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

Not Applicable

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Diagnostic Test: Urinary symptoms profile questionnaire; Diagnostic Test: Micturition calendar

• Registration Number: NCT03877107
• Lead Sponsor: EssaiClinique_PL-HPN

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).

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-13
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19
• Primary Completion: 2020-09-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single cohort	Micturition calendar	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.
single cohort	Urinary symptoms profile questionnaire	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital of Grenoble; 🇫🇷 Grenoble, France

University Hospital of Lyon; 🇫🇷 Lyon, France