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1.
JAMA Netw Open ; 7(6): e2415331, 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38842804

RESUMO

Importance: Because unprofessional behaviors are associated with patient complications, malpractice claims, and well-being concerns, monitoring concerns requiring investigation and individuals identified in multiple reports may provide important opportunities for health care leaders to support all team members. Objective: To examine the distribution of physicians by specialty who demonstrate unprofessional behaviors measured through safety reports submitted by coworkers. Design, Setting, and Participants: This retrospective cohort study was conducted among physicians who practiced at the 193 hospitals in the Coworker Concern Observation Reporting System (CORS), administered by the Vanderbilt Center for Patient and Professional Advocacy. Data were collected from January 2018 to December 2022. Exposure: Submitted reports concerning communication, professional responsibility, medical care, and professional integrity. Main Outcomes and Measures: Physicians' total number and categories of CORS reports. The proportion of physicians in each specialty (nonsurgeon nonproceduralists, emergency medicine physicians, nonsurgeon proceduralists, and surgeons) who received at least 1 report and who qualified for intervention were calculated; logistic regression was used to calculate the odds of any CORS report. Results: The cohort included 35 120 physicians: 18 288 (52.1%) nonsurgeon nonproceduralists, 1876 (5.3%) emergency medicine physicians, 6743 (19.2%) nonsurgeon proceduralists, and 8213 (23.4%) surgeons. There were 3179 physicians (9.1%) with at least 1 CORS report. Nonsurgeon nonproceduralists had the lowest percentage of physicians with at least 1 report (1032 [5.6%]), followed by emergency medicine (204 [10.9%]), nonsurgeon proceduralists (809 [12.0%]), and surgeons (1134 [13.8%]). Nonsurgeon nonproceduralists were less likely to be named in a CORS report than other specialties (5.6% vs 12.8% for other specialties combined; difference in percentages, -7.1 percentage points; 95% CI, -7.7 to -6.5 percentage points; P < .001). Pediatric-focused nonsurgeon nonproceduralists (2897 physicians) were significantly less likely to be associated with a CORS report than nonpediatric nonsurgeon nonproceduralists (15 391 physicians) (105 [3.6%] vs 927 [6.0%]; difference in percentages, -2.4 percentage points, 95% CI, -3.2 to -1.6 percentage points; P < .001). Pediatric-focused emergency medicine physicians, nonsurgeon proceduralists, and surgeons had no significant differences in reporting compared with nonpediatric-focused physicians. Conclusions and Relevance: In this cohort study, less than 10% of physicians ever received a coworker report with a concern about unprofessional behavior. Monitoring reports of unprofessional behaviors provides important opportunities for health care organizations to identify and intervene as needed to support team members.


Assuntos
Médicos , Humanos , Estudos Retrospectivos , Feminino , Masculino , Médicos/psicologia , Médicos/estatística & dados numéricos , Má Conduta Profissional/estatística & dados numéricos , Adulto , Pessoa de Meia-Idade , Medicina/estatística & dados numéricos
2.
Neurourol Urodyn ; 2024 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-38837735

RESUMO

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.

3.
Artigo em Inglês | MEDLINE | ID: mdl-38838689

RESUMO

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) post-treatment 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.

4.
Urology ; 2024 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-38795833

RESUMO

OBJECTIVE: To assess baseline UTI knowledge, interest in health resources, and platform preferences for information acquisition and dissemination. MATERIALS AND METHODS: Adult women who had a UTI in the past 12 months were recruited from Researchmatch.org to participate in a web-based quantitative study. Women with recurrent UTI (rUTI) were compared to women with a history of UTI (without rUTI). RESULTS: Six hundred and eighty-seven women were included in the study of which 27.4% (N = 188) had rUTI. Regarding knowledge, significantly more women without rUTI believe UTIs are caused by lack of cleanliness and that most women suffer from UTIs. Significantly more women with rUTI believe that UTIs are inherited and that getting older is associated with getting more UTIs. Regarding barriers to health information, significantly more women without rUTI feel that information is too complex and language barriers exist. More than 90% of subjects utilize their healthcare provider (HCP) for health information and most prefer office-based HCPs for health information. More than 50% of women with rUTI would like to receive UTI health updates. CONCLUSION: Misinformation exists regarding causes, management, and prevention of UTIs. This study identified perceived barriers as well as preferred educational platforms with the hope that this will drive improvements in UTI-related health education.

5.
J Urol ; : 101097JU0000000000004021, 2024 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-38716839
7.
Neurourol Urodyn ; 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38634481

RESUMO

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.

8.
Int Urogynecol J ; 35(5): 935-946, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38436669

RESUMO

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.


Assuntos
Menopausa , Noctúria , Humanos , Noctúria/epidemiologia , Noctúria/etiologia , Feminino , Menopausa/fisiologia , Fatores de Risco , Pessoa de Meia-Idade , Prevalência , Incidência , Terapia de Reposição de Estrogênios , Síndrome Metabólica/complicações , Síndrome Metabólica/epidemiologia , Obesidade/complicações , Fogachos
10.
Neurourol Urodyn ; 43(1): 161-166, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37822027

RESUMO

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.


Assuntos
Infecções Urinárias , Humanos , Feminino , Estados Unidos , Infecções Urinárias/etiologia , Antibacterianos/uso terapêutico , Urinálise , Recidiva , Saúde Pública
12.
Neurourol Urodyn ; 2023 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-37960970

RESUMO

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.

13.
Eur Urol Open Sci ; 57: 98-105, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38020522

RESUMO

Background: Transient increases in postvoid residual urine volume (PVR) requiring clean intermittent catheterization (CIC) have occurred with onabotulinumtoxinA treatment for overactive bladder (OAB). Objective: To evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVRmax) on CIC initiation in adults with OAB and urinary incontinence (UI). Design setting and participants: This was a pooled post hoc analysis of four placebo-controlled, multicenter randomized trials that included adults with idiopathic OAB after first onabotulinumtoxinA treatment (NCT00910845, NCT00910520, NCT01767519, NCT01945489). Patients had at least three urgency UI episodes over 3 d and at least eight micturitions per day, had inadequate management with at least one anticholinergic agent, and were willing to use CIC. Outcome measurements and statistical analysis: We measured the following outcomes: PVRmax within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity). Results and limitations: Of 1504 patients, 87.7% were women and 88.8% were White. The mean age was 60.5 yr across 10-yr age groups, baseline PVR was 13.8-35.0 ml, and estimated functional capacity was 293.5-475.7 ml. Mean baseline PVR was 21.3 ml overall versus 34.0 ml in the group that started CIC. The CIC incidence was 6.2% for women (range 1.1-8.4%) and 10.5% for men (range 0-14.6%). Higher CIC rates were observed for PVRmax >350 ml (women 91.9%, men 84.6%) in comparison to PVRmax of 201-350 ml (women 32.5%, men 17.4%) and PVRmax <200 ml (women 1.2%, men 1.6%). Overall, 2/1504 patients (both women) were unable to void spontaneously. The mean PVR ratio was highest at week 2. Some subgroups had small sample sizes. Conclusions: CIC incidence was low overall, was less frequent for women, was rare with PVRmax ≤200 ml, and did not appear to correlate with baseline PVR. Patient summary: After onabotulinumtoxinA treatment for OAB, patients sometimes insert a catheter to help in emptying their bladder after urinating. In this study, few patients needed a catheter, especially when less urine volume remained after urination.

14.
Neurourol Urodyn ; 42(8): 1589, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37899649
15.
Neurourol Urodyn ; 42(8): 1676-1685, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37670465

RESUMO

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.


Assuntos
Infecções Urinárias , Adulto , Humanos , Feminino , Infecções Urinárias/diagnóstico , Estrogênios/uso terapêutico , Extratos Vegetais/uso terapêutico , Vagina , Prevenção Secundária , Recidiva
16.
Adv Ther ; 40(11): 4741-4757, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37725308

RESUMO

Anticholinergics have been used in the treatment of overactive bladder (OAB), but their use is limited by poor tolerability and anticholinergic-related side effects. Increasingly, providers are discontinuing anticholinergic prescribing because of growing evidence of the association of anticholinergic use with increased risk of cognitive decline and other adverse effects. Newer medications for OAB, the ß3-adrenergic receptor agonists mirabegron and vibegron, do not have anticholinergic properties and are typically well tolerated; however, many insurance plans have limited patient access to these newer OAB medications by requiring step therapy, meaning less expensive anticholinergic medications must be trialed and/or failed before a ß3-agonist will be covered and dispensed. Thus, many patients are unable to easily access these medications. Step therapy and other drug utilization strategies (e.g., prior authorization) are often used to manage the growing costs of pharmaceuticals, but these policies do not always follow treatment guidelines and may harm patients as a result of treatment delays, discontinuations, or related increases in adverse events. Medical professionals have called for reform of drug utilization strategies through partnerships that include clinicians and policymakers. This narrative review discusses prescribing patterns for OAB treatment and the effect of switching between drugs, as well as the costs of step therapy and prior authorization on patients and prescribers.


Assuntos
Bexiga Urinária Hiperativa , Humanos , Bexiga Urinária Hiperativa/tratamento farmacológico , Antagonistas Colinérgicos/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversos
17.
Expert Rev Neurother ; 23(9): 763-774, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37556757

RESUMO

INTRODUCTION: Neurogenic detrusor overactivity (NDO) results in involuntary detrusor contractions during bladder filling or storage risking transmission of pressure to the upper urinary tracts and/or significant incontinence. The goals of bladder management in children with NDO prioritize the preservation of renal function, prevention of UTIs, and optimizing quality of life. First-line measures include intermittent catheterization and anticholinergic medication. However, when conservative measures fail, surgical intervention may be indicated. Historically, the next step was major reconstructive surgery to create a low-pressure urinary reservoir. The introduction of intravesical botulinum neurotoxin A (BoNT/A) for use in children in 2002 offered a less invasive option for management. However, its exact role is still evolving. AREAS COVERED: This article summarizes the mechanism of action of BoNT/A for management of NDO and evaluates the current literature defining common practice and clinical efficacy in children with NDO. The findings of the recently completed phase III trial for intravesical onabotulinumtoxinA in children are discussed in detail. EXPERT OPINION: As the first BoNT/A approved for use in children with NDO, onabotulinumtoxinA appears to be a safe and less invasive alternative to major reconstructive surgery. However, data defining appropriate patient selection and its role as a long-term treatment option continue to develop.


Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Bexiga Urinaria Neurogênica , Bexiga Urinária Hiperativa , Humanos , Criança , Toxinas Botulínicas Tipo A/uso terapêutico , Bexiga Urinaria Neurogênica/tratamento farmacológico , Qualidade de Vida , Urodinâmica , Bexiga Urinária Hiperativa/tratamento farmacológico , Resultado do Tratamento , Fármacos Neuromusculares/uso terapêutico
18.
BMC Urol ; 23(1): 64, 2023 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-37095473

RESUMO

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.


Assuntos
Bexiga Urinária Hiperativa , Adulto , Humanos , Adolescente , Bexiga Urinária Hiperativa/tratamento farmacológico , Qualidade de Vida , Estudos Prospectivos , Resultado do Tratamento , Acetanilidas/uso terapêutico , Método Duplo-Cego , Antagonistas Colinérgicos/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Antagonistas Muscarínicos/uso terapêutico
20.
Neurourol Urodyn ; 42(4): 778-784, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36780135

RESUMO

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.


Assuntos
Sintomas Inexplicáveis , Bexiga Urinária Hiperativa , Adulto , Humanos , Feminino , Masculino , Bexiga Urinária Hiperativa/diagnóstico , Qualidade de Vida , Dor , Ansiedade
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