Urinary IncontinenceNCT01479816
Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
An observational study of Urinary Incontinence, run by Ananias Diokno at 2 sites in United States.
Trial summary
This study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. This would create significant opportunities for focused prevention and early intervention strategies. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 702 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Dec 2015
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women 55 years and older
Who may be able to join
- Women
Who cannot join
- Men
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oakland University
Rochester, Michigan, 48309
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
This study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. This would create significant opportunities for focused prevention and early intervention strategies.
- Conditions
- Urinary Incontinence
- Keywords
- continence, index
- Medical subject headings
- Urinary Incontinence, Erythema Multiforme
What is being measured
The primary outcome is the main question the study is designed to answer.
Index Estimation for Urinary Incontinence Prediction
Several risk factors identified can serve as an index in predicting the development of urinary incontinence in elderly women.
Measured: 2 years
Secondary outcomes (1)
Predictive Reliability of Urinary Incontinence Index and its Validation
The urinary continence index developed in Outcome measure 1 will reliably predict the development of urinary incontinence in women when tested against existing datasets.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ananias Diokno
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Ananias Diokno, Corewell Health East
- Investigators
- Ananias Diokno, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479816
- Sponsor's protocol ID
- E2011-047
- Other IDs
- 1R01AG038673
- Status last verified
- Jul 2016
- First submitted
- 22 Nov 2011
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
- ClinicalTrials.gov ID
- NCT01479816
- Acronym / sponsor ID
- E2011-047
- Conditions
- Urinary Incontinence
- Keywords
- continence, index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Ananias DioknoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Nov 2011 (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.
This study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. This would create significant opportunities for focused prevention and early intervention strategies.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women 55 years and older
Key inclusion criteria (1 listed)
- Women
Key exclusion criteria (1 listed)
- Men
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
Index Estimation for Urinary Incontinence Prediction
Time frame: 2 years
Several risk factors identified can serve as an index in predicting the development of urinary incontinence in elderly women.
1 secondary outcome
Predictive Reliability of Urinary Incontinence Index and its Validation
Time frame: 3 years
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 21 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Ananias Diokno, MD principal investigator
Corewell Health East
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Ananias Diokno at 2 sites 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 1 inclusion and 1 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Index Estimation for Urinary Incontinence Prediction (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 21 Jul 2016.