Urinary Incontinence: Reproductive/Hormonal Risk Factors (RRISK3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00836979
First received: February 3, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition
Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Urinary Incontinence: Reproductive/Hormonal Risk Factors III

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Biospecimen Retention:   Samples With DNA

Sera will be banked for this cohort.


Estimated Enrollment: 2000
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836979

Locations
United States, California
Kaiser Division of Research
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
University of California, San Francisco
Investigators
Principal Investigator: Stephen K Van Den Eeden, PhD Kaiser Division of Research
Principal Investigator: Jeanette Brown, MD UCSF/Mr. Zion WHCRC
Principal Investigator: David Thom, MD UCSF/Family and Community Medicine
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00836979     History of Changes
Other Study ID Numbers: CN-08Svand-01-H, P50 DK64538
Study First Received: February 3, 2009
Last Updated: June 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Urinary Incontinence
Incontinence
bladder problems
bladder dysfunction

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014