Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Other: None- Observational Study

• Registration Number: NCT03808038
• Lead Sponsor: Arbor Research Collaborative for Health

Brief 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.

Study Timeline

• Study Start: 2017-05-26
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-16
• Last Update Submitted: 2019-01-16
• Study First Posted: 2019-01-17
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

1. age 18 or older,
2. willing and able to give informed consent,
3. able to speak, read, and understand English,
4. 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
5. 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

Exclusion Criteria

1. dementia or other cognitive impairment that would interfere with study participation,
2. known pregnancy or delivery within past 6 months (women only)
3. planned change in medications to treat LUTS in the middle of the study time frame,
4. receiving active treatment for any malignancy (including maintenance medications),
5. received surgery with general or spinal/epidural anesthesia in the past 3 months or planned surgery during the study time frame
6. lower urinary tract instrumentation (e.g. self-catheterization or cystoscopy) in past 3 months or planned during the study time frame and
7. prostate biopsy in the past 3 months or planned during the study time frame

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Diary Group	None- Observational Study	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
Daily Start Group	None- Observational Study	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
Diary Start Group	None- Observational Study	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

Primary Outcome Measures

Name	Time	Method
Determine ideal recall period for LUTS symptoms	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.

Trial Locations

Locations (6)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Washington; 🇺🇸 Seattle, Washington, United States