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PURPOSE OF REVIEW: In light of the updated AUA/SUFU guidelines on the diagnosis and treatment of overactive bladder (OAB), increased utilization of advanced therapies is expected in the coming years. The primary aim of this review is to summarize existing outcome and safety data on the use of neuromodulation in geriatric patients, as well as highlight recent advances in neuromodulation that may be particularly advantageous in the geriatric population. RECENT FINDINGS: There are mixed data demonstrating efficacy of sacral neuromodulation by decade of life, with older individuals most often demonstrating lower odds of progressing to stage 2 implantation. However, a large majority of patients still undergo stage 2 implantation with no significant increase in complications reported when compared to younger cohorts. Neuromodulation is broadening to have wider indications outside of OAB, which may be particularly beneficial in the elderly population (fecal incontinence, nonobstructive urinary retention, and constipation). Posterior tibial nerve stimulation remains a well tolerated and efficacious treatment for OAB, with new FDA-approved implantable devices joining the commercial market, which may expand access for elderly populations. SUMMARY: The data are encouraging and support the use of neuromodulation in geriatric patients.
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OBJECTIVE: To explore the financial interactions between urology residents and the healthcare industry over a 5-year training period, assessing the implications of these interactions on medical education and practice considering the Physician Payments Sunshine Act. DESIGN: Longitudinal analysis of Open Payments data for a single class of urology residents from 2018 to 2023. SETTING: Data were extracted from the CMS Open Payments Database and cross-referenced with residency program information from the American Urological Association (AUA) and the Accreditation Council for Graduate Medical Education (ACGME). PARTICIPANTS: A cohort of 314 urology residents were identified to have matched in 2018, with 173 residents having reported financial interactions through the Open Payments Program (OPP), representing 55% of the cohort. RESULTS: Analysis revealed that $129,632 was disbursed to the 173 residents throughout their surgical training, with a significant majority (approximately three-quarters or around $100,000) allocated for food and beverage. A statistically significant difference in payment amounts was observed between genders, with male residents receiving an average of $869 compared to $454 for female residents. Payments increased progressively with each postgraduate year (PGY) level, peaking in the fifth year. Despite notable disparities in compensation across AUA sections, no statistically significant variation was found (pâ¯=â¯0.21). The study also highlighted the underestimation of industry influence due to discretionary and heterogeneous reporting practices. CONCLUSIONS: The study underscores a significant, yet potentially underreported, financial interaction between urology residents and the healthcare industry, suggesting a deepening relationship as residents progress through their training. The findings call for a more uniform reporting system to enhance transparency and provide a clearer understanding of the industry's role in medical education and practice. Additionally, many residents may not be aware that their financial interactions are being documented and made public, a factor that could influence their professional behavior and expectations.
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Internato e Residência , Urologia , Internato e Residência/economia , Urologia/educação , Humanos , Estudos Longitudinais , Estados Unidos , Masculino , Feminino , Conflito de Interesses , Setor de Assistência à Saúde/economia , Setor de Assistência à Saúde/legislação & jurisprudência , Adulto , Educação de Pós-Graduação em Medicina/economiaRESUMO
PURPOSE: To review our 10-year experience with laser excision for urethral mesh erosion (UME) of mid-urethral slings (MUS). METHODS: Following Institutional Review Board approval, the charts of female patients with endoscopic laser excision of UME were retrospectively reviewed. Demographics, clinical presentation, surgical history, pre- and post-operative Urinary Distress Inventory-6 scores and quality of life ratings, operative reports, and outcomes were obtained from electronic medical records. UME cure was defined as no residual mesh on office cystourethroscopy 5-6 months after the final laser excision procedure. RESULTS: From 2011 to 2021, 23 patients met study criteria; median age was 56 (range 44-79) years. Twenty (87%) had multiple prior urogynecologic procedures. Median time from MUS placement to presentation with UME-related complaints was 5.3 [interquartile range (IQR) 2.3-7.6] years. The most common presenting symptom was recurrent urinary tract infection (rUTI) (n = 10). Median operating time was 49 (IQR 37-80) minutes. Median duration of follow-up was 24 (IQR 12-84) months. Fourteen (61%) required more than 1 laser excision procedure for UME. Although 5 were asymptomatic (22%), new (n = 5) or persistent (n = 8) urinary incontinence was the most common symptom on follow-up (57%). CONCLUSION: UME presenting symptoms are highly variable, necessitating a high index of suspicion in patients with a history of MUS, especially in the case of rUTI. Endoscopic laser excision is a minimally invasive, brief, safe, outpatient procedure with a high UME cure rate.
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Lasers de Estado Sólido , Slings Suburetrais , Incontinência Urinária por Estresse , Infecções Urinárias , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Telas Cirúrgicas , Qualidade de Vida , Cistoscopia , Slings Suburetrais/efeitos adversos , Incontinência Urinária por Estresse/cirurgiaRESUMO
Introduction: To review the postrobotic-assisted sacrocolpopexy (RASC) course of women admitted for 23 hours post-RASC and identify events requiring intensive medical care or potentially leading to deleterious outcome or urgent readmission if that patient had same-day discharge (SDD) instead of observed overnight. Methods: Patients undergoing RASC from January to December 2020 at one institution were identified and relevant data were obtained via retrospective chart review. Patient exclusions: RASC start time after 12:00 PM, concurrent posterior colporrhaphy, rectopexy, or hysterectomy, or conversion to open. Results: Sixty-nine patients (median age 71 years old) met study criteria with majority American Society of Anesthesiologists class 2 (n = 46, 67%) or 3 (n = 22, 32%). Patient characteristics included prior abdominal surgeries (n = 58, 84%), prior hysterectomy/prolapse repair (n = 25, 37%), known allergy to pain medication (n = 25, 36%), and administration of a postoperative antiemetic (n = 37, 54%) or intra-/postoperative keterolac (n = 36, 52%). Median surgery length was 269 minutes. Postoperative events that may have resulted in urgent readmissions if they had SDD were observed in 6% of patients. In the 1st week post-RASC, there were no readmissions. Conclusions: In this limited quality assurance study, patients undergoing RASC experienced no major complications requiring intensive care. Postoperative events were almost entirely nausea and pain, with no readmissions within the 1st week.
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Prolapso de Órgão Pélvico , Procedimentos Cirúrgicos Robóticos , Humanos , Feminino , Idoso , Alta do Paciente , Estudos Retrospectivos , Prolapso de Órgão Pélvico/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Dor , Complicações Pós-Operatórias , Procedimentos Cirúrgicos em Ginecologia/métodosRESUMO
INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.
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Terapia por Estimulação Elétrica , Estados Unidos , Humanos , United States Food and Drug Administration , Terapia por Estimulação Elétrica/efeitos adversos , Bases de Dados FactuaisRESUMO
OBJECTIVE: To assess the long-term patient outcomes, including the resolution of symptoms and need for subsequent procedures, after vaginal mesh removals (VMR) we evaluate our 14-year experience with VMR from a tertiary center with three FPMRS-trained surgeons. Although the use of transvaginal mesh (TVM) had decreased significantly before its ban in 2019, surgeons are still treating TVM complications and performing vaginal or open/robotic VMR for mesh-related complications. METHODS: A retrospective review of women undergoing VMR with 6 months minimum follow-up was undertaken. The data abstracted included demographics, provider notes, operative reports, pathology findings, outside medical records, peri-operative information, and reoperations. RESULTS: From 2006 to 2020, 133 patients were identified, and 113 patients met study criteria with at least 6 months follow-up. The most common presenting symptoms were dyspareunia (77%) and pain (71%). The majority of VMR were performed vaginally (84.5%). Vaginal mesh was removed from anterior (60%), posterior (11%), and anterior and posterior (10%) compartments. Two ureteral injuries and one rectal injury were repaired intraoperatively. VMR resulted in resolution of pain in 50% of patients. Some patients had persistent pain (21%) and a few developed de novo pain (4%). More than half of the patients had dyspareunia resolution (52%), but 12% had persistent dyspareunia and 2% developed de novo dyspareunia. CONCLUSION: VMR complexity requires advanced surgical expertise. Most patients undergoing VMR had resolution of their presenting symptoms. However, outcomes for pain, sexual function, continence, and/or prolapse can be unpredictable, resulting in multiple surgeries.
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Dispareunia , Prolapso de Órgão Pélvico , Slings Suburetrais , Humanos , Feminino , Prolapso de Órgão Pélvico/cirurgia , Prolapso de Órgão Pélvico/complicações , Telas Cirúrgicas/efeitos adversos , Dispareunia/epidemiologia , Dispareunia/etiologia , Slings Suburetrais/efeitos adversos , Dor , Resultado do Tratamento , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologiaRESUMO
OBJECTIVE: The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. METHODS: All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. RESULTS: Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. CONCLUSIONS: The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.
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Prolapso de Órgão Pélvico , Telas Cirúrgicas , Bases de Dados Factuais , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Próteses e Implantes , Telas Cirúrgicas/efeitos adversos , Estados Unidos , United States Food and Drug AdministrationRESUMO
IMPORTANCE: A better understanding of the effect of elective cesarean delivery (CD) on the development of pelvic floor disorders can help obstetricians counsel pregnant women. OBJECTIVE: This study aimed to perform a systematic review and meta-analysis evaluating whether primary elective CD is protective against pelvic floor disorders. STUDY DESIGN: Using the MOOSE criteria, electronic databases were searched for studies that compared the prevalence of pelvic floor disorders among primiparous women. Outcomes of interest were urinary incontinence (UI), fecal incontinence (FI), anal incontinence (AI), and pelvic organ prolapse (POP). Comparisons were made between CD before the onset of labor ("Elective CD"), CD after trial of labor ("Labor CD"), and vaginal delivery (VD). Risk ratios (RRs) were computed using STATA. Between-study heterogeneity was assessed via Cochrane's homogeneity test and review of the I2 statistic. RESULTS: Nineteen studies were included. The overall prevalence of UI for Elective CD was estimated at 7% (95% confidence interval [CI], 3%-13%), Labor CD at 14% (95% CI, 8%-21%), and VD at 26% (95% CI, 20%-32%). Meta-analysis demonstrated a decreased risk of UI after Elective CD compared with Labor CD (RR, 0.75; P = 0.011) or VD (RR, 0.43; P < 0.001). There was a decreased risk of FI or AI after Elective CD compared with VD, but not when compared with Labor CD. Only 2 studies examined POP, precluding meta-analysis. CONCLUSIONS: Among primiparous women, Elective CD may be protective against UI when compared with Labor CD. There was not a protective effect of Elective CD against FI and AI when compared with Labor CD. More data on the effect of elective CD on POP are needed.
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Incontinência Fecal , Distúrbios do Assoalho Pélvico , Incontinência Urinária , Cesárea/efeitos adversos , Parto Obstétrico/efeitos adversos , Incontinência Fecal/epidemiologia , Incontinência Fecal/etiologia , Feminino , Humanos , Masculino , Distúrbios do Assoalho Pélvico/epidemiologia , Distúrbios do Assoalho Pélvico/etiologia , Gravidez , Incontinência Urinária/epidemiologia , Incontinência Urinária/etiologiaRESUMO
OBJECTIVES: To compare continence outcomes and health-related quality of life (HRQOL) among women with limited activity restrictions vs traditional restrictions following mid-urethral sling (MUS) surgery. METHODS: Thirty-six women who underwent MUS surgery were randomized: (1) the Restrictions group was given traditional postoperative restrictions for 6 weeks while (2) the Limited Restrictions group was instructed to resume normal activities other than pelvic rest. Patients undergoing concomitant surgery for Stage III and IV prolapse were excluded. Participants completed questionnaires related to urinary symptoms (UDI-6, IIQ-7) for continence outcomes and HRQOL (SF-12) at baseline, 1 to 6 weeks, 3 months, 6 months, and at least 1 year after surgery. RESULTS: There was no difference in mean scores on the UDI-6 or IIQ-7 between groups at baseline or any time after surgery. The Limited Restrictions group reported better scores than the Restrictions group on the SF-12 mental health component at 1 week (56.7 vs 50.2, P = .01) and 4 weeks (58.4 vs 53.3, P = .04). The Restrictions group reported better SF-12 physical health scores at 5 weeks (55.7 vs 53.0, P = .02) but there was no difference in HRQOL scores between the two groups at any other time. CONCLUSION: In this pilot study, there was no difference in continence outcomes for women with traditional vs limited activity restrictions following MUS surgery. There were differences in HRQOL in the early post-operative period, but these differences were not sustained. Larger prospective studies are needed, but it appears that activity restrictions after MUS surgery may not be necessary.
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Convalescença , Exercício Físico , Qualidade de Vida , Slings Suburetrais , Incontinência Urinária por Estresse/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Projetos Piloto , Período Pós-Operatório , Autorrelato , Slings Suburetrais/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: We sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries including the terms "Male Sling," "InVance," "Virtue," or "Advance" from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, and manufacturer. We reviewed and categorized the event description text for each medical device report (MDR). RESULTS: A total of 497 adverse events related to the male sling were identified. The adverse events were classified as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths described. The slings involved were the Advance or Advance XP sling (69.8%), InVance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). The 4 most common adverse events described were urinary incontinence (46.7%), sling erosion (9.1%), mechanical malfunction (8.2%), and pain/numbness (8.2%). There was no increase in the number of reports in the years following the FDA warnings for urogynecologic mesh. CONCLUSION: There was an overall modest number of MDRs related to male slings and the majority of them were reported by the manufacturer. The reporting of adverse events for male slings does not seem to be affected by the controversy and scrutiny towards transvaginal mesh and midurethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings.
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PURPOSE: For patients with persistent irritative lower urinary tract symptoms, such as dysuria and urinary frequency, evaluation for the atypical organisms Ureaplasma and Mycoplasma has been a common part of care. However, these species are genitourinary colonizers and have not been established as causative pathogens in chronic lower urinary tract symptoms. We therefore sought to evaluate diagnostic testing patterns for Ureaplasma and Mycoplasma and characterize the associations of these bacteria with irritative lower urinary tract symptoms using molecular detection techniques. MATERIALS AND METHODS: Ureaplasma/Mycoplasma testing patterns for 2019 were assessed using an anonymized data repository. Clean catch urine specimens (179) were collected prospectively from female and male patients with and without irritative lower urinary tract symptoms. Quantitative polymerase chain reaction evaluated urinary Ureaplasma and Mycoplasma DNA concentrations, while next-generation sequencing assessed the relative abundance of Ureaplasma and Mycoplasma within the urinary bacterial population. RESULTS: Ureaplasma/Mycoplasma testing was common, with 575 tests performed in 2019 in our community hospital system. In our cohort, Ureaplasma and Mycoplasma were identified in similar proportions in symptomatic and asymptomatic subjects: 25% of female controls and 27% of females with lower urinary tract symptoms and 9.5% of asymptomatic males and 3.3% of men with symptoms (p=0.87 and p=0.91 for females and males, respectively). Regression analysis revealed that both abundance and concentrations of Mycoplasmataceae correlated negatively with a range of irritative lower urinary tract symptoms, including dysuria and urethral pain. CONCLUSIONS: A statistically significant negative correlation of Ureaplasma/Mycoplasma levels with a variety of lower urinary tract symptoms suggests that polymerase chain reaction-based Mycoplasmataceae detection has little diagnostic benefit in assessment of chronic irritative urinary symptoms.
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Sintomas do Trato Urinário Inferior/complicações , Mycoplasma/isolamento & purificação , Ureaplasma/isolamento & purificação , Sistema Urinário/microbiologia , Adolescente , Adulto , Criança , DNA Bacteriano/genética , Feminino , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Masculino , Técnicas de Diagnóstico Molecular , Mycoplasma/genética , Reação em Cadeia da Polimerase , Estudos Prospectivos , Análise de Sequência de DNA , Ureaplasma/genética , Adulto JovemRESUMO
AIMS: Evaluation and treatment of functional conditions of the lower urinary tract (fcLUT), a subset of benign urinary tract conditions, is highly subjective due to overlapping symptomatology. Despite high prevalence and socioeconomic cost, there has been little improvement in their treatment and lack of progress in understanding their pathophysiology. This study investigates trends in quantity, monetary amounts, and awardees' characteristics of federally funded research awards for fcLUT compared to nonurologic benign conditions (NUBCs) and urologic malignancies. METHODS: Data were extracted from the National Institutes of Health (NIH) and federal RePORTER databases in December 2019. We identified currently active awards in fcLUT, NUBC, and malignant urologic conditions and the associated demographic features of awardees. The authors also examined temporal funding trends for such awards. RESULTS: These database searches revealed that there are consistently fewer awards and funding dollars for the study of fcLUT compared to other benign conditions with similar prevalences. While most research topics have received increased funding in awards and overall funding dollars over time, fcLUT funding has remained relatively flat. Urologists are also underrepresented; only 11 of the 86 recipients of NIH R01 awards to study fcLUT have clinical training in urology. CONCLUSIONS: Even when compared to NUBC, funding for the study of fcLUT remains low and has stagnated over time. Further, investigators who are clinicians in the field of urology are in the minority of those doing this study. Given the need for clinical perspectives in fcLUT research, the lack of urologist representation will inhibit discovery and translational advances.
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Pesquisa Biomédica/economia , Sintomas do Trato Urinário Inferior/diagnóstico , Sintomas do Trato Urinário Inferior/terapia , National Institutes of Health (U.S.)/economia , Urologia/economia , Adulto , Bases de Dados Factuais , Humanos , Sintomas do Trato Urinário Inferior/economia , Pesquisadores , Estados UnidosRESUMO
OBJECTIVE: To better understand what urology applicants look for on interview day and what they care about in selecting a residency program through an analysis of anonymous online posts about the urology interview process. METHODS: We collected 3 years (2016-2018) of comments and posts from the Interview Impressions tab of the Urology Match Google Sheet for 133 urology residencies. Qualitative data analysis was performed using grounded theory methodology. RESULTS: We identified 6 categories of themes on (1) interview day structure, (2) diverse faculty, (3) program culture, (4) surgical training, (5) research, and (6) program benefits. These themes appeared in comments for 77%-86% of the residency programs except for research which was present for 44% of the programs. The efficiency and structure of interview day are very important. Applicants also care about young and diverse fellowship-trained faculty across a wide breadth of subspecialties. They believe they are able to discern the program culture and collegiality between residents and faculty. Applicants want a balance of surgical and clinical training with a focus on robotics and surgical autonomy. Not all applicants are interested in research but those that are appreciate a strong support system. Finally, additional program benefits and the positives and negatives of the program's location are frequently discussed. CONCLUSION: Analysis of anonymous social media posts can help improve the interview process for applicants and programs alike. Programs can also identify areas of improvement for residency training. Our findings provide additional insight towards the ultimate goal of improving the match process.
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Internato e Residência , Estudantes de Medicina , Urologia/educação , Educação de Pós-Graduação em Medicina , Bolsas de Estudo , Humanos , Internet , Motivação , Satisfação Pessoal , Pesquisa Qualitativa , Participação dos InteressadosRESUMO
OBJECTIVE: To provide guidance when performing bedside urologic procedures on severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive patients and offer considerations to maximize the safety of the patients and providers, conserve supplies, and provide optimal management of urologic issues. METHODS: Urologic trainees and attending physicians at our institution, who are familiar with existing safety recommendations and guidelines regarding the care of infected patients, were queried regarding their experiences to determine an expert consensus on best practices for bedside procedures for SARS-CoV-2 positive patients. RESULTS: Our team developed the following general recommendations for urologic interventions on SARS-CoV-2 positive patients: maximize use of telehealth (even for inpatient consults), minimize in-room time, use personal protective equipment appropriately, enlist a colleague to assist, and acquire all supplies that may be needed and maintain them outside the room. Detailed recommendations were also developed for difficult urethral catheterization, bedside cystoscopy, incision and drainage of abscesses, and gross hematuria/clot irrigations. CONCLUSION: As patients hospitalized with SARS-CoV-2 infection are predominantly men over 50 years old, there are significant urologic challenges common in this population that have emerged with this pandemic. While there is tremendous variation in how different regions have been affected, the demographics of SARS-CoV-2 mean that urologists will continue to have a unique role in helping to manage these patients. Here, we summarize recommendations for bedside urologic interventions specific to SARS-CoV-2 positive patients based on experiences from a large metropolitan hospital system. Regulations and requirements may differ on an institutional basis, so these guidelines are intended to augment specific local protocols.
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Betacoronavirus , Infecções por Coronavirus/epidemiologia , Técnicas de Diagnóstico Urológico , Pneumonia Viral/epidemiologia , Sistemas Automatizados de Assistência Junto ao Leito/organização & administração , Doenças Urológicas/terapia , Unidade Hospitalar de Urologia , Abscesso/terapia , COVID-19 , Cistoscopia/métodos , Drenagem , Hematúria/terapia , Humanos , Controle de Infecções , Pandemias , Equipamento de Proteção Individual , SARS-CoV-2 , Telemedicina , Irrigação Terapêutica/métodos , Cateterismo Urinário/métodosRESUMO
INTRODUCTION AND HYPOTHESIS: The purpose of this study was to apply a human factors research approach to identify flow disruptions, deviations in the optimal course of care, in robotic abdominal sacrocolpopexy procedures with the ultimate goal of developing system interventions to improve the safety and efficiency of robotic surgery. METHODS: Twenty-four robotic abdominal sacrocolpopexy procedures were observed for flow disruptions. Surgeries were divided into four phases: (1) patient arrival and induction of anesthesia; (2) port placement and robot docking; (3) console time; (4) undocking of robot, incision closure, and patient exiting the OR. RESULTS: Flow disruptions were observed at a rate of 10.9 ± 5.1 per hour. The most frequently observed flow disruptions involved training issues (2.8 ± 2.4 flow disruptions per hour), equipment (2.2 ± 1.6 flow disruptions per hour), and poor coordination (2.0 ± 1.3 flow disruptions per hour). The rate of flow disruptions was highest in phase 2 (19.2 ± 14.4 flow disruptions per hour). Cases with more experienced surgeons involved shorter console times by 1.5 h (95% CI: 0.1, 3.0, p = 0.033) and 1.8 fewer (95% CI: 1.2, 2.6, p = 0.001) flow disruptions per hour. Surgeries were 1 h shorter on average (95% CI: 0.1, 1.9, p = 0.034) in cases in which the patient was > 65 years old. Da Vinci S console times were 0.8 h longer (95% CI: 0.01, 1.5, p = 0.047) than Si. CONCLUSIONS: Flow disruptions in robotic abdominal sacrocolpopexy surgery occur about every 6 min. Flow disruption rates are highest during the most complex portions of the surgery. More experienced surgeons have lower flow disruption rates and operate more quickly.
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Abdome/cirurgia , Colposcopia/métodos , Ergonomia , Procedimentos Cirúrgicos em Ginecologia/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Background: The da Vinci Surgical System has led to a rapid growth in the volume of robot-assisted surgeries, with 877,000 surgeries performed in 2017. Despite the increasing prevalence of robotic urologic surgeries, few long-term studies exist that examine trends in reported adverse events (RAEs). We analyzed RAEs over the past decade. Materials and Methods: We extrapolated all entries from the Manufacturer and User Facility Device Experience (MAUDE) database with the manufacturer "Intuitive Surgical" from 2007 to 2017. Reports were analyzed for date and type of RAE (death, bodily injury, malfunction, and other). RAEs from urologic surgeries were analyzed further for specific information pertaining to death, bodily injury, and malfunction. Results: A total of 19,783 RAEs were analyzed. Instrument or robot malfunctions comprised the majority of RAEs (84.9%); bodily injuries comprised 8.2%. Death was the least common RAE (1.3%). RAEs for urologic robotic surgeries peaked in 2013 and 2014 and decreased since. A total of 69 (2.3%) deaths, 364 (12.2%) injuries, and 2544 (85.5%) instrument or robot malfunctions occurred. No reported deaths were attributed to system or mechanical malfunction, but rather to medical complications reported to be unrelated to surgery. The most common injuries were bowel (22.3%) and genitourinary (GU) (19.5%). Instrument malfunctions caused 16.8% of bodily injuries. Conclusions: RAEs for robotic urologic surgeries peaked in 2013 to 2014, and have decreased annually since. When malfunctions occurred, they did not result in death and infrequently resulted in bodily injury. Potential quality improvement targets include prevention of bowel and GU injuries through surgical coaching, and improved technology to prevent malfunction of the surgical system and instruments.
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Falha de Equipamento/estatística & dados numéricos , Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Urológicos/efeitos adversos , Cistectomia/efeitos adversos , Cistectomia/estatística & dados numéricos , Bases de Dados Factuais , Corpos Estranhos/epidemiologia , Genitália/lesões , Humanos , Intestinos/lesões , Nefrectomia/efeitos adversos , Nefrectomia/estatística & dados numéricos , Prostatectomia/efeitos adversos , Prostatectomia/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Estados Unidos/epidemiologia , United States Food and Drug Administration , Sistema Urinário/lesões , Procedimentos Cirúrgicos Urológicos/estatística & dados numéricos , Urologia , Lesões do Sistema Vascular/epidemiologiaRESUMO
There is a lack of information regarding malpractice claims and indemnity payments associated with robotic cases in surgery. Malpractice claims and indemnity payouts will elucidate and mitigate harms of future adoption of new technology into surgery. We analyzed claims filed against Intuitive Surgical, Inc. from 2000 to 2017. A law librarian identified product liability claims from 2000 to 2017 with the defendant "Intuitive Surgical, Inc." using the Bloomberg Law database. We reviewed all available legal documents pertaining to identified claims, and extracted data points including filing date, surgery date, surgery type, robot type, instrument type, complications, and case outcomes. Since 2000, 123 claims were filed; 108 met criteria for inclusion. Gynecologic surgeries comprised the majority of claims (62%, 67 claims), followed by urologic surgeries (20%, 22 claims). Number of claims filed peaked in 2013 (30%, 32 claims) and then decreased each year, with 6% (7 claims) filed in 2016, and only 1% (1 claim) filed in 2017. Of the 22 claims regarding robotic urologic surgeries, 19 claims (86%) pertained to prostatectomy. Commonly alleged injuries in urologic cases were bowel injury (8 claims), erectile dysfunction (5 claims), bowel fistulas (4 claims), and incontinence (4 claims). Device failure was cited in only 2 claims. Early adopters of robotic surgery were at highest risk of litigation. This risk subsequently decreased despite the wide spread adoption of this technology. Almost all claims were secondary to surgical complications and not device failure, thus demonstrating a need for more systematic training for novel devices and early adopters.
Assuntos
Seguro/estatística & dados numéricos , Imperícia/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos , Procedimentos Cirúrgicos Urológicos , Humanos , Revisão da Utilização de Seguros , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/legislação & jurisprudência , Procedimentos Cirúrgicos Urológicos/efeitos adversos , Procedimentos Cirúrgicos Urológicos/legislação & jurisprudênciaRESUMO
Recent studies exploring the effects of surgical robots on teamwork are revealing challenges not reflected in clinical studies. This study is a sub analysis of observational data collected from 89 procedures utilising the da Vinci systems. Previous analyses had demonstrated interactions between flow disruptions and contextual factors. This study sought a more granular analysis to provide better insight for improvement. Raters sub-classified disruptions, based upon the original notes, grouped according to four operative phases (pre-robot; docking; surgeon on console; undocking; and finish). The need for repeated utterances; additional supplies retrieval; fogging or matter on the endoscope and procedure-specific training were particularly disruptive. Variations across phases reflect differing demands across the operative course. Combined qualitative and quantitative observational methodologies can identify otherwise undocumented sources of process variation and potential failure. Future observational frameworks should attempt to merge human reliability analysis, a priori modelling, and post hoc analyses of observational data. Practioner Summary: Robotic surgery introduces new challenges into the operating room. Direct observation was used to classify and identify flow disruptions in order to diagnose problems in need of improvement. This technique complements other error prediction and system diagnostic methods which may not account for the complexity and transparency of health care.
Assuntos
Eficiência , Segurança de Equipamentos , Procedimentos Cirúrgicos Robóticos/normas , Humanos , Estudos Observacionais como Assunto , Procedimentos Cirúrgicos Robóticos/métodosRESUMO
OBJECTIVES: Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making. METHODS: We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents. Outcomes and measures used included annual rate of claim, mesh type, time interval between surgery and claim, defendants, and surgeon training. RESULTS: The search returned 76,865 results, and 2979 were excluded, leaving 73,915 claims. Of 739 claims (1%), 63.3% involved slings for SUI, 13.3% mesh for POP, and 165 (23.2%) involved both. The mesh named most often in claims was retropubic slings at 30.3% and transobturator slings at 27.1%. The number of cases filed increased significantly from 730 in 2011 to 11,798 in 2012, which then almost tripled in 2013 to 34,017. The interval from surgery to claim filing ranged from 4.8 to 5.3 years. Only 12% of implanting surgeons were or became board certified in Female Pelvic Medicine and Reconstructive Surgery. Only 4 cases named providers as codefendants. CONCLUSIONS: Most legal claims involved slings for SUI and began after the 2011 Food and Drug Administration communication about mesh for POP. The rise in lawsuits does not reflect the acceptably low complication rates for slings for SUI reported in the literature.
Assuntos
Avaliação de Processos e Resultados em Cuidados de Saúde , Procedimentos de Cirurgia Plástica/legislação & jurisprudência , Slings Suburetrais/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Tomada de Decisão Clínica , Feminino , Humanos , Avaliação de Resultados em Cuidados de Saúde , Prolapso de Órgão Pélvico/cirurgia , Procedimentos de Cirurgia Plástica/estatística & dados numéricos , Slings Suburetrais/estatística & dados numéricos , Telas Cirúrgicas/estatística & dados numéricos , Fatores de Tempo , Estados Unidos , Incontinência Urinária por Estresse/cirurgiaRESUMO
INTRODUCTION: We sought to apply the principles of human factors research to robotic-assisted radical prostatectomy to understand where training and integration challenges lead to suboptimal and inefficient care. MATERIALS AND METHODS: Thirty-four robotic-assisted radical prostatectomy and bilateral pelvic lymph node dissections over a 20 week period were observed for flow disruptions (FD) - deviations from optimal care that can compromise safety or efficiency. Other variables - physician experience, trainee involvement, robot model (S versus Si), age, body mass index (BMI), and American Society of Anesthesiologists (ASA) physical status - were used to stratify the data and understand the effect of context. Effects were studied across four operative phases - entry to insufflations, robot docking, surgical intervention, and undocking. FDs were classified into one of nine categories. RESULTS: An average of 9.2 (SD = 3.7) FD/hr were recorded, with the highest rates during robot docking (14.7 [SD = 4.3] FDs/hr). The three most common flow disruptions were disruptions of communication, coordination, and equipment. Physicians with more robotic experience were faster during docking (p < 0.003). Training cases had a greater FD rate (8.5 versus 10.6, p < 0.001), as did the Si model robot (8.2 versus 9.8, p = 0.002). Patient BMI and ASA classification yielded no difference in operative duration, but had phase-specific differences in FD. CONCLUSIONS: Our data reflects the demands placed on the OR team by the patient, equipment, environment and context of a robotic surgical intervention, and suggests opportunities to enhance safety, quality, efficiency, and learning in robotic surgery.