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Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder (NIRS/fBFB)

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ClinicalTrials.gov Identifier: NCT01619995
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : July 25, 2017
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Becky Clarkson, University of Pittsburgh

Brief Summary:
The goal of this project is to evaluate the applicability of non-invasive optical imaging for the measurement of brain function during investigation of the lower urinary tract.

Condition or disease
Urge Urinary Incontinence

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
Study Start Date : August 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women over 60 years

Inclusion Criteria:

  • ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes.
  • urinary incontinence (urge or predominantly urge) by clinical criteria.
  • able to accurately complete a voiding diary, to perform a 24-hour pad test under direction.

Exclusion Criteria:

  • significant mental impairment [mini mental status exam (MMSE) ≤ 20)
  • urethral obstruction
  • history of bladder cancer
  • spinal cord lesions
  • multiple sclerosis
  • pelvic radiation
  • interstitial cystitis
  • artificial sphincter implant
  • expected to have changes in medications/doses during the trial
  • medically unstable
  • Patients with factors that could cause transient UI [e.g., current urinary tract infection (UTI), acute confusion] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
  • conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619995

United States, Pennsylvania
Geriatric Continence Research Unit, NE547 Montefiore UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Principal Investigator: Werner Schaaefer, DI University of Pittsburgh

Responsible Party: Becky Clarkson, Research Instructor in Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01619995     History of Changes
Other Study ID Numbers: PRO10020240
1R03AG038583-01 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Becky Clarkson, University of Pittsburgh:
urge incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders