SHAREing Their Experiences with Bladder and UrinaryTract Health: Five Women Talk About Their Participation in the PLUS Research Consortium
At some point in their lives, the majority of women will face at least one health issue having to do with the bladder and/or urination. Such issues range from acute infections to chronic, sometimes painful conditions. These urologic health challenges can have far-reaching negative effects on a woman’s health and well-being. NIDDK-supported scientists with the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium have embarked upon a journey to improve both bladder health and overall health for women, with the help of hundreds of research volunteers across the country—including five women featured here who discussed their experiences participating in a foundational study called SHARE (see insets).
Bladder Issues: From Health to Health Burden
Urinating is a way to rid waste products of daily metabolism that would otherwise build up in the bloodstream. These toxic substances, once filtered from the blood, are sent to the bladder for storage in the form of urine. Periodically, urine is voided from the bladder out of the body through a tube-like structure called the urethra.
However, many problems can affect the bladder and urethra, resulting in symptoms that disrupt normal voiding and overall health. These problems, such as urinary incontinence (UI), urinary tract infections (UTIs), overactive bladder (OAB), and interstitial cystitis/bladder pain syndrome (IC/BPS), occur much more frequently in women than in men. Bothersome lower urinary tract symptoms, or LUTS, can also be caused by behaviors such as drinking too much fluid. Whatever the cause, LUTS can exacerbate or contribute to other chronic health problems in women, including obesity, diabetes, and depression, by creating barriers to engaging in physical and social activities (e.g., fear of embarrassment, risk of leaking urine, and need to maintain easy access to bathrooms).
Up to this point, almost all research on bladder conditions has been aimed at determining their causes and testing treatments. An understanding of healthy bladder function across the lifespan is still somewhat elusive. Such an understanding would help scientists and clinicians set goals for research to promote bladder health and develop prevention as well as improved treatment strategies for different lower urinary tract problems and symptoms.
The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium
In 2015, the NIDDK, in collaboration with other NIH components, established the PLUS Research Consortium. The overarching goal of this Consortium is to establish the scientific basis for future intervention studies that can promote bladder health and prevent LUTS and associated bladder conditions in girls and women.
PLUS is using several strategies to accomplish its mission: a transdisciplinary approach (i.e., one that harnesses multiple research disciplines to tackle important, complex questions); a research structure and research techniques to study not just biological factors, but also mental health, social and behavioral factors, and the impact of many other potentially important factors in a woman’s “environment” (e.g., home life, school, and work) that may contribute to bladder health; and the inclusion of the experiences and perspectives of adolescents and women.
PLUS investigators decided early on that defining and measuring the state of bladder health was a necessary component of the evidence for future prevention efforts. In one step toward reaching this objective, PLUS recently developed and published a novel, multi-faceted research definition of bladder health that can inform approaches for evaluation of bladder health promotion and prevention of LUTS both in research and in public health initiatives. Informed by the World Health Organization’s definition of health, the PLUS Consortium defined bladder health as “a complete state of physical, mental, and social wellbeing 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).” In a related effort, PLUS scientists analyzed comprehensive data on LUTS and LUTSspecific interference with physical and social activities from an existing community-based study. As a result, they estimate that only about one in five women ages 30 to 80 years old has optimal bladder health—underscoring the need for LUTS prevention and bladder health promotion.
Additionally, PLUS scientists have shed light on suspected associations between occupation, industry, and work environment and the risk of LUTS in women. They found that there was insufficient data from past studies to evaluate LUTS by occupation types. This represents a profound gap in knowledge and indicates that future studies should characterize factors such as voiding frequency and toilet access in a consistent manner by occupation and explore their relationships to LUTS development.
Paving the way to Prevention: Plus Clinical Studies
To obtain the evidence base for intervention studies to prevent LUTS and promote bladder health, PLUS scientists identified the need for a nationally representative long-term study in women and adolescent girls—one that would determine the distribution of bladder health conditions and expand our understanding of factors that promote bladder health or contribute to bladder conditions. As a result of its novel and visionary approach, PLUS developed a multi-pronged research strategy to lay the foundation for such a study. This strategy included talking to adolescent and adult women; scientific literature reviews; analyses of existing databases; and identification, development, and validation of an array of items (questions) to obtain measurable information about a person’s bladder health and about novel factors that contribute to bladder conditions, such as how much adolescent and adult women know about their bladders. Key studies that depended upon human volunteers are known by the acronyms SHARE, CLEAR, and VIEW.
SHARE: Every journey begins with a step, and in the case of the PLUS, a key first step was the Study of Habits, Attitudes, Realities and Experiences, or SHARE.
From its inception, PLUS made inclusion of the voices of women who are not researchers or clinicians a priority. Using principles of community engagement, PLUS quickly developed a plan for gaining broader community input on each step of the process in developing a definition of bladder health and the elements of a research method (tool) to measure bladder health. This plan resulted in SHARE.
A large, multi-center, focus-group based, qualitative study, SHARE was conducted in 2017 to understand how women conceive of and talk about their bladders and bladder health. PLUS held 44 focus groups, with more than 300 women and girls 11 to 80 years of age from racially, ethnically, and sociodemographically diverse backgrounds. Many participants had bladder health issues, while others did not. This differentiated SHARE from earlier studies of this kind, which focused on people with particular bladder conditions. Participants met in groups of approximately 5 to 10 persons of similar ages, together with a discussion facilitator and a study coordinator from the local PLUS study site.
Although participants were provided some basic information about the bladder, the focus groups were not meant to be classes—rather, they were forums for women and girls to talk about the bladder and bladder problems, how they monitor their own bladder behavior, what bladder health “looks like” to them, their experiences with navigating toilet access in public spaces such as workplaces and schools, and a variety of other topics. For many participants, the focus groups represented a venue in which to discuss issues or problems that are often swept under the rug due to embarrassment or cultural norms. Five of the participating women from sites across the country discussed their experiences in their respective SHARE focus groups for this feature (see insets).
PLUS scientists are in the process of interpreting the findings and publishing the results from the SHARE study. The information garnered from SHARE participants has been instrumental to the development of a multi-component measure of bladder health that will ultimately be used in the long-term observational study, and is informing other PLUS activities as well. For example, the focus groups provided key insights into the terms and language used by a very diverse group of women and girls to discuss bladder health and issues, as well as the emotional and social aspects of such discussions. Also, because the participants were grouped by age, how women’s experiences and perspectives differed across the lifespan could be more easily explored, analyzed, and incorporated into PLUS research efforts. Without SHARE, many of the other studies developed by PLUS would not have been possible.
CLEAR and VIEW: In preparation for its large-scale study, PLUS also needed to work methodically to identify the factors most likely to influence risk for or protection from bladder problems; develop ways to measure knowledge, attitudes, and beliefs about bladder function and health; and ultimately to draft research questions for the study. To put the draft questions through an initial test for usability, PLUS developed the Clarification of Language, Evaluation And Refinement, or CLEAR, study—a way to determine whether the questions are easily understood or need to be further refined. Candidate questions for a “Bladder Health Instrument,” will undergo full validation in the Validation of Bladder Health Instrument for Evaluation in Women, or VIEW, study. Validated and age- and culturally appropriate instruments will be developed for both English- and Spanish-speaking women. The validation process will reduce the number of items needed to determine the state of bladder health and the final instrument will be known as the Bladder Health Scale. PLUS researchers will then use the Bladder Health Scale to obtain the main results about bladder health and dysfunction in the planned long-term study in women and girls.
Going Forward in PLUS
The PLUS Research Consortium is expected to enter its second 5-year phase later in 2020, during which recruitment of participants for the national, long-term study will begin. It is anticipated that this study will determine the state of bladder health in adolescent and adult women in the United States and monitor changes in bladder health over time. These assessments, together with additional medical and other data gathered from a subset of study volunteers, will also expand the understanding of risk and protective factors to identify targets for future intervention studies.
Because of the suspected influence of access to toilets and the toilet environment on lower urinary tract symptoms, PLUS has also been developing a smartphone app called “Where I Go” to capture real time assessment of toilet access, safety, and cleanliness, and decision-making about when and where to go. PLUS researchers anticipate using this app in the longterm study. Finally, in anticipation of future efforts to promote bladder health and prevention strategies, PLUS will work on expanding its community engagement strategy to facilitate community-based participatory intervention and implementation research.
In all of its efforts, PLUS will continue to depend upon the individuals who contribute their time and experience to participate in clinical research that could benefit women and girls across the Nation and potentially even around the world.
For more information, visit the PLUS website: https://plusconsortium.umn.edu/.
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