Transcriptome-Based Prognostic and Predictive Biomarker Analysis of ENACT: A Randomized Controlled Trial of Enzalutamide in Men Undergoing Active Surveillance.

PURPOSE: Few studies have explored the potential for pharmacological interventions to delay disease progression in patients undergoing active surveillance (AS). This preplanned transcriptomic analysis of patient samples from the ENACT trial aims to identify biomarkers in patients on AS who are at increased risk for disease progression or who may derive the greatest benefit from enzalutamide treatment. PATIENTS AND METHODS: In the phase II ENACT (ClinicalTrials.gov identifier: NCT02799745) trial, patients on AS were randomly assigned 1:1 to 160 mg orally once daily enzalutamide monotherapy or continued AS for 1 year. Transcriptional analyses were conducted on biopsies collected at trial screening, year 1, and year 2. Three gene expression signatures were evaluated in samples collected at screening and in available samples from patients on AS at any time during surveillance (expanded cohort): Decipher genomic classifier, androgen receptor activity (AR-A) score, and Prediction Analysis of Microarray 50 (PAM50) cell subtype signature. RESULTS: The Decipher genomic classifier score was prognostic; higher scores were associated with disease progression in the expanded cohort and AS arm of the expanded cohort. Patients with higher Decipher scores had greater positive treatment effect from enzalutamide as measured by time to secondary rise in prostate-specific antigen >25% above baseline. In patients treated with enzalutamide, higher AR-A scores and PAM50 luminal subtypes were associated with a greater likelihood of negative biopsy incidence at year 2. CONCLUSION: This analysis suggests that the Decipher genomic classifier may be prognostic for disease progression in AS patients with low- to intermediate-risk prostate cancer. Higher Decipher and AR-A scores, as well as PAM50 luminal subtypes, may also serve as biomarkers for treatment response.

Enzalutamide Monotherapy vs Active Surveillance in Patients With Low-risk or Intermediate-risk Localized Prostate Cancer: The ENACT Randomized Clinical Trial.

Importance: There are few published studies prospectively assessing pharmacological interventions that may delay prostate cancer progression in patients undergoing active surveillance (AS). Objective: To compare the efficacy and safety of enzalutamide monotherapy plus AS vs AS alone in patients with low-risk or intermediate-risk prostate cancer. Design, Setting, and Participants: The ENACT study was a phase 2, open-label, randomized clinical trial conducted from June 2016 to August 2020 at 66 US and Canadian sites. Eligible patients were 18 years or older, had received a diagnosis of histologically proven low-risk or intermediate-risk localized prostate cancer within 6 months of screening, and were undergoing AS. Patients were monitored during 1 year of treatment and up to 2 years of follow-up. Data analysis was conducted in February 2021. Interventions: Randomized 1:1 to enzalutamide, 160 mg, monotherapy for 1 year or continued AS, as stratified by cancer risk and follow-up biopsy type. Main Outcomes and Measures: The primary end point was time to pathological or therapeutic prostate cancer progression (pathological, ≥1 increase in primary or secondary Gleason pattern or ≥15% increased cancer-positive cores; therapeutic, earliest occurrence of primary therapy for prostate cancer). Secondary end points included incidence of a negative biopsy result, percentage of cancer-positive cores, and incidence of a secondary rise in serum prostate-specific antigen (PSA) levels at 1 and 2 years, as well as time to PSA progression. Adverse events were monitored to assess safety. Results: A total of 114 patients were randomized to treatment with enzalutamide plus AS and 113 to AS alone; baseline characteristics were similar between treatment arms (mean [SD] age, 66.1 [7.8] years; 1 Asian individual [0.4%], 21 Black or African American individuals [9.3%], 1 Hispanic individual [0.4%], and 204 White individuals [89.9%]). Enzalutamide significantly reduced the risk of prostate cancer progression by 46% vs AS (hazard ratio, 0.54; 95% CI, 0.33-0.89; P = .02). Compared with AS, odds of a negative biopsy result were 3.5 times higher; there was a significant reduction in the percentage of cancer-positive cores and the odds of a secondary rise in serum PSA levels at 1 year with treatment with enzalutamide; no significant difference was observed at 2 years. Treatment with enzalutamide also significantly delayed PSA progression by 6 months vs AS (hazard ratio, 0.71; 95% CI, 0.53-0.97; P = .03). The most commonly reported adverse events during enzalutamide treatment were fatigue (62 [55.4%]) and gynecomastia (41 [36.6%]). Three patients in the enzalutamide arm died; none were receiving the study drug at the time of death. No deaths were considered treatment-related. Conclusions and Relevance: The results of this randomized clinical trial suggest that enzalutamide monotherapy was well-tolerated and demonstrated a significant treatment response in patients with low-risk or intermediate-risk localized prostate cancer. Enzalutamide may provide an alternative treatment option for patients undergoing AS. Trial Registration: ClinicalTrials.gov Identifier: NCT02799745.

Persistence with mirabegron or antimuscarinic treatment for overactive bladder syndrome: Findings from the PERSPECTIVE registry study.

OBJECTIVES: This analysis from the PERSPECTIVE (a Prospective, Non-interventional Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder) study evaluated treatment persistence with mirabegron or antimuscarinics over a 12-month period. METHODS: Participants were adults diagnosed with overactive bladder (OAB) by their health care provider (HCP), who were initiating mirabegron or antimuscarinic treatment. The HCP made all treatment decisions, and patients were followed for 12 months with no mandatory scheduled visits. Information requests were sent to patients at baseline and months 1, 3, 6, and 12. Patients were nonpersistent if they switched, discontinued, or added OAB medications/therapies to their initial treatment. Reasons for discontinuation and switching patterns were investigated. RESULTS: Overall, 1514 patients were included (613 mirabegron and 901 antimuscarinic initiators). Persistence rates decreased steadily over time in both groups. A low proportion of patients added or switched medication at each time point. Unadjusted Kaplan-Meier analysis showed similar persistence rates for both groups. When the data were adjusted for patient characteristics (age, sex, and OAB treatment status), mirabegron initiators had higher persistence rates. No significant differences were noted in unadjusted median time to end of persistence. However, end of treatment persistence by any cause was longer with mirabegron (median: 9.5 vs 6.7 months for antimuscarinics). HCPs stated that the most common reasons for nonpersistence were no symptomatic improvement and side effect aversion. CONCLUSIONS: Treatment persistence was longer for mirabegron compared with antimuscarinic initiators after controlling for patient characteristics. End of treatment persistence by any cause was also longer with mirabegron.

Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study.

OBJECTIVE: To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia. METHODS: The Phase 4 PLUS study comprised a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). Doses were increased to mirabegron 50 mg or matched placebo after 4 weeks. Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms, and changes in postvoid residual volume and maximum urinary flow (Qmax). RESULTS: The safety analysis set included 352 tamsulosin plus mirabegron (TAM + MIRA) and 354 tamsulosin plus placebo (TAM + PL) patients. The frequency of overall TEAEs was higher with TAM + PL, although a higher incidence of drug-related TEAEs was observed with TAM + MIRA. Most TEAEs were mild or moderate in severity. Drug-related serious TEAEs were reported for 3 patients (2 TAM + MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, 1 TAM + PL patient: lacunar stroke). Hypertension, headache, and nasopharyngitis were the most common TEAEs. Special interest TEAEs were infrequently reported. The most common was urinary retention and 2 TAM + MIRA patients required catheterization (neither led to discontinuation). No major changes in blood pressure or pulse rate were noted and similar electrocardiogram parameters were observed for both groups. Changes in mean postvoid residual volume and Qmax were not clinically meaningful. CONCLUSION: No unexpected safety concerns were noted in men receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia who subsequently received mirabegron add-on therapy.

Increased Healthcare Resource Utilization and Direct and Indirect Costs in Patients with Depression and Comorbid Overactive Bladder: Evidence From a Retrospective, Matched Case-Control Cohort Analysis.

INTRODUCTION: This study sought to compare healthcare resource utilization (HCRU), costs, and workplace productivity among patients with depression, with and without overactive bladder (OAB). METHODS: This retrospective, case-control cohort analysis compares HCRU, costs, and workplace productivity among propensity score matched patients with depression and OAB (case cohort) and patients with depression without OAB (control cohort). Patients were aged 18 years or older, insured/on Medicare, and had diagnosed depression and an antidepressant medication claim pre index. First OAB-related event was index for cases; controls were assigned a proxy (study period 12 months). Comparisons of HCRU and costs and regression models assessed the relationship between OAB and costs. For the workplace productivity subset analyses cases and controls were balanced on baseline covariates for the short-term disability analyses but as they were unbalanced for the absentee analyses, multivariate regression analyses were used for this subset. RESULTS: The study criteria were met by 39,085 cases and 308,736 controls, from which, 37,997 patients were successfully matched 1:1 (mean age 55 years; 81% female). Most depression-related HCRU measures were similar across cohorts; however, outpatient visits, ER visits, and number of unique depression medications were significantly higher (all p < 0.05) among cases. Cases also had 13% higher total depression-related costs (p < 0.0001). Total mean (standard deviation [SD]) depression-related costs were $1796 ($4235) for cases versus $1597 ($3863) for controls (p < 0.0001). For workplace productivity (absentee data: cases [n = 686], controls [n = 642]; short-term disability data: cases [n = 4395], controls [n = 4433]) absentee outcomes were similar across cohorts. However, a higher percentage of cases used short-term disability benefits compared to controls (21.3% versus 16.9%; p < 0.0001) and cases experienced more case days (11.0 versus 8.6 mean days) and received higher mean payments than controls ($1226 versus $1033; p < 0.0001) in this subset. CONCLUSIONS: OAB was associated with 13% higher depression-related costs and 4.4% more cases used short-term disability benefits.

Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis.

BACKGROUND: Cumulative exposure to one or more anticholinergic medications ("anticholinergic burden") is associated with an increased risk of adverse outcomes, particularly among older individuals. Mirabegron, an oral selective ß3-adrenergic receptor agonist, has demonstrated efficacy in managing the symptoms of overactive bladder without contributing to anticholinergic burden. However, it is not known whether the favorable safety profile of mirabegron relative to antimuscarinics varies with increasing age among a patient population who may have a high anticholinergic burden. OBJECTIVE: The primary objective of this study was to indirectly compare the safety and efficacy profile of mirabegron relative to antimuscarinics in older adults with overactive bladder. METHODS: A systematic literature review was conducted to identify randomized controlled trials that reported safety and efficacy endpoints among patients aged ≥ 65 years. Identified randomized controlled trials were subsequently synthesized via a network meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines in designing, performing, and reporting the literature review were followed. In line with current best practices, the network meta-analysis was conducted using a Bayesian approach and according to the overall general guidance for evidence synthesis developed by the National Institute for Health and Care Excellence decision support unit. Estimates of relative safety were assessed via the odds ratio and estimates of relative efficacy were assessed via means and credible intervals. RESULTS: A total of 3078 abstracts, 300 of which underwent full-text screening, were identified using the search criteria. Twenty articles reporting on 21 randomized controlled trials were eligible for data extraction and synthesis. Following review, five safety and five efficacy endpoints were considered for inclusion in the network meta-analysis. Regarding findings typical of anticholinergic exposure in older adults, mirabegron was not associated with an increased odds of dry mouth (odds ratio 95% credible interval 0.76 [0.26-2.37]) or constipation (1.08 [0.39-3.02]) relative to placebo, whereas antimuscarinics were strongly associated with these events (odds ratio range 3.78-7.85 and 2.12-4.66, respectively). In this older population, mirabegron was associated with a similar odds of experiencing adverse event-related treatment discontinuations relative to placebo (0.99 [0.57-1.70]), while the odds of experiencing an adverse event-related treatment discontinuation for antimuscarinics had a range of 1.14-3.03 (in most cases, the association was mild). No increased odds of experiencing overall treatment-emergent adverse events was observed for mirabegron or antimuscarinics (odds ratio range 1.25-1.55), apart from fesoterodine (2.23 [1.37-3.37]). Finally, a similar treatment effect was observed across all efficacy endpoints between mirabegron and antimuscarinics in this older population. CONCLUSIONS: This study indicates that the safety and efficacy profile of mirabegron remains favorable compared with antimuscarinics among older adults. This includes safety outcomes typically associated with anticholinergic burden, which were less frequently observed in patients treated with mirabegron.

Treatment patterns and costs among patients with OAB treated with combination oral therapy, sacral nerve stimulation, percutaneous tibial nerve stimulation, or onabotulinumtoxinA in the United States.

INTRODUCTION: Treatment patterns and costs were characterized among patients with overactive bladder (OAB) receiving later-line target therapies (combination mirabegron/antimuscarinic, sacral nerve stimulation [SNS], percutaneous tibial nerve stimulation [PTNS], or onabotulinumtoxinA). METHODS: In a retrospective cohort study using 2013 to 2017 MarketScan databases, two partially overlapping cohorts of adults with OAB ("IPT cohort": patients with incident OAB pharmacotherapy use; "ITT cohort," incident target therapy) with continuous enrollment were identified; first use was index. Demographic characteristics, treatment patterns and costs over the 24-month follow-up period were summarized. Crude mean (standard deviation [SD]) OAB-specific (assessed by OAB diagnostic code or pharmaceutical dispensation record) costs were estimated according to target therapy. RESULTS: The IPT cohort comprised 54 066 individuals (mean [SD] age 58.5 [15.0] years; 76% female), the ITT cohort, 1662 individuals (mean [SD] age 62.8 [14.9] years; 83% female). Seventeen percent of the IPT cohort were treated with subsequent line(s) of therapy after index therapy; among those, 73% received antimuscarinics, 23% mirabegron, and 1.4% a target therapy. For the ITT cohort, 32% were initially treated with SNS, 27% with onabotulinumtoxinA, 26% with combination mirabegron/antimuscarinic, and 15% with PTNS. Subsequently, one-third of this cohort received additional therapies. Mean (SD) costs were lowest among patients receiving index therapy PTNS ($6959 [$7533]) and highest for SNS ($29 702 [$26 802]). CONCLUSIONS: Costs for SNS over 24 months are substantially higher than other treatments. A treatment patterns analysis indicates that oral therapies predominate; first-line combination therapy is common in the ITT cohort and uptake of oral therapy after procedural options is substantial.

Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study.

AIMS: To characterize the epidemiology and treatment patterns of adult men (≥40 years) diagnosed with, or treated for, overactive bladder (OAB) and/or benign prostatic hyperplasia (BPH). METHODS: This retrospective observational study used data extracted from the IBM MarketScan Commercial Claims and Encounters database and the Medicare Supplemental Coordination of Benefits database. Men with BPH and/or OAB were identified and observed to assess treatment and diagnostic patterns. RESULTS: Within the entire study sample (N = 462 400), BPH diagnosis (61.5%) and BPH treatment (73.7%) were more common than the corresponding values for OAB (25.8% and 7.0%, respectively). Notably, among diagnosed individuals, the dispensation of a corresponding treatment was more likely in individuals diagnosed with BPH (183 672 out of 284 416 = 64.6%) compared with OAB (16 468 out of 119 236 = 13.8%). Among newly diagnosed and/or treated patients (n = 196 576), only 60.3% received treatment. Among treated patients, most experienced only a single type of treatment (93.4%), 6.6% went on to receive a secondary treatment and 3.5% a tertiary. The most common primary treatment was alpha-blocker monotherapy (76.9%) followed by tadalafil monotherapy (16.4%). Among those untreated at first diagnosis, the median time between diagnosis and treatment initiation was 128 days. CONCLUSIONS: Diagnosis and management of OAB among males are challenging given the inherent overlap in symptoms observed with BPH. Unsurprisingly, we found that BPH is diagnosed and treated more frequently than OAB; but the differences between diagnosis and treatment patterns for the two conditions highlight the potential undertreatment of OAB and misdirection of therapy for men with a combination of voiding and storage symptoms.

Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).

PURPOSE: PLUS investigated the efficacy and safety of mirabegron add-on therapy in men with overactive bladder symptoms receiving tamsulosin for underlying lower urinary tract symptoms attributable to benign prostatic hyperplasia. MATERIALS AND METHODS: In this phase 4 study a 4-week 0.4 mg tamsulosin run-in period was followed by a 12-week, randomized, double-blind, treatment period in which patients initially received 25 mg mirabegron or placebo add-on therapy. At 4 weeks doses were titrated to 50 mg mirabegron or placebo equivalent. Efficacy end points were changes from baseline to end of treatment in mean number of micturitions per day (primary), mean volume voided per micturition, number of urgency episodes per day, total urgency and frequency score, and total International Prostate Symptom Score (secondary). Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements. RESULTS: Of the 676 men most were 65 years old or older (380, 56.2%). Tamsulosin plus mirabegron was statistically superior to tamsulosin plus placebo in reducing the mean number of micturitions per day (-2.00 vs -1.62; adjusted difference -0.39; 95% CI -0.76, -0.02). Statistically superior results were noted for tamsulosin plus mirabegron in mean volume voided per micturition, urgency episodes per day, and total urgency and frequency score (not International Prostate Symptom Score). Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron. Urinary retention rates were higher in the tamsulosin plus mirabegron group. Post-void residual volume and maximum urinary flow results were not clinically meaningful. CONCLUSIONS: The results of PLUS underscore the utility of mirabegron add-on therapy to treat men with overactive bladder symptoms receiving tamsulosin for benign prostatic hyperplasia.

MR imaging findings of the prostate gland following prostate artery embolization: results from a prospective phase 2 study.

PURPOSE: To assess changes in imaging and volume characteristics of the prostate gland by magnetic resonance (MR) following prostatic artery embolization (PAE) for benign prostate hyperplasia. METHODS: With IRB approval, we analyzed prospectively acquired MR data of PAE patients at baseline and 6-month following treatment from 2015 to 2017. We reviewed prostate MRs looking for sequelae of embolization [changes in signal intensity and/or enhancement, infection/inflammation, infarction, edema, and change in intravesical prostatic protrusion (IPP)]. We calculated the total volume (TV) and central gland volumes (CGV) using DynaCAD® and measured change in volumes. Analyses were performed using SPSS with p < 0.05 considered significant. RESULTS: Forty-three patients (n = 43) met our inclusion criteria. 93% (30/43) and 100% (43/43) showed a decrease in TV and CGV at 6-months respectively. At baseline, median TV was 86 cc (range 29.4-232) and median CGV was 54.4 cc (range 12.9-165.5). Median decrease in TV was 18.2% (CI 13.3-27.2) (p = 0.0001) and median decrease in CGV was 26.7% (CI 20.4-35.9) (p = 0.0001). Thirty-seven percent (16/43) of patients had IPP at baseline; 100% showed a decrease in size of median lobe at follow-up. At 6-month follow-up, 33% (14/43) showed imaging features of infarction, 79% (34/43) had decrease in T2-signal intensity, and 51% (22/43) showed a decrease in enhancement. None had edema, peri-prostatic fat changes or infection/inflammation. CONCLUSION: PAE causes a statistically significant reduction in the TV and CGV. There is also a reduction of the degree of IPP. Non-specific findings of infarction, decrease in T2-signal, and enhancement were also seen.

Management of Recurrent Pelvic Fluid Collections in Adult Male Bladder Exstrophy Patients With Maintenance of Erectile Function.

OBJECTIVE: "To describe management options for pelvic fluid collections in adult patients with classic bladder exstrophy." METHODS: A single institution retrospective chart review was performed of patients who presented between 1998 and 2016 with a history of bladder exstrophy and pelvic fluid collections and 3 patients were identified. Patients had been followed for a mean of 9.0 years (1-23). RESULTS: All 3 patients required urinary diversions at various intervals following their exstrophy repair as newborns. All initially presented with symptomatic fluid collections located inferior to the bladder visualized by cross-sectional imaging. Mean age at presentation was 32.3 years (26-38 years). Two patients underwent drainage and sclerosing of cystic fluid collections with durable symptomatic relief for 1 patient. The other had recurrence of the fluid collections so he underwent marsupialization of the fluid collection which failed to sufficiently alleviate his symptoms. Ultimately, he along with the last patient, underwent open excision of the presumed hypoplastic prostate leading to resolution of pain symptoms, though the last patient did have some persistence of the fluid collection. All patients maintained their erectile function subsequent to these interventions. CONCLUSION: Adult patients with bladder exstrophy can present with painful cystic fluid collections potentially due to secretions from presumed hypoplastic prostate tissue. Sclerosing of the cyst can be successful in a subset of these patients, though some may require removal of the presumed prostatic tissue, which is curative and can be achieved with preservation of erectile function.

Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study.

OBJECTIVE: To evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). METHODS: A prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. RESULTS: 45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P < .0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P < .0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P < .0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P < .0001), QoL (2.4 ± 1.6, P < .0001) and Qmax (15.3 ± 12.3, P < .0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P < .0001) and QoL (2.3 ± 1.7, P < .0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P < .0001) and QoL (2.6 ± 1.6, P < .0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P = .057, 3 months 127 ± 114, P = .34, 6 months 112±116, P = .002 and 1 year 109±116 P = .025. Median decreases in TV and CG were 18% (CI: 13-27) (P = 0.0001) and 27% (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. CONCLUSION: This prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.

Anatomic Outcomes of Robotic Assisted Supracervical Hysterectomy and Concurrent Sacrocolpopexy at a Tertiary Care Institution at Initial Adaptation of the Procedure.

OBJECTIVE: The aim of the study was to review anatomic and surgical outcomes of robotic-assisted supracervical hysterectomy (RASCH) with concurrent sacrocolpopexy in the treatment of primary pelvic organ prolapse (POP) on initial adaption of this procedure. STUDY DESIGN: A retrospective chart review of patients undergoing RASCH with concurrent sacrocolpopexy between 2009 and 2012 was performed at a tertiary care academic institution, after initial adaption of this procedure. The primary outcome was change in vaginal support (assessed with the pelvic organ prolapse quantification [POP-Q]) at 3 months and 1 year postoperatively. Secondary measures assessed included estimated blood loss, operative times, hospital length of stay, and operative complications. RESULTS: Forty patients (N = 40) underwent RASCH with concurrent sacrocolpopexy. Twenty-six patients (65%) had preoperative stage II POP, and 35% had stage III POP. Three months after undergoing the procedure, 55% had achieved stage 0 POP. An additional 35% were categorized as stage I POP. At 1 year, 72.7% were stage I POP or lower. The mean (SD) operating time was 275 (82.3) minutes. Estimated blood loss and mean (SD) length of hospital stay were 163 (114.9) mL and 1.3 (0.8) days, respectively. There were no intensive care unit admissions. The most common postoperative complication was immediate urinary retention in 10% of patients; all cases resolved with time-limited intermittent self-catheterization. CONCLUSIONS: Even with initial adaptation of the procedure, RASCH with concurrent sacrocolpopexy for the repair of primary POP is effective in restoring anatomic support in the short term. Operative complications are minimal.

The UroCuff test: a non-invasive alternative to pressure flow studies in adult males with lower urinary tract symptoms secondary to bladder outlet obstruction.

INTRODUCTION: To assure that patients with lower urinary tract symptoms (LUTS) benefit from interventions, urologists must practice careful selection of surgical candidates. Currently, 15%-30% of men do not benefit optimally from these invasive and potentially morbid procedures. Success rates following transurethral resection of the prostate (TURP) are higher if bladder outlet obstruction (BOO) is confirmed prior to the procedure by invasive pressure flow studies (PFS). However, PFS may not be performed because of many reasons. We report a study of a non-invasive method of assessing BOO. MATERIALS AND METHODS: The UroCuff test was compared to invasive urodynamic studies in adult males with lower urinary tract symptoms. Patients undergoing PFS for LUTS presumed to be due to BOO were recruited from a single site to perform a penile cuff test (UroCuff) at the same time as PFS. Standard PFS were performed followed immediately by a penile cuff test in the same test setting. The results were compared using basic statistical analysis. RESULTS: A total of 19 men were evaluated by both PFS and UroCuff evaluation. Using PFS as the gold standard, the positive predictive value of the UroCuff penile cuff test to diagnose BOO was found to be 92%. The sensitivity of the UroCuff test for detecting BOO was 75%. When compared to PFS, patients preferred the UroCuff 100% of the time. CONCLUSIONS: The UroCuff test is accurate in predicting BOO when compared to conventional invasive pressure flow studies in men with LUTS. It is well tolerated and preferred over invasive pressure flow studies.

Acute right varicocele: a clue to congenital vascular anomaly.

Workup of acute unilateral right varicocele should encompass imaging to look for abdominal and retroperitoneal pathology, as well as congenital vascular anomalies. Management of the acute symptomatic varicocele due to upstream venous thrombosis should be primarily medical, with initiation of anticoagulation and early involvement of our hematology colleagues.

Completely intracorporeal robotic-assisted laparoscopic augmentation enterocystoplasty with continent catheterizable channel.

OBJECTIVE: To report our results from series of robotic-assisted laparoscopic augmentation enterocystoplasty (RALAE) performed in a completely intracorporeal fashion. METHODS: Patients who underwent RALAE with or without the creation of a catheterizable channel between 2006 and 2011 at the University of Texas, Houston and Northwestern Memorial Hospital were identified. Perioperative and follow-up data were analyzed. Preoperative and postoperative urodynamic data were analyzed when available. RESULTS: Twenty-two patients with neurogenic bladder underwent RALAE with or without the creation of a catheterizable channel. Fifteen patients underwent robotic augmentation enterocystoplasty alone, and 7 patients had creation of a catheterizable channel (4 Monti and 3 Mitrofanoff). There was 1 conversion to an open procedure in a patient undergoing concomitant creation of an appendicovesicostomy. Mean follow-up was 38.9 months (range, 6.2-72.1 months). Mean operative time was 365 minutes (range, 220-788 minutes); mean estimated blood loss was 110 mL (range, 30-250 mL). Median time to return of bowel function was 5 days (range, 2-17 days). Preoperative and postoperative urodynamic data were available for 13 patients. Mean cystometric capacity increased by 52%, and mean maximal bladder pressures decreased by 40. There were 5 minor complications (Clavien grade 1-2) and 4 major complications (Clavien grade 3-4). No patient experienced a wound infection. CONCLUSION: RALAE is a feasible approach that provides potential benefits over open bladder reconstruction in the neurogenic voiding dysfunction population.

Diagnostic discordance of electromyography (EMG) versus voiding cystourethrogram (VCUG) for detrusor-external sphincter dyssynergy (DESD).

AIMS: Detrusor sphincter dyssynergia (DSD) is defined as: "a detrusor contraction concurrent with an involuntary contraction of the urethral and/or periurethral striated muscle." In neurogenic etiology, this usually refers to involuntary contraction of the external striated sphincter and has classically been termed detrusor-external sphincter dyssynergia (DESD). There is currently no consensus regarding diagnosis [specifics of electromyographic (EMG) or voiding cystourethrographic (VCUG) determination], and little data on how well these modalities correlate. We explore the diagnostic congruence for DESD between needle EMG and VCUG in the neurogenic population. METHODS: Consecutive studies performed by a single urodynamicist at a major neurologic center were reviewed. Presence of DESD was determined by increased wire needle EMG activity and/or by dilated bladder neck and proximal urethra during detrusor contraction, in the absence of valsalva or attempt to inhibit voiding. Minimal acceptable criterion for agreement between the two tests was set at 70%. RESULTS: Fourty nine patients were diagnosed with DESD, had a videourodynamic study available, and had no history of sphincterotomy or stent. Binomial testing demonstrated significant disagreement (P < 0.000) in observed proportions. There was 60% agreement (28 patients) and 40% disagreement (21 patients) between EMG and VCUG for diagnosis of DESD. CONCLUSIONS: We found significant disagreement between needle EMG and VCUG for a positive diagnosis of DESD. A combination of EMG and VCUG may identify more cases of DESD than either modality alone and underscores the need for more strict criteria when defining this entity from a urodynamic standpoint.

Symptom scores: mumbo jumbo or meaningful measures?

Instruments designed to assess the severity of lower urinary tract symptoms have become a routine component of the diagnostic evaluation of men with benign prostatic hyperplasia (BPH). Several validated tools have been developed to this end, including the International Prostate Symptom Score, which is used most commonly today. Despite attempts to correlate symptom score severity with commonly measured objective parameters of BPH, no clear relationships have been found. The reason for this is likely multifactorial and suggests a complex relationship among subjective and objective variables. However, symptom scores show a good correlation with the patient's perception of quality of life and degree of bother. This is critical because the decision to treat should be largely based on these subjective variables. Moreover, symptom scores have been shown to represent a meaningful endpoint in assessing treatment response in clinical studies.

Urinary retention caused by adenocarcinoma arising in recurrent urethral diverticulum.

We present a case of adenocarcinoma arising in a urethral diverticulum. A 71-year-old woman presented with urinary retention and a mass in the anterior vaginal wall. A biopsy was performed and revealed adenocarcinoma. Anterior pelvic exenteration with continent urinary diversion was performed followed by adjuvant radiation therapy as the tumor was large and poorly differentiated. She developed stomal stenosis and underwent stomal revision. The patient has done well since, with no evidence of recurrence at 1-year follow-up at the time of this report.