Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Urinary Urgency Phenotyping Protocol

Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The purpose of this study is to define and characterize important subtypes of patients with urinary urgency to improve our understanding of the pathophysiology, risk factors, experiences, and comorbidities to lay the foundation for more effective treatment by focusing on the most bothersome and difficult to treat symptoms of urinary urgency and urgency urinary incontinence.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Women or men presenting for evaluation or treatment of urinary urgency/ UUI to one of the LURN sites. These symptoms are not required to be the primary symptom(s) of presentation, but must be bothersome to the participant.

• Age ≥ 18 years.

• The presence of any of the urinary urgency or urgency incontinence symptoms based on responses to the LUTS Tool with a 1-month recall period (Appendix A) as follows:

⁃ Answered sometimes, often, or always on either:

• During the past month, how often have you had a sudden need to rush to urinate?. Participants who answered never or rarely are not eligible since they are not deemed to have significant urinary urgency symptoms.

• How often have you had a sudden need to rush to urinate for the fear of leaking urine?

• Positive answer must also be associated with bother rating on that particular question of somewhat, quite a bit, or a great deal

• The ability to give informed consent and complete self-reported questionnaires electronically.

• Access to and willingness to utilize smart phone

Locations
United States
Iowa
University of Iowa
Iowa City
Illinois
Northwestern University
Chicago
Michigan
University of Michigan
Ann Arbor
Missouri
Washington University in St. Louis
Saint Louis
North Carolina
Duke University
Durham
Washington
University of Washington
Seattle
Time Frame
Start Date: 2021-02-17
Completion Date: 2025-10
Participants
Target number of participants: 840
Treatments
Prospective Observational Cohort Study
Men and women with lower urinary tract symptoms.
Prospective Observational Cohort Study Controls
Men and women who do not have urinary dysfunction.
Central Sensitization Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Central Sensitization Study Controls
Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Physical Activity and Sleep Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Physical Activity and Sleep Study Controls
Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Organ-Based Study
Women enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.
Organ-Based Study Controls
Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.
Qualitative Assessment of Patients with Urinary Urgency Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency who have treatment plans prescribed at the baseline visit.
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington, Northwestern University, University of Iowa, University of Michigan, Duke University
Leads: Arbor Research Collaborative for Health

This content was sourced from clinicaltrials.gov