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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783014
• Other study ID #: PADB-2016-01
• Status: Completed
• Start date: June 2016
• Est. completion date: March 13, 2020

Study information

• Verified date: August 2021
• Source: EvergreenHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 13, 2020
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

• 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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	EvergreenHealth	Kirkland	Washington

Sponsors (1)

Lead Sponsor	Collaborator
EvergreenHealth

Country where clinical trial is conducted

United States, 

References & Publications (17)

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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. — View Citation

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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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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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. — View Citation

Valentino RJ, Wood SK, Wein AJ, Zderic SA. The bladder-brain connection: putative role of corticotropin-releasing factor. Nat Rev Urol. 2011 Jan;8(1):19-28. doi: 10.1038/nrurol.2010.203. Epub 2010 Dec 7. Review. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour functional Magnetic Resonance Imaging (fMRI)
Secondary	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.	1 hour functional Magnetic Resonance Imaging (fMRI) - 10 Minutes questionnaire.