Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808038
• Other study ID #: LURN Recall Study
• Secondary ID: U01DK097780U01DK
• Status: Completed
• Start date: May 26, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: January 2019
• Source: Arbor Research Collaborative for Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Other:
• None- Observational Study
None- Observational Study

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health	Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Iowa, University of Michigan, University of Washington, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine ideal recall period for LUTS symptoms	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.	Through study completion - 30 days