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

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

The purpose of this study is to advance our understanding of people who experience urinary and bladder problems. We are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. We want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, we will have a better understanding of how to improve the care and treatment for people who have urinary and bladder problems.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians.

⁃ Age ≥ 18 years.

⁃ The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period.

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

‣ Table 1: LUTS Appropriate for Study Inclusion

• Daytime frequency

• Nocturia

• Urgency

• Incontinence/leakage (various types)

• Poor or absent sensation of bladder filling

• Slow/weak stream

• Splitting or spraying

• Intermittent stream/Double voiding

• Hesitancy

• Straining

• Dribbling at the end of flow

• Paruesis (shy bladder syndrome)

• Poor or absent sensation of urethra during void

• Feeling of incomplete emptying

• Post-micturition dribble (delayed)

• Abnormal bladder or urethral sensations

Locations
United States
Iowa
University of Iowa
Iowa City
Illinois
Northwestern University
Chicago
Michigan
University of Michigan
Ann Arbor
Missouri
Washington University
Saint Louis
North Carolina
Duke University
Durham
Washington
University of Washington
Seattle
Time Frame
Start Date: 2015-04
Completion Date: 2018-05
Participants
Target number of participants: 1879
Treatments
Surgical
Men and women presenting for clinical care for whom surgical treatment of their lower urinary symptoms is planned.~There will be no interventions, as this is an observational cohort.
Medical
Men and women presenting for clinical care for whom medical treatment of their lower urinary symptoms is planned.~There will be no interventions, as this is an observational cohort.
Controls
Men and women who are not experiencing lower urinary tract symptoms.~This group will undergo MRI, pain and auditory sensitivity testing.
Neuroimaging & Sensory Testing
Subjects from the Medical and Surgical Cohorts who agree to additional testing in the form of neuroimaging (via fMRI) and multimodal sensory testing.~This group will undergo MRI, pain and auditory sensitivity testing.
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