Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH (PLHPN)
Primary Purpose
Normal Pressure Hydrocephalus
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urinary symptoms profile questionnaire
Micturition calendar
Sponsored by
About this trial
This is an interventional diagnostic trial for Normal Pressure Hydrocephalus focused on measuring lower urinary tract dysfunction, urinary incontinence, normal pressure hydrocephalus, overactive bladder
Eligibility Criteria
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)
Sites / Locations
- University Hospital of GrenobleRecruiting
- University Hospital of LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single cohort
Arm Description
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.
Outcomes
Primary Outcome Measures
Effect of depletive lumbar puncture on overactive bladder symptoms 1
evaluation on USP questionnaire, subsection HAV [0-21]
Effect of depletive lumbar puncture on overactive bladder symptoms 2
evaluation on micturition calendar on 2 days [number of mictions/day]
Secondary Outcome Measures
Effect of shunt surgery on overactive bladder symptoms 1
evaluation on micturition calendar on 2 days [number of mictions/day]
Effect of shunt surgery on overactive bladder symptoms 2
evaluation on USP questionnaire, subsection HAV [0-21]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03877107
Brief Title
Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH
Acronym
PLHPN
Official Title
Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
EssaiClinique_PL-HPN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus
Keywords
lower urinary tract dysfunction, urinary incontinence, normal pressure hydrocephalus, overactive bladder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urinary symptoms profile questionnaire
Intervention Description
Validated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized
Intervention Type
Diagnostic Test
Intervention Name(s)
Micturition calendar
Intervention Description
Micturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized
Primary Outcome Measure Information:
Title
Effect of depletive lumbar puncture on overactive bladder symptoms 1
Description
evaluation on USP questionnaire, subsection HAV [0-21]
Time Frame
5 days after lumbar puncture
Title
Effect of depletive lumbar puncture on overactive bladder symptoms 2
Description
evaluation on micturition calendar on 2 days [number of mictions/day]
Time Frame
5 days after lumbar puncture
Secondary Outcome Measure Information:
Title
Effect of shunt surgery on overactive bladder symptoms 1
Description
evaluation on micturition calendar on 2 days [number of mictions/day]
Time Frame
3 to 4 months after surgery
Title
Effect of shunt surgery on overactive bladder symptoms 2
Description
evaluation on USP questionnaire, subsection HAV [0-21]
Time Frame
3 to 4 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Alexandre LONG, MD PHD
Phone
+334 76 76 76 42
Email
JALong@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa Bey, Resident
Phone
+66668636136
Email
elsa.bey88@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Alexandre LONG, MD PHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Alexandre LONG, MD PHD
Phone
+334 76 76 76 42
Email
JALong@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Elsa Bey, Resident
Facility Name
University Hospital of Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Tilikete, MD PHD
Email
caroline.tilikete@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Romain Manet, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH
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