Effect of Surgeon and Facility Volume on Outcomes of Benign Prostatic Hyperplasia Surgery: Implications of Disparities in Access to Care at High-Volume Centers.

OBJECTIVE: To report the effect of surgeon and facility volume on outcomes of transurethral resection of the prostate (TURP) and laser treatment of benign prostatic hyperplasia (BPH). We also investigate disparities in access to care by identifying demographic predictors of receipt of treatment at high-volume facilities. METHODS: We used New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS) data. We included 18,041 (41.4%) and 25,577 (58.6%) adult patients that underwent TURP and laser procedures in the outpatient setting between January 2005 and December 2018, respectively. Average annual surgeon and facility volumes were broken down by tertile. The effect of volume on short-term outcomes (30-day and 90-day readmission) was examined using mixed-effect logistic regression models. Cox-proportional-hazard models were used to assess the association between volume and long-term stricture development and reoperation. Demographic predictors of treatment at high-volume facilities were assessed using multinomial logistic regression. RESULTS: High-volume facilities were more likely to offer laser procedures compared to low-volume facilities. Higher facility and surgeon volume were associated with lower odds of 30 and 90-day readmissions compared to low-volume facilities. There was no difference in reoperation and stricture development between surgeon volume groups. Medicaid insurance, Hispanic ethnicity, and Black race were inversely associated with treatment at high-volume facilities. CONCLUSION: Higher surgeon and facility volumes were associated with lower odds of readmission. Higher facility volume was associated with lower hazards of reoperation and developing strictures. Medicaid insurance and non-white race were associated with lower odds of treatment at high-volume facilities, highlighting racial and socioeconomic disparities in access to high-volume BPH surgery facilities.

Role of Pessaries in the Treatment of Pelvic Organ Prolapse: A Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate the existing evidence on the efficacy of pessaries in improving quality of life when used for the treatment of pelvic organ prolapse (POP). DATA SOURCES: We searched for the terms "pelvic organ prolapse" and "pessar/y/ies/ium or vaginal support device," and "safety or safe or outcome or complication or efficacy or effective or effectiveness" in PubMed, EMBASE, and CINAHL on March 16, 2020. A search was also performed on ClinicalTrials.gov , with no studies fitting our strict inclusion and exclusion criteria. METHODS OF STUDY SELECTION: Studies that reported pretreatment and posttreatment mean scores and SDs after pessary treatment for standardized questionnaires were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for prolapse were excluded. Three reviewers independently screened studies. TABULATION, INTEGRATION, AND RESULTS: Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were pooled for meta-analysis when reported by at least three studies. The primary study outcome was change in mean pretreatment and posttreatment questionnaire scores, which included those for the PFDI-20 (Pelvic Floor Distress Inventory- Short Form 20), PFIQ-7 (Pelvic Floor Impact Questionnaire - Short Form 7), and subscale POPIQ (Pelvic Organ Prolapse Impact Questionnaire Long Form). A random-effects model was used to combine estimates and capture between-study heterogeneity using the I 2 -statistic. Eight studies including 627 patients were included for systematic review. The mean (SD) age was 63.0±12.2 years, and the majority of patients had stage III prolapse (48.1%) followed by stage II prolapse (43.2%) when reported. Although variable, the majority of studies conducted 3-month follow-up. A negative change in pretreatment and posttreatment scores was noted, signifying improvement after pessary use: PFDI-20 mean change -46.1 (95% CI -65.4 to -26.8); PFIQ-7 mean change -36.0 (95% CI -46.0 to -26.0); POPIQ-7 (Pelvic Organ Prolapse Impact Questionnaire-7) mean change -16.3 (95% CI -26.8 to -5.7). No significant heterogeneity was found. CONCLUSION: Based on improvements in standardized questionnaire scores, pessaries are effective treatment options for POP. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020172618.

Adverse Events for Overactive Bladder Medications From a Public Federal Database.

IMPORTANCE: Clinical data on the use of overactive bladder (OAB) medications are limited by the physician interpretation of adverse effects rather than those that are patient reported. OBJECTIVE: The aim of the study was to evaluate the association between OAB medications and adverse drug events (ADEs) through the self-reporting U.S. Food and Drug Administration Adverse Event Report System database. STUDY DESIGN: The U.S. Food and Drug Administration Adverse Event Report System (FAERS) database was queried from 2004 to 2019. Adverse drug events were recategorized. Disproportionality analysis was used to detect the risk signals for each OAB medication and ADEs. χ 2 values were calculated to assess the association between ADEs and dosage. RESULTS: A total number of 14,102 reports were identified. The most frequently reported OAB medications were mirabegron (35%), transdermal oxybutynin (27%), and solifenacin (25%). Neuropsychiatric (NP) ADEs were highest with tolterodine and fesoterodine usage (16% and 15.6%, respectively) and transdermal oxybutynin had the lowest (6.5%). Increasing the dose of tolterodine or fesoterodine was not associated with increased NP ADEs. Oxybutynin had the highest risk of affect/mood disorder, agitation, and balance/movement disorder; however, it had the lowest risk of headache/migraine compared with all OAB medications. Mirabegron compared with all other OAB medications had the lowest risk of affect/mood disorder and agitation; however, it had the highest risk of headache and migraines. CONCLUSIONS: The FAERS database not only is a repository of ADEs but also may represent evolving prescribing habits for OAB medications. Transdermal oxybutynin had the lowest NP ADEs and may be appropriate for selected individuals.

The Role of Pessaries in the Treatment of Women With Stress Urinary Incontinence: A Systematic Review and Meta-Analysis.

IMPORTANCE: Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility. OBJECTIVE: The objective of this study is to evaluate the existing evidence on the efficacy and safety of pessaries for the treatment of SUI. STUDY DESIGN: We searched for the terms "stress urinary incontinence" and "pessar/y/ies/ium" in PubMed, Embase, and Cinhal on June 10, 2020. Studies that characterized subjective and/or objective data were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for SUI were excluded. Two reviewers independently screened and assessed data quality and risk of bias according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Ten studies, including 376 patients, were included. In terms of subjective outcomes, 76% of 72 patients reported feeling continent after pessary treatment compared with 0% of 86 patients surveyed before pessary use (P < 0.0001). Both Urinary Distress Inventory and Incontinence Impact Questionnaire scores decreased significantly by 46.7% (n = 155 baseline, n = 139 follow-up; P < 0.0001) and 67.8% (n = 139 baseline, n = 107 follow-up; P < 0.0001), respectively. Significant objective measures associated with pessary use included increased urethral closure pressure (n = 122; g = 0.56; 95% confidence interval [CI], -0.66 to 1.77; P < 0.049) and decreased pad weight (n = 129 baseline; n = 118 follow-up; g = -0.89; 95% CI, -1.986 to 0.19; P = 0.009). Adverse events significantly decreased at greater than 6 months follow-up compared with less than 6 months follow-up, including pain (31.5%, n = 29/92 vs 14.3%, n = 5/35; P = 0.0513) and discomfort (50%, n = 46/92 vs 29.3%, n = 12/41; P = 0.0268). CONCLUSIONS: Based on both subjective and objective measures, pessaries are an effective conservative treatment option for SUI. This supports pessary use, though larger studies with longer-term follow-up are warranted.

Natural history of lower urinary tract symptoms among men undergoing stereotactic body radiation therapy for prostate cancer with and without a Rectal Hydrogel Spacer.

PURPOSE: Stereotactic body radiation therapy (SBRT) is increasingly used for prostate cancer, but has morbidity as both the bladder and rectum are radiated during treatment. Our goal was to document and compare lower urinary tract symptoms (LUTS) among men who underwent SBRT with and without SpaceOAR hydrogel (Augmenix, Inc., Bedford, MA). METHODS: We performed a retrospective analysis of 87 men (50 SpaceOAR and 37 non-SpaceOAR) who underwent SBRT. Primary outcomes were patient reported symptoms during radiation therapy, pharmacotherapy usage, and urologic and bowel survey scores up to 6-months post-SBRT. RESULTS: 78% of men were on α-inhibitors at the end of SBRT, an increase from 27.6% baseline usage (p < 0.001). Post-SBRT urinary frequency was more common in the non-SpaceOAR group versus the SpaceOAR group (68% versus 38%, p = 0.006), as was nocturia (35% vs. 8%, p = 0.002). Acute gastrointestinal symptoms did not differ. 58.8% of men were on α-inhibitors at 6-months of follow-up post-SBRT, an increase from 27.6% baseline usage (p < 0.001). Importantly, there was a difference of α-inhibitor use between non-SpaceOAR and SpaceOAR groups at the end of SBRT and at 1.5-, 3-, and 6-months follow up (86% vs. 53% [p = 0.002], 83% vs. 53% [p = 0.005], 72% vs. 49% [p = 0.038], respectively). CONCLUSION: LUTS after SBRT remains a significant problem for men undergoing treatment for prostate cancer. LUTS affects men during and up to 6-months following SBRT. Owing to these increased LUTS, preemptive minimally invasive solutions and their mechanisms of protection, including the SpaceOAR, should be further investigated.

Review of the Economics of Surgical Treatment Options for Benign Prostatic Hyperplasia.

PURPOSE OF REVIEW: The goal of this paper is to review the literature detailing US-based analyses for cost and cost-effectiveness of surgical treatment options for benign prostatic hypertrophy (BPH) and associated LUTS. RECENT FINDINGS: TURP offers the greatest degree of symptom improvement with its associated costs dependent upon operating room time, equipment, and length of hospital stay. Other studied surgical treatment modalities, including transurethral laser ablative, thermal ablative, and convective water vapor modalities as well as prostatic urethral lift and transabdominal procedures, generally carry higher costs and lower cost-effectiveness in both inpatient and outpatient settings, with specific exceptions. Compared to TURP, HoLEP and Greenlight PVP have demonstrated superior cost-effectiveness for mild, moderate, and severe BPH. Convective water vapor ablation, as with transurethral microwave/thermoablative therapies, has been observed to be less expensive per procedure than TURP on average. However, it conferred lower degrees of IPSS symptom improvement. Moreover, compared to TURP, prostatic artery embolization has demonstrated lower average costs coupled with inferior objective improvement in maximal flow rate, prostate volume reduction, PSA decline and minimal improvement in IPSS subjective outcome measures. For this review, selection bias, asymmetric patient groups, issues with study aggregation, and understudied cost contributors (including retreatment costs, long-term durability of symptom relief, recovery time, and work productivity limitations) were identified as key limitations. Nevertheless, this overview takes important steps to understand the costs of surgical treatment options for BPH, allowing for more informed clinical and policy decisions.

Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

OBJECTIVES: In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event. METHODS: We searched the Manufacturer and User Device Experience database from January 2015 to September 2020 for pertinent reported adverse events, which included the unique report key, event date, report date, event text descriptions, and resulting course of treatment. Per Manufacturer and User Device Experience database mandatory requirements, all reports were submitted by the manufacturer within 30 days of receiving the consumer's voluntary submission. RESULTS: A total of 257 reports were included for analysis. The most common reported adverse event was related to the string of the device, which broke with either removal or insertion of the device (230 of 257 [89.5%]). The majority of patients who required medical attention (133 of 257 [51.8%]) were evaluated and managed in the office setting (85 of 133 [63.9%]), whereas 37% (95 of 257) of patients were able to self-treat. CONCLUSIONS: Most complications attributed to device use were self-managed or managed in the outpatient setting. No emergent hospitalizations or deaths were attributed to their use, supporting their generally low-risk profile and high tolerability. Limitations of this review include the inability to decipher a denominator for these reported adverse events and the potential bias attributed to voluntary consumer reporting.

Nurse perspectives on the psychosocial care of patients with urinary incontinence in home hospice: A qualitative study.

BACKGROUND: Urinary incontinence is prevalent among patients receiving home hospice and presents multiple care management challenges for nurses and family caregivers. AIM: This study sought to understand how urinary incontinence influences the psychosocial care of patients receiving home hospice and the strategies that nurses employ to maximize patient and family comfort. DESIGN: Qualitative descriptive study using semi-structured interviews. SETTING/PARTICIPANTS: Nurses employed at a large not-for-profit hospice agency in New York City. RESULTS: Analyses of 32 interviews revealed three primary themes. First, nurses considered urinary incontinence to be associated with multiple psychosocial issues including embarrassment for patients and caregiver burden. Second, nurses described urinary incontinence as a threat to patient dignity and took steps to preserve their continence function. Third, nurses assisted patients and their families to cope with urinary incontinence through normalization, reframing incontinence as part of the disease process, mobilizing caregiving assistance, and encouraging use of continence supplies such as diapers and liners. CONCLUSION: Urinary incontinence influences the psychosocial care of patients receiving home hospice and nurses employ strategies to maximize patient and family comfort. Additional research is needed to examine the psychosocial benefits of facilitated discussions with patients and family members about incontinence, provision of caregiving support, and distribution of comprehensive incontinence supplies to patients with fewer resources.

The Mechanism of Action of cTIND for Minimally Invasive Ischemic Incision of the Prostate: In Vivo Study.

OBJECTIVES: To understand the histologic changes of prostate tissue induced by temporary implantable nitinol device (cTIND) in a canine model. METHODS: The cTIND is a small, symmetric device comprised of nitinol wire loops welded together on an axis, which exert radial force on the tissue to induce a targeted ischemic effect. The cTIND was implanted in three live canine models, which were monitored for 14 days post-index procedure. Device placement was monitored via serial fluoroscopy and biologic effects of cTIND were studied via histopathology. RESULTS: The cTIND was successfully placed in the canine models and remained securely in position until the animal was sacrificed on postoperative day 14. The cTIND treated tissue demonstrated an abrupt transition from normal, viable prostatic glandular tissue to an area of shrunken necrosis and fibrosis between the two. CONCLUSION: In the canine models, the cTIND created focal areas of ischemic necrosis resulting in incisions in the peri-urethral prostate with minimal inflammation.

Nurse Perspectives on Urinary Incontinence in the Home Hospice Setting.

CONTEXT: To date, no studies have characterized the impacts of urinary incontinence (UI) at the end of life in the home hospice (HH) setting. UI is highly prevalent at the end of life and adversely affects quality of life. OBJECTIVES: To characterize HH nurses' perspectives on UI in HH patients. METHODS: We conducted a qualitative descriptive study of interviews between HH nurses and the study investigator. Thirty-two interviews with HH nurses were transcribed and analyzed. Nurses were mostly female, college-educated, and had several years of experience in HH nursing. RESULTS: We identified findings in four major themes: 1) HH nurses' definition and identification of UI, 2) the absence of formal guidelines for diagnosing UI in HH patients, 3) UI's adverse effect on HH patients and their families, and 4) the lack of standardized guidelines for the management of UI in the HH setting. We found that there was a general lack of clarity on the subtypes of UI and no standardized guidelines for management of UI in the HH setting. Nurses reported that UI was bothersome to HH patients and their caregivers, citing patient discomfort, loss of dignity, and additional labor burden as reasons for this. Management strategies for UI lacked standardization. CONCLUSION: UI is a prevalent and debilitating condition in HH patients. There is a need for studies to further characterize the impacts of UI on HH patients and their caregivers. Formal training on UI subtypes and management is needed to facilitate proper documentation, research, and improve patient outcomes.

Safety and Efficacy of Outpatient Surgical Procedures for the Treatment of Benign Prostatic Enlargement in New York State and California (2005-2016).

PURPOSE: We compared outcomes of transurethral prostatectomy and laser prostatectomy in a real-world setting. MATERIALS AND METHODS: We present a prospectively collected observational cohort study of 85,682 men with benign prostatic enlargement in New York State and California who received transurethral prostatectomy or laser prostatectomy in outpatient and ambulatory surgery settings from January 2005 to December 2016. We used propensity score matching to adjust for differences in patient characteristics between groups. We analyzed short-term outcomes using mixed-effect logistic regressions and long-term outcomes using Cox regressions with a time-dependent treatment variable to account for nonproportionality. We performed a sensitivity analysis using multivariable regression models. RESULTS: Mean±SD patient age was 70.5±9.7 years, 71% of patients were White, and median followup was 3.8 years (IQR 1.8-6.3). Transurethral prostatectomy recipients had increased risk of 30-day hospital readmission/emergency room visit (OR 1.09, 95% CI 1.04-1.13, p <0.001) and decreased risk of reoperation (HR 0.81, 95% CI 0.76-0.88, p <0.001). Transurethral prostatectomy had a higher rate of urethral stricture (HR 1.47, 95% CI 1.22-1.75, p <0.001). CONCLUSIONS: Transurethral prostatectomy was associated with higher risk of short and long-term complications but a lower rate of long-term reoperation than laser prostatectomy for benign prostatic enlargement.

A Systematic Review on the Timing of Surgical Intervention for Benign Prostatic Enlargement (BPE).

PURPOSE OF REVIEW: Surgical intervention for benign prostatic enlargement (BPE) is typically reserved for those who fail medical therapy (i.e., α-blocker or 5-α reductase inhibitor treatment). We conducted a systematic review to determine whether timing of surgical intervention for BPE affects patient outcomes. RECENT FINDINGS: The studies we reviewed suggested that patients who undergo surgical intervention for BPE after failing medical therapy may have worse outcomes. Increased age, worsened bladder function, and worse overall health may contribute to worsened outcomes. To date, there are few high-quality studies on the timing of surgical intervention for BPE in the literature. Further prospective trials are needed to determine ideal timing for intervention.

A Systematic Review of Postoperative Delirium in the Urologic Patient.

PURPOSE OF REVIEW: Postoperative delirium (POD) is a common phenomenon among general surgery patients, but it is not well described in urologic surgical patients. We sought to define the incidence and predictive risk factors for POD in patients undergoing urologic surgery. RECENT FINDINGS: Eighteen articles were included for review. The pooled incidence rate of postoperative delirium after urologic surgery was 1.69% (0.69-46.97%). Longer intraoperative time, male sex, unmarried status, and age were shown to be risk factors for POD. POD is common after many urologic surgeries and leads to worse postoperative outcomes and higher healthcare utilization. Future studies are needed to better assess for and prevent POD.

Standardization of 532 nm Laser Terminology for Surgery in Benign Prostatic Hyperplasia: A Systematic Review.

Introduction: The use of GreenLight™ laser technology to remove the prostatic transitional zone transurethrally has grown considerably in recent years. This increased utilization has resulted in an increase in the number of terms that are used to describe various laser techniques. Variable terminology complicates literature analysis and publication, which can cause confusion when performing reviews and comparisons of the techniques in the available literature. It has therefore become necessary to simplify and standardize terminology used to describe transurethral prostate debulking procedures using the 532 nm laser to simplify communication on these techniques. Materials and Methods: We conducted a search on September 17, 2019, in the following databases: Ovid MEDLINE®, Ovid EMBASE, and PubMed. Results: Of the 1115 unique records found in our database search, a total of 27 articles were selected for inclusion. Of the 16 search terms used, we found that 4 terms could be used to describe the fundamental technique associated with each search term. These terms include "vaporization," "vaporesection," "vapoenucleation," and "enucleation." Conclusions: Standardizing terminology leads to an efficient consolidation of terms based on the above outcomes. This will streamline the literature search process for future publications and facilitate comparison of varying techniques.

Live imaging of leukocyte recruitment in a zebrafish model of chemical liver injury.

Studying early immune responses to organ damage in situ requires animal models amenable to intravital imaging. Here, we used transparent zebrafish larvae, a powerful animal model for innate immunity, to measure leukocyte recruitment to damaged livers. Bath application of metronidazole (Mtz) to fish expressing nitroreductase (NTR) under a liver-specific promoter damaged the organ within 24 hours causing oxidative stress, distorted liver morphology, accumulation of TUNEL-positive cells, and transcriptional upregulation of apoptotic and antioxidant genes. Inflammatory gene transcription in damaged hepatocytes was attenuated. In line with predominant apoptosis, macrophages were massively recruited into Mtz/NTR-damaged livers. By contrast, neutrophil infiltration was more variable and delayed, consistent with less abundant necrosis and an attenuated inflammatory capacity of damaged hepatocytes.