Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study

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.

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