
Brief Title:
Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH
Sponsor:
EssaiClinique_PL-HPN
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLHPN
Brief Summary:
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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None