Many overactive bladder (OAB) trials require that participants have at least a minimum number of urgency urinary incontinence (UUI) episodes to qualify for inclusion. Even though many patients complain of urgency with no or minimal UUI, few studies have fully characterized patients, particularly over time, with urinary urgency without significant UUI. This study compared men and women with urinary urgency with and without UUI with respect to urologic pain symptoms, pelvic floor symptoms, bowel function, mental health, sleep quality and physical function.

Adult women and men seeking treatment for their lower urinary tract symptoms (LUTS) were recruited into the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) one year observational cohort study from six US tertiary care centers. Participant characteristics and clinical data were collected at study enrollment. The following patient-reported measures were completed at baseline, 3-month, and 12-month visits: the LUTS Tool, the Functional Comorbidity Index (FCI), Genitourinary Pain Index (GUPI), the Pelvic-Floor Distress Inventory (PFDI-20, for females only), the Perceived Stress Scale (PSS), the International Physical Activity Questionnaire (I-PAQ) and Patient Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal (GI) bowel incontinence, GI constipation, GI diarrhea, depression, anxiety, sleep disturbance, and physical function (mobility) measures. Responses to LUTS Tool severity items were used to identify participant symptoms, with a response of “sometimes”, “often”, or “almost always” indicating symptom endorsement for frequency, nocturia, urgency, and urinary incontinence. Participants endorsing symptoms of urgency along with frequency and/or nocturia on the LUTS Tool were included in analysis. The UUI question on LUTS Tool was used to further characterize urgency participants into those with vs. without UUI. Clinical, demographic, and patient-reported data were compared between urgency participants with vs. without UUI using two-sample independent t-tests and chi-square tests or non-parametric alternatives where appropriate. Repeated measures linear regression models were fit with the following measures as dependent variables: GUPI pain subscale, GUPI urinary symptom subscale, GUPI QOL subscale, PROMIS Depression T-score, PROMIS Anxiety T-score, PSS total score, and PFDI-20 total score (females only). In each model, urgency with vs. without UUI was included as a dependent variable along with the following covariates: age, sex, race, employment status, education, diabetes (yes vs. no), FCI total, and visit.

At study enrollment, there were 612 participants fulfilling the urgency criteria based on LUTS Tool responses (201 urgency without UUI [33%] and 411 urgency with UUI [67%]). Among the 612 urgency participants at enrollment, the average age was 59.8±13.7 years and most participants were females (57%) and white (79%, Table 1). Urgency participants with UUI were more likely to be female (70% vs. 31%, p-value < .001), and had significantly higher average GUPI total (17.6 vs. 15.4, p-value = 0.005), GUPI QOL subscale (7.9 vs. 6.5, p-value < 0.001), PFDI-20 total (95.3 vs. 70.8, p-value < 0.001), PROMIS GI Bowel incontinence (5.7 vs. 4.8, p-value < 0.001), and PSS total (13.6 vs. 11.8, p-value = 0.006) scores. Urgency participants with UUI also scored an average of 1.4-3.0 points higher on PROMIS GI Constipation (p-value = 0.006), diarrhea (p-value = 0.009), depression (p-value < 0.001), anxiety (p-value < 0.001), and sleep disturbance (p-value = 0.038) measures and 3.8 points higher on the physical function, mobility measure (p-value <0.001). While statistically significant differences on the PROMIS measures were seen, average scores were close to the population average of 50 and differences between urgency groups were smaller than 4-5 points, or half a standard deviation. After controlling for age, sex, race, employment, education, diabetes, FCI total, and visit, urgency participants with UUI (compared to without UUI) had significantly worse condition-specific QOL (GUPI QOL subscale adjusted mean estimate 1.27 points higher, 95% CI = [0.85-1.69]), and higher PROMIS Depression (mean adjusted estimate 3.16 points higher, 95% CI = [2.02-4.30]), PROMIS Anxiety (mean adjusted estimate 2.73 points higher, 95% CI = [1.55-3.93]), PSS total (mean adjusted estimate 2.02 points higher, 95% CI = [1.05-2.99]), and PFDI-20 total (mean adjusted estimate 29.96 points higher, 95% CI = [19.22-40.69]) scores.

Urgency patients with UUI were more likely to be female compared to those without UUI. This notable difference in demographics could be an indication that significant sex specific differences in etiologies for urgency exist resulting in increased rates of the UUI phenotype in female patients. Further investigation into potential concomitant obstructive or other conditions in these patients is warranted.
In both men and women, urgency patients with UUI had more pelvic floor dysfunction, more psychosocial issues (depression, anxiety, perceived stress) and worse QOL compared to urgency patients without UUI. The decreased patient QOL and higher scores for depression, anxiety, and stress is likely a function of the increased psychosocial burden that having UUI contributes to the patient rather than it being an intrinsic part of the UUI. Further study is necessary to determine the relationship between these phenotype defining symptoms and the etiology for their symptoms.

We have characterized a large cohort of women and men with urgency with vs. without UUI. Significant differences were identified in pelvic floor symptoms, bowel function, mental health, sleep quality and physical function. Further detailed studies of these co-morbidities are required to both elucidate the mechanisms underlying these urinary symptoms and improve treatment outcomes.