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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00069368
First received: September 24, 2003
Last updated: February 4, 2011
Last verified: February 2011
  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: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, San Francisco
Investigators
Principal Investigator: Jeanette Brown, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Jeanette Brown, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00069368     History of Changes
Other Study ID Numbers: ORSCOR dk64538 (completed)
Study First Received: September 24, 2003
Last Updated: February 4, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014