NCT03808038

Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study

Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 515 (actual)
• Sponsor: Arbor Research Collaborative for Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
OTHER	None- Observational Study	None- Observational Study

Timeline

• Start date: 2017-05-26
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2019-01-17
• Last updated: 2019-01-17

Locations

6 sites across 1 country: United States