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

NCT03877107 | Unknown

• 1 other identifier: PL HPN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Normal Pressure Hydrocephalus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Effect of depletive lumbar puncture on overactive bladder symptoms 1

  evaluation on USP questionnaire, subsection HAV \[0-21\]

  5 days after lumbar puncture

• Effect of depletive lumbar puncture on overactive bladder symptoms 2

  evaluation on micturition calendar on 2 days \[number of mictions/day\]

  5 days after lumbar puncture

Secondary Outcomes (2)

• Effect of shunt surgery on overactive bladder symptoms 1

  3 to 4 months after surgery

• Effect of shunt surgery on overactive bladder symptoms 2

  3 to 4 months after surgery

Study Arms (1)

single cohort

OTHER

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; Diagnostic Test: Micturition calendar

Interventions

Urinary symptoms profile questionnaire DIAGNOSTIC_TEST

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

single cohort

Micturition calendar DIAGNOSTIC_TEST

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

single cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• /3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms
• Ventricular enlargement non explained by cortical atrophy

You may not qualify if:

• analphabetism or not french speaking
• Cognitive disability making understanding of study impossible (as informed consent)

Sponsors & Collaborators

• EssaiClinique_PL-HPN: lead

Study Sites (2)

University Hospital of Grenoble

Grenoble, 38000, France

RECRUITING

University Hospital of Lyon

Lyon, 69000, France

RECRUITING

Related Publications (18)

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  PMID: 23415160 RESULT

• 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.

  PMID: 1114545 RESULT

• 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.

  PMID: 22038765 RESULT

• 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.

  PMID: 18092331 RESULT

• 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.

  PMID: 18402070 RESULT

• 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.

  PMID: 24729303 RESULT

• 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.

  PMID: 23510566 RESULT

• 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.

  PMID: 20097391 RESULT

• 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.

  PMID: 26003249 RESULT

• 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.

  PMID: 18092336 RESULT

• 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.

  PMID: 24118122 RESULT

• 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.

  PMID: 26578001 RESULT

• 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.

  PMID: 24379955 RESULT

• 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.

  PMID: 7062072 RESULT

• 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.

  PMID: 19713705 RESULT

• 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.

  PMID: 3351510 RESULT

• 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.

  PMID: 28892272 RESULT

• 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.

  PMID: 27490149 RESULT

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure; Urinary Incontinence; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Study Officials

• Jean Alexandre LONG, MD PHD

  University Hospital, Grenoble

  STUDY DIRECTOR

Central Study Contacts

Jean Alexandre LONG, MD PHD

CONTACT

+334 76 76 76 42; JALong@chu-grenoble.fr

Elsa Bey, Resident

CONTACT

+66668636136; elsa.bey88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: March 13, 2019
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)