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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069368
• Other study ID #: ORSCOR dk64538 (completed)
• Status: Completed
• Phase: N/A
• First received: September 24, 2003
• Last updated: September 25, 2014
• Start date: July 2003
• Est. completion date: August 2009

Study information

• Verified date: September 2014
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2161
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 44 Years to 73 Years
• Eligibility: Previous participation in the Reproductive Risk Factors for Incontinence Study at Kaiser.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes
• Urinary Incontinence

Locations

Country	Name	City	State
United States	Kaiser Permanente, Northern California, Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Outcomes		1999-2012	No