This resubmission has undergone major revisions according to the suggestions of the reviewers. A population-based case-control study is proposed to examine risk factors of Female Pelvic Floor Disorders (FPFD: urinary incontinence, fecal incontinence, and pelvic organ prolapse) in conjunction with an on-going case-control study of breast cancer now underway. The SHINE Women's Health Study (formerly the Four Corners Study) is being conducted collaboratively through separate NCI R01 s funded in the states of CO, AZ, NM and UT. The current proposal will include all the SHINE study subjects in Colorado (controls and with breast cancer: 1400 women: 700 Hispanic and 700 White). Blood samples are collected for genetic and metabolic factors. In-person interviews for new subjects will include FPFD-related instruments. Subjects previously interviewed will be recontacted by telephone for FPFD-related information. We will use data from the SHINE Study's Health & Lifestyle History Questionnaire and Diet History Questionnaire, as well as data on cancer chemotherapy and hormonal therapy from case-patients. All subjects will respond to an FPFD Screening Questionnaire and Obstetrical History Interview. Those with evidence of FPFD will further respond to two condition-specific quality of life questionnaires, the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. For a 10% sample of subjects, data pertinent to FPFD will be compared to medical records. Because the subjects in the SHINE Study are in the same age group as those affected by FPFD, and because half will be Hispanic and half non-Hispanic White by design, this plan offers a special opportunity for examination in important minority populations of previously-suggested FPFD risk factors, as well as additional behavioral, hormonal, and genetic variables that may also be related to FPFD. In addition, we will assess the frequency of FPFD in recently diagnosed cancer patients, its relation to their therapy, and impact on their quality of life. Highly qualified research teams at the University of Colorado and the Cleveland Clinic Foundation, with extensive experience in clinical and epidemiological studies, will collaborate in the conduct of this study. By capitalizing on an NCI-funded study already collecting manyvariables of interest to us, we have the opportunity for a very cost-effective population-based epidemiological study of a category of ailments, FPFD, that ultimately trouble a high percentage of the female population (and perhaps a higher proportion of cancer patients), and for which ethnic variation is of substantial interest but epidemiological data are now quite limited.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD041162-04
Application #
6782633
Study Section
Special Emphasis Panel (ZRG1-SSS-9 (40))
Program Officer
Weber, Anne M
Project Start
2002-08-09
Project End
2007-07-31
Budget Start
2004-08-01
Budget End
2005-07-31
Support Year
4
Fiscal Year
2004
Total Cost
$351,004
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Daneshgari, Firouz; Imrey, Peter B; Risendal, Betsy et al. (2008) Differences in urinary incontinence between Hispanic and non-Hispanic white women: a population-based study. BJU Int 101:575-9