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

EssaiClinique_PL-HPN

Status: Unknown

Conditions: Normal Pressure Hydrocephalus

Treatments: Diagnostic Test: Urinary symptoms profile questionnaire; Diagnostic Test: Micturition calendar

Study type: Interventional

Funder types: Other

Identifiers

NCT03877107

PL HPN

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

single cohort

Other group

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.

Treatment:

Diagnostic Test: Micturition calendar

Diagnostic Test: Urinary symptoms profile questionnaire