NCT00069368

Brief Summary

This study consists of two studies with overlapping cohorts. One is a follow up epidemiological study of urinary incontinence, the other is a case control study of lower urinary tract dysfunction in women with diabetes. Study One: Subjects for the study will be a retrospective cohort of 2100 middle-aged and older women from a large health maintenance organization who have participated in the Reproductive Risk Factor for Incontinence Study at Kaiser (RRISK). The RRISK I study assembled a retrospective cohort of long-term female Kaiser Permanente members to determine the association between specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life. The study also provides descriptive information on urinary incontinence by type, age, ethnicity, severity and age of onset. Study Two: Women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction, including lower urinary tract symptoms, urinary incontinence, and ultimately bladder cystopathy. This sudy investigates the natural history, risk factors, and possible mechanisms of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared to women without diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,161

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2003

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 4, 2025

Status Verified

September 1, 2014

Enrollment Period

6.1 years

First QC Date

September 24, 2003

Last Update Submit

April 30, 2025

Conditions

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Urinary Outcomes

    1999-2012

Eligibility Criteria

Age44 Years - 73 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 40-69 on 1/1/99 who have been Kaiser Permanente members since age 18 and have had half or more of their deliveries at Kaiser Permanente or are nulliparous and have diabetes.

Previous participation in the Reproductive Risk Factors for Incontinence Study at Kaiser.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente, Northern California, Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceDiabetes Mellitus

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jeanette Brown, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2003

First Posted

September 26, 2003

Study Start

July 1, 2003

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 4, 2025

Record last verified: 2014-09

Locations