Clinical trial NCT03877107: Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH
Official title: Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Pressure Hydrocephalus
Keywords: lower urinary tract dysfunction
urinary incontinence
normal pressure hydrocephalus
overactive bladder
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Effect of depletive lumbar puncture on overactive bladder symptoms 1
timeFrame: 5 days after lumbar puncture
measure: Effect of depletive lumbar puncture on overactive bladder symptoms 2
timeFrame: 5 days after lumbar puncture
Secondary outcomes:
measure: Effect of shunt surgery on overactive bladder symptoms 1
timeFrame: 3 to 4 months after surgery
measure: Effect of shunt surgery on overactive bladder symptoms 2
timeFrame: 3 to 4 months after surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Lyon
country: France
facility: University Hospital of Lyon
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Alexandre LONG, MD PHD
role: STUDY_DIRECTOR
References:
citation: Mary P, Gallisa JM, Laroque S, Bedou G, Maillard A, Bousquet C, Negre C, Gaillard N, Dutray A, Fadat B, Jurici S, Olivier N, Cisse B, Sablot D. [Predictive value of postural and dynamic walking parameters after high-volume lumbar puncture in normal pressure hydrocephalus]. Rev Neurol (Paris). 2013 Apr;169(4):321-7. doi: 10.1016/j.neurol.2012.09.010. Epub 2013 Feb 12. French.
citation: Jonas S, Brown J. Neurogenic bladder in normal pressure hydrocephalus. Urology. 1975 Jan;5(1):44-50. doi: 10.1016/0090-4295(75)90300-3.
citation: Sakakibara R, Uchida Y, Ishii K, Kazui H, Hashimoto M, Ishikawa M, Yuasa T, Kishi M, Ogawa E, Tateno F, Uchiyama T, Yamamoto T, Yamanishi T, Terada H; SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Correlation of right frontal hypoperfusion and urinary dysfunction in iNPH: a SPECT study. Neurourol Urodyn. 2012 Jan;31(1):50-5. doi: 10.1002/nau.21222. Epub 2011 Oct 28.
citation: Sakakibara R, Kanda T, Sekido T, Uchiyama T, Awa Y, Ito T, Liu Z, Yamamoto T, Yamanishi T, Yuasa T, Shirai K, Hattori T. Mechanism of bladder dysfunction in idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2008;27(6):507-10. doi: 10.1002/nau.20547.
citation: Sakakibara R, Uchiyama T, Kanda T, Uchida Y, Kishi M, Hattori T. [Urinary dysfunction in idiopathic normal pressure hydrocephalus]. Brain Nerve. 2008 Mar;60(3):233-9. Japanese.
citation: Campos-Juanatey F, Gutierrez-Banos JL, Portillo-Martin JA, Zubillaga-Guerrero S. Assessment of the urodynamic diagnosis in patients with urinary incontinence associated with normal pressure hydrocephalus. Neurourol Urodyn. 2015 Jun;34(5):465-8. doi: 10.1002/nau.22600. Epub 2014 Apr 12.
citation: Kazui H, Mori E, Ohkawa S, Okada T, Kondo T, Sakakibara R, Ueki O, Nishio Y, Ishii K, Kawaguchi T, Ishikawa M, Takeda M. Predictors of the disappearance of triad symptoms in patients with idiopathic normal pressure hydrocephalus after shunt surgery. J Neurol Sci. 2013 May 15;328(1-2):64-9. doi: 10.1016/j.jns.2013.02.020. Epub 2013 Mar 16.
citation: Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.
citation: Sakakibara R. Lower urinary tract dysfunction in patients with brain lesions. Handb Clin Neurol. 2015;130:269-87. doi: 10.1016/B978-0-444-63247-0.00015-8.
citation: Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. doi: 10.1002/nau.20549.
citation: Sakakibara R, Panicker J, Fowler CJ, Tateno F, Kishi M, Tsuyusaki Y, Yamanishi T, Uchiyama T, Yamamoto T, Yano M. Is overactive bladder a brain disease? The pathophysiological role of cerebral white matter in the elderly. Int J Urol. 2014 Jan;21(1):33-8. doi: 10.1111/iju.12288. Epub 2013 Sep 30.
citation: Sakakibara R, Uchida Y, Ishii K, Hashimoto M, Ishikawa M, Kazui H, Yamamoto T, Uchiyama T, Tateno F, Kishi M, Tsuyusaki Y, Aiba Y, Tateno H, Nagao T, Terada H, Inaoka T; Members of SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Bladder recovery relates with increased mid-cingulate perfusion after shunt surgery in idiopathic normal-pressure hydrocephalus: a single-photon emission tomography study. Int Urol Nephrol. 2016 Feb;48(2):169-74. doi: 10.1007/s11255-015-1162-2. Epub 2015 Nov 17.
citation: Kang K, Hwang SK, Lee HW. Shunt-responsive idiopathic normal pressure hydrocephalus patient with delayed improvement after tap test. J Korean Neurosurg Soc. 2013 Nov;54(5):437-40. doi: 10.3340/jkns.2013.54.5.437. Epub 2013 Nov 30.
citation: Wikkelso C, Andersson H, Blomstrand C, Lindqvist G. The clinical effect of lumbar puncture in normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):64-9. doi: 10.1136/jnnp.45.1.64.
citation: Lim TS, Yong SW, Moon SY. Repetitive lumbar punctures as treatment for normal pressure hydrocephalus. Eur Neurol. 2009;62(5):293-7. doi: 10.1159/000235808. Epub 2009 Aug 27.
citation: Ahlberg J, Norlen L, Blomstrand C, Wikkelso C. Outcome of shunt operation on urinary incontinence in normal pressure hydrocephalus predicted by lumbar puncture. J Neurol Neurosurg Psychiatry. 1988 Jan;51(1):105-8. doi: 10.1136/jnnp.51.1.105.
citation: Aruga S, Kuwana N, Shiroki Y, Takahashi S, Samejima N, Watanabe A, Seki Y, Igawa Y, Homma Y. Effect of cerebrospinal fluid shunt surgery on lower urinary tract dysfunction in idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2018 Mar;37(3):1053-1059. doi: 10.1002/nau.23399. Epub 2017 Sep 11.
citation: Krzastek SC, Bruch WM, Robinson SP, Young HF, Klausner AP. Characterization of lower urinary tract symptoms in patients with idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2017 Apr;36(4):1167-1173. doi: 10.1002/nau.23084. Epub 2016 Aug 4.