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.

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.

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.