ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence

NCT ID: NCT00069368

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

44 Years

Maximum Eligible Age

73 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeanette Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Kaiser Permanente, Northern California, Division of Research

Oakland, California, United States

Site Status

Countries

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United States

Other Identifiers

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P50DK064538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ORSCOR dk64538 (completed)

Identifier Type: -

Identifier Source: org_study_id

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