Scientists seek to decode urinary urgency mysteries
NCT ID NCT04557748
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study aims to better understand different types of urinary urgency (a sudden, strong need to urinate) in 840 adults. Researchers will look at symptoms, experiences, and other health factors to find patterns. The goal is to lay the groundwork for more personalized and effective treatments in the future.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,030 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Men and women with urinary urgency an/or urgency incontinence who are treatment-naïve patients, patients undergoing current treatment, and those who have failed therapies for lower urinary tract symptoms.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University
Durham, North Carolina, 27715, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Washington
Seattle, Washington, 98195, United States
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Washington University in St. Louis
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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