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Completed
NCT04557748
LURN: Urinary Urgency Phenotyping Protocol
Conditions: Lower Urinary Tract Symptoms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 1030
Sponsor: Arbor Research Collaborative for Health
Location: Northwestern University Chicago Illinois
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* a. Clinical impression of bladder outlet obstruction (based on symptoms or urodynamics) as primary etiology of LUTS.
b. Gross hematuria/self-reported gross or visible urine in the blood. c. 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.
d. Primary complaint is pelvic pain. e. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchalgia.
f. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
g. Ongoing symptomatic urethral stricture. h. History of LUT or pelvic malignancy. i. Current chemotherapy or other cancer therapy. j. Pelvic device or implant complication (e.g., sling or mesh complications). k. In men, prostate biopsy in the previous 6 months. l. In women, current pregnancy or planned pregnancy during the follow-up period.
m. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
n. Augmentation cystoplasty or cystectomy. o. Presence of urinary tract fistula. p. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
q. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
r. Difficulty reading or communicating in English. s. No access to internet/smart phone. t. Indwelling Foley catheter/routine self-catheterization. u. In addition to the criteria listed above, pregnancy during the study will be a study end point.
Source: ClinicalTrials.gov (NCT04557748). StuddyBuddy aggregates publicly available trial information.