Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01619995

Acronym

NIRS/fBFB

Enrollment

Registered

2012-06-15

Start date

2011-08-31

Completion date

2013-07-31

Last updated

2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urge Urinary Incontinence

Keywords

urge incontinence

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to No maximum

Healthy volunteers

Yes

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)

Countries

United States

Outcome results