Text Size

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

This study is currently recruiting participants.
Verified June 2012 by University of Pittsburgh
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: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Urge Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women over 60 years

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619995

Contacts
Contact: Mary Jo Sychak 412-647-1272 mjs138@pitt.edu
Contact: Werner Schaefer, DI 412-647-1274 wes11@pitt.edu

Locations
United States, Pennsylvania
Geriatric Continence Research Unit, NE547 Montefiore UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Megan Kramer, BSN, RN     412-647-1271     mrk48@pitt.edu    
Contact: Mary Jo Sychak     412-647-1272     mjs138@pitt.edu    
Principal Investigator: Werner Schaefer, DI            
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
Principal Investigator: Werner Schaaefer, DI University of Pittsburgh
  More Information

No publications provided

Responsible Party: Werner Schaefer, Principal Investigation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01619995     History of Changes
Other Study ID Numbers: PRO10020240, 1R03AG038583-01
Study First Received: June 12, 2012
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
urge incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 17, 2012