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

Normal Pressure Hydrocephalus Clinical Trial

— PLHPN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03877107
• Other study ID #: PL HPN
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2019
• Source: University Hospital, Grenoble
• Contact: Jean Alexandre LONG, MD PHD
• Phone: +334 76 76 76 42
• Email: JALong[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble
France	University Hospital of Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
EssaiClinique_PL-HPN

Country where clinical trial is conducted

France, 

References & Publications (18)

Ahlberg J, Norlén L, Blomstrand C, Wikkelsö 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. — View 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- — View Citation

Campos-Juanatey F, Gutiérrez-Baños JL, Portillo-Martín 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: 10.10 — View Citation

Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. Review. — View Citation

Jonas S, Brown J. Neurogenic bladder in normal pressure hydrocephalus. Urology. 1975 Jan;5(1):44-50. — View 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. — View 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 Neu — View 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. — View 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. — View 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 pressu — View 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- — View 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. — View 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. — View 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 Neurologica — View 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 — View 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. Review. Japanese. — View 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. Review. — View Citation

Wikkelsø 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of depletive lumbar puncture on overactive bladder symptoms 1	evaluation on USP questionnaire, subsection HAV [0-21]	5 days after lumbar puncture
Primary	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	Effect of shunt surgery on overactive bladder symptoms 1	evaluation on micturition calendar on 2 days [number of mictions/day]	3 to 4 months after surgery
Secondary	Effect of shunt surgery on overactive bladder symptoms 2	evaluation on USP questionnaire, subsection HAV [0-21]	3 to 4 months after surgery