Urinary Incontinence: Reproductive/Hormonal Risk Factors

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT00836979
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2161

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Race/Ethnicity	up to 48 months	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.

Trial Locations

Locations (1)

Kaiser Division of Research; 🇺🇸 Oakland, California, United States