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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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
- 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]
- 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]
- 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]
- 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]
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
|Contact: Jean Alexandre LONG, MD PHD||+334 76 76 76 42||JALong@chu-grenoble.fr|
|Contact: Elsa Bey, Residentfirstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Romain Manet, MD|
|Study Director:||Jean Alexandre LONG, MD PHD||University Hospital, Grenoble|