Urinary Incontinence: Reproductive/Hormonal Risk Factors

NCT00836979 | Completed

• 2 other identifiers: CN-08Svand-01-HP50DK064538
• Study Type: observational
• Target: 2,161
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Incontinence; bladder problems; bladder dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (4)

• Hormones

  up to 48 months

• Gene Polymorphisms

  up to 48 months

• New UI and Progressive UI

  up to 48 months

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Kaiser Division of Research

Oakland, California, 94612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sera will be banked for this cohort.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: October 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)