Prostate cancer in transgender women: A propensity score-matched analysis of disease severity and survival.

BACKGROUND: Despite the rise in gender-affirming care, our understanding of prostate cancer (PCa) in transgender women (TGW) remains in its infancy. Health disparities and lack of PCa awareness and screening are possible barriers to providing quality care for this population. In addition, the implication of hormonal manipulation for the aggressiveness of PCa in TGW is yet to be determined. Here, this study sought to compare oncological characteristics and survival outcomes between transgender and cisgender (CG) patients with PCa via two national data sets. METHODS: The Veterans Affairs Informatics and Computing Infrastructure database (1999-2020) and the Surveillance, Epidemiology, and End Results-Medicare database (2010-2017) were reviewed. Demographic and clinical details were analyzed. Logistic regression analysis was performed on propensity score-matched groups to identify predictors of high-risk disease and metastasis in patients with PCa. Groups were matched 5:1 (CG:TGW) on the basis of age, race, year of diagnosis, and Charlson Comorbidity Index score. Primary outcomes included metastatic presentation, high-risk localized disease, overall survival (OS), and prostate cancer-specific mortality (PCSM). RESULTS: A total of 1194 patients were included (199 TGW; 995 CG). Associations between transgender identity and metastatic presentation (odds ratio [OR], 0.38; p = .2), high-risk localized disease (OR, 1.19; p = .50), or PCSM (hazard ratio [HR], 0.65; p = .3) were not detected. Transgender identity was associated with improved OS (HR, 0.67; p = .014). CONCLUSIONS: PCa-specific outcomes seem comparable between TGW and CG men, although the study was underpowered to detect modest differences. Further investigation into the incidence and outcomes of PCa in TGW is warranted.

Longitudinal study of cognitive decline among women with and without urinary incontinence.

BACKGROUND: Cross-sectional and short-term cohort studies have demonstrated an association between urinary incontinence and dementia, as well as lower performance on cognitive testing. The Health and Retirement Study, a longitudinal study of community-dwelling older adults, offers an opportunity to assess the temporal association between these conditions because it included an assessment of incontinence symptoms and biennial assessments of cognitive function. OBJECTIVE: This study aimed to evaluate if urinary incontinence before the age of 70 years had an effect on changes in cognitive function among women participating in the Health and Retirement Study. STUDY DESIGN: This secondary analysis included data from female respondents in the Health and Retirement Study aged 58 to 67 years with ≥2 cognitive assessments. Urinary incontinence was defined as any involuntary loss of any urine in the preceding 12 months. A control group without incontinence was reweighted for better comparability using coarsened exact matching for age and comorbidities. Validated methods, including neuropsychological test data, estimated a memory score and dementia probability for each participant biennially. Coprimary outcomes were the changes in memory score and dementia probability. Linear regression models were used to estimate the association of urinary incontinence with change in memory score and dementia probability, adjusting for baseline demographics and comorbidities. A subgroup analysis was performed to assess the effects of urinary incontinence frequency on these outcomes. The infrequent subgroup reported <15 days of leakage per month and the frequent subgroup reported ≥15 days of leakage per month. RESULTS: Among eligible female respondents, 40.6% reported urinary incontinence between the ages of 58 and 69 years. Baseline memory scores and dementia probability were similar between those with urinary incontinence (n=1706) and controls (n=2507). Memory score declined significantly in both cohorts, indicating poorer memory over time (-0.222 among those with incontinence [95% confidence interval, -0.245 to -0.199] vs -0.207 in controls [95% confidence interval, -0.227 to -0.188]). The decline of memory score was not statistically significantly different between cases and controls (mean difference, -0.015; 95% confidence interval, -0.045 to 0.015). Dementia probability increased significantly in both groups, indicating a greater probability of developing dementia by 0.018 among those with incontinence (95% confidence interval, 0.015-0.020) and by 0.020 among controls (95% confidence interval, 0.017-0.022). The change in dementia probability was not significantly different between groups (mean difference, -0.002; 95% confidence interval, -0.006 to 0.002). Frequent urinary incontinence was reported in 105 of 1706 (6%) of those with urinary incontinence. Memory score declined and dementia probability increased with time (P<.001) in frequent and infrequent urinary incontinence subgroups. There was no dose-response relationship. CONCLUSION: Measures of cognitive performance declined during approximately 10 years of observation. The changes in performance were not associated with the presence of urinary incontinence in the participants' younger years.

Patient-reported outcome measures for assessing urinary dysfunction following gender-affirming genital surgery: A narrative review of the literature.

INTRODUCTION: Gender-affirming genital surgery is one of several surgical procedures available to transgender and nonbinary (TGNB) individuals to improve congruence between their gender identity and sex assigned at birth. Despite increasing utilization of these procedures, patient-reported outcome measures (PROMs) to assess subjective outcomes following gender-affirming genital surgery remain limited. Our aim was to provide a synopsis of PROMs currently being used to evaluate urinary outcomes among TGNB patients following gender-affirming genital surgery and to assess each PROM for content that is relevant to TGNB patients. METHODS: A multidatabase search was performed (Embase and PubMed) using search terms that included transgender, patient-reported outcome measures, questionnaire, and gender-affirming surgery. Studies that assessed subjective outcomes related to urinary outcomes and pelvic floor dysfunction following gender-affirming genital surgery were reviewed. Gender-affirming genital surgery included vaginal reconstruction (vaginoplasty) and penile reconstruction (phalloplasty and metoidioplasty). Included studies were evaluated for relevant content items and summarized in table. RESULTS: Our literature search identified 820 unique articles. Twenty-seven full articles were included in the final review. Until recently, measurement tools have been limited to unvalidated ad hoc questionnaires or PROMs developed for other conditions, such as urinary incontinence or vaginal prolapse, that are validated among the predominantly cisgender general population. Of the selected studies, PROMs used to evaluate urinary and pelvic floor dysfunction following gender-affirming genital surgery included self-construced ad hoc questionnaires (10 studies), Amsterdam Overactive Pelvic Floor Scale (four studies), King's Health Questionnaire (two studies), Pelvic Floor Distress Inventory (PFDI)-20 (two studies), Sheffield Pelvic Organ Prolapse (one study), International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) (one study), and ICIQ-Female Lower Urinary Tract Symptoms (one study). The PFDI-20 asked about the most relevant symptoms to TGNB patients following genital surgery; however, not all cisgender validated questionnaires included important questions about voiding position, splayed or misdirected stream. The Affirming Surgery Form and Function Individual Reporting Measure (AFFIRM) questionnaire is the first PROM for assessing subjective urinary outcomes that are validated for TGNB individuals, and the GENDER-Q is a promising new PROM with the aim of evaluating outcomes following surgical and other gender-affirming treatments. CONCLUSION: Despite recent advancements, a need remains for standardized assessment tools to evaluate pelvic floor dysfunction and urinary symptoms following gender-affirming genital surgery. Questionnaires developed for the general population to assess symptoms of pelvic organ prolapse and other urinary dysfunction do not fully capture the experiences unique to TGNB individuals undergoing this type of surgery. Nonetheless, PROMs validated specifically for TGNB individuals are necessary to more accurately evaluate outcomes of gender-affirming genital surgery, allow for informed patient counseling, and create evidence-based changes to improve these interventions.

Antibiotic use, best practice statement adherence, and UTI rate for intradetrusor onabotulinumtoxin-A injection for overactive bladder: A multi-institutional collaboration from the SUFU Research Network (SURN).

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is a well-established treatment for overactive bladder (OAB). The American Urological Association (AUA) 2008 Antibiotic Best Practice Statement (BPS) recommended trimethoprim-sulfamethoxazole or fluoroquinolone for cystoscopy with manipulation. The aim of the study was to evaluate concordance with antibiotic best practices at the time of BTX-A injection and urinary tract infection (UTI) rates based on antibiotic regimen. METHODS: Men and women undergoing first-time BTX-A injection for idiopathic OAB with 100 units in 2016, within the SUFU Research Network (SURN) multi-institutional retrospective database were included. Patients on suppressive antibiotics were excluded. The primary outcome was concordance of periprocedural antibiotic use with the AUA 2008 BPS antimicrobials of choice for "cystoscopy with manipulation." As a secondary outcome we compared the incidence of UTI among women within 30 days after BTX-A administration. Each outcome was further stratified by procedure setting (office vs. operating room; OR). RESULTS: Of the cohort of 216 subjects (175 women, 41 men) undergoing BTX-A, 24 different periprocedural antibiotic regimens were utilized, and 98 (45%) underwent BTX-A injections in the OR setting while 118 (55%) underwent BTX-A injection in the office. Antibiotics were given to 86% of patients in the OR versus 77% in office, and 8.3% of subjects received BPS concordant antibiotics in the OR versus 82% in office. UTI rates did not vary significantly among the 141 subjects who received antibiotics and had 30-day follow-up (8% BPS-concordant vs. 16% BPS-discordant, CI -2.4% to 19%, p = 0.13). A sensitivity analysis of UTI rates based on procedure setting (office vs. OR) did not demonstrate any difference in UTI rates (p = 0.14). CONCLUSIONS: This retrospective multi-institutional study demonstrates that antibiotic regimens and adherence to the 2008 AUA BPS were highly variable among providers with lower rates of BPS concordant antibiotic use in the OR setting. UTI rates at 30 days following BTX-A did not vary significantly based on concordance with the BPS or procedure setting.

The Role of Vibrators in Women's Pelvic Health: An Alluring Tool to Improve Physical, Sexual, and Mental Health.

INTRODUCTION AND HYPOTHESIS: In limited studies vibrators have been shown to improve sexual function and pelvic floor health; however, there are even fewer studies on the effect of vibrator use on overall genitourinary and mental health. To investigate the effect of regular vibrator use on sexual, genitourinary, and mental health in addition to quality of life. METHODS: We performed a prospective pilot study of women aged 18 to 80 years recruited from a urogynecology clinic. Study participants were instructed to use a vibrator according to the protocol. Sexual function, pelvic floor function, mental health, and pelvic examination were assessed at the initial visit and at 3 months' follow-up using validated questionnaires. RESULTS: Of the 79 participants enrolled in the study, 53 women (66%) completed the study. The mean age of the participants was 54.7 years (range 19-80 years), and the majority of participants were white (n = 59, 74.7%), post-menopausal (n = 48, 60.8%), and not receiving systemic (n = 63, 79.7%) or local (n = 63, 79.7%) hormone therapy. Sexual function significantly improved over time (p = 0.002), whereas the rate of bothersome pelvic organ prolapse symptoms and pain scores significantly decreased (p = 0.034 and 0.0008 respectively). Rates of urge urinary incontinence decreased although this was not statistically significant (p = 0.059). There was a significant improvement in the gross appearance of lichen sclerosus lesions (p = 0.025) and in the severity of vaginal atrophy (p = 0.018). Rates of depression were significantly decreased (p = 0.011). CONCLUSIONS: Vibrator use was associated with improved sexual, genitourinary, and mental health.

Food Sensitivities in a Diverse Nationwide Cohort of Veterans With Interstitial Cystitis/Bladder Pain Syndrome.

PURPOSE: Prior studies suggest that certain foods exacerbate interstitial cystitis/bladder pain syndrome symptoms. However, these studies were limited in size and demographics. We assessed the presence of diet sensitivities among patients with interstitial cystitis/bladder pain syndrome and compared them with patients with other pelvic pain conditions and healthy controls. MATERIALS AND METHODS: We identified Veterans Affairs patients nationwide by querying ICD-9/10 codes for interstitial cystitis/bladder pain syndrome. Patients were assigned to interstitial cystitis, other pelvic pain, or healthy control cohorts after chart review. We mailed all patients the Shorter-Moldwin Food Sensitivity Questionnaire to evaluate the self-perceived effects of specific foods/beverages on urinary symptoms and/or bladder pain. RESULTS: In the interstitial cystitis/bladder pain syndrome cohort, 70% had ≥1 food sensitivity vs 37% of the other pelvic pain cohort and 32% of healthy controls (P < .001). The average number of sensitivities were similar between other pelvic pain conditions and healthy control cohorts, which were significantly less than in interstitial cystitis/bladder pain syndrome patients. Interstitial cystitis/bladder pain syndrome patients were more sensitive to acidic, spicy foods, and certain beverages vs other cohorts (all P < .001). Within the interstitial cystitis/bladder pain syndrome cohort, Black patients had significantly higher sensitivity to alcoholic and noncaffeinated beverages than Whites. Black patients did report significantly worsened urinary urgency than Whites (P < .05). CONCLUSIONS: In a diverse population of veterans, interstitial cystitis/bladder pain syndrome patients had significantly more food sensitivities than those without interstitial cystitis/bladder pain syndrome. This suggests that food sensitivities could be suggestive of interstitial cystitis/bladder pain syndrome, which could make the Shorter-Moldwin Food Sensitivity Questionnaire a helpful diagnostic tool and aid in distinguishing interstitial cystitis/bladder pain syndrome from conditions often confused with interstitial cystitis/bladder pain syndrome.

Experiences of Women With Interstitial Cystitis/Bladder Pain Syndrome: What Can We Learn From Women's Online Discussions?

PURPOSE: Interstitial cystitis/bladder pain syndrome is a debilitating chronic condition that disproportionately affects women at a ratio of 5:1. We sought to capture women's experiences with interstitial cystitis/bladder pain syndrome by conducting a large-scale digital ethnographic analysis of anonymous posts on Internet forums. MATERIALS AND METHODS: Online posts were identified using condition-specific keywords and data mining extraction services. Once posts were identified, a random sample of 200 online posts was coded and analyzed by hand using qualitative methods. A Latent Dirichlet Allocation probabilistic topic model was applied to the complete dataset to substantiate the qualitative analysis and allow for further thematic discovery. RESULTS: A total of 6,842 posts written by 3,902 unique users from 224 websites were identified. There was a significant overlap between the hand coding and Latent Dirichlet Allocation themes. Our analysis yielded the following themes: online community engagement, triggers and disease etiologies, medical comorbidities, quality of life impact, patient experience with medical care, and alternative therapies and self-management strategies. Additionally, our population appeared to have a high burden of nonurological associated syndromes. We identified barriers to patient-centered care and found that online peer support was important for women. CONCLUSIONS: Our digital ethnographic analysis is a novel application of qualitative methods using online sources. Social media analytics appears to capture a broader patient population than that typically included in clinic-based qualitative studies, such as patient interviews and focus groups. Understanding patient behaviors and concerns are important to guide strategies for improving care and the overall experience with this difficult-to-treat condition.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

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.

Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS: This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS: A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.

Pelvic organ prolapse recurrence after pregnancy following uterine-sparing prolapse repair: a systematic review and meta-analysis.

INTRODUCTION: We sought to determine rates of pelvic organ prolapse (POP) recurrence following pregnancy and delivery in reproductive-age women with prior hysteropexy. METHODS: Scopus, MEDLine, EMBASE, Cochrane Library, and ClinicalTrials.gov databases were searched from inception to May 2020 for combinations of any of the keywords: "pregnancy", "delivery", "fertility", or "cesarean" with a comprehensive list of uterine-sparing surgical procedures for POP repair. Using approach, 1,817 articles were identified describing surgical, uterine-sparing POP repair techniques and subsequent pregnancy and delivery outcomes in reproductive-age women.   RESULTS: Twenty-seven studies describing 218 pregnancies, including 215 deliveries and 3 abortions, were summarized using narrative review and descriptive statistics. Successful pregnancies were reported following a diverse range of uterine-sparing prolapse repairs, both native tissue and mesh-augmented, that utilized vaginal, open abdominal, and laparoscopic approaches. We observed shifts from native tissue repairs to mesh-augmented laparoscopic repairs over time. POP recurrence occurred in 12% of subjects overall, 15% after vaginal and 10% after abdominal prolapse repairs. While meta-analysis identified higher recurrence rates after vaginal delivery (15%) than cesarean section (10%), due to small study numbers, multiple confounders, and heterogeneity between studies, no significant differences in recurrence rates could be identified between vaginal and abdominal surgical approaches, utilization of mesh augmentation, or mode of delivery. CONCLUSION: Although literature on pregnancy following uterine-sparing POP repair is limited, available data suggest that prolapse recurrence after pregnancy and delivery remains similar to that after prolapse repair without subsequent pregnancies with few documented perinatal complications. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021247722.

Supracervical Hysterectomy Is Protective against Mesh Complications after Minimally Invasive Abdominal Sacrocolpopexy: A Population-Based Cohort Study of 12,189 Patients.

PURPOSE: Although minimally invasive (robotic or laparoscopic) abdominal sacrocolpopexy (MISC) has become the new gold standard for durable pelvic organ prolapse repair after the vaginal mesh controversy, current literature is limited. Our objective was to study reoperation for mesh complications after MISC. MATERIALS AND METHODS: All women undergoing MISC in California from January 2012 to December 2018 were identified from Office of Statewide Health Planning and Development data sets using appropriate ICD-9/10 (International Classification of Diseases 9th/10th Revision) and CPT® (Current Procedural Terminology) codes. Univariate and multivariable analyses were performed to assess associations between patient demographics, surgical details and our primary outcomes: rates of reoperation for a mesh complication. RESULTS: Of 12,189 women undergoing MISC 8,398 (68.9%) had concomitant hysterectomy. Total hysterectomy (TH) and supracervical hysterectomy (SCH) were performed in 5,027 (41.2%) and 3,371 (27.6%) cases, respectively. Reoperation rates for mesh complications were lower after SCH vs TH (overall: 0.7%, mean followup time 1,111 days vs 3.1%, mean followup time 1,095 days, p <0.001; subcohort with at least 4 years of followup: 2.1% vs 8.9%, p <0.001). Additionally, mesh complication rates were higher even if TH was performed remotely, as compared to concomitant SCH (5.2% vs 0.7%, p <0.001). The increased risk for reoperation due to mesh complications after TH was preserved on multivariable analysis (OR 4.20, 95% CI 2.72‒6.50, p <0.001). CONCLUSIONS: Concomitant TH at time of MISC is associated with a significantly higher rate of mesh complication as compared to SCH. The increased risk of a mesh complication associated with TH is present even if the TH was performed prior to the MISC.

Defining Properly Collected Urine: Thresholds to Improve the Accuracy of Urinalysis for Microscopic Hematuria Evaluation in Women.

PURPOSE: Microscopic hematuria is one of the most common office consults for urologists. While revised guidelines have risk-stratified patients to reduce unnecessary screening, they do not provide guidance concerning specimen quality. We sought to define "properly collected" specimens using catheterized urine samples as a reference to improve the utility of hematuria screening in women. MATERIALS AND METHODS: We prospectively acquired same-visit voided and catheterized urine samples from 46 women referred for microscopic hematuria from September 2016 to March 2020. Characteristics of pre-referral urinalysis were compared to the matched specimens. True microscopic hematuria was defined as ≥3 red blood cells per high power field on catheterization. RESULTS: Catheterized urinalyses had significantly fewer red blood and squamous epithelial cells in comparison to both referral urinalyses (p=0.006, p=0.001, respectively) and same-day void urinalyses (p=0.02, p=0.04, respectively). As no catheterized sample had >2 squamous epithelial cells, we applied this squamous epithelial cell threshold to referral urinalyses for analysis. Addition of this criterion for "properly collected specimen" increased the positive predictive value of referral urinalyses from 46.1% to 68.8% for true microscopic hematuria. Fewer than 2 squamous epithelial cells with elevated RBC was a significant predictor for true microscopic hematuria (p=0.003). CONCLUSIONS: Voided specimens in the urology clinic had significantly lower red blood cells than referral samples, indicating improved collection technique may reduce false positive urinalyses. Matched collection suggested that repeat collection by catheterization in women who present with >2 squamous epithelial cells per high power field on referral urinalysis may prevent unnecessary future work-up.

Updates to Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline.

PURPOSE: In 2019 the American Urological Association (AUA) released the evidence-based guideline "Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline." Information supporting the guideline came from a 2019 systematic evidence review prepared for the AUA by the Pacific Northwest Evidence-based Practice Center (EPC). The AUA used evidence found for 11 Key Questions (Appendix C) in the EPC's report to derive 16 Guideline Statements. In 2021 the EPC conducted an Update Literature Review (ULR) assessing abstracts from new studies published since the 2019 systematic review. The AUA asked the EPC to further assess a subset of studies included in the ULR report, to support potential changes to the 2019 guideline. MATERIALS/METHODS: A systematic-review utilized research from the Oregon Health & Science University. Pacific Northwest EPC was used to update the 2019 AUA Guideline on rUTI in women with new evidence published through 2021. RESULTS: Updates were made to reflect changes in literature since 2019. Updates include recent publications on antibiotic prophylaxis, non-antibiotic prophylaxis, and estrogen therapy. CONCLUSION: The presence of rUTI is crucial to the health of patients and its effects must be considered for the welfare of society. This document will undergo updating as the knowledge regarding current treatments and future treatment options continues to expand. .

Variation in Communication of Competing Risks of Mortality in Prostate Cancer Treatment Consultations.

PURPOSE: Men with prostate cancer prefer patient-specific, quantitative assessments of longevity in shared decision making. We sought to characterize how physicians communicate the 3 components of competing risks-life expectancy (LE), cancer prognosis and treatment-related survival benefit-in treatment consultations. MATERIALS AND METHODS: Conversation related to LE, cancer prognosis and treatment-related survival benefit was identified in transcripts from treatment consultations of 42 men with low- and intermediate-risk disease across 10 multidisciplinary providers. Consensus of qualitative coding by multiple reviewers noted the most detailed mode of communication used to describe each throughout the consultation. RESULTS: Physicians frequently failed to provide patient-specific, quantitative estimates of LE and cancer mortality. LE was omitted in 17% of consultations, expressed as a generalization (eg "long"/"short") in 17%, rough number of years in 31%, probability of mortality/survival at an arbitrary timepoint in 17% and in only 19% as a specific number of years. Cancer mortality was omitted in 24% of consultations, expressed as a generalization in 7%, years of expected life in 2%, probability at no/arbitrary timepoint in 40% and in only 26% as the probability at LE. Treatment-related survival benefit was often omitted; cancer mortality was reported without treatment in 38%, with treatment in 10% and in only 29% both with and without treatment. Physicians achieved "trifecta"-1) quantifying probability of cancer mortality 2) with and without treatment 3) at the patient's LE-in only 14% of consultations. CONCLUSIONS: Physicians often fail to adequately quantify competing risks. We recommend the "trifecta" approach, reporting 1) probability of cancer mortality 2) with and without treatment 3) at the patient's LE.

Do medication prescription patterns follow guidelines in a cohort of women with interstitial cystitis/bladder pain syndrome?

OBJECTIVE: To describe prescription prevalence of oral bladder pain medications among women with interstitial cystitis/bladder pain syndrome (IC/BPS) and to compare with current treatment guidelines. METHODS: We sampled female patients with an ICD-9/10 diagnosis of IC/BPS (595.1/N30.10) by querying active users of the Veterans Health Administration. Medical records were reviewed to determine whether patients met IC/BPS diagnostic criteria. A cohort of women with other pelvic pain disorders was identified. Prescription prevalence of typical non-narcotic oral bladder pain medications was compared between the two groups and healthy controls. Prescription prevalence was also compared before and after the diagnosis of IC/BPS was made using Poisson regression. RESULTS: There were 641 women who met criteria for IC/BPS and 197 women with "Other pelvic pain" disorders. Women with IC/BPS were prescribed a pain medication more often than those with "Other pelvic pain" (77% vs. 59%, p < 0.0001). Of the women with IC/BPS, 44% tried three or more pain medications. Of women with a diagnosis of IC/BPS, only 67% were prescribed an American Urological Association-recommended medication. Prescription prevalence increased after diagnosis for both pentosan polysulfate (10%-29%, p < 0.0001) and hydroxyzine (17%-40%, p < 0.0001), but not for amitriptyline or cimetidine. Amitriptyline was prescribed to 223 women with IC/BPS, only 125 of which (56%) had a documented history of depression. CONCLUSIONS: Many women with IC/BPS required multiple bladder prescriptions, highlighting the difficulty in finding an effective treatment for IC/BPS. Pentosan polysulfate and hydroxyzine were preferred IC/BPS medications. Our next step will be to analyze treatment patterns in those patients who did not receive medications.

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network.

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB. METHODS: Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models. RESULTS: 278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]). CONCLUSIONS: In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.

Barriers to safety and efficiency in robotic surgery docking.

BACKGROUND: The introduction of new technology into the operating room (OR) can be beneficial for patients, but can also create new problems and complexities for physicians and staff. The observation of flow disruptions (FDs)-small deviations from the optimal course of care-can be used to understand how systems problems manifest. Prior studies showed that the docking process in robotic assisted surgery (RAS), which requires careful management of process, people, technology and working environment, might be a particularly challenging part of the operation. We sought to explore variation across multiple clinical sites and procedures; and to examine the sources of those disruptions. METHODS: Trained observers recorded FDs during 45 procedures across multiple specialties at three different hospitals. The rate of FDs was compared across surgical phases, sites, and types of procedure. A work-system flow of the RAS docking procedure was used to determine which steps were most disrupted. RESULTS: The docking process was significantly more disrupted than other procedural phases, with no effect of hospital site, and a potential interaction with procedure type. Particular challenges were encountered in room organization, retrieval of supplies, positioning the patient, and maneuvering the robot. CONCLUSIONS: Direct observation of surgical procedures can help to identify approaches to improve the design of technology and procedures, the training of staff, and configuration of the OR environment, with the eventual goal of improving safety, efficiency and teamwork in high technology surgery.

The Application of Human Factors Engineering to Reduce Operating Room Turnover in Robotic Surgery.

BACKGROUND: Challenges associated with turnover time are magnified in robotic surgery. The introduction of advanced technology increases the complexity of an already intricate perioperative environment. We applied a human factors approach to develop systematic, data-driven interventions to reduce robotic surgery turnover time. METHODS: Researchers observed 40 robotic surgery turnovers at a tertiary hospital [20 pre-intervention (Jan 2018 to Apr 2018), 20 post-intervention (Jan 2019 to Jun 2019)]. Components of turnover time, including cleaning, instrument and room set-up, robot preparation, flow disruptions, and major delays, were documented and analyzed. Surveys and focus groups were used to investigate staff perceptions of robotic surgery turnover time. A multidisciplinary team of human factors experts and physicians developed targeted interventions. Pre- and post-intervention turnovers were compared. RESULTS: Median turnover time was 67 min (mean: 72, SD: 24) and 22 major delays were noted (1.1/case). The largest contributors were instrument setup (25.5 min) and cleaning (25 min). Interventions included an electronic dashboard for turnover time reporting, clear designation of roles and simultaneous completion of tasks, process standardization of operating room cleaning, and data transparency through monthly reporting. Post-intervention turnovers were significantly shorter (U = 57.5, p = .000) and ten major delays were noted. CONCLUSIONS: Human factors analysis generated interventions to improve turnover time. Significant improvements were seen post-intervention with a reduction in turnover time by a 26 min and decrease in major delays by over 50%. Future opportunities to intervene and further improve turnover time include targeting pre- and post-operative care phases.

Rates of Complications and Reoperation after Myomectomy-the Impact of Surgical Approach: A Statewide Population-based Cohort Study from 2005-2018.

STUDY OBJECTIVE: To assess rates of and factors associated with complications and reoperation after myomectomy. DESIGN: Population-based cohort study. SETTING: All non-Veterans Affairs facilities in the state of California from January 1, 2005, to December 31, 2018. PARTICIPANTS: Women undergoing abdominal or laparoscopic myomectomy for myoma disease were identified from the Office of Statewide Health Planning and Development datasets using appropriate International Classification of Diseases, Ninth and Tenth Revision and Current Procedural Terminology codes. INTERVENTIONS: Demographics, surgery facility type, facility surgical volume, and surgical approach were identified. Primary outcomes included complications occurring within 60 days of surgery and reoperations for myomas. Patients were followed up for over an average of 7.3 years. Univariate and multivariable associations were explored between the above factors and rates of complications and reoperation. All odds ratios (ORs) are adjusted ORs. MEASUREMENTS AND MAIN RESULTS: Of the 66 012 patients undergoing myomectomy, 5265 had at least one complication (8.0%). Advanced age, black, Asian race, MediCal and Medicare payor status, academic facility, and medical comorbidities were associated with increased odds of a complication. Minimally invasive myomectomy (MIM) was associated with decreased complications compared with abdominal myomectomy (AM) (OR, 0.29; 95% confidence interval [CI], 0.25-0.33; p <.001). Overall, 17 377 patients (26.3%) underwent reoperation. Medicare and MediCal payor status and medical comorbidities were associated with increased odds of a repeat surgery. Reoperation rates were higher in the MIM group over the entire study period (OR, 2.33; 95% CI, 1.95-2.79; p <.001). However, the odds of reoperation after MIM decreased each year (OR, 0.93; 95% CI 0.92-0.95; p <.001), with the odds of reoperation after AM surpassing MIM in 2015. CONCLUSION: This study identifies outcome disparities in the surgical management of myomas and describes important differences in the rates of complications and reoperations, which can be used to counsel patients on surgical approach. These findings suggest that MIM can be considered a lasting and safe approach in properly selected patients.

A Human Factors Approach to Vaginal Retained Foreign Objects.

STUDY OBJECTIVE: This study aimed to apply a structured human factors analysis to understand conditions contributing to vaginal retained foreign objects (RFOs). DESIGN: All potential vaginal RFO events from January 1, 2000, to May 21, 2019, were analyzed by trained human factors researchers. Each narrative was reviewed to identify contributing factors, classified using the Human Factors Analysis and Classification System for Healthcare. SETTING: An 890-bed, academic medical center in Southern California. PATIENTS: Patients who underwent a vaginal procedure in which a vaginal RFO-related event occurred were included in this study. However, no patient information was included, and only the relevant details from their procedures were included. INTERVENTIONS: No interventions were developed or implemented. MEASUREMENTS AND MAIN RESULTS: Over the 19-year period, 45 events were reported. The most common items were vaginal packing and vaginal sponges (53.33%). Less frequently retained items involved broken instruments (20.20%). Most cases were laparoscopic hysterectomies or vaginal deliveries. Based on the Human Factors Analysis and Classification System, 75 contributing factors were identified, consisting primarily of preconditions for unsafe acts (communication challenges, coordination breakdowns and issues with the design of tools/technology) and unsafe acts (errors). CONCLUSION: Although rare, vaginal RFOs do occur. The top 2 contributing factors were skill-based errors and communication breakdowns. Both types of errors can be addressed and improved with human factors interventions, including simulation, teamwork training, and streamlining workflow to reduce the opportunity for errors.