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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03877107
Acronym
PLHPN
Enrollment
100
Registered
2019-03-15
Start date
2019-03-13
Completion date
2021-03-01
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pressure Hydrocephalus

Keywords

lower urinary tract dysfunction, urinary incontinence, normal pressure hydrocephalus, overactive bladder

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).

Interventions

DIAGNOSTIC_TESTUrinary symptoms profile questionnaire

Validated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized

DIAGNOSTIC_TESTMicturition calendar

Micturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized

Sponsors

EssaiClinique_PL-HPN
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Effect of depletive lumbar puncture on overactive bladder symptoms 15 days after lumbar punctureevaluation on USP questionnaire, subsection HAV \[0-21\]
Effect of depletive lumbar puncture on overactive bladder symptoms 25 days after lumbar punctureevaluation on micturition calendar on 2 days \[number of mictions/day\]

Secondary

MeasureTime frameDescription
Effect of shunt surgery on overactive bladder symptoms 13 to 4 months after surgeryevaluation on micturition calendar on 2 days \[number of mictions/day\]
Effect of shunt surgery on overactive bladder symptoms 23 to 4 months after surgeryevaluation on USP questionnaire, subsection HAV \[0-21\]

Countries

France

Contacts

Primary ContactJean Alexandre LONG, MD PHD
JALong@chu-grenoble.fr+334 76 76 76 42
Backup ContactElsa Bey, Resident
elsa.bey88@gmail.com+66668636136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026