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Parkinson's DiseaseNCT02783014

Investigating Central Mechanisms of Overactive Bladder in Adults With Parkinson's Disease

An observational study of Parkinson's Disease, run by EvergreenHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with Parkinson's Disease (PD). The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB) and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional MRI). Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
How many people
20 participants
Where
1 siteUnited States
Study dates
Jun 2016to 13 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 10 adults with Parkinson's disease (PD) and Overactive Bladder (OAB) and 10 adults with PD only.

Who may be able to join

  • Diagnosis of PD by United Kingdom (UK) brain bank criteria.
  • PD patients with and without OAB as per bladder questionnaire.
  • No change in PD medications after screening, with no dose changes during the study, except that pro re nata (PRN) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
  • Patient willing and able to complete study questionnaires.
  • Use of other medication that could influence bladder function, will be permitted as long as the dose is stable during the study.
  • Patient expects to have valid health insurance for the duration of the study period.

Who cannot join

  • Women who are breast-feeding, pregnant or have the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
  • Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
  • Evidence of Urinary Tract Infection (UTI) at screening.
  • Bladder pain or history of chronic inflammation such as interstitial cystitis, recurrent UTIs, bladder stones, bladder obstruction, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs.
  • Adults who have an interstim device in place.
  • Claustrophobia, occupational risk for ferrous metal in the eye, or having an implantable medical device or foreign body precluding fMRI (e.g. cardiac pacemaker, metallic fragment, orthopedic hardware).
Show all 9Show fewer
  • Intravesical botulinum toxin treatment within the previous six months of screening.
  • Use of indwelling catheter or self-catheterization.
  • Any other serious and/or unstable medical condition

Trial locations and contacts

1 site in 1 country.

United States1 site

  • EvergreenHealth

    Kirkland, Washington, 98034

Other trials in United States

About this study

Official title: Case-control Study Investigating Central Mechanisms of Overactive Bladder in Adults With Parkinson's Disease and Overactive Bladder and Adults With Parkinson's Disease Only

This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with Parkinson's Disease (PD).

The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB) and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional MRI).

Read the detailed description

Overactive bladder (OAB) is a physical problem that causes strong urges to urinate, frequent urination, and sometimes urinary incontinence (accidental loss of urine control) commonly in patients with Parkinson' disease (PD) severely impacting their quality of life.

Unfortunately OAB in adults with PD is difficult to treat. This is largely because the mechanisms underlying OAB in adults with PD are not known. Recent functional MRI (fMRI) studies suggest that certain areas of the brain have an important role in OAB. Blood oxygenation level dependent (BOLD) fMRI is an imaging technique in which neural activity of a region of the brain can be measured by fluctuation in the BOLD signal. It is hoped that the findings of this study will allow the development of new treatments for adults with Parkinson's disease and overactive bladder.

Keywords
overactive bladder
Medical subject headings
Parkinson Disease, Urinary Bladder, Overactive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of perfusion activity in the Limbic System

    Comparison of the perfusion activity in the limbic system between subjects with Parkinson's Disease and Overactive Bladder and Parkinson's disease only using Blood Oxygenation Level Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) contrast maps. It will be performed at the second visit.

    Measured: 1 hour functional Magnetic Resonance Imaging (fMRI)

Secondary outcomes (1)

  1. Determination on the relationship of perfusion activity in the limbic system and anxiety.

    Determination of the relationship of perfusion activity in the limbic system and anxiety scores (using Zung's Self-rating Anxiety Scale (SAS)) in subjects with Parkinson's Disease and Overactive Bladder.

    Measured: 1 hour functional Magnetic Resonance Imaging (fMRI) - 10 Minutes questionnaire.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2017
  4. Study completion13 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783014
Sponsor's protocol ID
PADB-2016-01
Status last verified
Aug 2021
First submitted
23 May 2016
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bradley CS, Rovner ES, Morgan MA, Berlin M, Novi JM, Shea JA, Arya LA. A new questionnaire for urinary incontinence diagnosis in women: development and testing. Am J Obstet Gynecol. 2005 Jan;192(1):66-73. doi: 10.1016/j.ajog.2004.07.037.

    PubMed 15672005

  • Chao-Gan Y, Yu-Feng Z. DPARSF: A MATLAB Toolbox for "Pipeline" Data Analysis of Resting-State fMRI. Front Syst Neurosci. 2010 May 14;4:13. doi: 10.3389/fnsys.2010.00013. eCollection 2010.

    PubMed 20577591

  • Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8. doi: 10.1002/mds.20213.

    PubMed 15372591

  • Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.

    PubMed 1564476

  • Jain S. Multi-organ autonomic dysfunction in Parkinson disease. Parkinsonism Relat Disord. 2011 Feb;17(2):77-83. doi: 10.1016/j.parkreldis.2010.08.022. Epub 2010 Sep 20.

    PubMed 20851033

  • Kilpatrick LA, Kutch JJ, Tillisch K, Naliboff BD, Labus JS, Jiang Z, Farmer MA, Apkarian AV, Mackey S, Martucci KT, Clauw DJ, Harris RE, Deutsch G, Ness TJ, Yang CC, Maravilla K, Mullins C, Mayer EA. Alterations in resting state oscillations and connectivity in sensory and motor networks in women with interstitial cystitis/painful bladder syndrome. J Urol. 2014 Sep;192(3):947-55. doi: 10.1016/j.juro.2014.03.093. Epub 2014 Mar 26.

    PubMed 24681331

  • McGrother CW, Jagger C, Clarke M, Castleden CM. Handicaps associated with incontinence: implications for management. J Epidemiol Community Health. 1990 Sep;44(3):246-8. doi: 10.1136/jech.44.3.246.

    PubMed 2148771

  • Nardos R, Gregory WT, Krisky C, Newell A, Nardos B, Schlaggar B, Fair DA. Examining mechanisms of brain control of bladder function with resting state functional connectivity MRI. Neurourol Urodyn. 2014 Jun;33(5):493-501. doi: 10.1002/nau.22458. Epub 2013 Jul 3.

    PubMed 23908139

  • Sakakibara R, Nakazawa K, Uchiyama T, Yoshiyama M, Yamanishi T, Hattori T. Micturition-related electrophysiological properties in the substantia nigra pars compacta and the ventral tegmental area in cats. Auton Neurosci. 2002 Nov 29;102(1-2):30-8. doi: 10.1016/s1566-0702(02)00180-7.

    PubMed 12492133

  • Sakakibara R, Panicker J, Finazzi-Agro E, Iacovelli V, Bruschini H; Parkinson's Disease Subcomittee, The Neurourology Promotion Committee in The International Continence Society. A guideline for the management of bladder dysfunction in Parkinson's disease and other gait disorders. Neurourol Urodyn. 2016 Jun;35(5):551-63. doi: 10.1002/nau.22764. Epub 2015 Mar 25.

    PubMed 25810035

  • Sakakibara R, Shinotoh H, Uchiyama T, Sakuma M, Kashiwado M, Yoshiyama M, Hattori T. Questionnaire-based assessment of pelvic organ dysfunction in Parkinson's disease. Auton Neurosci. 2001 Sep 17;92(1-2):76-85. doi: 10.1016/S1566-0702(01)00295-8.

    PubMed 11570707

  • Sakakibara R, Tateno F, Kishi M, Tsuyuzaki Y, Uchiyama T, Yamamoto T. Pathophysiology of bladder dysfunction in Parkinson's disease. Neurobiol Dis. 2012 Jun;46(3):565-71. doi: 10.1016/j.nbd.2011.10.002. Epub 2011 Oct 10.

    PubMed 22015601

  • Sakakibara R, Uchiyama T, Yamanishi T, Shirai K, Hattori T. Bladder and bowel dysfunction in Parkinson's disease. J Neural Transm (Vienna). 2008;115(3):443-60. doi: 10.1007/s00702-007-0855-9. Epub 2008 Mar 10.

    PubMed 18327532

  • Song XW, Dong ZY, Long XY, Li SF, Zuo XN, Zhu CZ, He Y, Yan CG, Zang YF. REST: a toolkit for resting-state functional magnetic resonance imaging data processing. PLoS One. 2011;6(9):e25031. doi: 10.1371/journal.pone.0025031. Epub 2011 Sep 20.

    PubMed 21949842

  • Uchiyama T, Sakakibara R, Hattori T, Yamanishi T. Short-term effect of a single levodopa dose on micturition disturbance in Parkinson's disease patients with the wearing-off phenomenon. Mov Disord. 2003 May;18(5):573-8. doi: 10.1002/mds.10403.

    PubMed 12722172

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by EvergreenHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of perfusion activity in the Limbic System (time frame: 1 hour functional Magnetic Resonance Imaging (fMRI)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783014, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.

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