Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study
Completed
Conditions studied: Lower Urinary Tract Symptoms
In brief
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.
Key facts
- Study ID
- NCT02485808
- Run by
- Arbor Research Collaborative for Health
- People needed
- 1879
- Starts
- 2015-04-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2019-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Gross hematuria.
- Significant neurologic disease or injury, including but not limited to: cerebral vascular accident with residual defect, Alzheimer's dementia, Parkinson's disease, traumatic brain injury, spinal cord injury, complicated spinal surgery, multiple sclerosis.
- Primary complaint is pelvic pain.
- Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia.
- Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
- Current sexually transmitted infection. (deferral; subject can enroll after negative culture)
- Ongoing symptomatic urethral stricture.
- History of lower urinary tract or pelvic malignancy.
- Current chemotherapy or other cancer therapy.
- Pelvic device or implant complication (e.g., sling or mesh complications).
- Current functioning neurostimulator.
- Botox injection to the bladder or pelvic structures within the preceding 12 months.
- In men, prostate biopsy in the previous 3 months.
- In women, pregnancy.
- History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
- Augmentation cystoplasty or cystectomy.
- Presence of urinary tract fistula.
- Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
- Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
- Difficulty reading or communicating in English.
Where it is running
- Northwestern University — Chicago, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Washington University — St Louis, Missouri, United States
- Duke University — Durham, North Carolina, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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