Occupational groups and lower urinary tract symptoms: A cross-sectional analysis of women in the Boston Area Community Health Study.

OBJECTIVES: The objective of this study is to inform our hypothesis that the workplace toileting environment may impact lower urinary tract symptoms (LUTS); we examined the prevalence of LUTS across occupational groups in the Boston Area Community Health Survey. METHODS: At baseline, women (n = 3205) reported their occupation and frequency of 15 LUTS. Using the US Department of Labor's Standard Occupational Classification (SOC) system, we categorized women into 11 standard occupational groups. Prevalence ratios (PRs) were calculated by log-link generalized linear models, adjusting for age, race, education, fluid intake, and parity. Women classified in Office and Administrative Support were used as the reference group given their potential for fewer workplace toileting restrictions. RESULTS: Of the 3189 women with complete data, 68% of women reported any LUTS, ranging from 57% to 82% across the SOCs. Relative to women in Office and Administrative Support (n = 576), women in Computing, Engineering, and Science (n = 64) were more likely to report any LUTS (PR = 1.2, 95% confidence interval [95% CI]: 1.0-1.4) and urinating again in <2 h (PR = 1.7, 95% CI: 1.4-2.2), and women in Education, Legal, Community Service, Arts, and Media (n = 477), as well as Healthcare Practitioner and Technical Occupations (n = 162), were less likely to report perceived frequent daytime urination (PR = 0.6, 95% CI: 0.5-0.9 and PR = 0.6, 95% CI: 0.4-0.9, respectively). CONCLUSIONS: Our cross-sectional findings suggest that urination frequency varies across understudied occupational groups with various workplace toileting environments. Future studies should examine this relationship prospectively to inform the influence of workplace toileting environments on urination frequency, as well as the development and/or worsening of LUTS.

Validation of bladder health scales and function indices for women's research.

BACKGROUND: Existing bladder-specific measures lack the ability to assess the full range of bladder health, from poor to optimal health. OBJECTIVE: This study aimed to report evidence of validity of the self-administered, multidimensional bladder health scales and function indices for research in adult women. STUDY DESIGN: 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 in 7 clinical research centers. Construct validity of the bladder health scales and function indices was guided by a 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. Chi-square, Fisher exact, or t-tests were used for mode comparisons. 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 of urinary conditions. RESULTS: The sample included 1072 participants. Factor analysis identified 10 scales, with Cronbach's alpha ranging from 0.74 to 0.94. Intraclass correlation coefficients of scales ranged from 0.55 to 0.94. Convergent validity of the 10 scales and 6 indices ranged from 0.52 to 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration. CONCLUSION: 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.

Changes in Bladder Health over Time: A Longitudinal Analysis of Adult Women in the Boston Area Community Health Survey.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

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.

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.

Is the juice worth the squeeze? Transdisciplinary team science in bladder health.

AIMS: Prior 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. METHODS: Herein, 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. RESULTS: Strategies 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. CONCLUSION: A 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.

The Comprehensive Assessment of Self-Reported Urinary Symptoms: A New Tool for Research on Subtypes of Patients with Lower Urinary Tract Symptoms.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Terminology for bladder health research in women and girls: Prevention of Lower Urinary Tract Symptoms transdisciplinary consortium definitions.

AIM: To report research terminology and definitions for describing healthy bladder function among women and girls. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: PLUS 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.

Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study.

PURPOSE: The primary objective of this study was to evaluate reasons for seeking care among men and women with lower urinary tract symptoms. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Occupation and lower urinary tract symptoms in women: A rapid review and meta-analysis from the PLUS research consortium.

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 (I2 = 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.

The Prevention of Lower Urinary Tract Symptoms (PLUS) in girls and women: Developing a conceptual framework for a prevention research agenda.

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.

Evidence of the Impact of Diet, Fluid Intake, Caffeine, Alcohol and Tobacco on Lower Urinary Tract Symptoms: A Systematic Review.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Future Directions of Research and Care for Urinary Incontinence: Findings from the National Institute of Diabetes and Digestive and Kidney Diseases Summit on Urinary Incontinence Clinical Research in Women.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Nonbiologic factors that impact management in women with urinary incontinence: review of the literature and findings from a National Institute of Diabetes and Digestive and Kidney Diseases workshop.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Advancing a Comprehensive Approach to the Study of Lower Urinary Tract Symptoms.

PURPOSE: Lower urinary tract symptoms are common in the United States population, leading to significant economic, quality of life and public health issues. The burden will increase as the population ages, and risk factors for lower urinary tract symptoms, including diabetes and obesity, remain highly prevalent. Improving clinical management and establishing the knowledge base to prevent lower urinary tract symptoms will require a comprehensive research approach that examines factors beyond the lower urinary tract. While the study of extra-lower urinary tract factors has increased recently, current urological research does not systematically account for the broad set of potential contributing factors spanning biological, behavioral, psychological/executive function and sociocultural factors. A comprehensive assessment of potential contributors to risk, treatment response and progression is necessary to reduce the burden of this condition in the United States. MATERIALS AND METHODS: We considered challenges to continuing the predominantly lower urinary tract dysfunction centric approach that has dominated previous research of lower urinary tract symptoms. RESULTS: We developed a new, comprehensive framework for urology research that includes a broader set of potential factors contributing to lower urinary tract symptoms. This framework aims to broaden research to consider a comprehensive set of potential contributing factors and to engage a broad range of researchers in the investigation of as many extra-lower urinary tract factors as possible, with the goal of improving clinical care and prevention. CONCLUSIONS: We propose a new framework for future urology research, which should help to reduce the medical and economic burden of lower urinary tract symptoms in the United States population.

Development and psychometric evaluation of the urgency questionnaire for evaluating severity and health-related quality of life impact of urinary urgency in overactive bladder.

INTRODUCTION AND HYPOTHESIS: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial.

PURPOSE: We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence. MATERIALS AND METHODS: In this 12-week, randomized, double-blind, flexible dose, placebo controlled trial, subjects were community dwelling men and women 65 years old or older. Subjects had scores of 3 or more on the VES-13 (Vulnerable Elders Survey) and 20 or more on the MMSE (Mini-Mental State Examination), and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries. Subjects randomized to fesoterodine received 4 mg once daily for 4 weeks and could then increase to 8 mg based on discussion with the investigator. Subjects receiving 8 mg could decrease the dose to 4 mg at any time (sham escalation and de-escalation for placebo). The primary outcome measure was change in daily urgency urinary incontinence episodes. Secondary outcomes included changes in other diary variables and patient reported quality of life measures. Safety evaluations included self-reported symptoms and post-void residual volume. RESULTS: A total of 562 patients were randomized (mean age 75 years, 50.4% age 75 years or greater). Subjects had high rates of comorbidities, polypharmacy and functional impairment. At week 12 the fesoterodine group had significantly greater improvements in urgency urinary incontinence episodes per 24 hours (-2.84 vs -2.20, p = 0.002) and most other diary variables and quality of life, as well as a higher diary dry rate (50.8% vs 36.0%, p = 0.002). Adverse effects were generally similar to those of younger populations including risk of urinary retention. CONCLUSIONS: To our knowledge this is the first antimuscarinic study in a community based, significantly older, medically complex elderly population with urgency urinary incontinence. Flexible dose fesoterodine significantly improved urgency urinary incontinence episodes and other outcomes vs placebo, and was generally well tolerated.