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OpenTrials
Completed

NCT Number: NCT01619995

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

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.

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Key information

Conditions

Urge Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Geriatric Continence Research Unit, NE547 Montefiore UPMC

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: NIRS/fBFB

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 15, 2012
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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