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PURPOSE: Radiation dose intensification improves outcome in men with high-risk prostate cancer (HR-PCa). A prospective trial was conducted to determine safety, feasibility, and maximal tolerated dose of multilevel magnetic resonance imaging (MRI)-based 5-fraction SABR in patients with HR-PCa. METHODS AND MATERIALS: This phase I clinical trial enrolled patients with HR-PCa with grade group ≥4, prostate-specific antigen (PSA) ≥20 ng/mL, or radiographic ≥T3, and well-defined prostatic lesions on multiparametric MRI (mpMRI) into 4 dose-escalation cohorts. The initial cohort received 47.5 Gy to the prostate, 50 Gy to mpMRI-defined intraprostatic lesion(s), and 22.5 Gy to pelvic lymph nodes in 5 fractions. Radiation doses were escalated for pelvic nodes to 25 Gy and mpMRI lesion(s) to 52.5 Gy and then 55 Gy. Escalation was performed sequentially according to rule-based trial design with 7 to 15 patients per cohort and a 90-day observation period. All men received peri-rectal hydrogel spacer, intraprostatic fiducial placement, and 2 years of androgen deprivation. The primary endpoint was maximal tolerated dose according to a 90-day acute dose-limiting toxicity (DLT) rate <33%. DLT was defined as National Cancer Institute Common Toxicity Criteria for Adverse Events ≥grade 3 treatment-related toxicity. Secondary outcomes included acute and delayed gastrointestinal (GI)/genitourinary (GU) toxicity graded with Common Toxicity Criteria for Adverse Events. RESULTS: Fifty-five of the 62 enrolled patients were included in the analysis. Dose was escalated through all 4 cohorts without observing any DLTs. Median overall follow-up was 18 months, with a median follow-up of 42, 24, 12, and 7.5 months for cohorts 1 to 4 respectively. Acute and late grade 2 GU toxicities were 25% and 20%, while GI were 13% and 7%, respectively. Late grade 3 GU and GI toxicities were 2% and 0%, respectively. CONCLUSIONS: SABR dose for HR-PCa was safely escalated with multilevel dose painting of 47.5 Gy to prostate, 55 Gy to mpMRI-defined intraprostatic lesions, and 25 Gy to pelvic nodal region in 5 fractions. Longer and ongoing follow-up will be required to assess late toxicity.
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Neoplasias da Próstata , Radioterapia de Intensidade Modulada , Antagonistas de Androgênios , Fracionamento da Dose de Radiação , Humanos , Imageamento por Ressonância Magnética , Masculino , Estudos Prospectivos , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Neoplasias da Próstata/radioterapiaRESUMO
Urinary incontinence is a common problem among older adults that is often complicated by many nuanced ethical considerations. Unfortunately, there is a lack of guidance for healthcare professionals on how to navigate such concerns. This International Continence Society white paper aims to provide healthcare professionals with an ethical framework to promote best care practices in the care of older adults with urinary incontinence.
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Incontinência Urinária , Idoso , Humanos , Incontinência Urinária/etiologia , Incontinência Urinária/terapiaRESUMO
INTRODUCTION: The terminology for female and male pelvic floor muscle (PFM) assessment has expanded considerably since the first PFM function and dysfunction standardization of terminology document in 2005. New terms have entered assessment reports, and new investigations to measure PFM function and dysfunction have been developed. An update of this terminology was required to comprehensively document the terms and their definitions, and to describe the assessment method and interpretation of the finding, to standardize assessment procedures and aid diagnostic decision making. METHODS: This report combines the input of members of the Standardisation Committee of the International Continence Society (ICS) Working Group 16, with contributions from recognized experts in the field and external referees. A logical, sequential, clinically directed assessment framework was created against which the assessment process was mapped. Within categories and subclassifications, each term was assigned a numeric coding. A transparent process of 12 rounds of full working group and external review was undertaken to exhaustively examine each definition, plus additional extensive internal development, with decision making by collective opinion (consensus). RESULTS: A Terminology Report for the symptoms, signs, investigations, and diagnoses associated with PFM function and dysfunction, encompassing 185 separate definitions/descriptors, has been developed. It is clinically based with the most common assessment processes defined. Clarity and user-friendliness have been key aims to make it interpretable by clinicians and researchers of different disciplines. CONCLUSION: A consensus-based Terminology Report for assessment of PFM function and dysfunction has been produced to aid clinical practice and be a stimulus for research.
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Distúrbios do Assoalho Pélvico , Urologia , Consenso , Feminino , Humanos , Masculino , Diafragma da Pelve , Sociedades MédicasRESUMO
INTRODUCTION: The terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD) should be defined and organized in a clinically based consensus Report. METHODS: This Report has been created by a Working Group under the auspices and guidelines of the International Continence Society (ICS) Standardization Steering Committee (SSC) assisted at intervals by external referees. All relevant definitions for ANLUTD were updated on the basis of research over the last 14 years. An extensive process of 18 rounds of internal and external review was involved to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A Terminology Report for ANLUTD, encompassing 97 definitions (42 NEW and 8 CHANGED, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different groups involved not only in lower urinary tract dysfunction but additionally in many other medical specialties. CONCLUSION: A consensus-based Terminology Report for ANLUTD has been produced to aid clinical practice and research.
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Ginecologia/normas , Sintomas do Trato Urinário Inferior/diagnóstico , Terminologia como Assunto , Bexiga Urinaria Neurogênica/diagnóstico , Urologia/normas , Adulto , Consenso , Humanos , Sociedades MédicasRESUMO
AIMS: The working group initiated by the ICS Standardisation Steering Committee has updated the International Continence Society Standard "Good Urodynamic Practice" published in 2002. METHODS: On the basis of the manuscript: "ICS standard to develop evidence-based standards," a new ICS Standard was developed in the period from December 2013 to December 2015. In July, a draft was posted on the ICS website for membership comments and discussed at the ICS 2015 annual meeting. The input of ICS membership was included in the final draft before ICS approval and subsequent peer review (for this journal). RESULTS: This evidence-based ICS-GUP2016 has newly or more precisely defined more than 30 terms and provides standards for the practice, quality control, interpretation, and reporting of urodynamics; cystometry and pressure-flow analysis. Furthermore, the working group has included recommendations for pre-testing information and for patient information and preparation. On the basis of earlier ICS standardisations and updating according to available evidence, the practice of uroflowmetry, cystometry, and pressure-flow studies are further detailed. CONCLUSION: ICS-GUP2016 updates and adds on to ICS-GUP2002 to improve urodynamic testing and reporting both for individual care and scientific purposes.
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Urodinâmica/fisiologia , Urologia/normas , Humanos , SociedadesRESUMO
INTRODUCTION AND HYPOTHESIS: To understand the patient burden of study procedures/measures at completion of a randomized controlled trial (RCT) requiring extensive testing and follow-up visits. METHODS: A survey sent after completing the 2-year visit of an RCT comparing Burch colposuspension and fascial retropubic sling to treat stress urinary incontinence assessed degree of bother for seven study procedures, eight study-related factors, and possible motivations to participate in the study. RESULTS: A total of 450 study participants (88%) returned the survey. Urodynamic testing was the most bothersome procedure, followed by 24-h pad test and Q-tip test. Self-administered questionnaires were the least bothersome. Main reasons to participate in the study were to help others, obtain better knowledge about the condition, and be guided by a committed team of investigators/study coordinators. CONCLUSIONS: At the end of a large multicenter RCT, we learned from a confidential patient survey that the most burdensome activities involved invasive procedures, frequent visits, and multiple forms to fill out.
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Procedimentos Cirúrgicos em Ginecologia/métodos , Satisfação do Paciente , Slings Suburetrais , Incontinência Urinária por Estresse/cirurgia , Coleta de Dados , Feminino , Seguimentos , Humanos , Estudos Retrospectivos , Autorrelato , Inquéritos e Questionários , Resultado do TratamentoRESUMO
Leak point pressures have evolved over the last several years as tools for functional bladder assessment. Often, the term leak point pressure is used when referring to abdominal leak point pressures (ALPP). In fact, there are two leak point pressure measurements in urodynamics, ALPP and detrusor or bladder leak point pressures (DLPP). Defining these two leak point pressures and understanding their very different intrinsic values are important goals for the urodynamicist.