Clinical trial NCT00836979: Urinary Incontinence: Reproductive/Hormonal Risk Factors
Official title: Urinary Incontinence: Reproductive/Hormonal Risk Factors III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Incontinence
bladder problems
bladder dysfunction
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2009-02-04
Enrollment: 2161
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.)

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.

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.

Eligibility criteria: Inclusion Criteria:

* previously participated in the RRISK or RRISK2 studies at the kaiser Division of Research.

Exclusion Criteria:

* Not a part of the previous RRISK or RRISK2 cohorts.

Primary outcomes:
measure: Race/Ethnicity
timeFrame: up to 48 months
Secondary outcomes:
Other outcomes:
measure: Hormones
timeFrame: up to 48 months
measure: Gene Polymorphisms
timeFrame: up to 48 months
measure: New UI and Progressive UI
timeFrame: up to 48 months
measure: Pre-Diabetes
timeFrame: up to 48 months
Locations:
city: Oakland
country: United States
facility: Kaiser Division of Research
state: California
Study officials:
affiliation: Kaiser Division of Research
name: Stephen K Van Den Eeden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF/Mr. Zion WHCRC
name: Jeanette Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF/Family and Community Medicine
name: David Thom, MD
role: PRINCIPAL_INVESTIGATOR
References: