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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK097780 | U.S. NIH Grant/Contract | View source | |
| U01DK097772 | U.S. NIH Grant/Contract | View source | |
| U01DK097779 | U.S. NIH Grant/Contract | View source | |
| U01DK099932 | U.S. NIH Grant/Contract | View source | |
| U01DK100011 | U.S. NIH Grant/Contract | View source | |
| U01DK100017 | U.S. NIH Grant/Contract | View source | |
| U01DK097776 | U.S. NIH Grant/Contract | View source | |
| U01DK099879 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Michigan | OTHER |
| Northwestern University | OTHER |
| Duke University |
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The purpose of this study is to advance the understanding of people who experience urinary and bladder problems. The investigators are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. The investigators want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, the investigators will have a better understanding of how to improve the care and treatment for people who have urinary and bladder problems.
This protocol is part of an overall effort to create a state-of-the-art resource for measuring patient-reported health for patients with lower urinary tract dysfunction (LUTD). The primary purpose of this resource, known as the LURN PRO Battery, is to comprehensively characterize the self-reported experiences of patients with LUTD for the purpose of enhancing efforts to characterize and explain important subtypes of patients with LUTD (phenotypes). Secondary purposes of the LURN PRO Battery, for which additional development work will be required, include developing better patient-reported endpoints for clinical trials, monitoring symptoms in the course of clinical care, and screening patients into important subgroups for purposes of tailored interventions.
Incorporating methods the investigators have used successfully in prior measure validation work, the investigators propose to conduct a diary study in which patients record their symptoms at various time points - at the end of each day, or across multiple days. The investigators also ask them to complete self-report measures with different recall periods (i.e., 3-day, 7-day, and 30-day recall), and will determine how well each of these correspond to daily experiences recorded in more frequent assessments (i.e., end-of-day and 3-day patient bladder diaries). These data will help LURN investigators to determine the most appropriate reporting period for specific symptoms. This study can also help to identify causes of differences that exist between shorter and longer recall periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Diary Group | Group completed daily questionnaires for four weeks, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study |
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| Diary Start Group | Group completed bladder diaries in week 1, daily questionnaires in week 1, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study |
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| Daily Start Group | Group completed daily questionnaires in week 1, bladder diaries in week 2, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None- Observational Study | Other | None- Observational Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine ideal recall period for LUTS symptoms | The investigators will administer and analyze the correspondence between patient's average daily recall of their LUTS utilizing seven, daily questionnaires, their weekly recall of self-reported LUTS using a 7-day recall questionnaire, as well as a questionnaire assessing their monthly LUTS recall in order to determine the best recall period to utilize when administering LUTS questionnaires in clinical settings. | Through study completion - 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kevin P. Weinfurt, PhD | Duke University | Study Chair |
| Claire C. Yang, MD | University of Washington | Study Chair |
| Robert M. Merion, MD, FACS | Arbor Research Collaborative for Health - DCC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Iowa |
We do not plan to make IPD available.
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| University of Iowa | OTHER |
| University of Washington | OTHER |
| Washington University School of Medicine | OTHER |
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| Iowa City |
| Iowa |
| 52242 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University | Durham | North Carolina | 27715 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |