Urinary Incontinence: Reproductive/Hormonal Risk Factors

Urinary Incontinence Clinical Trial

— RRISK3  

Official title:

Urinary Incontinence: Reproductive/Hormonal Risk Factors III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836979
• Other study ID #: CN-08Svand-01-H
• Secondary ID: P50DK064538
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: April 3, 2015
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2161
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Urinary Incontinence

Locations

Country	Name	City	State
United States	Kaiser Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hormones	To further characterize the association between hormones and UI and to determine if phytoestrogens are a risk factor for UI we will (a) use pharmacy records, supplemented by self-report, to ascertain the type, dose, duration and delivery for estrogens and for selective estrogen reuptake inhibitors (SERMs) and test their association with UI; (b) estimate phytoestrogen exposure from self-reported intake of key foods and botanicals and test the association with UI using multivariate analysis.	up to 48 months	No
Other	Gene Polymorphisms	To test the association between estrogen receptor gene polymorphisms and UI we will use banked serum samples from the RRISK cohort to assay for polymorphisms of the two estrogen receptor genes (ESR1 and ESR2) and determine their associations with urinary incontinence.	up to 48 months	No
Other	New UI and Progressive UI	We will analyze approximately 20,000 person-years of observational data using multiple regression techniques to (a) determine rates of new UI and changes in UI frequency/severity (including remission) and (b) identify risk factors for new UI and change in UI severity.	up to 48 months	No
Other	Pre-Diabetes	To investigate the association between pre-diabetes and increased risk of UI recently reported by members of our group we will (a) examine the cross-sectional association between pre-diabetes and UI, controlling for multiple other variables including body mass, waist circumference, inflammatory markers, and coronary heart disease; (b) conduct in-person interviews, measure physical parameters, and obtain blood tests on the approximately 400 women in the current study cohort with pre-diabetes. This additional prospective data on pre-diabetic women will allow us to characterize the natural history of the association between pre-diabetes and progression or new onset of UI.	up to 48 months	No
Primary	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.	up to 48 months	No