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

University of Pittsburgh

Status: Completed

Conditions: Urge Urinary Incontinence

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01619995

1R03AG038583-01 (U.S. NIH Grant/Contract)

PRO10020240

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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)