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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:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Werner Schaefer, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01619995
First received: June 12, 2012
Last updated: May 27, 2015
Last verified: May 2015

June 12, 2012
May 27, 2015
August 2011
July 2013   (final data collection date for primary outcome measure)
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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
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Non-Probability Sample
women over 60 years
Urge Urinary Incontinence
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*   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)
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
Yes
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Werner Schaefer, University of Pittsburgh
University of Pittsburgh
National Institute on Aging (NIA)
Principal Investigator: Werner Schaaefer, DI University of Pittsburgh
University of Pittsburgh
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP