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PURPOSE OF REVIEW: There has been a need for an acceptable common minimum data set in the scientific literature as regards the surgical treatment of female stress urinary incontinence (SUI). Such a data set, if widely adopted, would improve the quality of the literature and allow objective comparisons between and across interventions. RECENT FINDINGS: The surgical treatment of female stress urinary incontinence has evolved considerably over the past few decades. The corresponding body of literature has grown exponentially describing the outcomes of hundreds of studies of these novel interventions. However, historically, the literature in this space has been of uneven quality. In order to improve the reporting of clinical studies, and ultimately patient outcomes, a standard minimum data set for trial design and publications was created by a collaborative group formed from leading scientific societies. SUMMARY: The consensus document created from this novel collaboration between members of SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction), AUGS (American Urogynecologic Society), and ICS (International Continence Society) provides clear guidance for the structure of clinical studies and reporting of results in the peer-reviewed literature. This has substantial potential ramifications for scientific journals, journal editors, peer reviewers, investigators, regulatory agencies, industry, clinicians, and patients.
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PURPOSE: The purpose of this guideline is to provide evidence-based guidance to clinicians of all specialties on the evaluation, management, and treatment of idiopathic overactive bladder (OAB). The guideline informs the reader on valid diagnostic processes and provides an approach to selecting treatment options for patients with OAB through the shared decision-making process, which will maximize symptom control and quality of life, while minimizing adverse events and burden of disease. METHODS: An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB from January 2013 to November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest. Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements. RESULTS: This guideline produced 33 statements that cover the evaluation and diagnosis of the patient with symptoms suggestive of OAB; the treatment options for patients with OAB, including Noninvasive therapies, pharmacotherapy, minimally invasive therapies, invasive therapies, and indwelling catheters; and the management of patients with BPH and OAB. CONCLUSION: Once the diagnosis of OAB is made, the clinician and the patient with OAB have a variety of treatment options to choose from and should, through shared decision-making, formulate a personalized treatment approach taking into account evidence-based recommendations as well as patient values and preferences.
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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.
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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.
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PURPOSE: The efficacy and safety of vibegron, a ß3-adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. MATERIALS AND METHODS: Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary end points were change from baseline at week 12 in mean daily micturitions and urgency episodes. Secondary end points were change from baseline at week 12 in mean nightly nocturia and daily urge urinary incontinence episodes, International Prostate Symptom Scoreâstorage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs). RESULTS: Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [95% CI], -0.74 [-1.02, -0.46]; P < .0001) and urgency episodes (-0.95 [-1.37, -0.54]; P < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (least squares mean difference, -0.22 [-0.36, -0.09]; P = .002), urge urinary incontinence episodes (-0.80 [-1.33, -0.27]; P = .003), International Prostate Symptom Scoreâstorage scores (-0.9 [-1.2, -0.6]; P < .0001), and volume voided (15.07 mL [9.13-21.02]; P < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were hypertension (9.0% vs 8.3%), COVID-19 (4.0% vs 3.1%), UTI (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). CONCLUSIONS: In this trial, vibegron met all primary and secondary end points and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.
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Agonistas de Receptores Adrenérgicos beta 3 , Hiperplasia Prostática , Bexiga Urinária Hiperativa , Humanos , Masculino , Hiperplasia Prostática/complicações , Hiperplasia Prostática/tratamento farmacológico , Bexiga Urinária Hiperativa/tratamento farmacológico , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Método Duplo-Cego , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 3/administração & dosagem , Pirimidinonas/uso terapêutico , Pirimidinonas/efeitos adversos , Pirimidinonas/administração & dosagem , Pirrolidinas/uso terapêutico , Pirrolidinas/efeitos adversos , Pirrolidinas/administração & dosagem , Inibidores de 5-alfa Redutase/uso terapêutico , Inibidores de 5-alfa Redutase/efeitos adversos , Antagonistas Adrenérgicos alfa/uso terapêutico , Quimioterapia CombinadaRESUMO
PURPOSE: The purpose of this guideline is to provide evidence-based guidance to clinicians of all specialties on the evaluation, management, and treatment of idiopathic overactive bladder (OAB). The guideline informs the reader on valid diagnostic processes and provides an approach to selecting treatment options for patients with OAB through the shared decision-making process, which will maximize symptom control and quality of life, while minimizing adverse events and burden of disease. METHODS: An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB from January 2013 to November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest. Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements. RESULTS: This guideline produced 33 statements that cover the evaluation and diagnosis of the patient with symptoms suggestive of OAB; the treatment options for patients with OAB, including non-invasive therapies, pharmacotherapy, minimally invasive therapies, invasive therapies, and indwelling catheters; and the management of patients with BPH and OAB. CONCLUSION: Once the diagnosis of OAB is made, the clinician and the patient with OAB have a variety of treatment options to choose from and should, through shared decision-making, formulate a personalized treatment approach taking into account evidence-based recommendations as well as patient values and preferences.
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Bexiga Urinária Hiperativa , Urologia , Humanos , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/terapia , Urologia/normas , Tomada de Decisão Compartilhada , Sociedades Médicas/normasRESUMO
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.
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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.
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Bexiga Urinária Hiperativa , Humanos , Bexiga Urinária Hiperativa/tratamento farmacológico , Antagonistas Colinérgicos/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversosRESUMO
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.
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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 terapêuticoRESUMO
OBJECTIVE: To assess contemporary adherence to the minimum data set proposed for future publication in the 1997 American Urological Association (AUA) guidelines on the surgical management of female SUI in 1997. guidelines among recently published literature. MATERIALS AND METHODS: We reviewed all publications included in the AUA/SUFU Surgical Treatment of Female SUI Guidelines and included articles that reported surgical outcomes for SUI treatment. They were abstracted for the reporting of the previously defined 22 data points. Each article received a compliance score as a percent of parameters met out of the 22 data points. RESULTS: Three hundred eighty articles from the 2017 AUA guidelines search, in combination with an independent updated literature search were included. There was an average compliance score of 62%. The best compliance rates for individual data points were: defined criteria for success (95%) and patient history (97%). The lowest compliance rates were: minimum follow-up >48 months (8%) and post-treatment micturition diary (17%). There was no difference between mean rates of reporting for articles before and after the SUFU/AUA 2017 guidelines (61% pre vs 65% post). CONCLUSION: Adherence to reporting the most recent minimum standards in the current SUI literature is largely suboptimal. This apparent lack of compliance may suggest a role for a more stringent editorial review process, or alternatively that the prior suggested data set was overly burdensome and/or irrelevant.
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Fidelidade a Diretrizes , Incontinência Urinária por Estresse , Feminino , Humanos , Estados Unidos , Incontinência Urinária por Estresse/cirurgia , Guias de Prática Clínica como AssuntoRESUMO
PURPOSE OF REVIEW: Urethral bulking agents are an effective treatment for stress urinary incontinence in select females. The material and techniques used for urethral bulking are constantly evolving. With the introduction of several new agents, there is an ongoing debate over which agent is the most effective, durable, and safe. RECENT FINDINGS: Current available bulking agents include Bulkamid®, Macroplastiue®, Durasphere®, Coaptite®, or Urolastic®. Each of these agents has its own biophysical properties that affect its efficacy and safety. Evidence evaluating bulking agents has increased over time but there is no definitive data that suggest superiority of one agent over another. The ideal urethral bulking agent for female stress incontinence has yet been identified. Currently available agents have acceptable short-term and medium-term efficacy with few adverse events.
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Incontinência Urinária por Estresse , Feminino , Humanos , Resultado do Tratamento , Uretra , Incontinência Urinária por Estresse/terapiaRESUMO
OBJECTIVES: To determine if reduction in urgency in patients with refractory overactive bladder syndrome (rOAB) is correlated with a reduction in voiding frequency and symptom bother. METHODS: Data from a prospective series of women with rOAB undergoing radiofrequency ablation of the subtrigonal tissue, termed selective bladder denervation (SBD), was analyzed. Main outcome measures included urgency voids, nonurgency voids, and urgency urinary incontinence (UUI) epidsodes from a 3-day voiding diary and quality of life (QoL) measures (Overactive Bladder Questionnaire Short Form [OAB-q SF]). RESULTS: The dataset comprised 62 completer subjects at 6 months. Compared to baseline, UUI and urgency voids were lower (P < .001), but nonurgency voids were increased (P < .001) and QoL measures were improved (P < .001), but functional bladder capacity did not increase. At baseline and 6 months post treatment, symptom bother was correlated with urgency voids (P < .05) but inversely correlated with nonurgency voids (P < .001). Urgency and nonurgency voids were inversely related at baseline and at 6 months (P < .0001). Following treatment, urgency voids decreased by 41% and nonurgency voids increased by 33%. CONCLUSIONS: As with other interventions for OAB, SBD resulted in a reduction in OAB symptoms and an improvement in QoL measures. However, the decrease in urgency voids was offset by an increase in nonurgency voids, suggesting that habit or defensive voiding is a significant driver of urinary frequency. It is not certain if this is a unique finding of the SBD effect, but these data do suggest that analyses of outcomes of other OAB interventions are warranted to gain a better understanding of the genesis of OAB symptoms.
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Bexiga Urinária Hiperativa , Incontinência Urinária , Feminino , Humanos , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Bexiga Urinária Hiperativa/complicações , Incontinência Urinária de Urgência/etiologiaRESUMO
PURPOSE: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) needs to balance a variety of factors when making treatment decisions. In addition to the patient's urologic symptoms and urodynamic findings, other issues that may influence management options of the lower urinary tract include cognition, hand function, type of neurologic disease, mobility, bowel function/management, and social and caregiver support. This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared decision-making manner, such that the patient's quality of life can be optimized with respect to their bladder management. MATERIALS AND METHODS: A comprehensive search for studies assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted from January 2001 through October 2017 and was rerun in February 2021 to capture newer literature. The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base. RESULTS: This guideline was developed to inform clinicians on the proper evaluation, diagnosis, and risk stratification of adult patients with NLUTD and the non-surgical and surgical treatment options available. Additional statements on urinary tract infection and autonomic dysreflexia were developed to guide the clinician. CONCLUSIONS: NLUTD patients may undergo non-surgical and surgical treatment options depending on their level of risk, symptoms, and urodynamic findings. Appropriate follow-up, primarily based on their risk stratification, must be maintained after treatment.
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Assistência ao Convalescente/normas , Sintomas do Trato Urinário Inferior/terapia , Bexiga Urinaria Neurogênica/terapia , Urologia/normas , Antagonistas Adrenérgicos alfa/uso terapêutico , Adulto , Assistência ao Convalescente/métodos , Terapia Combinada/métodos , Terapia Combinada/normas , Tomada de Decisão Compartilhada , Terapia por Exercício/métodos , Terapia por Exercício/normas , Humanos , Cateterismo Uretral Intermitente/métodos , Cateterismo Uretral Intermitente/normas , Sintomas do Trato Urinário Inferior/diagnóstico , Sintomas do Trato Urinário Inferior/etiologia , Medição de Risco/métodos , Medição de Risco/normas , Sociedades Médicas/normas , Estados Unidos , Bexiga Urinaria Neurogênica/complicações , Bexiga Urinaria Neurogênica/diagnóstico , Urodinâmica , Procedimentos Cirúrgicos Urológicos/métodos , Procedimentos Cirúrgicos Urológicos/normas , Urologia/métodosRESUMO
PURPOSE: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) needs to balance a variety of factors when making treatment decisions. In addition to the patient's urologic symptoms and urodynamic findings, other issues that may influence management options of the lower urinary tract include cognition, hand function, type of neurologic disease, mobility, bowel function/management, and social and caregiver support. This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared decision-making manner, such that the patient's quality of life can be optimized with respect to their bladder management. MATERIALS AND METHODS: A comprehensive search for studies assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted from January 2001 through October 2017 and was rerun in February 2021 to capture newer literature. The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base. RESULTS: This guideline was developed to inform clinicians on the proper evaluation, diagnosis, and risk stratification of patients with NLUTD and the non-surgical and surgical treatment options available. Additional statements on urinary tract infection and autonomic dysreflexia were developed to guide the clinician. This Guideline is for adult patients with NLUTD and pediatric NLUTD will not be discussed. CONCLUSIONS: NLUTD patients should be risk-stratified as either low-, moderate-, high-, or unknown-risk. After diagnosis and stratification, patients should be monitored according to their level of risk at regular intervals. Patients who experience new or worsening signs and symptoms should be reevaluated and risk stratification should be repeated.
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Sintomas do Trato Urinário Inferior/diagnóstico , Bexiga Urinaria Neurogênica/diagnóstico , Urologia/normas , Adulto , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Sociedades Médicas/normas , Estados Unidos , Bexiga Urinaria Neurogênica/complicações , Urodinâmica , Urologia/métodosRESUMO
OBJECTIVE: To identify potential technical factors during initial mid-urethral sling (MUS) placement that contribute to subsequent sling revision procedures. METHODS: A retrospective chart review was performed examining synthetic MUS reoperations at a single institution from 2008-2020. The implanting surgeon's operative note, when available, was critically reviewed with respect to trocar placement, sling location, and tensioning technique. The reoperative report was reviewed for aberrant intraoperative findings relating to the index surgery. RESULTS: A total of 306 women underwent revision of their MUS. Operative reports from the implanting surgeon were available for 276 (90.2%) women. Review of index operative reports revealed 47 unambiguous descriptions of improper technique, including 19 cases of described excessive tensioning and 2 cases of MUS placement despite noted urethral injury during the index case. Indications for reoperation were clinical obstruction (63%), pain (40%), and mesh erosion/exposure (33%). In 186 (67.4%) women, there was an intraoperative finding during the revision that likely contributed to the need for reoperation. Among these 186 women, 110 (59.1%) slings were noted to have been placed too proximally, 78 (41.9%) were over-suspended, and 57 (30.6%) were placed too deep in the periurethral fascia. CONCLUSION: Review of the index operative note and findings at operative re-exploration of MUS surgeries, often reveals evidence that the initial MUS implantation was technically suboptimal. Such findings suggest that intraoperative surgical technique is a critically important factor contributing to postoperative complications in MUS surgery. This underscores the importance of surgical training and adherence to surgical principles during the placement of a synthetic MUS.
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Complicações Pós-Operatórias/etiologia , Implantação de Prótese/efeitos adversos , Slings Suburetrais/efeitos adversos , Adulto , Idoso , Competência Clínica , Feminino , Humanos , Pessoa de Meia-Idade , Reoperação , Estudos Retrospectivos , Procedimentos Cirúrgicos Urológicos/efeitos adversosRESUMO
A need exists for local (ie, bladder-specific) interventions to treat overactive bladder (OAB) with low risk of unwanted postprocedural outcomes. Gene therapy targeted to leverage endogenous physiology in bladder cells may assist in restoring normal cell and organ function. Herein, we review the potential promise of gene therapy for treating OAB, focusing on gene transfer of URO-902, a non-viral naked plasmid DNA expressing the big potassium (BK) channel. We searched PubMed for articles concerning functional aspects of the BK channel and its potential use for gene transfer as local OAB treatment. Results from preclinical, phase 1, and phase 2 studies of URO-902 for erectile dysfunction and phase 1 studies of URO-902 for OAB are included. The BK channel has been extensively studied; however, URO-902 is the first gene therapy used in clinical trials directed toward treating OAB via the BK channel. In both URO-902 studies, there were no serious adverse events considered treatment related and no adverse events leading to early withdrawal. Both studies included secondary efficacy endpoints with promising results suggesting improvement in OAB symptoms, and quality of life, with use of URO-902 versus placebo. Gene therapy involving the BK channel, such as gene transfer with URO-902, has demonstrated promising safety and efficacy results in women with OAB. Findings warrant further investigation of the use of URO-902 for OAB treatment.
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OBJECTIVES: This analysis from the PERSPECTIVE (a Prospective, Non-interventional Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder) study evaluated treatment persistence with mirabegron or antimuscarinics over a 12-month period. METHODS: Participants were adults diagnosed with overactive bladder (OAB) by their health care provider (HCP), who were initiating mirabegron or antimuscarinic treatment. The HCP made all treatment decisions, and patients were followed for 12 months with no mandatory scheduled visits. Information requests were sent to patients at baseline and months 1, 3, 6, and 12. Patients were nonpersistent if they switched, discontinued, or added OAB medications/therapies to their initial treatment. Reasons for discontinuation and switching patterns were investigated. RESULTS: Overall, 1514 patients were included (613 mirabegron and 901 antimuscarinic initiators). Persistence rates decreased steadily over time in both groups. A low proportion of patients added or switched medication at each time point. Unadjusted Kaplan-Meier analysis showed similar persistence rates for both groups. When the data were adjusted for patient characteristics (age, sex, and OAB treatment status), mirabegron initiators had higher persistence rates. No significant differences were noted in unadjusted median time to end of persistence. However, end of treatment persistence by any cause was longer with mirabegron (median: 9.5 vs 6.7 months for antimuscarinics). HCPs stated that the most common reasons for nonpersistence were no symptomatic improvement and side effect aversion. CONCLUSIONS: Treatment persistence was longer for mirabegron compared with antimuscarinic initiators after controlling for patient characteristics. End of treatment persistence by any cause was also longer with mirabegron.
Assuntos
Bexiga Urinária Hiperativa , Agentes Urológicos , Acetanilidas , Adulto , Humanos , Antagonistas Muscarínicos , Estudos Prospectivos , Sistema de Registros , Tiazóis , Resultado do Tratamento , Bexiga Urinária Hiperativa/tratamento farmacológicoRESUMO
OBJECTIVE: To present the clinical and radiological characteristics of women with severe structural deterioration of the bladder and upper urinary tract secondary to Primary Bladder Neck Obstruction (PBNO), and their outcomes after bladder neck incision (BNI). METHODS: Retrospective evaluation of adult women who underwent BNI for PBNO at one institution. Patients were assessed for symptoms, renal function, structural abnormalities of the urinary tract and video-urodynamics. PBNO diagnosis was confirmed with video-urodynamics in all patients. BNI was performed at the 4-5 and/or 7-8 o'clock positions. Postoperative symptoms, PVR, uroflowmetry and renal function were evaluated and compared to baseline. RESULTS: Median patient age was 56.5 years (range 40-80). All presented with urinary retention-four were on clean intermittent Catheterization (CIC) and two with a Foley catheter. All patients had bladder wall thickening and diverticula. Four women had elevated creatinine levels, bilateral hydronephrosis was present in five (83.3%). After BNI, all patients resumed spontaneous voiding without the need for CIC. Median Qmax significantly improved from 2.0 [1.0-4.0] mL/s to 15 [10-22.7] mL/s (p = 0.031). Median PVR decreased from 150 to 46 [22-76] mL (p = 0.031). There were no postoperative complications. Creatinine levels returned to normal in 3/4 (75%) patients. CONCLUSION: PBNO in women may result in severe damage to the bladder and upper urinary tract. Despite severe structural abnormalities of the bladder, BNI was effective in reducing symptoms and improving structural and functional abnormalities of the lower and upper urinary tract.
Assuntos
Obstrução do Colo da Bexiga Urinária/patologia , Sistema Urinário/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X , Obstrução do Colo da Bexiga Urinária/diagnóstico por imagem , Obstrução do Colo da Bexiga Urinária/fisiopatologia , Sistema Urinário/diagnóstico por imagem , Sistema Urinário/fisiopatologia , UrodinâmicaRESUMO
A Cowper's Duct syringocele is a rare diagnosis and currently there exists no clinical guidelines for evaluation and management. This clinical challenge illustrates the case presentation, evaluation, diagnosis, and treatment options for of a newly diagnosed Cowper's Duct syringocele.
Assuntos
Glândulas Bulbouretrais , Disuria/etiologia , Doenças Uretrais/complicações , Adulto , Glândulas Bulbouretrais/patologia , Dilatação Patológica/complicações , Humanos , Masculino , Doenças Uretrais/diagnósticoRESUMO
AIMS: To identify risk factors for urinary retention following AdVance™ Sling placement using preoperative urodynamic studies to evaluate bladder contractility. METHODS: A multi-institutional retrospective review of patients who underwent an AdVance Sling for post-prostatectomy stress urinary incontinence from 2007 to 2019 was performed. Acute urinary retention (AUR) was defined as the complete inability to void or elevated post-void residual (PVR) leading to catheter placement or the initiation of intermittent catheterization at the first void trial postoperatively. Bladder contractility was evaluated based on preoperative urodynamics. RESULTS: Of the 391 patients in this study, 55 (14.1%) experienced AUR, and 6 patients (1.5%) had chronic urinary retention with a median follow-up of 18.1 months. In total, 303 patients (77.5%) underwent preoperative urodynamics, and there was no significant difference between average PdetQmax (26.4 vs. 27.4 cmH2 O), Qmax (16.6 vs. 16.2 ml/s), PVR (19.9 vs. 28.1 ml), bladder contractility index (108 vs. 103) for patients with or without AUR following AdVance Sling. Impaired bladder contractility preoperatively was not predictive of AUR. Time to postoperative urethral catheter removal was predictive of AUR (odds ratio, 0.83; 95% confidence interval, 0.73-0.94; p = .003). CONCLUSIONS: Chronic urinary retention after AdVance Sling placement is uncommon and acute retention is generally self-limiting. No demographic or urodynamic factors were predictive of AUR. Patients who developed AUR were more likely to have their void trials within 2 days following AdVance Sling placement versus longer initial catheterization periods, suggesting that a longer duration of postoperative catheterization may reduce the occurrence of AUR.