A Community-Based Education Program for Overactive Bladder in a Predominantly Minority Older Female Population: A Pilot Study.

INTRODUCTION: Knowledge gaps regarding available treatment and social stigmatization are barriers to care in patients with overactive bladder (OAB). We assessed the feasibility of an OAB education program targeting older community-dwelling females. METHODS: Community-dwelling women over 55 years old were recruited. Eligible participants underwent an education program covering continence-promotion strategies. The Overactive Bladder Questionnaire-Short Form and Short Form-12 were completed at baseline, 1 week, 3 months, and 6 months post-intervention to measure symptom bother and condition-specific and general quality of life (QoL). Data were analyzed using a linear mixed-effects model for repeated measures. RESULTS: Thirty-seven female patients with OAB symptoms at baseline were assessed with the majority from Latino/Hispanic or Black/African American ethnic/racial backgrounds. For our youngest subgroup (≤68 years old), significant improvements were observed at 3 and 6 months compared to 1 week post-intervention for symptom bother (3 months, -22.75, p = 0.006; 6 months, -25.76; p = 0.001) and condition-specific and health-related QoL subscale scores for concern (3 months, +23.76, p = 0.006; 6 months, +22.15, p = 0.011) and social interaction (3 months, +21.11, p = 0.017; 6 months, +20.51; p = 0.021). For all age subgroups, improvements in general QoL measures for mental health were seen at 3 and 6 months compared to baseline (3 months, +7.57, p = 0.02; 6 months, +6.70; p = 0.048). CONCLUSIONS: Statistically significant improvements in symptom bother, condition-specific, and general QoL measures were observed following an OAB education program pilot study in a predominantly minority female population. Further studies are needed to support efficacy and optimize program design.

Immune Deficiency Does Not Increase Inflatable Penile Prosthesis Reoperation Rates.

INTRODUCTION: Immunocompromised patients are postulated to have higher rates of post-operative infection. We sought to determine if inflatable penile prosthesis (IPP) reoperation rates (due to infection, erosion, device malfunction or patient dissatisfaction) are higher among immunocompromised men. METHODS: We analyzed men who underwent initial IPP insertion from 2000 to 2016 in the New York Statewide Planning and Research Cooperative System database. Immunocompromised patients were propensity-score matched in a 1:3 fashion with immunocompetent patients. We estimated and compared reoperation rates (including removal, reoperation due to infection, revision, or replacement of an IPP after an index procedure) at 30 days, 90 days, 1 year and 3 years of follow up between immunocompromised men and controls by performing a Kaplan Meier analysis and Log-rank tests. Cox proportional hazards models were built to examine the overall association between immune deficient status and the risk of reoperation. MAIN OUTCOME MEASURE: Reoperation rate and time to reoperation after index IPP placement. RESULTS: A total of 245 immunocompromised patients who received an initial IPP between 2000 and 2016 were identified. After propensity score matching, we analyzed 235 immunocompromised men and 705 controls. There was no difference in overall reoperation rates between immunocompromised men and controls within any time period assessed (30 days, 90 days, 1 year, or 3 years). In our Cox proportional hazards model, the hazards of overall reoperation, removal, or revision/replacement (HR 1.11 [95% CI 0.74-1.67], HR 1.58 [95% CI 0.90-2.79)], and HR 0.83 [95% CI 0.47-1.45], respectively) were not significant different between immunocompromised men and controls. Reoperation due to infection was also not significantly different between immunocompromised and immunocompetent men (HR 2.06 [95% CI 0.97-4.40]). STRENGTHS & LIMITATIONS: This study is strengthened by its size as the largest cohort of immunocompromised men treated with IPP to date in the literature, but is limited by the retrospective nature of the database which may introduce selection bias and by the low event rate for IPP reoperation. CONCLUSIONS: Reoperation rates, including those due to infection, are not significantly different between immunocompromised men and immunocompetent controls. Therefore, immune status in appropriately selected candidates does not appear to place patients at substantially higher risk of explant or revision. Gaffney CD, Fainberg J, Aboukhshaba A, et al. Immune Deficiency Does Not Increase Inflatable Penile Prosthesis Reoperation Rates. J Sex Med 2021;18:1427-1433.

Impact of duloxetine on male fertility: A randomised controlled clinical trial.

This study assessed the impact of duloxetine (serotonin and norepinephrine reuptake inhibitor) on semen parameters, sperm DNA fragmentation and serum hormones. We performed a double-blind, placebo-controlled, randomised clinical trial of duloxetine 60mg or placebo daily for 6 weeks (5 weeks full dose and 1 week taper). The primary outcome was the proportion of men with abnormal DNA fragmentation during and after duloxetine administration. Secondary outcomes were changes in semen parameters and hormones on treatment (2 and 6 weeks) and after discontinuation (8 and 10 weeks). Sixty-eight healthy males aged 18-65 were included. Duloxetine was not associated with an increase in the proportion of participants with abnormal sperm DNA fragmentation terminal deoxynucleotidyl transferase dUTP nick-end labelling scores (>25%) on treatment (p = 0.09) or after treatment (p = 0.56), nor did median sperm DNA fragmentation increase on treatment. Compared with placebo, there were no changes in bulk semen parameters during treatment. Limited changes in hormonal values were detected. This first published human study of a serotonin and norepinephrine reuptake inhibitor on male fertility revealed no clinically meaningful effects on sperm DNA fragmentation, semen parameters or serum hormones. Duloxetine, and possibly other serotonin and norepinephrine reuptake inhibitors, may be considered for men desiring fertility who require antidepressant treatment.

Look local: the value of cancer surveillance and reporting by American Indian clinics.

INTRODUCTION: Cancer incidence and mortality rates for American Indians in the Northern Plains region of the United States are among the highest in the nation. Reliable cancer surveillance data are essential to help reduce this burden; however, racial data in state cancer registries are often misclassified, and cases are often underreported. METHODS: We used a community-based participatory research approach to conduct a retrospective ascertainment of cancer cases in clinic medical records over a 9-year period (1995-2003) and compared the results with the state cancer registry to evaluate missing or racially misclassified cases. Six tribal and/or urban Indian clinics participated in the study. The project team consisted of participating clinics, a state cancer registry, a comprehensive cancer center, an American Indian/Alaska Native Leadership Initiative on Cancer, and a set of diverse organizational partners. Clinic personnel were trained by project staff to accurately identify cancer cases in clinic records. These records were then matched with the state cancer registry to assess misclassification and underreporting. RESULTS: Forty American Indian cases were identified that were either missing or misclassified in the state registry. Adding these cases to the registry increased the number of American Indian cases by 21.3% during the study period (P = .05). CONCLUSIONS: Our results indicate that direct reporting of cancer cases by tribal and urban Indian health clinics to a state cancer registry improved the quality of the data available for cancer surveillance. Higher-quality data can advance the efforts of cancer prevention and control stakeholders to address disparities in Native communities.

Peyronie's Disease: An Outcomes-Based Guide to Non-Surgical and Novel Treatment Modalities.

The clinical landscape of Peyronie's disease is everchanging. There has been growing interest in non-invasive therapeutic options that could assist patients with achieving a meaningful reduction in penile curvature without surgical intervention. These therapies are wide-ranging in terms of their mechanisms of action, efficacies, and short- and long-term safety profiles. Recently, an abundance of outcomes literature on longstanding and novel non-surgical treatment modalities has been published. For sexual medicine providers hoping to offer patients the most up-to-date and evidence-based treatments for the management of Peyronie's disease, it can be challenging to gain a thorough understanding of this body of literature. In this clinical management review, the workup and current theories on the pathophysiology of Peyronie's disease are reviewed, and the most recent outcomes data on the currently available non-surgical treatment modalities are presented. With an accurate understanding of the current landscape of Peyronie's disease treatment, sexual health providers will be able to better evaluate and engage in evidence-based shared decision-making with their patients.

Adverse Event Reporting of Commonly Used Gender-Specific Implantable Medical Devices in the United States.

BACKGROUND: Evidence suggests that more women are harmed by implantable medical devices than men. It is unknown whether this difference includes gender-specific devices. METHODS: In this study, we examine the differences in reported adverse events between 6 female- and 5 male-specific implantable devices from the Manufacturer and User Facility Device Experience (MAUDE) database from 1993 to 2018. Primary endpoints were injury type (life-threatening, disability, death) and the rate of device evaluation by the manufacturer. Proportions of valid entries across these variables were compared using either the Fisher exact test or χ2 test. RESULTS: Female-specific devices had higher rates of life-threatening outcomes (1.6% versus 0.3%, P < 0.001), disabilities (5.0% versus 4.3%, P < 0.001), and deaths (0.6% versus 0.1%, P < 0.001) compared with the male-specific devices. Of the 8159 devices that were evaluated by the manufacturer, 56% were female specific while 44% were male specific. Female-specific devices were evaluated far less frequently by the manufacturer (4.5% versus 38.2%, P < 0.001). CONCLUSIONS: Increased adverse events reports for female-specific devices and associated high-grade complications necessitates improved postmarket surveillance.

Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database.

Robotic prostatectomy is the most commonly performed robotic procedure in the United States. Increasing utilization of this procedure necessitates characterization of robot malfunctions and associated patient injuries. We performed a review of adverse events reported to a publicly available database. We searched the Manufacturer and User Facility Device Experience (MAUDE) database for reported adverse events (RAE) involving the intuitive surgical system. Reports involving prostatectomy from 2014 to 2019 were extracted and analyzed for data regarding death, patient injury, and device malfunction. Of 9109 reported adverse events (RAE), 602 were extracted for robotic prostatectomy over the study period. Seven were patient deaths (1.2%), 53 (8.8%) were patient injuries (Table 1), and 542 (90.0%) were malfunctions (Table 2). Malfunctions resulted in 25 aborted cases, 21 open conversions, and 25 laparoscopic conversions (71/542, 13.1%; Fig. 1). Instrument failures comprised the majority (76.4%) of malfunctions. Seven malfunctions (1.3%) resulted in patient injury. The most common device-related injury involved the monopolar curved scissors. No reported deaths were related to robot malfunction. Instrument failures comprise majority of the malfunctions of the Da Vinci robot during robot-assisted laparoscopic prostatectomy. When malfunctions do occur they are usually recoverable and rarely lead to patient injury.

Impact of Body Mass Index on Outcomes Following Anatomic GreenLight Laser Photoselective Vaporization of the Prostate.

Introduction: Obesity can lead to increased risk of perioperative complications in surgical patients, but evidence is lacking regarding the impact of obesity on bladder outlet surgery outcomes. We sought to assess the safety and efficacy of GreenLight photoselective vaporization of the prostate (PVP) in obese patients by comparing functional outcomes and complications in men, stratified according to the body mass index (BMI). Materials and Methods: A retrospective analysis was undertaken of 424 men who underwent 180W GreenLight PVP between 2012 and 2016 at two tertiary medical centers. Patients were stratified based on the World Health Organization (WHO) classification of obesity as determined by BMI. Normal weight men had BMI <25 kg/m2, overweight men had BMI between 25 and 30 kg/m2, and obese men had BMI greater than 30 kg/m2. Primary endpoints examined were differences in intraoperative outcomes and incidence of intraoperative and postoperative complications between BMI groups. Secondary endpoints were improvements in the International Prostate Symptom Score, quality of life score, and the uroflowmetry variables, maximum urinary flow rate and postvoid residual. Results: The BMI groups did not differ regarding operative time or lasing time after matching for prostate volume, but overweight patients in the matched cohort still required higher mean energy use than normal weight men (258.6 kJ vs 233.9 kJ; p = 0.017). No significant differences between BMI groups were observed for intraoperative complications, postoperative complications, or readmission rates. All functional parameters were significantly improved at 24 months for each group, with no differences in improvement between groups. On multivariable analysis, BMI was not a significant predictor for outcomes following PVP. Conclusions: Increased BMI has a negligible effect on intraoperative parameters and does not affect postoperative complication rates or functional outcomes. GreenLight XPS 180W PVP is a safe and effective procedure in overweight and obese men.

Use of Botulinum Toxin A (BoNT-A) in Detrusor External Sphincter Dyssynergia (DESD): A Systematic Review and Meta-analysis.

We performed a systematic review to examine the efficacy and outcomes of Botulinum Toxin A (BoNT-A) as the primary intervention strategy for patients with detrusor external sphincter dyssynergia. Eleven studies were included in the analysis (n = 353; 16% female, 84% male). BoNT-A was effective in 60%-78% of patients for reducing postvoid residual, mean detrusor pressure, detrusor leak point pressure, and mean urethral pressure 1 month after injection. Most patients required reinjection after an average of 4-9 months. BoNT-A was not associated with any significant adverse events, and may improve quality of life, as well as urodynamic parameters for detrusor external sphincter dyssynergia.

Anticholinergic Burden in the Elderly Population: An Emerging Concern.

Antimuscarinics are commonly used to treat overactive bladder, but increase anticholinergic burden, which has been associated with multiple adverse outcomes in older patients. We advocate for standardization of anticholinergic risk assessment and reevaluation of anticholinergic prescribing practices for the elderly.

Validation of risk factors for recurrence of renal cell carcinoma: Results from a large single-institution series.

PURPOSE: To validate prognostic factors and determine the impact of obesity, hypertension, smoking and diabetes mellitus (DM) on risk of recurrence after surgery in patients with localized renal cell carcinoma (RCC). MATERIALS AND METHODS: We performed a retrospective cohort study among patients that underwent partial or radical nephrectomy at Weill Cornell Medicine for RCC and collected preoperative information on RCC risk factors, as well as pathological data. Cases were reviewed for radiographic evidence of RCC recurrence. A Cox proportional-hazards model was developed to determine the contribution of RCC risk factors to recurrence risk. Disease-free survival and overall survival were analyzed using the Kaplan-Meier method and log-rank test. RESULTS: We identified 873 patients who underwent surgery for RCC between the years 2000-2015. In total 115 patients (13.2%) experienced a disease recurrence after a median follow up of 4.9 years. In multivariate analysis, increasing pathological T-stage (HR 1.429, 95% CI 1.265-1.614) and Nuclear grade (HR 2.376, 95% CI 1.734-3.255) were independently associated with RCC recurrence. In patients with T1-2 tumors, DM was identified as an additional independent risk factor for RCC recurrence (HR 2.744, 95% CI 1.343-5.605). Patients with DM had a significantly shorter median disease-free survival (1.5 years versus 2.6 years, p = 0.004), as well as median overall survival (4.1 years, versus 5.8 years, p<0.001). CONCLUSIONS: We validated high pathological T-stage and nuclear grade as independent risk factors for RCC recurrence following nephrectomy. DM is associated with an increased risk of recurrence among patients with early stage disease.