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

This study is ongoing, but not recruiting participants.

First Received: September 24, 2003 Last Updated: March 19, 2009 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:	University of California, San Francisco
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00069368

Purpose

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.

Condition
Urinary Incontinence Diabetes

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Urinary Incontinence

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2350
Study Start Date:	July 2003
Estimated Study Completion Date:	August 2009

Eligibility

Ages Eligible for Study:	44 Years to 73 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069368

Locations

United States, California
Kaiser Permanente, Northern California, Division of Research
Oakland, California, United States, 94612

Sponsors and Collaborators

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

University of California, San Francisco

Investigators

Principal Investigator:

Jeanette Brown, MD

University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco ( Jeanette Brown, MD )
Study ID Numbers:	ORSCOR dk64538
Study First Received:	September 24, 2003
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00069368 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Healthy

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urologic Diseases
Urination Disorders
Urinary Incontinence

ClinicalTrials.gov processed this record on November 22, 2009