NCT03877107

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: EssaiClinique_PL-HPN · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Normal Pressure Hydrocephalus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-13
• Primary completion: 2020-09-01
• Completion: 2021-03-01
• First posted: 2019-03-15
• Last updated: 2019-03-19

Locations

2 sites across 1 country: France