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

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01619995
Collaborator
National Institute on Aging (NIA) (NIH)
43
Enrollment
1
Location
23
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Aug 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      60 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      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)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Geriatric Continence Research Unit, NE547 Montefiore UPMC Pittsburgh Pennsylvania United States 15213

      Sponsors and Collaborators

      • University of Pittsburgh
      • National Institute on Aging (NIA)

      Investigators

      • Principal Investigator: Werner Schaaefer, DI, University of Pittsburgh

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Becky Clarkson, Research Instructor in Medicine, University of Pittsburgh
      ClinicalTrials.gov Identifier:
      NCT01619995
      Other Study ID Numbers:
      • PRO10020240
      • 1R03AG038583-01
      First Posted:
      Jun 15, 2012
      Last Update Posted:
      Jul 25, 2017
      Last Verified:
      Jul 1, 2017
      Keywords provided by Becky Clarkson, Research Instructor in Medicine, University of Pittsburgh
      urge incontinence
      Additional relevant MeSH terms:
      Urinary Incontinence
      Urinary Incontinence, Urge

      Study Results

      No Results Posted as of Jul 25, 2017