LURN: Urinary Urgency Phenotyping Protocol

Arbor Research Collaborative for Health

Status: Active, not recruiting

Conditions: Lower Urinary Tract Symptoms

Treatments: Other: Qualitative Assessment of Patients with Urinary Urgency; Other: Observational Controls; Other: Physical Activity and Sleep Tracker Controls; Other: Physical Activity and Sleep Tracker; Other: Observational; Other: Central Sensitization; Other: Organ-Based

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04557748

U01DK099879 (U.S. NIH Grant/Contract)

U01DK099932 (U.S. NIH Grant/Contract)

U01DK097772 (U.S. NIH Grant/Contract)

U01DK100011 (U.S. NIH Grant/Contract)

U01DK097780 (U.S. NIH Grant/Contract)

LURN 2

U01DK100017 (U.S. NIH Grant/Contract)

U01DK097779 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

840 participants in 9 patient groups

Prospective Observational Cohort Study

Description:

Men and women with lower urinary tract symptoms.

Treatment:

Other: Observational

Prospective Observational Cohort Study Controls

Description:

Men and women who do not have urinary dysfunction.

Treatment:

Other: Observational Controls

Central Sensitization Study

Description:

Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.

Treatment:

Other: Central Sensitization

Central Sensitization Study Controls

Description:

Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.

Treatment:

Other: Central Sensitization

Physical Activity and Sleep Study

Description:

Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.

Treatment:

Other: Physical Activity and Sleep Tracker

Physical Activity and Sleep Study Controls

Description:

Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.

Treatment:

Other: Physical Activity and Sleep Tracker Controls

Organ-Based Study

Description:

Women enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.

Treatment:

Other: Organ-Based

Organ-Based Study Controls

Description:

Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.

Treatment:

Other: Organ-Based

Qualitative Assessment of Patients with Urinary Urgency Study

Description:

Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency who have treatment plans prescribed at the baseline visit.

Treatment:

Other: Qualitative Assessment of Patients with Urinary Urgency