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INTRODUCTION AND HYPOTHESIS: As surgeons increase the volume of robotic abdominal sacrocolpopexies (rASCs) and become more experienced, a subsequent decrease in the number of adverse events is expected over time. Further, as the leading manufacturer of the operative robot (Intuitive Surgical) improves the technology, adverse events should also decrease. We hypothesized that there has been a decrease in adverse event reporting for rASCs and that serious adverse events are rare. METHODS: We performed a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. All entries with the manufacturer "Intuitive Surgical" were exported from 2007 to 2017. All entries with "sacrocolpopexy" were then isolated and analyzed. RESULTS: The number of adverse events reported for rASC peaked in 2013 and 2014, at 107 and 124 respectively. In 2015 and 2016, the number dropped to 11 and 7 respectively. There were 334 reported adverse events from 2007 to 2017. Five (1.50%) were categorized as death, 33 (9.88%) as injury, and 296 (88.62%) as malfunction. Analysis of the malfunction reports found that 15 out of 296 (5.07%) were converted to open surgery, 4 out of 296 (1.3%) were converted to laparoscopic surgery, 4 out of 296 (1.3%) cases were aborted, and 6 out of 296 (2.03%) malfunctions resulted in patient injury. CONCLUSIONS: Although the MAUDE database has its limitations, it does indicate that the number of adverse events reported for rASC peaked in 2013 and 2014 and has decreased annually since then. This may be due to improved proficiency of the surgeon and surgical team, in addition to improvements in the robot. When malfunctions do occur, they infrequently cause serious injury or have an impact on surgical approach.
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Prolapso de Órgão Pélvico/cirurgia , Gestão de Riscos/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Vagina/cirurgia , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Sacro/cirurgia , Fatores de Tempo , Estados Unidos , United States Food and Drug AdministrationRESUMO
INTRODUCTION: A variety of procedures for the endoscopic surgical treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to medical therapy have existed for decades. The present study examines trends in surgeon compensation for these treatments within Canada. METHODS: The physician fee schedule for BPH surgery across 10 Canadian provinces for the years 2010 and 2023 were obtained. A descriptive study examining first, the provincial reimbursement for transurethral resection of prostate (TURP) and laser ablative/enucleation surgery; second, the difference in TURP reimbursement between 2010 and 2023; and third, the annual change in TURP reimbursement juxtaposed with the annual change in the provincial Consumer Price Index (CPI) and annual salary for the working population aged 35-44. RESULTS: Seven of 10 Canadian provinces reimburse laser BPH surgery equally to TURP. The average provincial TURP reimbursement is $545, ranging from $451 in Ontario to $688 in Saskatchewan. Since 2010, TURP reimbursement has varied by province from a 0% net change in Ontario to an increase of 21% in Nova Scotia. Reimbursement for TURP has increased at a slower pace than the local CPI, and for half of the provinces at a slower pace than the annual salary for people aged 35-44. CONCLUSIONS: The compensation model for endoscopic BPH surgery does not have a unified structure in Canada that is consistent across provinces, nor does it keep up with inflation, possibly impacting future recruitment, increasing geographic disparities, and most importantly, limiting the adoption of new BPH therapies.
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OBJECTIVE: To determine whether existing data support the use of multiple passes in Aquablation for LUTS due to BPH. METHODS: Data were obtained from 2sources. The WATER trial (NCT02505919) is a prospective, multicenter, double-blind, randomized controlled trial of Aquablation vs TURP in prostate volumes of 30 - 80 ml. The WATER II trial (NCT03123250) is a prospective single-arm multicenter trial of Aquablation in prostate volumes of 80-150ml. The number of passes was determined by the procedural data collected and the video recordings of all study cases. RESULTS: In total, 127 Aquablation subjects underwent a single pass, 90 underwent multiple passes (80 had 2passes and 10 underwent 3passes), and 65 underwent TURP (in WATER only). Men undergoing 2or more passes with Aquablation had larger prostates but few differences in other baseline parameters, including prostate size range. Compared to a single pass, the use of 2or more passes during Aquablation resulted in lower IPSS scores (by â¼4 points, P = .0002) and lower IPSS QoL scores (by â¼0.7 points, P = .0096) at the later timepoints of 24 and 36 months. Similarly, 36-month Qmax values were higher (by â¼5 ml/sec, P = .0220) in those with 2or more passes than in those with 1pass. There was no statistically significant difference in ejaculatory dysfunction between groups. CONCLUSION: Independent of prostate volume, a multiple treatment pass protocol led to improved voiding outcomes and IPSS improvement.
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Técnicas de Ablação , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Estudos Prospectivos , Qualidade de Vida , Técnicas de Ablação/efeitos adversos , Técnicas de Ablação/métodos , Ressecção Transuretral da Próstata/efeitos adversos , Ressecção Transuretral da Próstata/métodos , Água , Resultado do TratamentoRESUMO
PURPOSE: Erosion of a midurethral sling is common in women who are treated for stress urinary incontinence. This complication is usually managed by retropubic exploration. We report a novel technique to manage erosion in patients who refuse retropubic exploration. PATIENTS AND METHODS: Two women (ages 47 and 53 years) with stress urinary incontinence were treated with a midurethral sling. Postoperatively, at 24 and 22 months, respectively, the sling had eroded through the high urethra near the bladder neck. A three-port extraperitoneal laparoscopic approach was used to remove the urethral slings and repair the bladder. RESULTS: The procedure was accomplished in 80 and 75 minutes, respectively, with no complications. Both patients remained continent. CONCLUSION: A minimally invasive extraperitoneal surgical technique can be used to manage midurethral sling erosion in women.
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Remoção de Dispositivo/métodos , Slings Suburetrais/efeitos adversos , Doenças da Bexiga Urinária/etiologia , Incontinência Urinária por Estresse/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Peritônio , Falha de Prótese , Doenças da Bexiga Urinária/cirurgiaRESUMO
After robot-assisted laparoscopic prostatectomy, total anatomic reconstruction (TR) with the additions of a circumapical urethral dissection, a dynamic detrusor cuff trigonoplasty, and placement of a suprapubic catheter was performed in 49 patients from June to July 2012. Continence at 6 weeks after catheter removal was assessed for an initial group of 23 patients, and also at 2 weeks in an additional 26 patients who most recently had undergone surgery. Follow-up appointments and telephone interviews were used to assess pad use and continence. Of the initial 23 patients receiving the modified TR, 60.9% had 0 pad use at 6 weeks. By 2 weeks, 65.4% of the most recent 26 patients operated on achieved continence with 0-1 pad use. Preservation and reconstruction of the pelvic floor and supporting bladder structures leads to an earlier return of continence. These key steps need to be validated and confirmed in larger and randomized trials.