Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility

• ClinicalTrials.gov Identifier: NCT03250988
• Recruitment Status: Completed
• First Posted: August 16, 2017
• Last Update Posted: October 9, 2018
• Sponsor: Vanderbilt University Medical Center
• Collaborator: Allergan
• Information provided by (Responsible Party): David Charles, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: August 8, 2017
• First Posted Date: August 16, 2017
• Last Update Posted Date: October 9, 2018
• Actual Study Start Date: January 30, 2018
• Actual Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2017)

Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility [ Time Frame: Up to three months after consent is obtained ]

Prevalence of spasticity will be determined by recording the presence/absence of spasticity based on the neurological examination performed on all consenting residents of the long-term care facility. Prevalence of urinary incontinence will be determined by medical record review of all consenting residents of the long-term care facility. The research coordinator will report prevalence of comorbid spasticity and incontinence as a descriptive statistic.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 14, 2017)

• Quality of life in residents of a long-term care facility [ Time Frame: Up to three months after consent is obtained ]
  Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their perceived health-related quality of life. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their health-related quality of life.
• Physical and mental well-being in residents of a long-term care facility [ Time Frame: Up to three months after consent is obtained ]
  Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their physical and mental well-being. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their physical and mental well-being.
• Perceived disability in residents of a long-term care facility [ Time Frame: Up to three months after consent is obtained ]
  Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their perceived disability. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their disability.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
• Official Title: Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
• Brief Summary: The purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.
• Detailed Description: The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral. This will be done by assessing the relatedness of comorbid conditions in patients with spasticity. Emphasis will be placed on urinary incontinence, as previous work has suggested a link between the two conditions. An additional aim of this study is to assess health-related quality of life measures in this population. A medical record review will be performed for all consenting participants residing in Tennessee State Veterans' Homes, which is a long-term care facility in Murfreesboro, TN. Participants will also be asked to complete a brief questionnaire assessing their perceived health-related quality of life, physical wellbeing, and mental wellbeing.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Nursing home residents

Condition

• Spasticity, Muscle
• Muscular Diseases
• Musculoskeletal Disease
• Muscle Hypertonia
• Muscle Spasticity
• Neuromuscular Manifestations
• Signs and Symptoms
• Nervous System Diseases
• Neurologic Manifestations

Intervention

Diagnostic Test: Neurological Examination

The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.

• Study Groups/Cohorts: Not Provided

Publications *

• Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. Review.
• Thompson AJ, Jarrett L, Lockley L, Marsden J, Stevenson VL. Clinical management of spasticity. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):459-63.
• Pfister AA, Roberts AG, Taylor HM, Noel-Spaudling S, Damian MM, Charles PD. Spasticity in adults living in a developmental center. Arch Phys Med Rehabil. 2003 Dec;84(12):1808-12.
• Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. Epub 2003 Dec 18.
• Welmer AK, von Arbin M, Widén Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21(4):247-53. Epub 2006 Jan 27.
• Bushman W, Steers WD, Meythaler JM. Voiding dysfunction in patients with spastic paraplegia: urodynamic evaluation and response to continuous intrathecal baclofen. Neurourol Urodyn. 1993;12(2):163-70.
• Marciniak C, O'Shea SA, Lee J, Jesselson M, Dudas-Sheehan D, Beltran E, Gaebler-Spira D. Urinary incontinence in adults with cerebral palsy: prevalence, type, and effects on participation. PM R. 2014 Feb;6(2):110-20; quiz 120. doi: 10.1016/j.pmrj.2013.07.012. Epub 2013 Aug 23. Erratum in: PM R. 2014 Nov;6(11):1066.
• Durrant J, Snape J. Urinary incontinence in nursing homes for older people. Age Ageing. 2003 Jan;32(1):12-8. Review.
• von Gontard A, de Jong TP, Rantell A, Nieuwhof-Leppink A, Badawi JK, Cardozo L. Do we manage incontinence in children and adults with special needs adequately? ICI-RS 2014. Neurourol Urodyn. 2016 Feb;35(2):304-6. doi: 10.1002/nau.22823. Review.
• Chua K, Chuo A, Kong KH. Urinary incontinence after traumatic brain injury: incidence, outcomes and correlates. Brain Inj. 2003 Jun;17(6):469-78.
• Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288-94. doi: 10.1002/nau.20668. Review.
• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
• Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
• Johnson TM, Ouslander JG, Uman GC, Schnelle JF. Urinary incontinence treatment preferences in long-term care. J Am Geriatr Soc. 2001 Jun;49(6):710-8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 20, 2018): 60
• Original Estimated Enrollment (submitted: August 14, 2017): 140
• Actual Study Completion Date: August 1, 2018
• Actual Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female subjects of any race, aged 18 and above
• Resident of the selected long-term care facility
• The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.

Exclusion Criteria:

• Subjects for whom participation in the study may cause medical harm

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03250988
• Other Study ID Numbers: 170963
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: David Charles, Vanderbilt University Medical Center
• Study Sponsor: Vanderbilt University Medical Center
• Collaborators: Allergan

Investigators

• Principal Investigator: David Charles, M.D.; Vanderbilt University Medical Center

• PRS Account: Vanderbilt University Medical Center
• Verification Date: October 2018