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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Werner Schaefer, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01619995
First received: June 12, 2012
Last updated: June 14, 2012
Last verified: June 2012

June 12, 2012
June 14, 2012
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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.
 
Recruiting
80
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
Yes
Contact: Mary Jo Sychak 412-647-1272 mjs138@pitt.edu
Contact: Werner Schaefer, DI 412-647-1274 wes11@pitt.edu
United States
 
NCT01619995
PRO10020240, 1R03AG038583-01
Yes
Werner Schaefer, University of Pittsburgh
University of Pittsburgh
National Institute on Aging (NIA)
Principal Investigator: Werner Schaaefer, DI University of Pittsburgh
University of Pittsburgh
June 2012

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