Urinary Incontinence: Reproductive/Hormonal Risk Factors (RRISK3)
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | February 3, 2009 | ||||||||||||
| Last Updated Date | June 7, 2013 | ||||||||||||
| Start Date ICMJE | October 2008 | ||||||||||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Race/Ethnicity To investigate the two- to three-fold greater prevalence of stress UI in White women, compared to Black and Asian women which we previously reported we will (a) create and compare risk factor models of UI for each racial/ethnic group (White, Black, Hispanic, Asian); b) determine the extent to which racial differences can be explained by differences in newly measured exposures and genetic polymorphisms in addition to previously identified risk factors. To increase study power, we will enroll an additional 450 women (150 Black, 150 Asian and 150 Hispanic) into the RRRISK cohort. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00836979 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE |
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| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Urinary Incontinence: Reproductive/Hormonal Risk Factors | ||||||||||||
| Official Title ICMJE | Urinary Incontinence: Reproductive/Hormonal Risk Factors III | ||||||||||||
| Brief Summary | This study is a continuation or follow-up of two previous studies (RRISK and RRISK2) conducted at the Kaiser Division of Research. This study will invite previous study participants, as well as a randomly selected group of Northern California Kaiser Permanente Members, to participate in an interview, mailed survey and lab visit. The purpose of this study is to examine the risk factors for bladder and pelvic problems. |
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| Detailed Description | Using a cohort established during two previous studies (RRISK, CN-97Svand-01-H and RRISK2 CN-02Svand-07-H), this study will follow a well characterized cohort of middle-aged and older women who have been members of Kaiser Permanente Medical Care Plan (KPMCP) of Northern California continuously since age 18. The cohort is composed of over 2000 women for whom we have data from abstracted medical records, in-person interview, voiding diaries, physical assessments, laboratory data, and banked sera. Our cohort is unique in including a substantial number of women from the 4 major ethnic/race groups (white non-Hispanic, Black, Asian and Hispanic.) For this study, we will re-interview as many study participants from RRISK and RRISK2 as are willing. This study will also expand to further increase its diversity by adding a total of 450 Black, Asian and Hispanic women to the cohort. The overall goal of the study is to advance our understanding of mechanisms of Urinary Incontinence and facilitate the translational development of novel approaches to treatment and prevention. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Sera will be banked for this cohort. |
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| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | A previously identified cohort of approximately 2000 women who are members of Kaiser Permanente Northern California (KPNC) health plan, having seen a Provider for bladder/incontinence related issues and have previously participated in the RRISK and RRISK2 studies. We will also randomly identify an additional cohort of women who are current members KPNC which report race/ethnicity as Asian, Hispanic or Black/African American (to total an additional 450 women across all groups.) |
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| Condition ICMJE | Urinary Incontinence | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||||||
| Estimated Completion Date | August 2014 | ||||||||||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | 40 Years to 69 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00836979 | ||||||||||||
| Other Study ID Numbers ICMJE | CN-08Svand-01-H, P50 DK64538 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Kaiser Permanente | ||||||||||||
| Study Sponsor ICMJE | Kaiser Permanente | ||||||||||||
| Collaborators ICMJE | University of California, San Francisco | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Kaiser Permanente | ||||||||||||
| Verification Date | June 2013 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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