Urge Urinary IncontinenceNIRS/fBFBNCT01619995
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
An observational study of Urge Urinary Incontinence, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urge Urinary Incontinence
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women over 60 years
Who may be able to join
- 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.
Who cannot join
- significant mental impairment [mini mental status exam (MMSE) ≤ 20)
- urethral obstruction
- history of bladder cancer
- spinal cord lesions
- multiple sclerosis
- pelvic radiation
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Geriatric Continence Research Unit, NE547 Montefiore UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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.
- Conditions
- Urge Urinary Incontinence
- Keywords
- urge incontinence
- Medical subject headings
- Urinary Incontinence, Urge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Becky Clarkson, University of Pittsburgh
- Investigators
- Werner Schaaefer, DI, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619995
- Sponsor's protocol ID
- PRO10020240
- Other IDs
- 1R03AG038583-01
- Acronym
- NIRS/fBFB
- Status last verified
- Jul 2017
- First submitted
- 12 Jun 2012
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder
- ClinicalTrials.gov ID
- NCT01619995
- Acronym / sponsor ID
- NIRS/fBFB / PRO10020240
- Conditions
- Urge Urinary Incontinence
- Keywords
- urge incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women over 60 years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- significant mental impairment [mini mental status exam (MMSE) ≤ 20)
- urethral obstruction
- history of bladder cancer
- spinal cord lesions
- multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Schaaefer, DI principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urge Urinary Incontinence, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.