ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 24, 2003 | ||||
| Last Updated Date | February 4, 2011 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00069368 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 2350 | ||||
| Estimated Completion Date | August 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Previous participation in the Reproductive Risk Factors for Incontinence Study at Kaiser. |
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| 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 Number ICMJE | NCT00069368 | ||||
| Other Study ID Numbers ICMJE | ORSCOR dk64538 (completed) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jeanette Brown, MD, University of California, San Francisco | ||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators ICMJE | University of California, San Francisco | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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