Clinical trial NCT03808038: Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study
Official title: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms
Bladder Symptoms
Recall
Lower Urinary Tract Dysfunction
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Michigan
name: Northwestern University
name: Duke University
name: University of Iowa
name: University of Washington
name: Washington University School of Medicine
First posted: 2019-01-17
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine ideal recall period for LUTS symptoms
timeFrame: Through study completion - 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Duke University
name: Kevin P. Weinfurt, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: Claire C. Yang, MD
role: STUDY_CHAIR
affiliation: Arbor Research Collaborative for Health - DCC
name: Robert M. Merion, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: