Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study

NCT03808038 | Completed DMC

• 9 other identifiers: LURN Recall StudyU01DK097780U01DK097772U01DK097779U01DK099932U01DK100011U01DK100017U01DK097776U01DK099879
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 6

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms; Bladder Symptoms; Recall; Lower Urinary Tract Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

No Diary Group

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

Other: None- Observational Study

Diary Start Group

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

Other: None- Observational Study

Daily Start Group

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

Other: None- Observational Study

Interventions

None- Observational Study OTHER

None- Observational Study

Daily Start Group; Diary Start Group; No Diary Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arbor Research Collaborative for Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Michigan: collaborator
• Northwestern University: collaborator
• Duke University: collaborator
• University of Iowa: collaborator
• University of Washington: collaborator
• Washington University School of Medicine: collaborator

Study Sites (6)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27715, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin P. Weinfurt, PhD

  Duke University

  STUDY CHAIR

• Claire C. Yang, MD

  University of Washington

  STUDY CHAIR

• Robert M. Merion, MD, FACS

  Arbor Research Collaborative for Health - DCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 17, 2019
• Study Start: May 26, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)