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

This study has been completed.
Sponsor:
Collaborator:
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
  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

Further study details as provided by University of Pittsburgh:

Enrollment: 43
Study Start Date: August 2011
Study Completion Date: July 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Geriatric Continence Research Unit, NE547 Montefiore UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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: May 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
urge incontinence

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

ClinicalTrials.gov processed this record on July 01, 2015