LURN: Urinary Urgency Phenotyping Protocol

Active, not recruiting

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Other: Physical Activity and Sleep Tracker; Other: Organ-Based; Other: Central Sensitization; Other: Physical Activity and Sleep Tracker Controls; Other: Qualitative Assessment of Patients with Urinary Urgency; Other: Observational; Other: Observational Controls

• Registration Number: NCT04557748
• Lead Sponsor: Arbor Research Collaborative for Health

Brief 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.

Detailed Description

LURN is pursuing deeper phenotyping of patients with urinary urgency and UUI using distinct, but related, projects. The Urinary Urgency Phenotyping Protocol is the overarching effort, and will comprise five integrated projects. Project A, the Observational Cohort, will be a large-scale accrual of male and female participants with urinary urgency and age-matched controls without any LUTS. Standardized clinical data, comprising information typically gathered at the patient clinic encounter, self-report symptom, urologic and non-urologic data, and biosamples will be collected. Using this group of participants, subsets will be identified for more focused and in-depth studies of urinary urgency and urgency incontinence. This more focused effort will be conducted as Project B: the Central Sensitization Study; Project C: the Physical Activity and Sleep Study; Project D: the Organ-Based Study; and Project E: the Qualitative Assessment of Patients with Urinary Urgency Study.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Study Start: 2021-02-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-06
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 840

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physical Activity and Sleep Study	Physical Activity and Sleep Tracker	Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Organ-Based Study Controls	Organ-Based	Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.
Central Sensitization Study	Central Sensitization	Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Central Sensitization Study Controls	Central Sensitization	Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Physical Activity and Sleep Study Controls	Physical Activity and Sleep Tracker Controls	Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Qualitative Assessment of Patients with Urinary Urgency Study	Qualitative Assessment of Patients with Urinary Urgency	Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency who have treatment plans prescribed at the baseline visit.
Prospective Observational Cohort Study	Observational	Men and women with lower urinary tract symptoms.
Prospective Observational Cohort Study Controls	Observational Controls	Men and women who do not have urinary dysfunction.
Organ-Based Study	Organ-Based	Women enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.

Primary Outcome Measures

Name	Time	Method
Change in lower urinary tract symptoms	Baseline, 3 months, 6 month, 9 months,12 months	Participants will be classified as treatment responders if they achieve at least a 10-point reduction from baseline on the OAB-q and/or respond "much better" or "very much better" on the PGI-I

Secondary Outcome Measures

Name	Time	Method
Examine the presence of sensory hypersensitivity in urinary urgency (with or without urgency incontinence)	Baseline	Participants will rate pain intensity and unpleasantness on 0-100 numeric rating scales when ascending pressure is applied to the suprapubic area using a hand-held algometer
Assess the relationship between physical activity and sleep quality in men and women with bothersome urinary urgency	Baseline and 3 months	Participants will wear a mobile tracker for two weeks at baseline and at 3 months to capture the average number of steps per 24 hours and number of nocturnal voids
The role of the urethra and its interaction with the bladder in LUT function and dysfunction	Baseline	Urodynamic studies will be performed on urethra and bladder to assess urethral closure pressure, urethral sensation, and bladder volume

Trial Locations

Locations (6)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Washington; 🇺🇸 Seattle, Washington, United States