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

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ClinicalTrials.gov Identifier: NCT03877107
Recruitment Status : Unknown
Verified March 2019 by EssaiClinique_PL-HPN, University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : March 15, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
EssaiClinique_PL-HPN, University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Diagnostic Test: Urinary symptoms profile questionnaire Diagnostic Test: Micturition calendar Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Diagnostic Test: Urinary symptoms profile questionnaire
Validated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized

Diagnostic Test: Micturition calendar
Micturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized




Primary Outcome Measures :
  1. Effect of depletive lumbar puncture on overactive bladder symptoms 1 [ Time Frame: 5 days after lumbar puncture ]
    evaluation on USP questionnaire, subsection HAV [0-21]

  2. Effect of depletive lumbar puncture on overactive bladder symptoms 2 [ Time Frame: 5 days after lumbar puncture ]
    evaluation on micturition calendar on 2 days [number of mictions/day]


Secondary Outcome Measures :
  1. Effect of shunt surgery on overactive bladder symptoms 1 [ Time Frame: 3 to 4 months after surgery ]
    evaluation on micturition calendar on 2 days [number of mictions/day]

  2. Effect of shunt surgery on overactive bladder symptoms 2 [ Time Frame: 3 to 4 months after surgery ]
    evaluation on USP questionnaire, subsection HAV [0-21]



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877107


Contacts
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Contact: Jean Alexandre LONG, MD PHD +334 76 76 76 42 JALong@chu-grenoble.fr
Contact: Elsa Bey, Resident +66668636136 elsa.bey88@gmail.com

Locations
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France
University Hospital of Grenoble Recruiting
Grenoble, France, 38000
Contact: Jean Alexandre LONG, MD PHD    +334 76 76 76 42    JALong@chu-grenoble.fr   
Principal Investigator: Elsa Bey, Resident         
University Hospital of Lyon Recruiting
Lyon, France, 69000
Contact: Caroline Tilikete, MD PHD       caroline.tilikete@chu-lyon.fr   
Sub-Investigator: Romain Manet, MD         
Sponsors and Collaborators
EssaiClinique_PL-HPN
Investigators
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Study Director: Jean Alexandre LONG, MD PHD University Hospital, Grenoble
Publications of Results:

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Responsible Party: EssaiClinique_PL-HPN, Clinical Professor, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03877107    
Other Study ID Numbers: PL HPN
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EssaiClinique_PL-HPN, University Hospital, Grenoble:
lower urinary tract dysfunction
urinary incontinence
normal pressure hydrocephalus
overactive bladder
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases