Status:
COMPLETED
Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study
Lead Sponsor:
Arbor Research Collaborative for Health
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Conditions:
Lower Urinary Tract Symptoms
Eligibility:
All Genders
18+ years
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 sy...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT03808038
Start Date
May 26 2017
End Date
May 31 2018
Last Update
January 17 2019
Active Locations (6)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Washington University
St Louis, Missouri, United States, 63110