The specific aims of the ERIDS Pilot are to 1) develop and validate a survey instrument to assess symptoms of lower urinary tract (LUT) dysfunction in a random sample population of black, Hispanic, and white women; 2) determine the reliability with which such a population can complete a prospective urinary diary; 3) determine the type of incentive required to ensure sufficient recruitment of subjects from an in-home to an in-clinic evaluation segment of the protocol so that data will be generalizable; and 4) demonstrate the feasibility of protocol standardization at the three geographically and ethnically distinct pilot sites. The broad overall objective of the ERIDS Pilot is to field test the techniques to be used in the final ERIDS Project which intends to prospectively study urinary incontinence (UI) and LUT dysfunction in black, Hispanic, and white women in eight U.S. cities. These studies will help fill a significant gap in our adult female UI knowledge base which has been built nearly exclusively on the study of white populations. While the 1988 NIH UI Consensus Conference called for studies to examine UI in minority populations virtually no progress has been made in this area. Healthy People 2000 also underscores the significant health disadvantages that exist for African-Americans and for some of the Hispanic subgroups. A lack of knowledge about UI in minority populations adds to this disadvantage, placing them at greater risk for inaccurate diagnosis and inappropriate therapy. The ERIDS Pilot will develop, utilize, and validate all of the techniques, instruments, and sequencing to be used in the final project, differing only in that it 1) will enroll only 50 subjects at each of the three sites and 2) will not be longitudinal. The pilot will employ an observational epidemiologic study design using a stratified random population sample. The first level of the evaluation will utilize a detailed, structured in-person interview of each eligible consenting subject. At the second level, subjects will complete a one-week urinary diary to prospectively establish voiding and incontinence patterns. Next, each subject will be asked to proceed to the clinical levels of the evaluation and offered a financial and health related incentive to do so. Consenting subjects will attend a clinic session for a review of their history, a general physical, neurological, and pelvic examination, and a urinalysis, the third level of evaluation. The final fourth level of the evaluation will involve urodynamic testing of all qualifying subjects.
The aims of the third and fourth level evaluations are to objectively document the functional and structural status of the LUT.
The aims of the entire four level evaluation are to determine the continence status of the subjects, to identify the clinical subtypes (subjective symptoms) and physiologic subtypes (objective urodynamic conditions of UI in those subjects who are incontinent), and to assess other symptoms of LUT dysfunction. Also, a number of putative risk factors for UI, several general and UI specific quality of life measures, internal and external barriers to seeking care for UI, and various urodynamic and anatomic parameters related to UI will be assessed. Ultimately the methods developed in the pilot will be used longitudinally to examine racial differences in the prevalence, incidence, and natural history of UI and other LUT dysfunction.
