The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is pursuing phenotyping of patients with urinary urgency and urge urinary incontinence (UUI) using distinct, but related, projects. The Urinary Urgency Phenotyping Protocol (LURN II) 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 lower urinary tract symptoms (LUTS). Standardized clinical data, self-report symptoms, 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.

To define and characterize important subtypes of patients with urinary urgency to understand the pathophysiology, risk factors, experiences, and comorbidities to lay the foundation for more effective treatment.

The aims of LURN II are:

• Identify clinically-relevant subtypes of patients with urinary urgency
• Understand the roles of diet; psychosocial factors; central sensitization; physical activity; sleep; and pelvic floor, sexual, bowel, and urethral/bladder function in urinary urgency
• Refine self-reported measurement of urinary urgency using LURN SI-10, SI-29, and other items from the LURN Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)
• Explore patient factors that have an impact on treatment adherence and efficacy
• Generate knowledge to inform the development of individualized treatments for patients with urinary urgency

The outcome measures for LURN II are:

• Change in lower urinary tract symptoms – 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
• Examine the presence of sensory hypersensitivity in urinary urgency (with or without urgency incontinence) – 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 – 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 –Urodynamic studies will be performed on urethra and bladder to assess urethral closure pressure, urethral sensation, and bladder volume

Case inclusion criteria:

• Women or men presenting for evaluation or treatment of urinary urgency/UUI to one of the LURN sites (Note: 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
• The ability to give informed consent and complete self-reported questionnaires electronically
• Access to and willingness to utilize a smart phone

Case exclusion criteria:

• Clinical impression of bladder outlet obstruction as primary etiology of LUTS
• Current gross hematuria/self-reported gross or visible blood in the urine
• Significant neurologic disease or injury
• Primary complaint is pelvic pain
• Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia
• Pelvic or endoscopic genitourinary surgery within the preceding 6 months
• Ongoing symptomatic urethral stricture
• History of LUT or pelvic malignancy
• Current chemotherapy or other cancer therapy
• Pelvic device or implant complications
• In men, prostate biopsy in the previous 6 months
• In women, current pregnancy or planned pregnancy during the follow-up period
• 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
• Inability to relay valid information, actively participate in the study, or provide informed consent
• Difficulty reading or communicating in English
• No access to internet/smart phone
• Indwelling Foley catheter/routine self-catheterization

Case deferral criteria:

• Positive urine culture/self-reported urinary tract infection or bladder infection – Patients need to be treated and have a subsequent negative result before eligible
• Current sexually-transmitted infection – Patients need to be treated and have a subsequent test before eligible
• Recent (within 6 months) pregnancy
• Urological surgical procedure within the last 6 months

Control Selection

Controls will be individuals 18 years and older without urinary urgency or other LUTS. Controls should have no urinary frequency (<8 voids/day), nocturia (0-1 void/night), urgency, or any urinary incontinence, including urgency incontinence, as assessed by the LUTS Tool – 1-month version. Controls will be age-matched to the urinary urgency cohort using binning to ensure similar distributions of age between the two cohorts.

Control exclusion criteria:

• See exclusion criteria for the participants with urinary urgency
• A clinical diagnosis of overactive bladder (OAB)
• Currently using medications specifically for LUTS
• History of surgical procedure to treat LUTD
• A post-void residual of 150cc or more/self-reported difficulty emptying the bladder

Control deferral criteria:

• Positive urine culture/self-reported urinary tract infection or bladder infection – Participants need to be treated and have a subsequent negative result before eligible
• Recent (within 6 months) pregnancy

The study is ongoing; outcomes are not yet available.