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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619995
First Posted: June 15, 2012
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Becky Clarkson, University of Pittsburgh
June 12, 2012
June 15, 2012
July 25, 2017
August 2011
July 2013   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01619995 on ClinicalTrials.gov Archive Site
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Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
women over 60 years
Urge Urinary Incontinence
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2013
July 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
60 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01619995
PRO10020240
1R03AG038583-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
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Becky Clarkson, University of Pittsburgh
University of Pittsburgh
National Institute on Aging (NIA)
Principal Investigator: Werner Schaaefer, DI University of Pittsburgh
University of Pittsburgh
July 2017