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.

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.

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.

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.

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.

Irritative voiding symptoms and microscopic hematuria caused by intraperitoneal calcified fat necrosis.

A previously healthy 60-year-old man presented with urinary urgency and microhematuria. The workup revealed no urothelial lesions, but did suggest a calcified intraperitoneal mass causing extrinsic compression of the bladder. Laparoscopic exploration revealed a glistening, spherical mass attached by a stalk to the sigmoid colon. Removal and histologic examination of the mass revealed calcified fat necrosis, most likely due to the spontaneous torsion and calcification of an appendix epiploicae. The patient's symptoms and microhematuria resolved after removal. This case represents an unusual occurrence of irritative voiding symptoms probably due to the extrinsic compression of the bladder by a mass of membranous fat necrosis.