Recurrent and complicated urinary tract infections in women: Utility of advanced testing to enhance care.

BACKGROUND: The United States currently faces a public health crisis with regarding to antibiotic-resistant bacteria, and new urinary tract infection (UTI) diagnostics are needed. Women with recurrent UTI (rUTI) and complicated UTI (cUTI) are at particular risk given their complexity and the paucity of adequate testing modalities. The standard urine culture (SUC) is the cornerstone for diagnosis, but it has many shortcomings. These pitfalls lead to dissatisfaction and frustration among women afflicted with rUTI and cUTI, as well as overuse of antibiotics. One innovation is PCR UTI testing, which has been shown to outperform SUC among symptomatic women. AIMS: This article discusses UTI PCR testing, as well as a possible role in clinical practice. MATERIALS AND METHODS: Published literature was reviewed and summarized. RESULTS: Management of rUTI and cUTI is complex, and providers should have all diagnostics available to facilitate providing optimal care. Urine PCR testing faces reimbursement issues despite fulfilling clinical indication parameters as described by insurance companies. DISCUSSION: The role of UTI PCR testing remains unclear. Reimbursement issues have led to underuse and limited real-world outcomes reinforcing benefit. CONCLUSION: This study proposes an algorithm for PCR testing among women with rUTI and cUTI.

Coping With Interstitial Cystitis/Bladder Pain Syndrome.

AIMS: Compensatory coping, or maladaptive alterations in behavior with the intention of preventing or managing symptoms, is increasingly being explored as a key factor in how people respond to bladder conditions. Preliminary investigations have identified relations between coping behaviors and psychological distress in urologic conditions, including interstitial cystitis/bladder pain syndrome (IC/BPS). However, previous explorations of coping have not accounted for heterogeneity in coping behaviors or addressed the likelihood that some coping behaviors may be more adaptive than others. This study sought to examine how two specific types of coping behaviors, primary control coping and disengaged coping, are related to distress and symptoms in IC/BPS, and to explore the potential role of pain phenotype in this relationship. MATERIALS AND METHODS: A secondary data analysis was conducted with a large community data set (N = 677 women with IC/BPS) and employed descriptive and inferential statistics to characterize coping patterns and explore novel predictors of distress. RESULTS: Results indicated that almost all participants engaged in at least one compensatory coping behavior within the last week. Both types of coping behaviors correlated with psychological symptoms, and when controlling for relevant clinical variables (i.e., age and severity of urinary symptoms), disengaged coping behaviors were significantly associated with psychological distress. Further, the addition of pain phenotype to multiple regression models resulted in a more effective predictive model when considering the relation between coping behaviors and depression. CONCLUSIONS: By investigating more deeply the relationship between coping and distress, understanding of potential risk factors and mechanisms is increased, offering valuable insights for intervention strategies for IC/BPS patients.

Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature.

INTRODUCTION AND OBJECTIVES: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. METHODS: The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. RESULTS: The WG outlined standardization in four major areas: (1) study design, (2) pretreatment demographics and characterization of the study population, (3) intraoperative events, and (4) posttreatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD-must be included; ADDITIONAL-may be included for a specific study and is inclusive of the Standard items; OPTIMAL-may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY-not relevant. CONCLUSIONS: A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.

Is Our Limited Understanding of the Effects of Nerve Stimulation Resulting in Poor Outcomes and the Need for Better "Rescue Programming" in SNM and PTNS, and Lost Opportunities for New Sites of Stimulation? ICI-RS 2024.

AIMS: Sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) are strongly recommended by international guidelines bodies for complex lower urinary tract dysfunctions. However, treatment failure and the need for rescue programming still represent a significant need for long-term follow-up. This review aimed to describe current strategies and future directions in patients undergoing such therapies. MATERIALS AND METHODS: This is a consensus report of a Think Tank discussed at the Annual Meeting of the International Consultation on Incontinence - Research Society (ICI-RS), June 6-8, 2024 (Bristol, UK): "Is our limited understanding of the effects of nerve stimulation resulting in poor outcomes and the need for better 'rescue programming' in SNM and PTNS, and lost opportunities for new sites of stimulation?" RESULTS: Rescue programming is important from two different perspectives: to improve patient outcomes and to enhance device longevity (for implantable devices). Standard SNM parameters have remained unchanged since its inception for the treatment of OAB, nonobstructive urinary retention, and voiding dysfunction. SNM rescue programming includes intermittent stimulation (cycling on), increased frequency and changes in pulse width (PW). The effect of PW setting on SNM outcomes remains unclear. Monopolar configurations stimulate more motor nerve fibers at lower stimulation voltage; hence, this could be an option in patients who failed bipolar stimulation in the long term. Unfortunately, there is little evidence for rescue programming for PTNS. However, the development of implantable devices for intermittent stimulation of the tibial nerve may increase long-term adherence to therapy and increase interest in alternative programming. There has been recent promising neurostimulation targeting the pudendal nerve (PNS), especially in BPS/IC. More recently, preliminary data addressed the benefits of high-frequency bilateral pudendal nerve block for DESD and adaptive PNS on both urgency and stress UI in women. CONCLUSION: The exploration of rescue programming and new stimulation sites remains underutilized, and there are opportunities that could potentially expand the therapeutic applications of nerve stimulation. By broadening the range of target sites, clinicians may be able to tailor treatments according to individual patient needs and underlying conditions, thereby improving overall outcomes. However, further studies are still needed to increase the level of evidence, potentially allowing for an individualized treatment both in patients who are candidates for electrostimulation and in those who have already received surgical implants but seek a better outcome.

A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial.

AIMS: This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI). METHODS: Adult females were randomized 2:1 to iltamiocel (150 × 106 cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3-day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open-label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations. RESULTS: The study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow-up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants. CONCLUSION: The study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014-002919-41.

Nocturia in Menopausal Women: The Link Between Two Common Problems of the Middle Age.

INTRODUCTION AND HYPOTHESIS: The aim of this review is to discuss the link between menopause and nocturia and to give an overview of the increasing prevalence, risk factors, causative factors, treatment needs and options for nocturia in peri-menopausal women. METHODS: This opinion article is a narrative review based on the expertise and consensus of a variety of key opinion leaders, in combination with an extensive literature review. This literature search included a thorough analysis of potential publications on both the PubMed Database and the Web of Science and was conducted between November 2022 and December 2022. The following key words were used "nocturia" and "menopause" or "nocturnal frequency and menopause." Moreover, key words including "incidence," "prevalence," "insomnia," "estrogen therapy," "metabolic syndrome," and "hot flushes" were used in combination with the aforementioned key words. Last, the reference lists of articles obtained were screened for other relevant literature. RESULTS: The perimenopause can be a trigger for inducing nocturia. Typically, obesity, body mass index (BMI), and waist circumference are risk factors for developing peri-menopausal nocturia. Presumably the development of peri-menopausal nocturia is multifactorial, with interplay among bladder, sleep, and kidney problems due to estrogen depletion after the menopause. First, impaired stimulation of estrogen receptors in the urogenital region leads to vaginal atrophy and reduced bladder capacity. Moreover, menopause is associated with an increased incidence of overactive bladder syndrome. Second, estrogen deficiency can induce salt and water diuresis through blunted circadian rhythms for the secretion of antidiuretic hormone and the activation of the renin-angiotensin-aldosterone system. Additionally, an increased incidence of sleep disorders, including vasomotor symptoms and obstructive sleep apnea signs, is observed. Oral dryness and a consequent higher fluid intake are common peri-menopausal symptoms. Higher insulin resistance and a higher risk of cardiovascular diseases may provoke nocturia. Given the impact of nocturia on general health and quality of life, bothersome nocturia should be treated. Initially, behavioral therapy should be advised. If these modifications are inadequate, specific treatment should be proposed. Systemic hormone replacement is found to have a beneficial effect on nocturia, without influencing sodium and water clearance in patients with nocturnal polyuria. It is presumed that the improvement in nocturia from hormonal treatment is due to an improvement in sleep disorders.

Mixed urinary incontinence: Are there effective treatments?

The aim of this debate article is to discuss whether effective treatments are available for mixed urinary incontinence (MUI). Because patients with MUI have both stress and urgency urinary incontinence (SUI and UUI) episodes and current treatment guidelines currently recommend treating the predominant symptom first, this article presents standard and emerging treatments for both SUI and UUI before discussing how well these treatments meet the medical needs of patients with MUI. Standard treatments presented include noninvasive options such as lifestyle changes and pelvic floor exercises, pharmacological agents, and surgery. Treatment of all three types of urinary incontinence (UI) is usually initiated with noninvasive options, after which treatment options diverge based on UI subtype. Multiple pharmacological agents have been developed for the treatment of UUI and overactive bladder, whereas surgery remains the standard option for SUI and stress-predominant MUI. The divide between UUI and SUI options seems to be propagated in emerging treatments, with most novel pharmacological agents still targeting UUI and even having SUI and stress-predominant MUI as exclusion criteria for participation in clinical trials. Considering that current treatment options focus almost exclusively on treating the predominant symptom of MUI and that emerging pharmacological treatments exclude patients with stress-predominant MUI during the development phase, effective treatments for MUI are lacking both in standard and emerging practice. Ideally, agents with dual mechanisms of action could provide symptom benefit for both the stress and urgency components of MUI.

The bladder contractility and bladder outlet obstruction indices in children. Results of a global Delphi consensus study.

AIMS: This Delphi study was planned to examine global expert consensus with regard to utility, accuracy, and categorization of Bladder Contractility Index (BCI), Bladder Outlet Obstruction Index (BOOI), and the related evidence. This manuscript deals with children and follows previous manuscripts reporting on adult men and women. METHODS: Eighteen experts were invited to answer the two-round survey including three foundation questions and four survey questions. Consensus was defined as ≥75% agreement. The ordinal scale (0-10) in Round 1 was classified into "strongly agree," "agree," "neutral," "disagree," and "strongly disagree" for the final round. A systematic search for evidence was conducted for therapeutic studies that have examined outcome stratified by the indices in children. RESULTS: Eleven experts participated in the survey with 100% completion. Consensus was not noted with regard to any of the questions. There was a general trend toward disagreement with the utility of the BCI and BOOI in children. Systematic search yielded one publication pertaining the value of the indices in predicting long-term outcome in boys treated for posterior urethral valves. CONCLUSIONS: This global Delphi survey of experts showed a general disinclination to use numerical indices for bladder contractility and bladder outflow obstruction in children. There is very little data on the use of the BCI and BOOI indices in children. The establishment of urodynamic indices in children might help refine the treatment of functional urological disorders in children.

The bladder contractility and bladder outlet obstruction indices in adult women. Results of a global Delphi consensus study.

AIMS: This Delphi study was planned to examine global expert consensus with regard to utility, accuracy, and categorization of the bladder contractility index (BCI), bladder outlet obstruction index (BOOI), and the related evidence. This manuscript deals with adult women and follows a previous manuscript reporting on adult men. METHODS: Twenty-nine experts were invited to answer the two-round survey including three foundation questions and 12 survey questions. Consensus was defined as ≥75% agreement. The ordinal scale (0-10) in round 1 was classified into "strongly agree," "agree," "neutral," "disagree," and "strongly disagree" for the final round. A systematic search for evidence was conducted for therapeutic studies that have examined outcome stratified by the indices in women. RESULTS: Eighteen experts participated in the survey with 100% completion. Consensus was noted with regard to 2 of 12 questions, both in the negative. The experts had a consensus that BOOI was neither accurate nor useful and a similar negative trend was noted with regard to BCI. However, there was support, short of consensus, for the utility on an index of bladder contractility and bladder outflow obstruction. Systematic search yielded eight publications pertaining to stress urinary incontinence (n = 6), pelvic organ prolapse (n = 1), and intra-sphincteric botulinum toxin (n = 1). CONCLUSIONS: Experts had significant concerns with regard to the use of the male BCI and BOOI in adult women despite a general recognition of the need for numerical indices of contractility and obstruction. Systematic search showed a striking lack of evidence in this regard.

The bladder contractility and bladder outlet obstruction indices in adult men: Results of a global Delphi consensus study.

AIMS: This Delphi study was planned to examine global expert consensus with regard to utility, accuracy, and categorization of Bladder Contractility Index (BCI) and Bladder Outlet Obstruction Index (BOOI) and the related evidence. METHODS: Twenty-eight experts were invited to answer the two-round survey including three foundation questions and 15 survey questions. Consensus was defined as ≥75% agreement. The ordinal scale (0-10) in round 1 was classified into "strongly agree," "agree," "neutral," "disagree," and "strongly disagree" for the final round. A systematic search for evidence was conducted for therapeutic studies that have examined outcome stratified by the indices in men. RESULTS: Nineteen experts participated in the survey with 100% completion. Consensus was noted with regard to 6 of 19 questions. Experts strongly agreed with utility of quantifying bladder contractility and bladder outflow obstruction with near unanimity regarding the latter. There was consensus that BCI and BOOI were accurate, that BCI was clinically useful, and for defining severe bladder outflow obstruction as BOOI > 80. Systematic search yielded 69 publications (BCI 45; BOOI 50). Most studies examined the indices as a continuous variable or by standard cutoffs (BCI 100, 150; BOOI 20, 40). CONCLUSION: There is general agreement among experts on need for indices to quantify bladder contractility and bladder outflow obstruction as well as with regard to accuracy and utility of BCI and BOOI indices. Few studies have examined the discriminant power of existing cutoffs or explored new ones. This is an extraordinary knowledge gap in the field of urology.

The biopsychosocial impacts of anxiety on overactive bladder in women.

AIMS: Links between emotional state and the bladder have long been recognized, as psychological comorbidity is a common feature of overactive bladder (OAB). However, how psychological factors might contribute to the development and severity of OAB remains unclear. Therefore, we sought to examine the effect of anxiety on OAB with a specific focus on bladder hypersensitivity. METHODS: In a sample of 120 adult women with OAB, we compared those with at least mild anxiety (PROMIS Anxiety score ≥55) to those with lower anxiety. Analyses focused on patient-reported questionnaires assessing urinary symptom severity and quality of life, psychological stress symptoms, general somatic symptoms, and results of quantitative sensory testing (QST), including temporal summation to heat pain (TSP). TSP was used to index elevated C-fiber responsiveness (i.e., central sensitization). RESULTS: Thirty-six (30%) women had at least mild anxiety. While there were no group differences for urinary symptom severity, more anxious women reported worse OAB-specific quality of life, greater psychological stress burden, higher stress reactivity, and greater somatic symptoms. On QST, there were no differences between anxiety groups for pain threshold (43.6 ± 3.1°C vs. 44.0 ± 3.1°C, p = 0.6) and tolerance (47.3 ± 1.5°C vs. 47.4 ± 1.6°C, p = 0.7). However, those with anxiety had significantly higher TSP than those without anxiety (6.0 ± 4.8 vs. 3.7 ± 3.9, p = 0.006), indicating greater central sensitization. CONCLUSIONS: Women with OAB and at least mild anxiety symptoms reported greater psychosocial burdens (i.e., psychological stress, stress reactivity, OAB-specific QOL) and somatic symptom severity and demonstrated greater central sensitization on QST than those without anxiety. These findings support the hypothesis that anxiety and psychological stress impact hypersensitivity mechanisms that may underlie and contribute to OAB, although further research is needed to better understand how and to what extent.

Recurrent urinary tract infection management and prevention techniques among a population-based cohort of women.

INTRODUCTION: Recurrent urinary tract infection (rUTI), defined as three or more UTIs in 12 months, has psychological, physical, and financial burden. Many women with rUTI are not satisfied with care and report only starting preventative measures after several infections. The goal of this study is to elucidate current UTI management trends and the implementation of UTI prevention strategies. METHODS: A web-based study was sent to a national sample of adult women enrolled in ResearchMatch.org. Women were recruited to participate if they had a self-reported UTI in the past 12 months. RESULTS: Of the 755 subjects, nearly 30% reported rUTI. Among women with rUTI, more than 50% reported being peri- or postmenopausal, and two-thirds reported vaginal symptoms. 15.8% of women with rUTI reported dissatisfaction with care versus 7.9% of women without rUTI. Most women see their primary care physician for UTI management and only 26% of women with rUTI follow with a urologist. More than 65% of women increase their fluid intake, wipe from front to back, and urinate after sexual activity to prevent UTIs. Significantly more women with rUTI use transvaginal estrogen, cranberry extract, and low-dose prophylactic antibiotics. These interventions appear to be driven by urologists. CONCLUSION: Most women who have had a UTI in the last 12 months implement lifestyle changes to prevent future infections. Most women see their PCP for UTI management and women with rUTI are twice as likely to report dissatisfaction with care. Despite urologists optimizing medical rUTI prevention, they appear to be underutilized.

Compensatory coping and depression in women with interstitial cystitis/bladder pain syndrome.

INTRODUCTION: Women with genitourinary pain, a hallmark symptom of interstitial cystitis/bladder pain syndrome (IC/BPS), are at a two- to four-fold risk for depression as compared to women without genitourinary pain. Despite the pervasive impact of IC/BPS on psychological health, there is a paucity of empirical research on understanding the relation between IC/BPS and psychological distress. It has been previously reported that women with overactive bladder use increased compensatory coping and these behaviors are associated with heightened anxiety and stress. However, it is unknown whether a similar pattern emerges in IC/BPS populations, as ICBPS and OAB share many similar urinary symptoms. The current study examined the relationship between compensatory coping behaviors and symptoms of psychological distress in a sample of women with IC/BPS to inform understanding of risk and potential mechanisms for intervention. METHOD: This was a secondary analysis of an observational cohort of women with bladder symptoms. Fifty-five adult women with IC/BPS completed validated assessments of genitourinary symptoms, emotional distress, and bladder coping behaviors. Five compensatory coping behaviors were summed to create a total Bladder Coping Score. Linear regression examined associations between individual coping behaviors, total compensatory coping scores, and other risk variables. RESULTS: Most (93%) participants reported use of at least one compensatory coping behavior. Age, education level, history of vaginal birth, and symptom severity were all associated with greater compensatory coping scores, and anxiety was not. Beyond the influence of symptom severity, higher levels of depression were significantly associated with higher compensatory coping scores. DISCUSSION: Greater compensatory coping was associated with increased depression but not anxiety, suggesting different profiles of coping and psychological distress may exist among different types of bladder dysfunction.

Functional neuroimaging related to lower urinary tract sensations: Future directions for study designs and selection of patient groups: ICI-RS 2023.

OBJECTIVES: Neuroimaging studies have advanced our understanding of the intricate central nervous system control network governing lower urinary tract (LUT) function, shedding light on mechanisms for urine storage and voiding. However, a lack of consensus in methodological approaches hinders the comparability of results among research groups and limits the translation of this knowledge to clinical applications, emphasizing the need for standardized methodologies and clinical utilization guidelines. METHODS: This paper reports the discussions of a workshop at the 2023 meeting of the International Consultation on Incontinence Research Society, which reviewed uncertainties and research priorities to progress the field of neuroimaging in LUT control and dysfunction. RESULTS: Neuroimaging holds great potential for improving our understanding of LUT control and pathophysiological conditions. To date, functional neuroimaging techniques have not yet achieved sufficient strength to make a direct clinical impact. Potential approaches that can improve the clinical utilization of neuroimaging were discussed and research questions proposed. CONCLUSIONS: Neuroimaging offers a valuable tool for investigating LUT control, but it's essential to acknowledge the potential for oversimplification when interpreting brain activity due to the complex neural processing and filtering of sensory information. Moreover, technical limitations pose challenges in assessing key brain stem and spinal cord centers, particularly in cases of neurological dysfunction, highlighting the need for more reliable imaging of these centers to advance our understanding of LUT function and dysfunction.

Clinical hypnosis can reduce lower urinary tract symptoms in individuals with chronic pain.

STUDY PURPOSE: Lower urinary tract symptoms (LUTS) can occur in chronic pain populations at high rates and drastically affect quality of life. Hypnosis is a nonpharmacological treatment used in chronic pain known to have beneficial implications to health outside of pain reduction. This study evaluated the potential for hypnosis to reduce LUTS in a sample of individuals with chronic pain, if baseline LUTS severity affected outcomes, and specific LUTS that may respond to hypnosis. METHODS: Sixty-four adults with chronic pain and LUTS at a level of detectable symptom change (American Urological Association Symptom Index, AUASI 3) participated in an 8-week group hypnosis protocol. Participants completed validated assessments of LUTS, pain, and overall functioning before, after, 3- and 6-months posttreatment. Linear mixed effects models assessed improvement in LUTS over time while accounting for known factors associated with outcome (e.g., age, gender). The interaction of baseline symptom severity and treatment assessed the potential effect of baseline symptoms on change scores. RESULTS: Participants experienced significant and meaningful improvements in LUTS following group hypnosis (p = 0.006). There was a significant interaction between baseline symptom severity and treatment (p < 0.001), such that those with severe symptoms experienced the most pronounced gains over time (e.g., an 8.8 point reduction). Gains increased over time for those with moderate and severe symptoms. Changes in LUT symptoms occurred independently of pain relief. CONCLUSIONS: This pilot study suggests hypnosis has the potential to drastically improve LUTS in individuals with chronic pain, even when pain reduction does not occur. Results provide initial evidence for the treatment potential of hypnosis in urologic pain (and possibly non-pain/benign) populations, with randomized trials needed for definitive outcomes.

Sleep Disorders, Comorbidities, Actions, Lower Urinary Tract Dysfunction, and Medications ("Sleep C.A.L.M.") in the evaluation and management of nocturia: A simple approach to a complex diagnosis.

INTRODUCTION: Nocturia arises from a fundamental mismatch between nocturnal urine production, storage capacity, and sleep architecture, which may be driven by abnormalities of the genitourinary tract, but also by sleep disorders, medical diseases, patient actions/lifestyle factors, or medications. This article introduces a novel system for organizing the complex differential diagnosis for nocturia, as proposed by an international collective of practicing urologists, physician specialists, and sleep experts: "Sleep CALM"-Sleep Disorders, Comorbidities, Actions, Lower Urinary Tract Dysfunction, and Medications. METHODS: Narrative review of current evidence regarding the relevance of each "Sleep CALM" factor to nocturia pathogenesis, evaluation, and management. RESULTS: Nocturia and sleep disorders are highly intertwined and often bidirectional, such that nocturnal awakenings for reasons other than a sensation of bladder fullness should not be used as grounds for exclusion from nocturia treatment, but rather leveraged to broaden therapeutic options for nocturia. Nocturia is an important potential harbinger of several serious medical conditions beyond the genitourinary tract. Urologists should have a low threshold for primary care and medical specialty referral for medical optimization, which carries the potential to significantly improve nocturnal voiding frequency in addition to overall health status. Adverse patient actions/lifestyle factors, lower urinary tract dysfunction, and medication use commonly coexist with disordered sleep and comorbid medical conditions, and may be the primary mediators of nocturia severity and treatment response, or further exacerbate nocturia severity and complicate treatment. CONCLUSION: "Sleep CALM" provides a memorable and clinically relevant means by which to structure the initial patient history, physical exam, and clinical testing in accordance with current best-practice guidelines for nocturia. Although not intended as an all-encompassing diagnostic tool, the "Sleep CALM" schema may also be useful in guiding individualized ancillary testing, identifying the need for specialty referral and multidisciplinary care, and uncovering first-line treatment targets.

Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder.

BACKGROUND: Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective ß3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. METHODS: This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. DISCUSSION: OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.

Associations Between Unmet Social Needs and Overactive Bladder.

PURPOSE: There is growing interest in how social determinants of health may explain relationships between social conditions and health. Overactive bladder is common in the United States, posing a significant public health burden. It was the goal of the present study to assess whether overactive bladder was associated with unmet social needs in a large, cross-sectional sample of patients. MATERIALS AND METHODS: A community-based sample of adults was recruited electronically to complete questionnaires on clinical and demographic information, urinary symptoms and unmet social needs. Multivariable logistic regression was used to assess for association between overactive bladder and multiple unmet social needs. RESULTS: The sample of 3,617 participants had a mean±SD age of 47.9±17.3 years. The majority of participants identified as White, non-Hispanic (83.5%), and female (77.6%). A total of 1,391 patients (38.5%) were found to have overactive bladder. The presence of overactive bladder was associated with numerous unmet social needs, including housing instability, food insecurity, worry about utilities, lack of transportation, skipping medical appointments, needing legal help, stress in personal relationships, worry about toilet access and plumbing at home, and lack of social supports. On multivariable analysis adjusting for multiple covariates, all associations between overactive bladder and social needs remained significant. CONCLUSIONS: Multiple unmet social needs were associated with overactive bladder, which may have implications for the overall management of overactive bladder patients. It is important for providers to consider these unmet social needs of patients, as highlighting and addressing these factors hopefully can help improve care of individuals with overactive bladder.

Sexual Dysfunction in Women after Traumatic Pelvic Fracture Negatively Affects Quality of Life and Mental Health.

BACKGROUND: While the impact of female sexual dysfunction (FSD) on mental health and overall health-related quality of life (HrQOL) has been previously documented, no prior work has evaluated this relationship in women following traumatic pelvic injuries. AIM: This study aims to understand the relationship of FSD with HrQOL and depression in women with a history of traumatic pelvic fracture. METHODS: Data were collected with an electronic survey that included queries regarding mental and sexual health. Inverse probability weighting and multivariate regression models were utilized to assess the relationships between sexual dysfunction, depression and HrQOL. OUTCOMES: Study outcome measures included the Female Sexual Function Index (FSFI) to evaluate sexual functioning, the 8-item patient health questionnaire (PHQ-8) to assess depression symptoms, and the visual analog scale (VAS) component of the EuroQol 5 Dimensions Questionnaire (EQ-5D) to determine self-reported HrQOL. RESULTS: Women reporting FSD had significantly higher PHQ-8 scores with a median PHQ-8 score of 6 (IQR 2, 11) relative to those without FSD who had a median score of 2 (IQR 0, 2) (P < .001). On multivariate linear regression, presence of FSD was significantly associated with higher PHQ-8 scores (ß = 4.91, 95% CI 2.8-7.0, P < .001). FSFI score, time from injury, and age were all independently associated with improved HrQOL, with FSFI having the largest effect size (ß = 0.62, 95% CI 0.30-0.95, P < .001). CLINICAL IMPLICATIONS: These results underscore importance of addressing not just sexual health, but also mental health in female pelvic fracture survivors in the post-injury setting. STRENGTHS AND LIMITATIONS: This study is one of the first to examine women with traumatic pelvic fractures who did not sustain concomitant urinary tract injuries. Study limitations include low response rate and the inherent limitations of a cross-sectional study design. CONCLUSION: Patients with persistent, unaddressed FSD after pelvic fracture are at unique risk for experiencing depression and reporting worse health-related quality of life due to complex biopsychosocial mechanisms. Gambrah HA, Hagedorn JC, Dmochowski RR, et al. Sexual Dysfunction in Women after Traumatic Pelvic Fracture Negatively Affects Quality of Life and Mental Health. J Sex Med 2022;19:1759-1765.