Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 6
- 主要终点
- Determine ideal recall period for LUTS symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older,
- •willing and able to give informed consent,
- •able to speak, read, and understand English,
- •able to reliably complete self-reported questionnaires online at specified times (i.e., may exclude those who do not keep a regular schedule of sleeping during night hours), and
- •experienced at least moderate severity and bother from at least 1 of the 7 targeted symptoms in the past 2 weeks and in the past 3 months
排除标准
- •dementia or other cognitive impairment that would interfere with study participation,
- •known pregnancy or delivery within past 6 months (women only)
- •planned change in medications to treat LUTS in the middle of the study time frame,
- •receiving active treatment for any malignancy (including maintenance medications),
- •received surgery with general or spinal/epidural anesthesia in the past 3 months or planned surgery during the study time frame
- •lower urinary tract instrumentation (e.g. self-catheterization or cystoscopy) in past 3 months or planned during the study time frame and
- •prostate biopsy in the past 3 months or planned during the study time frame
结局指标
主要结局
Determine ideal recall period for LUTS symptoms
时间窗: Through study completion - 30 days
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.
次要结局
未报告次要终点