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

Tracking Information

First Received Date ^ICMJE

September 24, 2003

Last Updated Date

March 19, 2009

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00069368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Retrospective

Condition ^ICMJE

Urinary Incontinence
Diabetes

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2350

Estimated Completion Date

August 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

44 Years to 73 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069368

Responsible Party

Jeanette Brown, MD, University of California, San Francisco

Study ID Numbers ^ICMJE

ORSCOR dk64538

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

University of California, San Francisco

Investigators ^ICMJE

Principal Investigator:

Jeanette Brown, MD

University of California, San Francisco

Information Provided By

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

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP