Laser excision of urethral mesh erosion: a 10-year experience.

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.

Identifying Patient and Surgical Criteria for Same-Day Discharge After Robotic-Assisted Sacrocolpopexy.

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.

Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data.

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.

Seeking the Truth About Primary Elective Cesarean Delivery and Pelvic Floor Disorders: A Systematic Review and Meta-Analysis.

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.

IMACTIV: A Pilot Study of the Impact of Unrestricted Activity Following Urethral Sling Surgery.

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.

Underrepresentation of functional conditions of the lower urinary tract in adults in US federal research funding.

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.

Considerations for Bedside Urologic Procedures in Patients With Severe Acute Respiratory Syndrome Coronavirus-2.

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.

Flow disruptions in robotic-assisted abdominal sacrocolpopexy: does robotic surgery introduce unforeseen challenges for gynecologic surgeons?

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.

Robotic Urologic Surgery: Trends in Food and Drug Administration-Reported Adverse Events Over the Last Decade.

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.

Robotic urologic surgery: trends in litigation over the last decade.

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.

The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics.

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.

Diagnosing barriers to safety and efficiency in robotic surgery.

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.

Surgical flow disruptions during robotic-assisted radical prostatectomy.

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.

Teaching mid-urethral sling surgery to residents: Impact on operative time and postoperative outcomes.

AIMS: The purpose of this study was to determine the impact of resident teaching on outcomes of mid-urethral sling surgery. METHODS: A retrospective review of female patients who underwent an outpatient transobturator (TOT) synthetic mid-urethral sling procedure with and without concomitant prolapse repair by two surgeons (JA, KE) in a tertiary female pelvic medicine practice was performed. Total procedure time (TPT = time from incision to closure including sling placement and any prolapse procedure), estimated blood loss (EBL), and postoperative complications including urinary retention, mesh exposure, reoperation, vaginal bleeding, and leg pain were compared between cases with and without the presence of a resident. RESULTS: One hundred thirty-four women underwent an outpatient transobturator sling procedure. Fifty-seven patients (43%) had a concomitant prolapse procedure. A resident was present at 57% (76/134) of cases. The average observed TPT (±SEM) was 60.6 ± 3.1 min when a resident was present and 46.6 ± 2.5 min when a resident was not present (P = 0.001). However, residents were more likely to be present when concomitant procedures were performed (P = 0.003). After adjusting for this, the presence of a resident increased TPT by an estimated 7.9 ± 2.5 min (P = 0.002). There was no statistical difference in EBL or postoperative complications. CONCLUSIONS: Resident participation in transobturator sling procedures resulted in a statistically significant, although clinically small, increase in operative time and had no significant impact on EBL or postoperative complications.

Reducing Operating Room Turnover Time for Robotic Surgery Using a Motor Racing Pit Stop Model.

BACKGROUND: Operating room (OR) turnover time, time taken between one patient leaving the OR and the next entering, is an important determinant of OR utilization, a key value metric for hospital administrators. Surgical robots have increased the complexity and number of tasks required during an OR turnover, resulting in highly variable OR turnover times. We sought to streamline the turnover process and decrease robotic OR turnover times and increase efficiency. METHODS: Direct observation of 45 pre-intervention robotic OR turnovers was performed. Following a previously successful model for handoffs, we employed concepts from motor racing pit stops, including briefings, leadership, role definition, task allocation and task sequencing. Turnover task cards for staff were developed, and card assignments were distributed for each turnover. Forty-one cases were observed post-intervention. RESULTS: Average total OR turnover time was 99.2 min (95% CI 88.0-110.3) pre-intervention and 53.2 min (95% CI 48.0-58.5) at 3 months post-intervention. Average room ready time from when the patient exited the OR until the surgical technician was ready to receive the next patient was 42.2 min (95% CI 36.7-47.7) before the intervention, which reduced to 27.2 min at 3 months (95% CI 24.7-29.7) post-intervention (p < 0.0001). CONCLUSIONS: Role definition, task allocation and sequencing, combined with a visual cue for ease-of-use, create efficient, and sustainable approaches to decreasing robotic OR turnover times. Broader system changes are needed to capitalize on that result. Pit stop and other high-risk industry models may inform approaches to the management of tasks and teams.