Naturalistic Bladder Filling Reveals Subtypes in Overactive Bladder Syndrome That Differentially Engages Urinary Urgency-Related Brain Circuits: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

PURPOSE: Overactive bladder (OAB) may be attributed to dysfunction in supraspinal brain circuits. Overactive bladder participants enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network) study reported sensations of urinary urgency during a bladder-filling paradigm while undergoing brain functional MRI to map supraspinal dysfunction. MATERIALS AND METHODS: OAB participants and controls (CONs) completed 2 resting-state functional MRI scans following consumption of 350 mL water. Scans were conducted at fuller and emptier bladder states, interleaved with voiding. Urgency ratings (0-10) were assessed. Patterns of urgency during bladder filling were investigated using latent class trajectory models. Clusters of participants encompassing each pattern (ie, subtype) were derived from aggregated groups of OAB and CON independent of diagnosis. RESULTS: Two distinct patterns of urgency trajectories were revealed: first subtype with OAB and CON who were unresponsive to bladder filling (OAB-1 and CON-1) and second highly responsive subtype predominantly containing OAB (OAB-2). OAB-2 participants scored significantly higher on urinary symptoms but not pain or psychosocial measures. Neuroimaging analyses showed change in urgency due to both bladder filling and voided volume related to multiple loci of brain network connectivity in OAB-2, and in some cases, different than OAB-1 and/or CON-1. Sensorimotor to dorsomedial/dorsolateral prefrontal connectivity mediated the relationship between stimulus (voided volume) and percept (urgency) in OAB-2. CONCLUSIONS: Our results reveal different OAB subtypes with latent class trajectory models of urgency ratings during natural bladder filling. Functional MRI revealed differences in pathophysiology between subtypes, namely sensorimotor-prefrontal connectivity is a key locus in OAB patients with higher urinary symptoms.

Structural Changes in Brain White Matter Tracts Associated With Overactive Bladder Revealed by Diffusion Tensor Magnetic Resonance Imaging: Findings From a Symptoms of Lower Urinary Tract Dysfunction Research Network Cross-Sectional Case-Control Study.

PURPOSE: Our objective was to investigate structural changes in brain white matter tracts using diffusion tensor imaging (DTI) in patients with overactive bladder (OAB). MATERIALS AND METHODS: Treatment-seeking OAB patients and matched controls enrolled in the cross-sectional case-control LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network) Neuroimaging Study received a brain DTI scan. Microstructural integrity of brain white matter was assessed using fractional anisotropy (FA) and mean diffusivity. OAB and urgency urinary incontinence (UUI) symptoms were assessed using the OAB Questionnaire Short-Form and International Consultation on Incontinence Questionnaire-Urinary Incontinence. The Lower Urinary Tract Symptoms Tool UUI questions and responses were correlated with FA values. RESULTS: Among 221 participants with evaluable DTI data, 146 had OAB (66 urinary urgency-only without UUI, 80 with UUI); 75 were controls. Compared with controls, participants with OAB showed decreased FA and increased mean diffusivity, representing greater microstructural abnormalities of brain white matter tracts among OAB participants. These abnormalities occurred in the corpus callosum, bilateral anterior thalamic radiation and superior longitudinal fasciculus tracts, and bilateral insula and parahippocampal region. Among participants with OAB, higher OAB Questionnaire Short-Form scores were associated with decreased FA in the left inferior fronto-occipital fasciculus, P < .0001. DTI differences between OAB and controls were driven by the urinary urgency-only (OAB-dry) but not the UUI (OAB-wet) subgroup. CONCLUSIONS: Abnormalities in microstructural integrity in specific brain white matter tracts were more frequent in OAB patients. More severe OAB symptoms were correlated with greater degree of microstructural abnormalities in brain white matter tracts in patients with OAB.

Using structured problem solving to promote fluid consumption in the prevention of urinary stones with hydration (PUSH) trial.

BACKGROUND: Structured Problem Solving (SPS) is a patient-centered approach to promoting behavior change that relies on productive collaboration between coaches and participants and reinforces participant autonomy. We aimed to describe the design, implementation, and assessment of SPS in the multicenter Prevention of Urinary Stones with Hydration (PUSH) randomized trial. METHODS: In the PUSH trial, individuals with a history of urinary stone disease and low urine output were randomized to control versus a multicomponent intervention including SPS that was designed to promote fluid consumption and thereby prevent recurrent stones. We provide details specifically about training and fidelity assessment of the SPS coaches. We report on implementation experiences related to SPS during the initial conduct of the trial. RESULTS: With training and fidelity assessment, coaches in the PUSH trial applied SPS to help participants overcome barriers to fluid consumption. In some cases, coaches faced implementation barriers such as variable participant engagement that required tailoring their work with specific participants. The coaches also faced challenges including balancing rapport with problem solving, and role clarity for the coaches. CONCLUSIONS: We adapted SPS to the setting of kidney stone prevention and overcame challenges in implementation, such as variable patient engagement. Tools from the PUSH trial may be useful to apply to other health behavior change settings in nephrology and other areas of clinical care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03244189.

Phenotyping of Urinary Urgency Patients Without Urgency Incontinence, and Their Comparison to Urgency Incontinence Patients: Findings From the LURN Study.

PURPOSE: We characterize patients with urinary urgency with vs without urgency urinary incontinence who presented to clinics actively seeking treatment for their symptoms. MATERIALS AND METHODS: Participants who enrolled in the Symptoms of Lower Urinary Tract Dysfunction Research Network were categorized into urinary urgency with vs without urgency urinary incontinence. Participants were followed for 1 year; their urinary symptoms, urological pain, psychosocial factors, bowel function, sleep disturbance, physical activity levels, physical function, and quality of life were compared. Mixed effects linear regression models were used to examine the relationships between urgency urinary incontinence and these factors. RESULTS: Among 683 participants with urinary urgency at baseline, two-thirds (n=453) also had urgency urinary incontinence; one-third (n=230) had urinary urgency-only without urgency urinary incontinence. No differences were detected in urological pain between urinary urgency-only and urgency urinary incontinence. Those with urgency urinary incontinence had more severe urgency and frequency symptoms, higher depression, anxiety, perceived stress scores, more severe bowel dysfunction and sleep disturbance, lower physical activity levels, lower physical function, and worse quality of life than those with urinary urgency-only. Among those with urinary urgency-only at baseline, 40% continued to have urinary urgency-only, 15% progressed to urgency urinary incontinence, and 45% had no urgency at 12 months. Fifty-eight percent with urgency urinary incontinence at baseline continued to report urgency urinary incontinence at 12 months, while 15% improved to urinary urgency-only, and 27% had no urgency. CONCLUSIONS: Patients with urgency urinary incontinence have severe storage symptoms, more psychosocial symptoms, poorer physical functioning, and worse quality of life. Our data suggested urgency urinary incontinence may be a more severe manifestation of urinary urgency, rather than urinary urgency and urgency urinary incontinence being distinct entities.

Risk Factors for Increased Stent-associated Symptoms Following Ureteroscopy for Urinary Stones: Results From STENTS.

PURPOSE: The STudy to Enhance uNderstanding of sTent-associated Symptoms sought to identify risk factors for pain and urinary symptoms, as well as how these symptoms interfere with daily activities after ureteroscopy for stone treatment. MATERIALS AND METHODS: This prospective observational cohort study enrolled patients aged ≥12 years undergoing ureteroscopy with ureteral stent for stone treatment at 4 clinical centers. Participants reported symptoms at baseline; on postoperative days 1, 3, 5; at stent removal; and day 30 post-stent removal. Outcomes of pain intensity, pain interference, urinary symptoms, and bother were captured with multiple instruments. Multivariable analyses using mixed-effects linear regression models were identified characteristics associated with increased stent-associated symptoms. RESULTS: A total of 424 participants were enrolled. Mean age was 49 years (SD 17); 47% were female. Participants experienced a marked increase in stent-associated symptoms on postoperative day 1. While pain intensity decreased ∼50% from postoperative day 1 to postoperative day 5, interference due to pain remained persistently elevated. In multivariable analysis, older age was associated with lower pain intensity (P = .004). Having chronic pain conditions (P < .001), prior severe stent pain (P = .021), and depressive symptoms at baseline (P < .001) were each associated with higher pain intensity. Neither sex, stone location, ureteral access sheath use, nor stent characteristics were drivers of stent-associated symptoms. CONCLUSIONS: In this multicenter cohort, interference persisted even as pain intensity decreased. Patient factors (eg, age, depression) rather than surgical factors were associated with symptom intensity. These findings provide a foundation for patient-centered care and highlight potential targets for efforts to mitigate the burden of stent-associated symptoms.

Treatment patterns in women with urinary urgency and/or urgency urinary incontinence in the symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study.

BACKGROUND: Limited epidemiological data exist describing how patients engage with various treatments for overactive bladder (OAB). To improve care for patients with OAB, it is essential to gain a better understanding of how patients interface with OAB treatments longitudinally, that is, how often patients change treatments and the pattern of this treatment change in terms of escalation and de-escalation. OBJECTIVES: To describe treatment patterns for women with bothersome urinary urgency (UU) and/or urgency urinary incontinence (UUI) presenting to specialty care over 1 year. STUDY DESIGN: The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) study enrolled adult women with bothersome UU and/or UUI seeking care for lower urinary tract symptoms (LUTS) between January 2015 and September 2016. An ordinal logistic regression model was fitted to describe the probabilities of escalating or de-escalating level of treatment during 1-year follow-up. RESULTS: Among 349 women, 281 reported UUI and 68 reported UU at baseline. At the end of 1 year of treatment by a urologist or urogynecologist, the highest level of treatment received by participants was 5% expectant management, 36% behavioral treatments (BT), 26% physical therapy (PT), 26% OAB medications, 1% percutaneous tibial nerve stimulation, 3% intradetrusor onabotulinum toxin A injection, and 3% sacral neuromodulation. Participants using BT or PT at baseline were more likely to be de-escalated to no treatment than participants on OAB medications at baseline, who tended to stay on medications. Predictors of the highest level of treatment included starting level of treatment, hypertension, UUI severity, stress urinary incontinence, and anticholinergic burden score. CONCLUSIONS: Treatment patterns for UU and UUI are diverse. Even for patients with significant bother from OAB presenting to specialty clinics, further treatment often only involves conservative or medical therapies. This study highlights the need for improved treatment algorithms to escalate patients with persistent symptoms, or to adjust care in those who have been unsuccessfully treated.

Total fluid intake, caffeine, and other bladder irritant avoidance among adults having urinary urgency with and without urgency incontinence: The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

INTRODUCTION: Caffeine has long been vilified as a cause for urinary urgency incontinence (UUI) along with other potential bladder irritants such as carbonation, alcohol, and acidic juices. The objective of this study was to assess the fluid intake behavior of people with urgency, UUI, and those with lower urinary tract symptoms (LUTS) without UUI or urgency to assess if they avoided certain potential bladder irritants or had different fluid intake. We hypothesized that patients with UUI would avoid caffeine as a self-management method more so than these other two groups. METHODS: Treatment-seeking men and women with LUTS in the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Observational Cohort study completed a baseline 3-day voiding and intake diary. "Complete" diaries had 3 days of data and no missing intake or voided volumes. Beverages with any caffeine, alcohol, carbonation, or acidic juice were identified and the total volume was recorded as well as the type of beverage containing caffeine to calculate the daily caffeine dose. RESULTS: Four hundred and ninety-one participants (277 men and 214 women) with a median age of 63 had complete diaries. Urinary urgency was more prevalent in women than men (79% vs. 55%, p < 0.0001) as was UUI (84% vs. 47%, p < 0.0001). Total fluid intake over 3 days was lower among the urgency group versus the nonurgency group (median [interquartile range] 5.2 [4.0-6.8] L vs. 5.7 [4.3-7.0] L, p = 0.028) and the UUI group compared to the urgency without incontinence group were less likely to consume alcohol (26% vs. 37%, p = 0.04). After adjusting for sex, BMI, age, and total intake volume, UUI participants had 54% lower odds of consuming any caffeine (odds ratio = 0.46, 95% confidence interval = 0.22-0.96, p = 0.04) than those without incontinence, but among those that did consume caffeine, no difference in the volume of caffeinated beverages or milligrams of caffeine consumed was detected between those with UUI and those with urgency without incontinence. No difference in carbonation or acidic juice intake was detected between groups. CONCLUSIONS: Individuals with urgency consume a lower volume of fluid than those without urgency. UUI participants more often abstain from caffeine, but among those that consume caffeine, the dose is similar to those without UUI. One explanation for these results is that only a subset of individuals with urgency or UUI are caffeine sensitive.

Development and validation of models predicting treatment patterns in women with urinary urgency and/or urgency incontinence: A Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study.

PURPOSE: To develop a tool to predict a woman's treatment pattern for bothersome urinary urgency (UU) and/or UU incontinence over 1 year after presenting for care at urology or urogynecology clinics. METHODS: The Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study enrolled adult women with bothersome UU and/or UU incontinence using the lower urinary tract symptoms (LUTS) Tool who were seeking care for LUTS. Treatments for UU and/or urgency incontinence were ordered from least to most invasive. Ordinal logistic and Cox proportional hazard regression models were fit to predict the most invasive level of treatment during follow-up and overactive bladder (OAB) medication discontinuation, respectively. Binary logistic regression was performed to predict sling treatment during the study follow-up. Clinical tools were then created using the models listed above to predict treatment pattern over 12 months. RESULTS: Among 349 women, 281 reported UU incontinence, and 68 reported UU at baseline. The highest level of treatment during the study was as follows: 20% no treatment, 24% behavioral treatments, 23% physical therapy, 26% OAB medication, 1% percutaneous tibial nerve stimulation, 3% onabotulinumtoxin A, and 3% sacral neuromodulation. Slings were placed in 10% (n = 36) of participants before baseline and in 11% (n = 40) during study follow-up. Baseline factors associated with predicting the most invasive level of treatment included baseline level of treatment, hypertension, UU incontinence severity, stress urinary incontinence (SUI) severity, and anticholinergic burden score. Less severe baseline depression and less severe UU incontinence were associated with OAB medication discontinuation. UU and SUI severity were associated with sling placement during the study period. Three tools are available to predict: (1) highest level of treatment; (2) OAB medication discontinuation; and (3) sling placement. CONCLUSIONS: OAB treatment prediction tools developed in this study can help providers individualize treatment plans and identify not only patients at risk for treatment discontinuation but also patients who may not be escalated to potentially beneficial OAB treatments, with the goal to improve clinical outcomes for patients suffering from this chronic and often debilitating condition.

Experimental Pain and Auditory Sensitivity in Overactive Bladder Syndrome: A Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Study.

PURPOSE: The objective of this study was to investigate the presence of nonbladder sensory abnormalities in participants with overactive bladder syndrome (OAB). MATERIALS AND METHODS: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) study participants with OAB symptoms and controls were recruited from 6 U.S. tertiary referral centers. Quantitative sensory testing (QST) was performed to determine pressure pain sensitivity at the thumbnail bed and auditory sensitivity. Fixed and mixed effect multivariable linear regressions and Weibull models were used to compare QST responses between groups. Pearson correlations were used to assess the relationship between QST measures. Associations between QST and self-reported symptoms were explored with linear regression. RESULTS: A total of 297 participants were analyzed (191 OAB, 106 controls; 76% white, 51% male). OAB cases were older than controls (57.4 vs 52.2 years, p=0.015). No significant differences in experimental thumbnail (nonbladder) pain or auditory sensitivity were detected between OAB cases and controls. Correlations between pressure and auditory derived metrics were weak to moderate overall for both groups, with some significantly stronger correlations for cases. Exploratory analyses indicated increased pressure pain and auditory sensitivity were modestly associated with greater self-reported bladder pain and pain interference with physical function. CONCLUSIONS: As a group, no significant differences between OAB cases and controls were observed in experimental nonbladder pain or auditory sensitivity during QST. Associations between QST outcomes and clinical pain raise the possibility of centrally mediated sensory amplification in some individuals with OAB.

Impact of Sleep Disturbance, Physical Function, Depression and Anxiety on Male Lower Urinary Tract Symptoms: Results from the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

PURPOSE: The impact of nonurological factors on male lower urinary tract symptoms (LUTS) remains unclear. We investigated cross-sectional and longitudinal associations among anxiety, depression, physical function, sleep quality and urinary symptom subdomains. MATERIALS AND METHODS: Data from 518 men in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network) study were analyzed to identify associations between Patient-Reported Outcomes Measurement Information System® (PROMIS®) depression, anxiety, sleep disturbance and physical function measures and LUTS subdomains, as derived from the American Urological Association Symptom Index and LUTS Tool. Multivariable linear regression was used to assess the relationships between PROMIS measures and LUTS subdomains at baseline and at 3- and 12-month followup. RESULTS: Baseline depression and anxiety were associated with urinary incontinence (p <0.001), voiding symptoms (p <0.001) and quality of life (p=0.002), whereas baseline sleep disturbance was associated with voiding and storage symptoms and quality of life (p <0.001 for all). Urinary symptom severity improved in all subdomains at 3 and 12 months. Similar associations between PROMIS measures and LUTS subdomains were observed at all time points, but baseline depression, anxiety, sleep disturbance and physical function measures were not associated with longitudinal trajectories of LUTS. CONCLUSIONS: Urinary symptom subdomains are independently associated with modifiable clinical variables including sleep quality and depression at all time points, but these variables do not predict the degree of improvement in LUTS following urological evaluation and treatment over the medium term. Bidirectional assessment and randomized experiments may improve our understanding of these relationships.

Comparing clinical bladder diaries and recalled patient reports for measuring lower urinary tract symptoms in the symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

PURPOSE: Bladder diaries are a key source of information about lower urinary tract symptoms (LUTS); however, many patients do not complete them as instructed. Questionnaire-based patient-reported outcome measures (PROMs) are another option for reporting LUTS but may have recall bias. We assessed the strength of the associations between PROMs and a 3-day bladder diary. MATERIALS AND METHODS: Symptomatic adults from 6 tertiary care sites completed a 3-day paper bladder diary and 3-, 7-, and 30-day electronic PROMs. We assessed the linear associations between mapped pairs of diary variables and responses to PROM items using biserial and polyserial correlation coefficients with 95% confidence intervals. RESULTS: Of 290 enrolled participants, 175 (60%) completed the bladder diary as instructed and at least one corresponding PROM. Linear associations were strongest between the diary and 3-day recall of daytime frequency (r = 0.75) and nighttime frequency (r = 0.69), followed by voids with urgency sensations (r = 0.62), and an item reporting any incontinence (r = 0.56). Linear associations between bladder diary and specific incontinence variables (e.g., stress, urgency) were low to negligible (ranging from r = 0.16-0.39). Linear associations were consistent across the 3-, 7-, and 30-day recall periods. CONCLUSIONS: Missing and unusable bladder diary data were common, highlighting the patient burden associated with this method of data collection. A questionnaire-based PROM is a reasonable alternative to a diary for reporting voiding frequency and may offer an easier option for reporting some symptoms.

Quality of life impact and recovery after ureteroscopy and stent insertion: insights from daily surveys in STENTS.

BACKGROUND: Our objective was to describe day-to-day evolution and variations in patient-reported stent-associated symptoms (SAS) in the STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS), a prospective multicenter observational cohort study, using multiple instruments with conceptual overlap in various domains. METHODS: In a nested cohort of the STENTS study, the initial 40 participants having unilateral ureteroscopy (URS) and stent placement underwent daily assessment of self-reported measures using the Brief Pain Inventory short form, Patient-Reported Outcome Measurement Information System measures for pain severity and pain interference, the Urinary Score of the Ureteral Stent Symptom Questionnaire, and Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index. Pain intensity, pain interference, urinary symptoms, and bother were obtained preoperatively, daily until stent removal, and at postoperative day (POD) 30. RESULTS: The median age was 44 years (IQR 29,58), and 53% were female. The size of the dominant stone was 7.5 mm (IQR 5,11), and 50% were located in the kidney. There was consistency among instruments assessing similar concepts. Pain intensity and urinary symptoms increased from baseline to POD 1 with apparent peaks in the first 2 days, remained elevated with stent in situ, and varied widely among individuals. Interference due to pain, and bother due to urinary symptoms, likewise demonstrated high individual variability. CONCLUSIONS: This first study investigating daily SAS allows for a more in-depth look at the lived experience after URS and the impact on quality of life. Different instruments measuring pain intensity, pain interference, and urinary symptoms produced consistent assessments of patients' experiences. The overall daily stability of pain and urinary symptoms after URS was also marked by high patient-level variation, suggesting an opportunity to identify characteristics associated with severe SAS after URS.

Prevalence of Urinary Incontinence among a Nationally Representative Sample of Women, 2005-2016: Findings from the Urologic Diseases in America Project.

PURPOSE: Urinary incontinence is frequently underreported and underdiagnosed in the clinical setting. We analyzed 12 years of data from a large, nationally representative sample of women in the United States to assess the prevalence, severity, and daily impact of urinary incontinence and its subtypes at the population level. MATERIALS AND METHODS: We analyzed data from 15,003 women aged ≥20 years who participated in the 2005-2016 National Health and Nutrition Examination Survey. We estimated the prevalence of urinary incontinence in the prior year, overall and by subtype (stress, urgency or mixed). Among women with urinary incontinence, we additionally assessed symptom severity using the validated 4-level Incontinence Severity Index, as well as impact on daily activities. RESULTS: The 2005-2016 prevalence of any urinary incontinence was 53%; 16% of women had mixed urinary incontinence, 26% had stress only and 10% had urgency only. While urgency urinary incontinence and mixed urinary incontinence were highest among women aged ≥60 years, stress urinary incontinence was highest among women aged 40-59 years. NonHispanic Black women had higher prevalence of urgency urinary incontinence and lower prevalence of stress urinary incontinence compared to other racial/ethnic groups. Of women with urinary incontinence, 30% reported moderate or severe symptoms, which were more common among older than younger women. In addition, 24% of women with urinary incontinence reported that the condition affected their daily activities. CONCLUSIONS: Our study demonstrates a high prevalence of urinary incontinence among a nationally representative population of women in the United States, with many reporting that urinary incontinence affected their daily activities. Age and racial/ethnic trends varied by urinary incontinence subtype.

Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.

RATIONALE & OBJECTIVE: Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake. STUDY DESIGN: We describe the rationale and design of the Prevention of Urinary Stones With Hydration (PUSH) Study, a randomized trial of a multicomponent behavioral intervention program to increase and maintain high fluid intake. Participants are randomly assigned (1:1 ratio) to the intervention or control arm. The target sample size is 1,642 participants. SETTING & PARTICIPANTS: Adults and adolescents 12 years and older with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of urinary stone disease and comorbid conditions precluding increased fluid intake. INTERVENTIONS: All participants receive usual care and a smart water bottle with smartphone application. Participants in the intervention arm receive a fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions. Control arm participants receive guideline-based fluid instructions. OUTCOMES: The primary end point is recurrence of a symptomatic stone during 24 months of follow-up. Secondary end points include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms. LIMITATIONS: Periodic 24-hour urine volumes may not fully reflect daily behavior. CONCLUSIONS: With its highly novel features, the PUSH Study will address an important health care problem. FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT03244189.

Trends in Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia, 2004 to 2013: the Urologic Diseases in America Project.

PURPOSE: Our current understanding of recent trends in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia is incomplete, particularly in younger men. The 2018 Urologic Diseases in America Project attempted to fill this gap by analyzing multiple large administrative claims databases which include men of all ages and permit longitudinal followup. To our knowledge we report these findings for the first time in the scientific literature. MATERIALS AND METHODS: The 2 data sources used in this study included the de-identified Optum® Clinformatics® Data Mart database for men 40 to 64 years old and the Medicare 5% Sample for men 65 years old or older. To assess trends in lower urinary tract symptoms/benign prostatic hyperplasia related medication prescriptions and surgical procedures from 2004 to 2013 we created annual cross-sectional cohorts and a longitudinal cohort of patients with incident lower urinary tract symptoms/benign prostatic hyperplasia and 5 years of followup. RESULTS: The use of medications related to lower urinary tract symptoms/benign prostatic hyperplasia increased with age, particularly among men 40 to 60 years old. While medication use increased with time, surgical procedures decreased. Increasing age correlated with a higher rate of surgical procedures in the longitudinal cohort. Younger men were more likely to elect treatments of lower urinary tract symptoms/benign prostatic hyperplasia which reportedly optimize sexual function. CONCLUSIONS: Medication use increased and surgery decreased during the study period. Treatment approaches to lower urinary tract symptoms/benign prostatic hyperplasia varied greatly by patient age. While the minority of men in the fifth and sixth decades of life required treatment, a sharp increase in treatment use was seen between these decades. Younger men were more likely to elect less invasive surgical options. Future studies of lower urinary tract symptoms/benign prostatic hyperplasia should focus on age specific treatment selection.

National Trends in the Surgical Management of Urinary Incontinence among Insured Women, 2004 to 2013: The Urologic Diseases in America Project.

PURPOSE: The objective of this study was to examine national trends in the surgical management of urinary incontinence in women in the United States from 2004 to 2013. MATERIALS AND METHODS: We analyzed the CDM (Optum® de-identified Clinformatics® Data Mart) for women 18 to 64 years old and the CMS (Centers for Medicare and Medicaid Services) Medicare 5% Sample for women 65 years old or older. We created annual cross-sectional cohorts and assessed trends in the annual prevalence of urinary incontinence related surgical procedures overall and by age, race/ethnicity and geographic region. RESULTS: We observed a decline in the percent of women with urinary incontinence who underwent surgical treatment according to the CMS (from 4.7% in 2004 to 2.7% in 2013) and the CDM (from 12.5% in 2004 to 9.1% in 2013). This trend persisted independently of age, race/ethnicity and geographic region. Slings were the most common procedure but started to decline in 2011, ultimately decreasing by about 50% during the study period. Compared to other groups the prevalence of urinary incontinence related surgical procedures, including slings, was highest among women 35 to 54 years old and White women, and lowest among women residing in the Northeast. These sociodemographic patterns persisted with time. During the study period injection procedures remained stable, sacral neuromodulation increased slightly but remained uncommon and suspension decreased to nearly 0% of all anti-incontinence procedures. CONCLUSIONS: Surgical management of female urinary incontinence experienced several shifts from 2004 to 2013, including a decline in sling procedures. Age, racial/ethnic and regional differences in treatment persisted with time. Improved understanding of the drivers of these trends may help direct future development of treatments of pelvic floor disorders.

A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10.

PURPOSE: Lower urinary tract symptoms are common in men and women. Members of the LURN (Lower Urinary Tract Dysfunction Research Network) sought to create a brief, clinically relevant tool to improve existing measurements of lower urinary tract symptoms in men and women. MATERIALS AND METHODS: Using a modified Delphi methodology during an expert consensus meeting we reduced the LURN CASUS (Comprehensive Assessment of Self-Reported Urinary Symptoms) questionnaire to a brief set of clinically relevant items measuring lower urinary tract symptoms. The sum score of these items was evaluated by comparing it to the AUA SI (American Urological Association Symptom Index), the UDI-6 (Urinary Distress Inventory Short Form) in women only and the CASUS lower urinary tract symptoms screening questions using the Pearson correlation, regression analysis and ROC curves. RESULTS: The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms (score range 0 to 38). The correlation between LURN SI-10 and AUA SI scores was 0.77 in men and 0.70 in women. The UDI-6 and the LURN SI-10 correlated highly in women (r=0.76). The LURN SI-10 showed good accuracy to predict moderate and severe lower urinary tract symptoms as defined by the AUA SI (ROC AUC range 0.82-0.90). Similar accuracy was shown in predicting different levels of symptom status using the UDI-6 (AUC range 0.84-0.86). CONCLUSIONS: The LURN SI-10 correlates well with the AUA SI and the UDI-6. It includes items related to a broader spectrum of lower urinary tract symptoms, particularly incontinence, bladder pain and post-micturition symptoms, and it applies to men and women.

Prevalence, subtypes, and correlates of nocturia in the symptoms of Lower Urinary Tract Dysfunction Research Network cohort.

AIMS: We determined the prevalence, severity, and correlates of nocturia in a large clinical cohort of patients. METHODS: Patients presenting with lower urinary tract symptoms (LUTS) completed 3-day bladder diaries. Nocturia was quantified based on the mean number of nighttime voids documented over the 3 days. Nocturia subtypes (global polyuria, nocturnal polyuria [NP], reduced global bladder capacity, and reduced nocturnal bladder capacity) were assessed. Bother due to nocturia was measured by the LUTS Tool. Sleep quality was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Scale. Multivariable multinomial regression was used to explore patient characteristics associated with nocturia. RESULTS: In 502 participants with analyzable diaries (285 men and 217 women), the mean number of nocturia episodes over 3 days was 0 in 103 (20.5%), >0 to <1 in 151 (20.1%), 1 to <2 in 165 (32.9%), and ≥2 in 83 (16.5%). Sixty-seven percent of the participants with nocturia ≥1 reported significant bother from their nocturia. NP was the most common nocturia subtype and was present in 17% of those with nocturia = 0, 40% of those with nocturia >0 to <1, 65% of those with nocturia 1 to <2%, and 77% with nocturia 2+. Higher degrees of nocturia were associated with male sex, greater sleep disturbance, and a higher likelihood of exhibiting multiple nocturia subtypes. CONCLUSIONS: Nocturia ≥1 occurred in 49% of LUTS patients and caused significant bother in the majority of them. The most common subtype was NP, but a substantial proportion of patients exhibited additional characteristics.

Patient demographic and psychosocial characteristics associated with 30-day recall of self-reported lower urinary tract symptoms.

AIMS: Measurement of self-reported lower urinary tract symptoms (LUTS) typically uses a recall period, for example, "In the past 30 days…." Compared to averaged daily reports, 30-day recall is generally unbiased, but recall bias varies by item. We examined the associations between personal characteristics (eg, age, symptom bother) and 30-day recall of LUTS using items from the Symptoms of Lower Urinary Tract Dysfunction Research Network Comprehensive Assessment of Self-reported Urinary Symptoms questionnaire. METHODS: Participants (127 women and 127 men) were recruited from 6 US tertiary care sites. They completed daily assessments for 30 days and a 30-day recall assessment at the end of the study month. For each of the 18 tested items, representing 10 LUTS, the average of the participant's daily responses was modeled as a function of their 30-day recall, the personal characteristic, and the interaction between the 30-day recall and the characteristic in separate general linear regression models, adjusted for sex. RESULTS: Nine items representing 7 LUTS exhibited under- or overreporting (recall bias) for at least 25% of participants. Bias was associated with personal characteristics for six LUTS. Underreporting of incontinence was associated with older age, lower anxiety, and negative affect; overreporting of other LUTS was associated with, symptom bother, symptom variability, anxiety, and depression. CONCLUSIONS: We identified under- or overreporting that was associated with personal characteristics for six common LUTS. Some cues (eg, less bother and lower anxiety) were related to recall bias in an unexpected direction. Thus, providers should exercise caution when making judgments about the accuracy of a patient's symptom recall based on patient demographic and psychosocial characteristics.

Relationship of symptom severity and bother in individuals seeking care for lower urinary tract symptoms.

AIMS: Bother attributed to lower urinary tract symptoms (LUTS) drives care-seeking and treatment aggressiveness. The longitudinal relationship of LUTS severity and bother in a care-seeking cohort, however, is not well understood. We aim to conduct a longitudinal evaluation of LUTS severity and bother and identify characteristics of patients with discordant LUTS bother relative to severity. METHODS: Men and women with LUTS seeking care at six US tertiary care centers enrolled in the symptoms of lower urinary tract dysfunction research network study. Patients reporting at least one urinary symptom based on the LUTS Tool were prospectively enrolled from June 2015 to January 2017. Correlations were used to assess the relationship between LUTS severity and bother. Discordance scores (ie, the difference between bother and severity) were used to classify patients with high and low bother. Patients were classified as having high or low bother phenotypes if scores were one standard deviation above or below zero, respectively. Repeated measures multinomial logistic regression evaluated characteristics associated with high and low bother phenotypes. RESULTS: LUTS severity and bother were at least moderately correlated for all symptom items and highly correlated for 13 out of 21 items. Correlations were highest for urgency, and lowest for daytime frequency and urinary incontinence. Odds of being in high bother phenotype were lowest at 3 and 12 months (3 months vs baseline odds ratio [OR] = 0.71, 95% confidence ninterval [CI] = 0.54-0.94; 12 months vs baseline OR = 0.66, 95% CI = 0.48-0.91), and highest for those who endorsed all urgency questions (OR = 3.65, 95% CI = 2.17-6.13). Odds of being in the low bother phenotype were lowest for patients who endorsed all urgency items (OR = 0.33, 95% CI = 0.26-0.42), and all frequency items (OR = 0.68, 95% CI = 0.53-0.88). CONCLUSIONS: LUTS severity and bother correlate highly and measurement of both in clinical practice is likely redundant. There are patient factors associated with discordance which may justify additional evaluation.