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

March 15, 2019 updated by: EssaiClinique_PL-HPN

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Recruiting
        • University hospital of Grenoble
        • Contact:
        • Principal Investigator:
          • Elsa Bey, Resident
      • Lyon, France, 69000
        • Recruiting
        • University Hospital of Lyon
        • Contact:
        • Sub-Investigator:
          • Romain Manet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
5 days after lumbar puncture
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]
5 days after lumbar puncture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
3 to 4 months after surgery
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]
3 to 4 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EssaiClinique_PL-HPN

Investigators

  • Study Director: Jean Alexandre LONG, MD PHD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL HPN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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