National Urogynecology Research Agenda: A Path Forward for Advancing the Treatment and Management of Pelvic Floor Disorders

Women's health research is woefully underfunded. A 2021 study found that in disease states that unequally affect one gender, a disproportionate amount of funding from the National Institutes of Health (NIH) went to male-dominated areas. The authors found that in approximately 75% of cases, the funding was provided to male-dominated diseases.1 In addition to the disproportionately smaller amount of NIH research funding that is allocated to women's health, the majority goes to research involving reproductive-aged women and is often allocated specifically to pregnancy and maternity issues.2 The Office of Research of Women's Health noted that of the proportion of the overall NIH research spending by disease, condition, and special initiative from fiscal year 2017 to 2019, only 10% was allocated to women's health research; however, in that same year, the proportion of that money spent on contraception and pregnancy was 78.6% of the total, despite the fact that women spend the minority of their lives bearing children.2 Women's health care should encompass the full life span of women, including conditions affecting postreproductive and geriatric women, the fastest-growing segment of the U.S. population. Pelvic floor disorders (PFDs) are common conditions that can significantly affect a woman's quality of life. Approximately 25% of women experience at least 1 PFD, and this percentage is likely higher in women older than 65 years, as it is well established that all PFDs increase after menopause.3,4 PURPOSE The American Urogynecologic Society (AUGS) recognizes the importance of evaluating the conditions women face throughout their lives, including conditions that become more prevalent in the postreproductive years. Furthermore, the mission of AUGS is to drive excellence in comprehensive care for women with PFDs. Aligning the mission of AUGS with the need to increase the amount of research funding directed toward women's health beyond maternity and reproductive care identified an opportunity to develop a National Urogynecology Research Agenda focused on research funding for PFDs. At the direction of the AUGS Board of Directors, the AUGS Scientific Committee was charged with the task of creating a Research Agenda that would serve the urogynecology research community by synthesizing and presenting key gaps and research priorities for a variety of PFDs. Six conditions were prioritized for inclusion in the Research Agenda, including pelvic organ prolapse (POP), lower urinary tract symptoms, recurrent urinary tract infections (rUTIs), bladder pain syndrome/interstitial cystitis (BPS/IC) and myofascial pelvic pain (MFPP), female sexual health, and fecal incontinence (FI). Once the working group generated a manuscript and the internal revisions were complete, the Research Agenda was reviewed and edited by 9 external reviewers and then subsequently by the AUGS Publications Committee and the AUGS Board of Directors. Edits were considered, and revisions made accordingly to create the final Research Agenda (https://www.augs.org/research-agenda/). RESULTS The following is a summary of the 6 topics of interest identified for the National Urogynecology Research Agenda. Lower Urinary Tract Symptoms/Urinary Incontinence Stress urinary incontinence (SUI) affects 14%–41% of biologic female patients between the ages of 30 and 60 years.5,6 Overactive bladder in women has been estimated to affect millions with its greatest prevalence (>50%) in adults 60 years or older.7 Numerous studies have demonstrated the negative impact of overactive bladder and SUI on independence, self-esteem, mental health conditions, and interpersonal relationships.8–11 Voiding dysfunction is described using a variety of symptoms that depart from normal voiding sensation and function.7 A large international survey study of a cohort of women older than 40 years reported 5.2% experienced voiding symptoms and 14.9% experienced coexisting voiding and storage symptoms.12,13 The etiologies of voiding dysfunction in women are not well understood. Further, the understanding of the impact of voiding dysfunction on quality of life is limited in part due to the historic lack of validated questionnaires for female voiding dysfunction. The following categories were identified as outstanding knowledge gaps for conditions of lower urinary tract symptoms: clinical phenotyping; combined therapies; voiding dysfunction; health disparities; central nervous system control mechanisms, neuromodulation, and electrostimulation outcomes; biomaterials for SUI treatment; impact of pregnancy/childbirth on lower urinary tract symptoms management; and the impact of anticholinergic medications on cognition. Pelvic Organ Prolapse Pelvic organ prolapse is the descent of 1 or more of the anterior, posterior, or apical pelvic floor compartments, which affects up to 50% of all women.14 This condition can severely affect quality of life, prompting 1 in 7 women in the United States to undergo surgical correction of POP.15,16 Worsening POP has also been associated with deteriorating physical function, anxiety, depression, fatigue, sleep disturbance, and lower satisfaction with participation in social roles.17 Overall, the pathophysiologic mechanisms underlying the development, progression, and severity of POP are inadequately understood. No effective preventive strategies exist against POP, and current treatment modalities are delayed and compensatory. Identified themes within POP that require further exploration in well-designed studies are the following: normal and abnormal functional anatomy and biomechanics; molecular, cellular, genetic, and biomechanical factors; therapies for prevention; treatment, treatment failure and recurrence; health disparities; and societal impact and financial burden of treatment modalities. Fecal Incontinence Fecal incontinence, or accidental bowel leakage, defined as unintentional leakage of mucous, liquid, or solid stool, is a prevalent condition, affecting up to 24% of women.18 Fecal incontinence has a profound negative impact on women's quality of life, as well as a substantial economic burden both at the individual and health care system levels. As a result of the associated stigma, women with FI often suffer in silence. As the prevalence increases with age, paralleling the rapidly growing aging population, the impact of FI on society will continue to expand. Research gaps were identified, and recommendations were provided for the following categories: pathogenesis; classifications of FI types; treatments and prevention; reporting/validated measures; psychosocial consequences and providing support; and research inclusion/diversity. Recurrent UTIs Urinary tract infections are some of the most common bacterial and fungal infections, and they disproportionately affect women. More than one half of women have 1 UTI in their lifetimes, and approximately one third develop rUTI. Women suffering from rUTIs experience burdens related to symptoms and treatment, including adverse effects from antibiotics and risks posed by multidrug- and azole-resistant bacteria. Despite the substantial impact of rUTI, there is a paucity of evidence upon which to base accurate diagnosis, treatment, and prevention. The rUTI working group identified the following research categories: characterization of host-microbial interaction in the female bladder and with neighboring microbial niches, biomarker rapid detection, and patient-centered outcomes and care equity. Recommendations around these categories generally focused on large, multicenter, socioeconomically diverse studies that explore patient-centered outcomes and the impact of rUTI in diverse communities. Sexual Health in Women With PFDs Patients with PFD have a high prevalence of sexual dysfunction, and lack of improvement in sexual function after pelvic reconstructive surgery is viewed by patients as a serious complication. Patients may be embarrassed by urine loss during sexual activity and how their genitalia appear and/or express concerns that their prolapse may prohibit sexual activity.19,20 The societal and economic burden of sexual dysfunction in women with PFDs is high. A more thorough understanding of the prevalence of sexual dysfunction among each of the individual PFDs is essential. There is an urgent need to raise awareness of the importance of sexual function in women with PFDs and to investigate treatments and solutions rather than simply defining the conditions.21,22 Knowledge gaps included the need to improve overall understanding of basic anatomy and physiology and how they relate to sexual function; standardization in terminology, screening, and reporting; patient-centered counseling and changes with PFD surgery on sexual function; and explore sexual health and dysfunction in understudied populations with PFDs. Bladder Pain Syndrome/Interstitial Cystitis and Myofascial Pelvic Pain Bladder pain syndrome/interstitial cystitis and MFPP are 2 chronic pain conditions that are commonly assessed and treated by urogynecologists. Bladder pain syndrome/interstitial cystitis is characterized by bladder pain with associated urinary urgency, frequency, and nocturia lasting greater than 6 weeks in the absence of other identifiable causes.23 Bladder pain syndrome/interstitial cystitis symptoms are common; yet, the condition is often underdiagnosed with a lack of understanding the disease pathogenesis. The etiology of BPS/IC is multifactorial with interactions between autoimmune, neuroendocrine, allergic, and infectious pathways.24,25 Myofascial pelvic pain can be acute; however, the chronic syndrome is characterized by pain originating from the pelvic floor muscles.26 Myofascial pelvic pain is persistent or episodic and occurs in the absence of a local pathological condition with symptoms suggestive of lower urinary tract, sexual, bowel, or gynecological dysfunction.27–31 The etiology of MFPP is also not well understood and is likely multifactorial. Several theories have been suggested, including metabolic imbalance at the motor end plate in peripheral tissue, central sensitization of pain, and neuromuscular microtrauma.32–35 For BPS/IC, 4 categories were identified: diagnosis, disease phenotypes, current treatments, and treatments on the horizon. For MFPP, the following categories were included: prevalence, etiology, diagnosis, and treatment. For each of these categories, knowledge gaps/research priorities were elaborated on with recommendations given for each in the final Research Agenda. CONCLUSION There are extensive areas to be explored in women's health research, especially for conditions women face throughout their lives, including conditions such as PFDs that become more prevalent in the postreproductive years. The main goal of the Research Agenda is to synthesize and present key gaps and research priorities for a variety of PFDs. There is a clear need to increase funding to investigate these crucial topics. The intention is that this agenda will serve as a living document to be updated as knowledge advances and research priorities evolve. This document will also help to guide researchers when putting forth funding applications and should be used by PFD advocates when championing research dollars that can be directed toward women's health care beyond reproduction.

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