Brain Imaging Plus Urodynamics to Investigate the Brain's NCT01619995

Updated 05/28/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01619995
Other study ID #	PRO10020240
Secondary ID	1R03AG038583-01
Status	Completed
Phase	N/A
First received	June 12, 2012
Last updated	July 21, 2017
Start date	August 2011
Est. completion date	July 2013

Study information
Verified date	July 2017
Source	University of Pittsburgh
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial 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.

Recruitment information / eligibility
Status	Completed
Enrollment	43
Est. completion date	July 2013
Est. primary completion date	July 2013
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Female
Age group	60 Years and older
Eligibility	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)

Study Design

Related Conditions & MeSH terms

Locations
Country	Name	City	State
United States	Geriatric Continence Research Unit, NE547 Montefiore UPMC	Pittsburgh	Pennsylvania

Sponsors *(2)*
Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States,

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