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Objective : To provide a scoping review of the economic burden of non-cancerous genitourinary conditions (NCGUCs). Methods : A scoping review of the literature surrounding the economic costs associated with NCGUCs was conducted for literature published between 1990-2020. The articles were screened and relevant articles were selected for review. These articles were abstracted with information pertaining to the costs surrounding NCGUCs. A descriptive analysis of the data was conducted. Results : We found 3298 articles in our scoping review. Of these, we found 38 relevant articles related to pelvic floor dysfunction and pelvic organ prolapse, interstitial cystitis, neurogenic bladder, nocturia, urinary tract infections, urolithiasis, urinary incontinence, benign prostatic hyperplasia, overactive bladder, and erectile dysfunction of which the data is reviewed. Conclusion : Although the data in estimating the economic burden is limited, existing evidence demonstrates a significant component of health care spending on NCGUCs. Much of the spending is out-of-pocket and indirect costs that are difficult to measure which may increase the magnitude of the costs. There is a need for future research that takes a holistic look at the economic impact of NCGUCs.

Our goal was to describe changes in bladder health, defined as "a complete state of physical, mental, and social well-being related to bladder function that permits daily activities, adapts to short-term stressors, and allows optimal well-being," in women over time.We used data on 15 lower urinary tract symptoms (LUTS) and interference from urinary experiences assessed at the baseline and 5-year followup interviews of the BACH (Boston Area Community Health) Survey to estimate changes in bladder health over time in women. Associations between baseline and followup bladder health (defined as the maximum frequency of LUTS or interference at each time point) were calculated by ordinal logistic regression and generalized linear models.A total of 2,526 women provided complete information on bladder health at baseline and followup. Over the 5-year followup, 6.5% of women maintained optimal bladder health (no LUTS or interference), 33.6% developed worse bladder health (including 10.4% who transitioned from optimal to less than optimal health), 31.4% maintained their less than optimal bladder health status and 28.7% improved. Despite these changes, women with poorer bladder health at baseline were still more likely to have poorer bladder health 5 years later (eg multivariable-adjusted relative risk=3.27, 95% confidence interval: 2.49-4.29 for severe LUTS/interference at followup among those with severe LUTS/interference at baseline).Findings from our large secondary analysis of BACH Survey data suggest considerable variability in bladder health over time, and underscore the importance of bladder health promotion to prevent the initial onset and progression of poor bladder health in women.

(s): Existing bladder-specific measures lack ability to assess a range of bladder health from poor to optimal health. We report evidence for validity of the self-administered, multidimensional Bladder Health Scales and Function Indices for research in adult women.A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms surrounding 7 clinical research centers. Construct validity of the Bladder Health Scales and Function Indices was guided by Multitrait-Multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed effects Intraclass Correlation Coefficient models. Mode comparisons used chi-square, Fisher Exact or t-tests. Convergent validity was evaluated using Pearson correlations with the external construct measures and known-group validity was established with comparison of women known and unknown to be symptomatic with urinary conditions.The sample included 1,072 participants. Factor analysis identified ten scales with Cronbach's alpha ranging 0.74-0.94. Intraclass correlation coefficients of scales ranged from 0.55-0.94. Convergent validity of ten scales and six indices ranged from 0.52- 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration.The paper and electronic forms of the Bladder Health Scales and Function Indices are reliable and valid measures of bladder health for use in women's health research.

Background: Little research to date has investigated the spectrum of bladder health in women, including both bladder function and well-being. Therefore, we expanded our previous baseline analysis of bladder health in the Boston Area Community Health (BACH) Survey to incorporate several additional measures of bladder-related well-being collected at the 5-year follow-up interview, including one developed specifically for women. Methods: At follow-up, participants reported their frequency of 15 lower urinary tract symptoms (LUTS), degree of life impact from and thought related to urinary symptoms or pelvic/bladder pain/discomfort, and perception of their bladder condition. Prevalence ratios were calculated by generalized linear models with robust variance estimation, adjusting for LUTS risk factors and individual LUTS. The BACH Survey was approved by the New England Research Institutes Institutional Review Board and all participants provided written informed consent. Results: Generally similar findings were observed in the 5-year cross-sectional analysis as at baseline, irrespective of how we categorized LUTS or measured bladder-related well-being. Approximately one in five women (16.2%–18.0% of 2527 eligible women) reported no LUTS and no diminished bladder-related well-being, the majority (55.8%–65.7%) reported some LUTS and/or diminished well-being, and a further one in five (16.9%–26.6%) reported the maximum frequency, number, or degree of LUTS and/or diminished well-being. Measures of storage function (urinating again after

Author(s): Schmitz, Kathryn H; Bavendam, Tamara; Brady, Sonya S; Brubaker, Linda; Burgio, Kathryn; Harlow, Bernard L; James, Aimee; Lukacz, Emily S; Miller, Janis M; Newman, Diane K; Palmer, Mary H; Rudser, Kyle; Sutcliffe, Siobhan; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium | Abstract: AimsPrior research on lower urinary tract symptoms (LUTS) has focused on the treatment and management of these conditions with scant attention to prevention. The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was formed to address the complexities of preventing LUTS and promoting bladder health.MethodsHerein, we describe challenges faced and strategies used to develop the PLUS Research Consortium into an engaged and productive transdisciplinary scientific team. We apply four previously defined team science phases (development, conceptualization, implementation, and translation) to frame our progress.ResultsStrategies to progress through the development phase included the generation of a shared mission, and valuing of other disciplinary perspectives. The conceptualization phase included generating a shared language and developing a team transdisciplinary orientation. During the implementation phase, the group developed roles and procedures and focused on conflict management. The translation phase includes continued refinement of the mission and goals, implementation of research protocols, and robust dissemination of the scientific work products related to bladder health.ConclusionA diverse group has matured into a productive transdisciplinary team science consortium. Achieving this outcome required dedicated effort for each member to engage in activities that often required more time than single discipline research activities. Provision of the necessary time and tools has fostered a transdisciplinary team science culture and rich research agenda that reflects the complexity of the health issue to be addressed. Our experience may be useful for others embarking on team science projects.

Authorship and dissemination policies vary across NIH research consortia. Our purpose was to describe elements of real-life policies in use by eligible U01 clinical research consortia. Principal investigators of eligible, active U01 clinical research projects identified in the NIH Research Portfolio Online Reporting Tools database were asked to share relevant policies. The characteristics of key policy elements, determined a priori, were reviewed and quantified, when appropriate. Eighty-one research projects met search criteria and 21 groups provided policies which were examined for key elements (e.g., in quotations): “manuscript proposals reviewed and approved by committee” (90%); “guidelines for acknowledgements” (86%); “formation of the writing team” (71%); “process for final manuscript review and approval” (71%), “responsibilities for lead author” (67%), “guidelines for other types of publications” (67%); “draft manuscript review and approval” (62%); “recommendation for number of members per consortium site” (57%); and “requirement to identify individual contributions in the manuscript” (19%). Authorship/dissemination policies for large team science research projects are highly variable. Creation of an NIH policies repository and accompanying toolkit with model language and recommended key elements could improve comprehensiveness, ethical integrity, and efficiency in team science work while reducing burden and cost on newly funded consortia and directing time and resources to scientific endeavors.

Objective To examine the recent epidemiology of pediatric urinary stone disease (USD) in the United States. Methods We utilized the 2004-2016 Optum© Clinformatics® Data Mart database, a de-identified adjudicated administrative health claims database that includes 15-18 million individuals covered annually by commercial insurance in all 50 US states. The analysis included 12,739,125 children aged 0-18 years. We calculated annual rates of USD, ambulatory visits, and procedures, and the prevalence of prescription fills. Results The 2005-2016 USD rate was 59.5 cases per 100,000 person-years. The annual rate rose gradually from 2005 to a peak of 65.2 cases per 100,000 person-years in 2011. The USD rate increased with increasing age, and was highest among females compared to males, non-Hispanic Whites compared to other race/ethnic groups, and those residing in the South compared to other geographic regions. The overall 2005-2016 rate in the 120 days following a USD episode was 1.9 for ambulatory visits, 0.24 for surgical procedures, and 1.1 for imaging procedures. Ureteroscopy was the most common surgical procedure and CT scan was the most common imaging procedures, although ultrasound utilization increased over time. Medications were filled in 46.9% of cases, and use was lowest among males (43.1%), Asians (34.8%), and in the Northeast (34.3%). Opiate agonists were the most prevalent prescription (39.9%). Conclusion Our study provides one of the most comprehensive examinations of pediatric USD to date, demonstrating shifting rates and treatment patterns over time, as well as differences by age, gender, race/ethnicity, and geographic region.

To improve the potential for finding clinically important subtypes of patients with lower urinary tract symptoms we developed the CASUS (Comprehensive Assessment of Self-reported Urinary Symptoms). We used it to present data on the experiences of lower urinary tract symptoms in treatment seeking women and men from a prospective observational cohort.We created an initial list of lower urinary tract symptoms that were confirmed in 22 qualitative interviews with providers, and 88 qualitative interviews with care seeking and noncare seeking women and men with lower urinary tract symptoms. Items from extant measures were adopted and revised, and new items were developed. All items were evaluated for understanding in 64 cognitive interviews. Items were administered to a prospective cohort of female and male patients with lower urinary tract symptoms who were seeking care. Analyses were done to describe item response distributions and correlations among item responses separately for women and men.A total of 444 males and 372 females provided responses to the CASUS. Several sets of items showed different relationships for women compared to men. In particular the associations between sensation related items and incontinence related items were generally positive among females but often negative among males.After using an intensive development process the CASUS addresses a wide range of lower urinary tract symptoms. It should help identify clinically important subtypes of patients. Further, item collection can provide the foundation for shorter measures for use in the clinic and as trial end points.

Author(s): Lowder, Jerry L; Bavendam, Tamara G; Berry, Amanda; Brady, Sonya S; Fitzgerald, Colleen M; Fok, Cynthia S; Goode, Patricia S; Lewis, Cora E; Mueller, Elizabeth R; Newman, Diane K; Palmer, Mary H; Rickey, Leslie; Stapleton, Ann; Lukacz, Emily S | Abstract: AimTo report research terminology and definitions for describing healthy bladder function among women and girls.MethodsThe Prevention of Lower Urinary tract Symptoms (PLUS) Consortium developed research terminology and definitions for elements of healthy bladder function based on existing understanding of storage and emptying functions of the bladder and accepted definitions of lower urinary tract symptoms (LUTS). The novel concept of a bladder "bioregulatory" function was also proposed. Elements of bladder function corresponding to bladder health (BH) and LUTS were developed and refined using an iterative process. A comprehensive reference table structured by bladder function (Storage, Emptying, and Bioregulatory) and elements of each function was created to document proposed research terminology and definitions.ResultsThe BH research definitions for each bladder function are: (1) Storage: the ability to hold urine for a reasonable duration of time and sense bladder fullness without fear of or concern about urgency, discomfort or leakage; (2) Emptying: the ability to empty the bladder completely in a timely, efficient, effortless, comfortable manner; and (3) Bioregulatory: the bladder barrier protects the individual/host from pathogens, chemicals, and malignancy. Research definitions for seven Storage, seven Emptying, and three Bioregulatory elements of function are presented. Novel LUTS research definitions were developed when gaps in existing definitions were identified or nonclinical language was desired.ConclusionsPLUS BH definitions reflect a transdisciplinary approach to standardizing research definitions for elements of bladder function from a perspective of health rather than dysfunction and provide a framework for studying BH in clinical practice, public health promotion, and LUTS prevention.

Urologic chronic pelvic pain syndrome (UCPPS), which encompasses interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, is characterized by chronic pain in the pelvic region or genitalia that is often accompanied by urinary frequency and urgency. Despite considerable research, no definite aetiological risk factors or effective treatments have been identified. The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network uses a novel integrated strategy to characterize UCPPS as a systemic disorder that potentially involves multiple aetiologies. The first phase, MAPP I, included >1,000 participants who completed an intensive baseline assessment followed by a 12-month observational follow-up period. MAPP I studies showed that UCPPS pain and urinary symptoms co-vary, with only moderate correlation, and should be evaluated separately and that symptom flares are common and can differ considerably in intensity, duration and influence on quality of life. Longitudinal clinical changes in UCPPS correlated with structural and functional brain changes, and many patients experienced global multisensory hypersensitivity. Additionally, UCPPS symptom profiles were distinguishable by biological correlates, such as immune factors. These findings indicate that patients with UCPPS have objective phenotypic abnormalities and distinct biological characteristics, providing a new foundation for the study and clinical management of UCPPS.

Objective To provide a conceptual framework to guide investigations into burdens of noncancerous genitourinary conditions (NCGUCs), which are extensive and poorly understood. Methods The National Institute of Diabetes and Digestive and Kidney Diseases convened a workshop of diverse, interdisciplinary researchers and health professionals to identify known and hidden burdens of NCGUCs that must be measured to estimate the comprehensive burden. Following the meeting, a subgroup of attendees (authors of this article) continued to meet to conceptualize burden. Results The Hidden Burden of Noncancerous Genitourinary Conditions Framework includes impacts across multiple levels of well-being and social ecology, including individual (ie, biologic factors, lived experience, behaviors), interpersonal (eg, romantic partners, family members), organizational/institutional (eg, schools, workplaces), community (eg, public restroom infrastructure), societal (eg, health care and insurance systems, national workforce/economic output), and ecosystem (eg, landfill waste) effects. The framework acknowledges that NCGUCs can be a manifestation of underlying biological dysfunction, while also leading to biological impacts (generation and exacerbation of health conditions, treatment side effects). Conclusion NCGUCs confer a large, poorly understood burden to individuals and society. An evidence-base to describe the comprehensive burden is needed. Measurement of NCGUC burdens should incorporate multiple levels of well-being and social ecology, a life course perspective, and potential interactions between NCGUCs and genetics, sex, race, and gender. This approach would elucidate accumulated impacts and potential health inequities in experienced burdens. Uncovering the hidden burden of NCGUCs may draw attention and resources (eg, new research and improved treatments) to this important domain of health.

Summary Background Lower urinary tract symptoms (LUTS) are common in children and adolescents. Non-invasive tests evaluating bladder function are generally preferred over invasive tests, yet few studies have explored the range of normative values for these tests in healthy, asymptomatic children. Objective To define normative reference ranges for non-invasive tests of bladder function in healthy, asymptomatic girls and adolescents. Study design A comprehensive search strategy was performed in seven electronic databases through October 2019. English-language studies reporting data on voiding frequency, voided and postvoid residual volumes (PVR) and uroflowmetry results in healthy, asymptomatic girls (mean age ≥ 5 years) were included. Two independent reviewers performed study review, data extraction, and quality assessment. Overall mean estimates and 95% confidence intervals for each bladder function parameter were calculated using random effects models, and 95% normative reference values were estimated. Results Ten studies met eligibility criteria for the meta-analysis (n = 2143 girls, age range: 3–18). Mean estimates of maximum voided volume and PVR were 233.4 ml (95% CI 204.3–262.6; n = 1 study) and 8.6 ml (95% CI 4.8–12.4; n = 2 studies) respectively. Pooled mean estimates for uroflowmetry parameters were: 21.5 ml/s (95% CI 20.5–2.5) for maximum flow rate (n = 6 studies), 12.5 ml/s (95% CI 11.2–13.8) for mean flow rate (n = 6 studies), 6.8 s (95% CI 4.4–9.3) for time to maximum flow (n = 3 studies), 15.7 s (95% CI 13.0–18.5) for flow time (n = 3 studies), and 198.7 ml (95% CI 154.2–234.2) for voided volume (n = 9 studies). No studies reported estimates of voiding frequency. Between-study heterogeneity was high (89.0–99.6%). Conclusions Although we were able to calculate pooled mean estimates for several parameters, the small number of included studies and the wide age ranges of participants preclude generalization of reference values to all healthy girls. Further research is needed to determine normative reference values within specific age groups.

Objective To examine US trends in neuromodulation for urinary incontinence (UI) treatment from 2004 to 2013. Methods This study utilized 2 data sources: the Optum© de-identified Clinformatics® Data Mart Database for privately insured adults aged 18-64 years with a UI diagnosis (N≈40,000 women and men annually) and the Medicare 5% Sample for beneficiaries aged ≥65 years with a UI diagnosis (N≈65,000 women and men annually). We created annual cross-sectional cohorts and assessed prevalence of UI-related neuromodulation procedures among men and women separately from 2004 to 2013. Analyses were conducted overall and stratified by age, race/ethnicity, and geographic region. Results Nearly all neuromodulation procedures occurred in outpatient settings. Sacral neuromodulation (SNM) procedures for UI in both women and men grew steadily from 2004 to 2013, with more procedures performed in women than men. Among women with UI, SNM prevalence grew from 0.1%-0.2% in 2004 to 0.5%-0.6% in 2013. Posterior tibial nerve stimulation (PTNS) experienced growth from 2011 to 2013. Chemodenervation of the bladder with onabotulinumtoxinA (BTX) combined with other injectable procedures (including urethral bulking) remained stable over time. Conclusions From 2004 to 2013, SNM procedures remained relatively uncommon but increased consistently. PTNS experienced growth starting in 2011 when PTNS-specific insurance claims became available. BTX trends remain unclear; future studies should assess it separately from other injectable procedures. Neuromodulation has a growing role in UI treatment, and ongoing trends will be important to examine.

INTRODUCTION AND OBJECTIVE:Urinary incontinence (UI) is a common and impactful condition that affects women across their lifetime. Our knowledge of the burden of UI at a nation-wide level remains l...

Prevention strategies have been effective in many areas of human health, yet have not been utilized for lower urinary tract symptoms (LUTS) or bladder health (BH). This commentary outlines LUTS prevention research initiatives underway within the NIH-sponsored Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). Prevention science involves the systematic study of factors associated with health and health problems, termed protective and risk factors, respectively. PLUS is enhancing traditional prevention science approaches through use of: (1) a transdisciplinary team science approach, (2) both qualitative and quantitative research methodology (mixed methodology), and (3) community engagement. Important foundational work of PLUS includes development of clear definitions of both BH and disease, as well as a BH measurement instrument that will be validated for use in the general population, adolescents, and Latinx and Spanish-speaking women.1 The BH measurement instrument will be used in an upcoming nationally-representative cohort study that will measure BH and investigate risk and protective factors. PLUS investigators also developed a conceptual framework to guide their research agenda; this framework organizes a broad array of candidate risk and protective factors that can be studied across the life course of girls and women.1 As PLUS begins to fill existing knowledge gaps with new information, its efforts will undoubtedly be complemented by outside investigators to further advance the science of LUTS prevention and BH across additional populations. Once the BH community has broadened its understanding of modifiable risk and protective factors, intervention studies will be necessary to test LUTS prevention strategies and support public health efforts. LUTS providers may be able to translate this evolving evidence for individual patients under their care and act as BH advocates in their local communities.

Author(s): Brady, Sonya S; Bavendam, Tamara G; Berry, Amanda; Fok, Cynthia S; Gahagan, Sheila; Goode, Patricia S; Hardacker, Cecilia T; Hebert-Beirne, Jeni; Lewis, Cora E; Lewis, Jessica B; Kane Low, Lisa; Lowder, Jerry L; Palmer, Mary H; Wyman, Jean F; Lukacz, Emily S; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium | Abstract: AIMS:The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was established by the National Institutes of Health in 2015 to expand research beyond the detection and treatment of lower urinary tract symptoms (LUTS) to the promotion and preservation of bladder health and prevention of LUTS in girls and women. While many multi-disciplinary scientific networks focus on pelvic floor dysfunction and LUTS, the PLUS Consortium stands alone in its focus on prevention. This article describes the PLUS approach to developing a conceptual framework to guide the Consortium's initial prevention research agenda. METHODS:The conceptual framework was informed by traditional social ecological models of public health, biopsychosocial models of health, Glass and McAtee's Society-Behavior-Biology Nexus, and the World Health Organization's conceptual framework for action on the social determinants of health. RESULTS:The PLUS conceptual framework provides a foundation for developing prevention interventions that have the greatest likelihood of promoting and preserving bladder health among diverse populations. CONCLUSIONS:PLUS Consortium work is premised on the notion that programs, practices, and policies designed to promote health will have optimal impact if the conceptual foundation upon which efforts are based is comprehensive and informed by multiple disciplines. The PLUS conceptual framework is broadly applicable to domains of health that have historically focused on the treatment of illness and symptoms rather than the promotion of health. It is also applicable to domains of health that have been examined from a predominantly biological or social ecological perspective, without integration of both perspectives.

Background: Bladder health in women and girls is poorly understood, in part, due to absence of a definition for clinical or research purposes. This article describes the process used by a National Institutes of Health funded transdisciplinary research team (The Prevention of Lower Urinary Tract Symptoms [PLUS] Consortium) to develop a definition of bladder health. Methods: The PLUS Consortium identified currently accepted lower urinary tract symptoms (LUTS) and outlined elements of storage and emptying functions of the bladder. Consistent with the World Health Organization's definition of health, PLUS concluded that absence of LUTS was insufficient and emphasizes the bladder's ability to adapt to short-term physical, psychosocial, and environmental challenges for the final definition. Definitions for subjective experiences and objective measures of bladder dysfunction and health were drafted. An additional bioregulatory function to protect against infection, neoplasia, chemical, or biologic threats was proposed. Results: PLUS proposes that bladder health be defined as: “A complete state of physical, mental, and social well-being related to bladder function and not merely the absence of LUTS. Healthy bladder function permits daily activities, adapts to short-term physical or environmental stressors, and allows optimal well-being (e.g., travel, exercise, social, occupational, or other activities).” Definitions for each element of bladder function are reported with suggested subjective and objective measures. Conclusions: PLUS used a comprehensive transdisciplinary process to develop a bladder health definition. This will inform instrument development for evaluation of bladder health promotion and prevention of LUTS in research and public health initiatives.

The primary objective of this study was to evaluate reasons for seeking care among men and women with lower urinary tract symptoms.Participants were recruited from urology and urogynecology clinics, and the community. The sample was enriched with persons expected to have abnormal or diminished bladder sensations (eg participants with lower back surgery and participants 65 years old or older). Interviews were performed in person beginning with an open-ended assessment of urinary symptoms and associated bother followed by more directed questions, including reasons for seeking or not seeking treatment. We also examined the relationship between symptom frequency and bother using the LUTS (Lower Urinary Tract Symptoms) Tool.A total of 88 participants, including 38 men and 50 women, with a mean ± SD age of 52.2 ± 14.3 years provided information about urinary symptoms, including a range of quality of life consequences and coping behaviors. They sought treatment mostly because of new, continuing or bothersome symptoms. Factors associated with not seeking treatment included low symptom severity and concerns about the costs vs the benefits of treatment (eg side effects of medication). Symptom frequency and bother were associated with each other across symptoms assessed by the LUTS Tool.In this large qualitative study we obtained useful insights into the impact of lower urinary tract symptoms from the perspective of the person with the symptoms. Removing barriers and misconceptions about the treatment of lower urinary tract symptoms may increase the number of people who seek clinical care and improve the clinical course of men and women who experience lower urinary tract symptoms.

Diet, fluid intake and caffeine, alcohol and tobacco use may have effects on lower urinary tract symptoms. Constructive changes in these modifiable nonurological factors are suggested to improve lower urinary tract symptoms. To better understand the relationship between nonurological factors and lower urinary tract symptoms, we performed a systematic literature review to examine, grade and summarize reported associations between lower urinary tract symptoms and diet, fluid intake and caffeine, tobacco and alcohol use.We performed PubMed® searches for eligible articles providing evidence on associations between 1 or more nonurological factors and lower urinary tract symptoms. A modified Oxford scale was used to grade the evidence.We reviewed 111 articles addressing diet (28 studies), fluid intake (21) and caffeine (21), alcohol (26) and tobacco use (44). The evidence grade was generally low (6% level 1, 24% level 2, 11% level 3 and 59% level 4). Fluid intake and caffeine use were associated with urinary frequency and urgency in men and women. Modest alcohol use was associated with decreased likelihood of benign prostatic hyperplasia diagnosis and reduced lower urinary tract symptoms in men. Associations between lower urinary tract symptoms and ingestion of certain foods and tobacco were inconsistent.Evidence of associations between lower urinary tract symptoms and diet, fluid intake and caffeine, alcohol and tobacco use is sparse and mostly observational. However, there is evidence of associations between increased fluid and caffeine intake and urinary frequency/urgency, and between modest alcohol intake and decreased benign prostatic hyperplasia diagnosis and lower urinary tract symptoms. Given the importance of these nonurological factors in daily life, and their perceived impact on lower urinary tract symptoms, higher quality evidence is needed.

Urinary incontinence (UI)—defined as a complaint of involuntary loss of urine—is common in women, with major public health, financial, and quality of life (QoL) implications. Despite the high toll of UI and the availability of effective conservative treatments, many women with UI do not seek care. Those who do often continue to experience symptoms. Improving UI treatment may require a comprehensive approach to urology research, including a broad set of potentially influential factors beyond biologic. To explore the effects of nonbiologic factors (NBF) on UI management and treatment response, the National Institute of Diabetes and Digestive and Kidney Diseases convened a workshop for clinical and psychosocial researchers. Participants proposed a UI treatment pathway: recognizing the problem, willingness to seek treatment, access to care, receiving quality treatment, engaging in self-management, and adhering to chosen treatments; discussed potential NBFs that may affect the pathway; and identified areas for future research. After the meeting, a rapid literature review was conducted to assess the current state of research on NBFs in women with UI. Participants identified several patient-level NBFs that may influence the UI management pathway, including QoL and perceived bother; stigma, shame, and embarrassment; knowledge and perceptions; social determinants of health; cultural and language characteristics; personal characteristics and skills; and physical abilities. Additionally, participants acknowledged that provider- and system-level factors also play a role and likely interact with patient-level factors. NBFs that potentially affect the UI management pathway are not well understood, and a comprehensive, interdisciplinary approach to research is needed to understand and appropriately support effective UI treatment.

Lower urinary tract symptoms (LUTS) are common in men and impose significant economic, health and quality of life burdens. Despite an expanding view of LUTS etiology and challenges with medical and surgical treatments, LUTS research has continued to focus primarily on surgical or pharmaceutical treatment of urinary tract dysfunction, with little attention to behavioral, cognitive, or social factors. Further, self-management research is relatively underdeveloped in urology, despite its potential to support behavioral, pharmacologic, and surgical treatments for LUTS. The National Institute of Diabetes and Digestive and Kidney Diseases convened urologists, behavioral scientists, public health professionals, and other key stakeholders at the How to Help Men with LUTS Help Themselves meeting in September 2016. Meeting participants discussed the potential role of self-management in men with LUTS and identified key research needs to advance self-management science in their treatment. Meeting participants concluded that research including a well-designed randomized clinical trial (RCT) evaluating the effect of behavioral interventions could have a major impact on how LUTS are recognized and managed. However, researchers must first address key questions about self-management of LUTS in men to improve our understanding of LUTS and existing LUTS treatments, determine which patient subgroups will most benefit from self-management, identify the aspects of self-management most likely to benefit patients, and develop strategies to successfully implement LUTS self-management into medical practice. This manuscript outlines these key research questions.

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.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.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.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.

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.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.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.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.

Background: Little research to date has focused on lower urinary tract symptom (LUTS) prevention and bladder health promotion in women. To address this gap, the Prevention of LUTS Research Consortium developed the following working bladder health definition: "A complete state of physical, mental, and social well-being related to bladder function [that] permits daily activities [and] allows optimal well-being." To begin to inform and quantify this definition, we used data from the Boston Area Community Health Survey, drawing upon its rare collection of information on LUTS and LUTS-specific interference with activities. Methods: At baseline, participants reported their frequency of 15 LUTS and interference with 7 activities. Prevalence ratios (PRs) were calculated by generalized linear models with robust variance estimation, adjusting for LUTS risk factors and individual LUTS. Results: Of the 3169 eligible participants, 17.5% reported no LUTS or interference, whereas the remaining 82.5% reported some frequency of LUTS/interference: 15.1% rarely; 21.7% a few times; 22.6% fairly often/usually; and 22.9% almost always. LUTS independently associated with interference were urgency incontinence, any incontinence, urgency, nocturia, perceived frequency, and urinating again after

Chronic conditions constitute the leading cause of death and disability in the USA and constitute 86 per cent of the nation's annual healthcare expenses. Approximately half of all American adults have at least one chronic condition; 25 per cent of these Americans have two or more chronic conditions. The National Institutes of Health have funded many projects that explain epidemiology, risk factors, and prevention and treatment of chronic conditions, though research questions remain. This commentary discusses some past projects, current areas of interest, and funding opportunities from many NIH Institutes, Centers, and Offices.

AIMS: Chronic, infrequent voiding may be a risk factor for lower urinary tract symptoms (LUTS) in women. To inform this hypothesis, we conducted a rapid literature review and meta-analysis of LUTS by occupation as an indirect measure of infrequent voiding behaviors. METHODS: Two independent medical librarians searched Pubmed.gov studies (1990–2017) on adult women for occupations, industries, and workplace environment and LUTS outcomes: overactive bladder (OAB), urinary incontinence (UI), urinary tract infections (UTIs), and individual voiding and storage LUTS. Two authors reviewed full text articles meeting content criteria. Among studies with similar UI definitions, we estimated the prevalence of monthly UI using a random effects meta-analysis model. RESULTS: Of 1078 unique citations identified, 113 underwent full article review and 33 met inclusion criteria. Twenty-six of these studies examined specific occupation groups, including nurses/midwives (n = 6 studies), healthcare workers/support staff (n = 6), military personnel (n = 3), teachers (n = 3), and other groups (n = 7), whereas eight compared findings across broad occupation groups. UI was reported in 30 studies (23% using validated measures), OAB in 6 (50% validated), and UTIs in 2 (non-validated). In pooled models, the degree of heterogeneity was too high (I(2) = 96.9–99.2%) among the studies to perform valid prevalence estimates for LUTS. CONCLUSIONS: Current literature limits the ability to evaluate LUTS by occupation types. Future studies should characterize voiding frequency and toilet access in a consistent manner by occupation and explore its relation to LUTS development.

© Copyright 2018, Mary Ann Liebert, Inc. 2018. Lower urinary tract symptoms (LUTS) are highly prevalent in women, and are expected to impose a growing burden to individuals and society as the population ages. The predominance of research related to LUTS has focused on underlying pathology, disease mechanisms, or the efficacy of treatments for women with LUTS. Although this research has been vital for helping to reduce or ameliorate LUTS conditions, it has done little to prevent the onset of LUTS. Health promotion and prevention require an expansion of scientific inquiry beyond the traditional paradigm of studying disease mechanisms and treatment to the creation of an evidence base to support recommendations for bladder health promotion and, in turn, prevention of LUTS. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) introduced the concept of prevention as an important priority for women's urologic research as a prelude to supporting the formation of the Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium. In this article, we introduce the PLUS research consortium to the scientific community; share the innovative paradigms by which the consortium operates; and describe its unique research mission: to identify factors that promote bladder health across the life course and prevent the onset of LUTS in girls and women.

Despite intensive work in the field, urinary incontinence (UI) treatment is characterized by unintended side effects, uncertain durability, high risk of complications, and inconsistent outcomes. Therapy is generally directed toward underlying anatomic and physiologic causes, with little attention to important cognitive, psychosocial and behavioral aspects of UI. Recognition that the variability in UI treatment success is likely driven at least in part by individual variability—combined with a demonstrated need for better outcomes for patients with UI; a torrent of technical advances involving -omic, mobile health, and data science technologies; and growth of intra- and transdisciplinary research—has made the development of a science base to enable better targeting of UI treatments based on individual patient characteristics both interesting and feasible . The National Institute of Diabetes and Digestive and Kidney Diseases convened expert stakeholders to conceptualize research needed to individualize UI treatment. Such research will be facilitated by an interdisciplinary approach that considers factors spanning urinary, local/regional and systemic biology; individual behaviors; mind and mental functioning; and social determinants of health. Over time, continued interdisciplinary collaboration will likely contribute to the evolution of a transdisciplinary perspective that may enhance and accelerate future research.

AIMS: Historically, urine has been viewed primarily as a waste product with little biological role in the overall health of an individual. Increasingly, data suggest that urine plays a role in human health beyond waste excretion. For example, urine might act as an irritant and contribute to symptoms through interaction with—and potential compromise of—the urothelium. METHODS: To explore the concept that urine may be a vehicle for agents with potential or occult bioactivity and to discuss existing evidence and novel research questions that may yield insight into such a role, the National Institute of Diabetes and Digestive and Kidney Disease invited experts in the fields of comparative evolutionary physiology, basic science, nephrology, urology, pediatrics, metabolomics, and proteomics (among others) to a Urinology Think Tank meeting on February 9, 2015. RESULTS: This report reflects ideas that evolved from this meeting and current literature, including the concept of urine quality, the biological, chemical, and physical characteristics of urine, including the microbiota, cells, exosomes, pH, metabolites, proteins, and specific gravity (among others). Additionally, the manuscript presents speculative, and hopefully testable, ideas about the functional roles of urine constituents in health and disease. CONCLUSION: Moving forward, there are several questions that need further understanding and pursuit. There were suggestions to consider actively using various animal models and their biological specimens to elaborate on basic mechanistic information regarding human bladder dysfunction.

Over the last five decades, healthcare advances have yielded quantum improvements in life expectancy for individuals with congenital genitourinary conditions (CGCs), leading to a crisis of care. Many individuals with CGC enter adulthood unprepared to manage their condition. Pediatric CGC specialists lack training to manage adulthood-related healthcare issues, while adult genitourinary specialists lack training within the context of CGCs. To address these challenges, the National Institutes of Diabetes and Digestive and Kidney Diseases convened individuals with CGCs and experts from a variety of fields to identify research needs to improve transitional urology care. This manuscript outlines identified research needs.

In this report, sex/gender research relevant to reproduction on Earth, in conjunction with the extant human and animal observations in space, was used to identify knowledge gaps and prioritize recommendations for future sex- and gender-specific surveillance and monitoring of male and female astronauts. With overall increased durations of contemporary space missions, a deeper understanding of sex/gender effects on reproduction-related responses and adaptations to the space environment is warranted to minimize risks and insure healthy aging of the men and women who travel into space.

Urinary urgency is the cardinal symptom of overactive bladder (OAB). However, there is no single instrument that assesses the context, severity, intensity, and daily life impact of urinary urgency. The purpose of this manuscript is to describe the methods and results of the qualitative and quantitative research conducted to develop a new tool for this purpose, the Urgency Questionnaire (UQ). Qualitative data from interviews with patients with urinary urgency were used to develop and refine the items and response options of the UQ. Three studies were used to evaluate psychometric properties: a clinical trial of tolterodine (Detrol; n = 974); a psychometric validation study (n = 163); and a test–retest validation study (n = 47). Item and exploratory factor analysis (EFA) were performed to assess the subscale structure, and the psychometric performance of the resulting scales was evaluated. Fifteen Likert-scale items and four VAS questions were retained. A four-factor solution was shown to best fit the data, with the subscales: Impact on Daily Activities, Time to Control Urgency, Nocturia, and Fear of Incontinence. All subscales and VAS items demonstrated good reliability (Cronbach’s α 0.79–0.94), convergent and discriminant validity, and responsiveness to change. The UQ differentiated between OAB patients and controls. The results provide quantitative evidence that urinary urgency, as assessed by the UQ, is a pathological sensation distinctive from the normal urge to void and suggest that the UQ might be a reliable, valid, and responsive instrument for evaluating the severity and HRQL impact of urinary urgency in OAB.

Adherence with oral medication for overactive bladder syndrome is suboptimal. To improve adherence, the YourWay plan was developed to assist patients and health care providers in defining treatment expectations and facilitating communication.To evaluate medication adherence among patients with overactive bladder syndrome enrolled in the YourWay patient support plan, patient adoption of behavioral interventions, patient satisfaction with the plan, and physician experience with the plan.In this 13-week, single-arm, open-label, multicenter, noninterventional study, fesoterodine-naïve patients received a prescription for fesoterodine 4 or 8 mg and a packet including a 14-day fesoterodine sample, educational materials, and progress tracker. Patients registered for the YourWay plan, which included an educational resource kit, interactive voice-response calls, and optional online and mail support. The primary end point was the proportion of patients who filled a prescription for a ≥ 90-day supply of fesoterodine within 90 days of enrollment. Secondary end points were the proportion of patients who filled ≥ 1 prescription and ≥ 2 prescriptions (post hoc), patient evaluation of their experience and satisfaction with the YourWay plan, and differences between prescription fillers and nonfillers in plan adoption and assessment (post hoc). We surveyed an independent sample of physicians to assess their experience with YourWay.Of 500 study completers, 10.4% filled a prescription for a ≥ 90-day supply of fesoterodine. Of those filling a prescription, 26.2% filled ≥ 1 prescription and among those, 61.0% refilled their prescription at least once. Many behavioral recommendations were adopted by 82% to 94% of patients. Fillers were more likely to take fesoterodine as directed, whereas adoption of behavioral recommendations or plan satisfaction did not differ between fillers and nonfillers. Most patients reported that the plan was informative and feasible to implement, and that they were satisfied with various aspects of the plan. Physicians also reported positive experiences.Most patients adopted YourWay components and viewed the plan positively, although adherence remained a challenge.

Summary Background: Patients’ treatment goals for overactive bladder (OAB) and other lower urinary tract symptoms (LUTS) may not be aligned with their healthcare provider’s goals. Successful management of OAB symptoms is improved by individualised treatment plans with attainable treatment goals. Goal attainment setting may facilitate patient–provider interaction and the development of a personalised treatment plan based on realistic, individual goals, thereby increasing patient satisfaction and therapeutic outcomes. The purpose of this study was to validate the utility of the Self-Assessment Goal Achievement (SAGA) questionnaire for LUTS in helping patients identify and achieve realistic treatment goals. Methods: The 2-module SAGA questionnaire consists of nine prespecified (fixed) items and five open-ended items for goal identification and ranking (baseline module) and goal achievement rating (follow-up module). Adult patients in the United States (n = 104) seeking treatment for LUTS, including symptoms of OAB, completed the SAGA baseline module, micturition diary, other patient-reported outcome measures (PROs), and discussed their urinary goals with a clinician at baseline. The SAGA follow-up module was completed 2–4 months later. SAGA was validated based on analyses of face, concurrent, known-groups, and convergent validity and item distribution. Results: Among the nine fixed goals of SAGA, four were ranked as very important by > 50% of patients (i.e. reduce night-time frequency, daytime frequency, urine leakage, urgency). Most patients did not change the importance level of their goals after discussion with their healthcare provider. Pearson correlations between SAGA, diary variables and PRO scores were generally of low to moderate strength. The global mean (SD) follow-up SAGA T-score was 32.54 (12.54), indicating that overall goal attainment was not achieved after 3 months. The goal attainment score was significantly different between groups differing in symptom severity, health-related quality of life, bladder control and continence status. Conclusions: The results support the validity of SAGA as a measure of patients’ goals and goal achievement for the treatment of LUTS, including symptoms of OAB. SAGA may improve healthcare provider–patient interactions and treatment outcomes in clinical practice.

Female urinary incontinence is prevalent, costly and morbid. Participants in a NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) sponsored summit reviewed findings from NIH (National Institutes of Health) funded clinical research on urinary incontinence in women and discussed the future of urinary incontinence research.The NIDDK convened the Summit on Urinary Incontinence Clinical Research in Women on March 14, 2014. Participants representing a broad range of clinical expertise reviewed completed NIH sponsored urinary incontinence related studies, including results from community based epidemiological studies such as the BACH (Boston Area Community Health) Survey and from randomized clinical trials such as PRIDE (Program to Reduce Incontinence by Diet and Exercise), and studies conducted by the Pelvic Floor Disorders Network and the Urinary Incontinence Treatment Network.BACH Survey results improved our understanding of precursors, incidence, prevalence and natural history of urinary incontinence in a diverse group of women. The Pelvic Floor Disorders Network study found that anticholinergic medications and onabotulinumtoxinA are efficacious for treating urge urinary incontinence, and Burch colposuspension and retropubic mid urethral polypropylene slings are efficacious for decreasing stress urinary incontinence following pelvic organ prolapse surgery in women with potential stress urinary incontinence. The Urinary Incontinence Treatment Network study found that fascial slings were better than colposuspension, and that retropubic and transobturator mid urethral polypropylene slings were equivalent for stress urinary incontinence. In patients with stress urinary incontinence a preoperative urodynamic study was noninferior to basic office examinations for surgical outcome. The addition of behavioral intervention did not allow female patients to discontinue antimuscarinics for urge urinary incontinence. PRIDE showed that modest weight reductions significantly decreased urinary incontinence.Strategies for future research on urinary incontinence should include a focus on early disease, risk factor identification, better phenotyping, incorporation of new technologies, patient centered research and prevention.