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Background The differential risk of incident dementia associated with receiving various overactive bladder (OAB) drugs is unknown. Objective To estimate the association of antimuscarinic OAB drug (exposure), compared with a β-3 agonist (mirabegron), and incident dementia. Design, setting, and participants A population-based nested case-control study was conducted in patients treated with OAB medications in Ontario, Canada. A total of 11 392 patients aged ≥66 yr with a new diagnosis of dementia between 2010 and 2017, and 29 881 age- and sex-matched controls without dementia were included in the study. Intervention Receipt of an antimuscarinic OAB drug or receipt of mirabegron, within the previous 6–12 mo. Outcome measurements and statistical analysis Cases developed dementia and Alzheimer’s disease. Controls were derived from the general population and matched to cases based on important baseline characteristics. Odds ratios (ORs) for incident dementia, adjusted for demographic and health-related characteristics, were determined. Results and limitations Patients receiving solifenacin (OR 1.24; 95% confidence interval 1.08–1.43) and darifenacin (OR 1.30; 95% CI 1.08–1.56) in the prior 6 mo had increased odds of incident dementia compared with those receiving mirabegron. In the 6 mo to 1 yr prior to diagnosis, receipt of solifenacin (OR 1.34; 95% CI 1.11–1.60), darifenacin (OR 1.49; 95% CI 1.19–1.86), tolterodine (OR 1.21; 95% CI 1.02–1.45), and fesoterodine (OR 1.39; 95% CI 1.14–1.71) was associated with increased odds of incident dementia compared with receipt of mirabegron. No effect was seen with oxybutynin or trospium. Limitations included misclassification of the outcome and residual confounding associated with the use of health administrative databases. Conclusions Older adults receiving solifenacin and darifenacin in the 6 mo prior to diagnosis, and those receiving solifenacin, darifenacin, tolterodine, or fesoterodine in the year prior to diagnosis, have increased odds of incident dementia, compared with those receiving mirabegron. Oxybutynin and trospium were not associated with dementia, likely due to a protopathic bias. Careful drug selection is warranted when treating patients with OAB. Patient summary In a large Canadian cohort of patients who developed dementia after starting an overactive bladder (OAB) medication, those taking some anticholinergic medications for OAB have an increased risk of dementia compared with those taking mirabegron.

Introduction:Iatrogenic ureteral injuries (IUIs) are rare but can lead to significant consequences if unrecognized at the time of injury. We compare the impact of immediate vs delayed recog...

Objective To characterize afferent nipple valve obstruction in Kock diversions presenting with hydronephrosis and discuss appropriate work-up and management. Methods We retrospectively reviewed 7 cases of afferent nipple valve obstruction. Results The median time from diversion creation to afferent nipple valve intervention was 17-years. Presentations included febrile-UTIs, worsening renal function and hydronephrosis. All patients underwent upper tract imaging confirming bilateral hydronephrosis or hydronephrosis of a solitary kidney followed by nephrostomy tube insertion to drain the obstructed kidney(s). On nephrostogram assessment afferent nipple valve obstruction was confirmed by a lack of contrast passing through the valve. In 4 of these patients the afferent valve could not be cannulated while in one patient endoscopic retrograde balloon dilation was performed but failed after 12-months. One patient had successful antegrade balloon dilation (four-years follow-up). In five patients and the one patient who failed retrograde balloon dilation open surgical repair of the afferent nipple valve was successful (median follow-up time 5-years). Conclusion It is essential to consider afferent nipple valve obstruction in a patient with a Kock diversion presenting with bilateral hydronephrosis/hydronephrosis of a solitary kidney, even after many years following the original diversion. Appropriate work-up consists of upper tract imaging, endoscopy and retrograde studies or nephrostomy insertion with nephrostogram. Management options include endoscopic retrograde or antegrade balloon dilation or valve incision. Failing that, surgical repair may be successful with long-term upper tract preservation.

In this study we perform a review of the literature on systemic muscle weakness after administration of botulinum toxin A, to describe the factors that predispose patients to this adverse event and to suggest strategies for prevention. Our search criteria included the terms “Botulinum toxin, Abobotulinum toxin, Dysport®, Onabotulinum toxin, Botox®, Incobotulinum toxin and Xeomin®, muscle weakness, generalized muscle weakness and respiratory distress.” Statistical analysis was completed using IBM® SPSS software. We identified 2029 articles and narrowed this to 38 articles referencing 63 specific cases (including two studies form our institution) and 11 case series. Our analysis of 11 case series suggested that systemic muscle weakness is a rare event with botulinum toxin A. Of the 63 cases identified, the most common indications for use were spasticity (49.2%) and neurogenic detrusor overactivity (22.2%). The median age was low at 34 years, and the majority were female (76.2%). Furthermore, 47.6% of the cases were associated with the abobotulinum toxin A formulation. On average, the doses administered were 3.2 times the recommended dose (standard deviation 1.9) suggested for the particular botulinum toxin A formulation and indication. If systemic muscle weakness did occur, indication for botulinum toxin A being upper tract gastrointestinal disorder was associated with more severe impairment (W2 = 10.2, p = 0.001). Based on data from the identified cases of systemic muscle weakness with botulinum toxin A, this adverse event was more common in female, younger, patients with spasticity or neurogenic detrusor overactivity indication or those receiving abobotulinum toxin A formulation and/or higher botulinum toxin A doses. A prevention strategy may include reducing the dose of botulinum toxin A to those recommended by the US FDA.

Aim This study describes patients with different degrees and combinations of symptom resolution in response to fesoterodine exposure to aid physicians in counselling patients with overactive bladder (OAB) on the likelihood of treatment success. Methods Data came from 12‐week fixed‐dose studies of fesoterodine. The proportions of patients experiencing symptom resolution and change in patient‐reported outcome measures (PROM) at 4, 8, and 12 weeks were calculated. Treatment‐emergent adverse events (TEAE) were reported according to response in urinary urgency episodes (UUE). The relationship between PROM and response was examined. Results Out of 6689 patients, 81.6% female, urgency urinary incontinence (UUI) episodes/24 h were more responsive to fesoterodine than UUE; with roughly 50% of patients reporting a 50% reduction and fewer than 10% reporting absence of UUE at 12 weeks compared to approximately 40%–50% reporting absence of UUI. TEAE was numerically lower in patients with greater response. There was a statistically significant relationship between improvement in urinary urgency and associated change in OAB‐q symptom bother scores, r = 0.54, p

Objective To assess postoperative outcomes from the Adjustable TransObturator Male System (ATOMS) and identify factors influencing failure to achieve continence. Patients and Methods A multicentered analysis was performed on all patients treated for postprostatectomy incontinence using the third-generation ATOMS at 9 Canadian tertiary referral centers. The primary outcome was continence (defined as requiring ≤1 pad postoperatively for patients requiring ≥2 pads preoperatively and 0 pads for those requiring 1 pad preoperatively). Secondary outcomes included improvement (>50% change in pad use), patient satisfaction, explantation, and postoperative complications. Results Two hundred and eighty nine patients with a mean age of 68.9 years were analyzed. Pre-operatively mean pad per day use was 4.2 (1-12), 31.5% of patients reported severe incontinence (≥5 pads/day), 33.9% had concurrent radiotherapy and 19.4% had failed previous incontinence surgery. Overall continence rate was 73.3% (n = 212) at a mean follow-up of 19.6 months. More than eighty nine percent (89.3%) (n = 258) of patients experienced >50% improvement, 84.4% (n = 244) of patients were satisfied with the results of surgery. More than seven percent (7.9%) (n = 23) required device explantation. On multivariate Cox regression analysis, concurrent radiotherapy (hazard ratio [H.R.] 2.3, P Conclusion ATOMS is a safe and efficacious for treatment of postprostatectomy incontinence. However, patients with prior radiation, increased pre-operative pad use, or diabetes are less likely to achieve continence.

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.

Background The rate of primary and secondary treatment while on active surveillance (AS) for localized prostate cancer at the general population level is unknown. Our objective was to determine the patterns of secondary treatments after primary surgery or radiation for patients who undergo AS. Methods This was a population‐based retrospective cohort study of men aged 50‐80 years old in Ontario, Canada, between 2008 and 2016. We identified 26 742 patients with prostate cancer, a Gleason grade score ≤7, and an index prostate‐specific antigen ≤10 ng/mL. Patients were categorized as undergoing AS with or without delayed primary treatment (DT; treatment >6 months after diagnosis) versus immediate treatment (IT; treatment ≤6 months). Patients receiving DT and IT were propensity score matched and the rate of secondary treatment (surgery or radiation ± androgen deprivation treatment) was compared using Cox proportional hazards models. Results We identified 10 214 patients who underwent AS and 11 884 patients who underwent IT. Among patients undergoing AS, 3724 (36.5%) eventually underwent DT and among them, 406 (10.9%) underwent secondary treatment. The median time to DT was 1.2 years (IQR 0.5‐8.1 years). The relative rate of undergoing secondary treatment was similar in the DT vs IT group (HR 0.92; 95% CI: 0.79‐1.08). The risk of death in the DT group was higher compared to patients who did not undergo treatment (HR 1.23, 95% CI: 1.01‐1.49). Conclusions Among patients with localized prostate cancer on AS, one third undergo DT. The rate of secondary treatment was similar between the DT and IT groups. Patients in the DT group may experience a higher risk of mortality compared to those who remained on AS., For men with localized prostate cancer who are candidates for active surveillance, one third receive delayed primary treatment. Active surveillance is a safe approach, as there appears to be no adverse risk of progression with similar rates of secondary treatment compared to patients who underwent immediate treatment.

Background In older patients with overactive bladder (OAB), mirabegron, a β3-adrenoreceptor agonist, represents an alternative treatment that may have a favorable risk–benefit profile. Objectives Our objective was to further examine the safety and tolerability of mirabegron versus placebo treatment in patients aged ≥ 65 years with OAB-wet. Methods We conducted a 12-week, double-blind, randomized, placebo-controlled phase IV study to compare mirabegron with placebo. Community-dwelling patients aged ≥ 65 years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24 h over a 3-day diary) were randomized to receive placebo or mirabegron 25 mg/day (optional dose escalation to 50 mg/day at week 4 or 8). Safety analyses were performed for adverse events (AEs) and vital signs on all randomized patients who received one or more dose of study drug. Results Treatment-emergent AEs (TEAEs), the majority mild or moderate in severity, were reported in 39.4% of placebo patients and 44.2 and 49.8% of those who received mirabegron 25 mg or 50 mg, respectively. The most common TEAEs in mirabegron-treated patients were urinary tract infection, headache, and diarrhea. The incidence of TEAEs was slightly higher in mirabegron patients aged ≥ 75 years than in those aged

Purpose:Previous studies have shown an association between urinary incontinence and increased mortality independently of demographics and health status. However, they do not account for the effect ...

Mirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.To summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.Mirabegron: 25 and 50mg; antimuscarinics: solifenacin (2.5, 5, and 10mg) and tolterodine extended release (4mg).Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (65 vs ≥65yr and75 vs ≥75yr) and sex were assessed. Solifenacin 2.5 and 10mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).Baseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24h by age (65 vs ≥65yr), nocturia by age (65 vs ≥65yr and75 vs ≥75yr), and urgency episodes by previous OAB medication.Data from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.Overactive bladder is a complex of symptoms including a compelling desire to pass urine that leads to increased frequency, which may lead to a degree of incontinence if you do not reach the toilet in time and may wake you from sleep. We pooled data from 10 different studies of mirabegron in patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women. No new safety concerns were identified, and mirabegron improved the symptoms of overactive bladder.

Objective To compare the long-term outcomes of initial management of pelvic fracture urethral injury (PFUI) in a large cohort of trauma patients undergoing urethral reconstruction. Materials and Methods 119 patients underwent urethral reconstruction by a single surgeon for PFUI at our centre between 1998-2018. We compared initial PFUI management - primary re-alignment versus suprapubic tube (SPT) insertion alone. Multivariable Cox proportional hazard analysis was used to assess the association between primary intervention and the risk of having a complication. Results PFUI was initially managed with primary realignment (57%) or SPT alone (43%). Ultimately, all patients underwent a primary perineal urethral anastomosis after a median of 7 months (IQR: 5-14). Overall, 27 patients (23%) had one or more long-term complications after a median 25 months (IQR:7-66), including urethral stricture, de novo erectile dysfunction, and urinary incontinence. On multivariable analysis, initial PFUI management did not predict for complications. Conclusions No difference was found in long-term outcomes after urethral reconstruction when comparing initial PFUI management of primary re-alignment versus SPT insertion.

ObjectivesTo compare the risk of bladder cancer and bladder cancer mortality among patients with chronic bladder catheterisation (indwelling or intermittent) to patients from the general population.DesignRetrospective cohort study.SettingPopulation-based study in Ontario, Canada between 2003 and 2018.ParticipantsAdult patients 18–90 years of age with chronic bladder catheterisation were hard matched to patients from the general population without a history of bladder catheterisation.InterventionsThe presence of a chronic catheter was defined as a minimum of two physician encounters for bladder catheterisation, suprapubic tube insertion or home care for catheter care separated by at least 28 days. Urinary tract infection (UTI) rates were collected.Main outcome measuresBladder cancer and bladder cancer-specific mortality after a 1-year lag period were compared between groups.ResultsWe identified 36 903 patients with chronic catheterisation matched to 110 709 patients without a history of catheterisation. Patients were followed for a median of 8.8 years (IQR: 5.2–11.9 years). The median age was 62 years (IQR: 50–71) and 52% were female. More patients in the catheter group developed bladder cancer (393 (1.1%) vs 304 (0.3%),pConclusionsThis is the first study to quantify the increase in bladder cancer incidence and mortality in a large, diverse cohort of patients with chronic indwelling or intermittent bladder catheterisation. The risk was highest among patients with a chronic catheter beyond 2.9 years.

Introduction: Although intraoperative iatrogenic ureteric injuries (IUI) are rare, significant consequences can occur if they are unrecognized at the time. The focus of our study is to characterize the associated morbidity and identify predictors of delayed recognition of IUI. Methods: Sunnybrook Health Sciences Centre Research Ethics Board approved the study. Patients with a diagnosis of IUI between 2002 and 2020 were identified through an institutional electronic medical record system. Data pertaining to the demographic characteristics, diagnosis, and management of IUI and overall outcomes were collected retrospectively. Results: Of the 103 patients identified, 83% were female, 52% had previous abdominal surgery, and 18% had previous radiation. The median age was 67 (21–88) years. Twenty percent were not recognized at the time of surgery. Although delayed recognition was not a significant predictor for poor outcome after subsequent repair (i.e., hydronephrosis, ureteric stricture/obstruction), it was associated with substantial morbidity to the patient (i.e., additional procedures) and increased cost to the healthcare system (i.e., longer hospital stay, readmission to hospital). Patients who underwent laparoscopic surgery had an 11 times more likely chance of having an unrecognized IUI as compared to those who underwent open surgery (odds ratio 11.515, p=0.0001). Conclusions: Delayed recognition of IUI may be associated with considerable adverse effects. In this retrospective case series, we identified laparoscopic surgery as a significant predictor for delayed recognition of IUI. This information underscores the need for future studies to facilitate intraoperative identification of ureteric injuries, particularly during laparoscopic procedures.

Context Radiotherapy used for treating localized prostate cancer is effective at prolonging cancer-specific and overall survival. Still, acute and late pelvic toxicities are a concern, with gastrointestinal (GI) and genitourinary (GU) sequelae being most common as well as other pelvic complications. Objective To present a critical review of the literature regarding the incidence and risk factors of pelvic toxicity following primary radiotherapy for prostate cancer and to provide a narrative review regarding its management. Evidence acquisition A collaborative narrative review of the literature from 2010 to present was conducted. Evidence synthesis Regardless of the modality used, the incidence of acute high-grade pelvic toxicity is low following conventionally fractionated external beam radiotherapy (EBRT). After moderate hypofractionation, the crude cumulative incidences for late grade 3 or higher (G3+) GI and GU complications are as high as 6% and 7%, respectively. After extreme hypofractionation, the 5-yr incidences of G2+ GU and GI toxicities are 3–9% and 0–4%, respectively. Following brachytherapy monotherapy, crude rates of late G3+ GU toxicity range from 6% to 8%, while late GI toxicity is rare. With combination therapy (EBRT and brachytherapy), the cumulative incidence of late GU toxicity is high, between 18% and 31%; however, the prevalence is lower at 4–14%. Whole pelvic radiotherapy remains a controversial treatment option as there is increased G3+ GI toxicity compared with prostate-only treatment, with no overall survival benefit. Proton beam therapy appears to have similar toxicity to photon therapies currently in use. With respect to specific complications, urinary obstruction and urethral stricture are the most common severe urinary toxicities. Rectal and urinary bleeding can be recurrent long-term toxicities. The risk of hip fracture is also increased following prostate radiotherapy. The literature is mixed on the risk of in-field secondary pelvic malignancies following prostate radiotherapy. Urinary and GI fistulas are rare complications. Management of these toxicities may require invasive treatment and reconstructive surgery for refractory and severe symptoms. Conclusions There has been progress in the delivery of radiotherapy, enabling the administration of higher doses with minimal tradeoff in terms of slightly increased or equal toxicity. There is a need to focus future improvements in radiotherapy on sparing critical structures to reduce GU and GI morbidities. While complications such as fistulae, bone toxicity, and secondary malignancy are rare, there is a need for higher-quality studies assessing these outcomes and their management. Patient summary In this report, we review the literature regarding pelvic complications following modern primary prostate cancer radiotherapy and their management. Modern radiotherapy technologies have enabled the administration of higher doses with minimal increases in toxicity. Overall, high-grade long-term toxicity following prostate radiotherapy is uncommon. Management of late high-grade pelvic toxicities can be challenging, with patients often requiring invasive therapies for refractory cases.

Introduction In the development of terminology of the lower urinary tract, due to its increasing complexity, the terminology for male lower urinary tract and pelvic floor symptoms and dysfunction needs to be updated using a male-specific approach and via a clinically-based consensus report. Methods This report combines the input of members of the Standardisation Committee of the International Continence Society (ICS) in a Working Group with recognized experts in the field, assisted by many external referees. Appropriate core clinical categories and a subclassification were developed to give a numeric coding to each definition. An extensive process of 22 rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). Results A Terminology Report for male lower urinary tract and pelvic floor symptoms and dysfunction, encompassing around 390 separate definitions/descriptors, has been developed. It is clinically-based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in male lower urinary tract and pelvic floor dysfunction. Male-specific imaging (ultrasound, radiology, CT, and MRI) has been a major addition whilst appropriate figures have been included to supplement and help clarify the text. Conclusions A consensus-based Terminology Report for male lower urinary tract and pelvic floor symptoms and dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

Aims SYNERGY II was a 12‐month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy. Conclusions Mirabegron and solifenacin combination therapy was a well‐tolerated and effective treatment for patients with OAB symptoms irrespective of their age.

Psychological distress is prevalent among men with prostate cancer (PCa). However, the variation in antidepressant use among individuals throughout the survivorship period is unknown. We sought to examine the variation and trends in receipt of antidepressants after PCa treatment, among patients with nonmetastatic PCa. Using population-based linked administrative data, we identified men ≥66 yr old who underwent surgery (n=4952), radiotherapy (n=4994), or surveillance (n=2136), and these men were matched to general population controls (n=57127). One year prior to PCa treatment, 7.7% of men received an antidepressant prescription, which increased to 10.5% in the year after treatment. In difference-in-differences analysis, adjusted for demographic and health characteristics, men had increased odds of antidepressant receipt up to 5 yr after surgery (odds ratio [OR] 1.49; 95% confidence interval [CI] 1.35–1.64; p≤0.0001) or radiotherapy (OR 1.33; 95% CI 1.21–1.47; p≤0.0001). Men did not have an increased risk of antidepressant receipt up to 5 yr after surveillance (OR 1.15; 95% CI 0.94–1.41; p=0.16). Limitations include the potential for selection bias and misclassification due to the retrospective design of the study and the use of administrative databases. Thus, men with nonmetastatic PCa who initially receive surgery or radiotherapy, but not those who initially undergo surveillance, have an increased risk of antidepressant receipt after treatment. Patient summary In this report, we examined antidepressant prescription for men after treatment of nonmetastatic prostate cancer across the entire population of men ≥66 yr in Ontario, Canada, from 2002 to 2009. For men diagnosed with nonmetastatic prostate cancer, the risk of antidepressant receipt at 5 yr after treatment was significantly increased after surgery or radiotherapy, but not after surveillance. Providers and patients should consider the psychological effects of prostate cancer treatment during the survivorship period.

Introduction: Approximately 50% of all high-grade renal traumas (HGRT, American Association for the Surgery of Trauma [AAST] grade 4/5) have associated collecting system injuries. Although most of these collecting system injuries will heal spontaneously, approximately 20–30% of these injuries are managed with ureteric stents. The objective of the study was to review the management of HGRT with collecting system injuries in a level 1 trauma center. Methods: This was a single-center, retrospective cohort study of trauma patients with HGRT and collecting system injuries from 1998–2019. Results: We identified 147 patients with HGRT. Of the 105 patients who had trauma computed tomography (CT) imaging within 24 hours, 46 were found to have collecting system injuries. Seven of these patients underwent intervention based on initial CT findings; the remaining 39 patients with urinary extravasation were conservatively managed. Of the 37 patients who underwent reimaging, 22 (59%) demonstrated a stable or resolving collection and 15 (41%) demonstrated continued urinary extravasation. Resolution of extravasation on subsequent imaging was observed in 10 of those patients, while five patients (14%) required intervention (four stents, one percutaneous drain) for symptoms/signs of urinary extravasation. Conclusions: In this study, most patients with HGRT and collecting system injuries did not require intervention unless the patient became symptomatic. The majority of collecting system injuries resolved with no intervention. This study underscores the need for future prospective trials to investigate the necessity of intervening in HGRT collecting system injuries and, secondarily, the need for routine reimaging in these asymptomatic patients.

Introduction: We sought to review outcomes of urethrovaginal fistula (UVF) repair, with or without concurrent fascial sling placement. Methods: All patients diagnosed with UVF at our center from 1988–2017 were included in this study. Patient charts were reviewed from a prospectively kept fistula database, and patient characteristics and surgical outcomes were described. Descriptive statistics were applied to compare complication rates between patients with or without fascial sling placement at the time of UVF repair. Results: A total of 41 cases of UVF were identified, all of which underwent surgical repair. Median age at diagnosis was 49 years (interquartile range [IQR] 35–62). All patients had undergone pelvic surgery. UVF etiology was secondary to stress urinary incontinence (SUI) surgery in 17 patients (41%) and urethral diverticulum repair in seven patients (17%). The most common presenting symptom was continuous incontinence in 19 patients (46%). Nineteen patients had a fascial sling placed at the time of surgery (46%), with no significant difference in complication rates (26% vs. 23%, p=0.79). Two patients had Clavien-Dindo grade I complications (5%) and one had a grade III complication (2%). Four patients had long-term complications (10%), including urinary retention, chronic pain, and urethral stricture. Two patients had UVF recurrence (5%). Median followup after surgery was 21 months (IQR 4–72). Conclusions: UVF should be suspected in patients with continuous incontinence following a surgical procedure. Most UVF surgical repairs are successful and can be done with concurrent placement of a fascial sling.

Key Points Question What is the rate of secondary sarcoma among patients with nonmetastatic cancer of the prostate, bladder, colon, rectum or anus, cervix, uterus, or testis who were treated with combinations of surgery, radiation, or chemotherapy compared with patients treated with surgery alone and with the general population? Findings In this cohort study of 173 580 patients, the rate of secondary sarcoma among patients treated with radiotherapy was increased compared with patients who had surgery alone and with the general population. The risk was highest among those who received both chemotherapy and radiotherapy. Meaning This study provides further evidence to support the association of radiotherapy with secondary sarcoma; the finding of an increase in risk with combination radiotherapy and chemotherapy, in particular, merits further study., This cohort study compares the risk of secondary sarcoma among patients treated with combinations of surgery, radiation, and chemotherapy with patients treated with surgery alone and with the general population., Importance The association of radiation and chemotherapy with the development of secondary sarcoma is known, but the contemporary risk has not been well characterized for patients with cancers of the abdomen and pelvis. Objective To compare the risk of secondary sarcoma among patients treated with combinations of surgery, radiation, or chemotherapy with patients treated with surgery alone and the general population. Design, Setting, and Participants This population-based cohort study included 173 580 patients in Ontario, Canada, with nonmetastatic cancer of the prostate, bladder, colon, rectum or anus, cervix, uterus, or testis. Patients were enrolled from January 1, 2002, to January 31, 2017. Data analysis was conducted from March 1, 2019, to January 31, 2020. Exposures Treatment combinations of radiation, chemotherapy, and surgery. Main Outcome and Measures Diagnosis of sarcoma based on histologic codes from the Ontario Cancer Registry. Time to sarcoma was compared using a cause-specific proportional hazard model. Results Of 173 580 patients, most were men (125 080 [72.1%]), and the largest group was aged between 60 and 69 years (58 346 [33.6%]). Most patients had genitourinary cancer (86 235 [51.4%]) or colorectal cancer (69 241 [39.9%]). Overall, 64 301 (37.1%) received surgery alone, 51 220 (29.5%) received radiation alone, 15 624 (9.0%) were treated with radiation and chemotherapy, 15 252 (8.8%) received radiation with surgery, and 11 822 (6.8%) received all 3 treatments. A total of 332 patients (0.2%) had sarcomas develop during a median (interquartile range) follow-up of 5.7 (2.2-8.9) years. The incidence of sarcoma was 0.3% among those who underwent radiation alone (138 of 51 220) and radiation with chemotherapy (40 of 15 624), 0.2% among those who received radiation and surgery (36 of 15 252) and all 3 modalities (25 of 11 822), and 0.1% among those who received surgery with chemotherapy (13 of 14 861) and surgery alone (80 of 64 801). Compared with a reference group of patients who had surgery alone, the greatest risk of sarcoma was found among patients who underwent a combination of radiation and chemotherapy (cause-specific relative hazard [csRH], 4.07; 95% CI, 2.75-6.01; P

Aims To identify risk factors for urinary retention following AdVance™ Sling placement using preoperative urodynamic studies to evaluate bladder contractility. Methods A multi-institutional retrospective review of patients who underwent an AdVance Sling for post-prostatectomy stress urinary incontinence from 2007 to 2019 was performed. Acute urinary retention (AUR) was defined as the complete inability to void or elevated post-void residual (PVR) leading to catheter placement or the initiation of intermittent catheterization at the first void trial postoperatively. Bladder contractility was evaluated based on preoperative urodynamics. Results Of the 391 patients in this study, 55 (14.1%) experienced AUR, and 6 patients (1.5%) had chronic urinary retention with a median follow-up of 18.1 months. In total, 303 patients (77.5%) underwent preoperative urodynamics, and there was no significant difference between average PdetQmax (26.4 vs. 27.4 cmH2 O), Qmax (16.6 vs. 16.2 ml/s), PVR (19.9 vs. 28.1 ml), bladder contractility index (108 vs. 103) for patients with or without AUR following AdVance Sling. Impaired bladder contractility preoperatively was not predictive of AUR. Time to postoperative urethral catheter removal was predictive of AUR (odds ratio, 0.83; 95% confidence interval, 0.73-0.94; p = .003). Conclusions Chronic urinary retention after AdVance Sling placement is uncommon and acute retention is generally self-limiting. No demographic or urodynamic factors were predictive of AUR. Patients who developed AUR were more likely to have their void trials within 2 days following AdVance Sling placement versus longer initial catheterization periods, suggesting that a longer duration of postoperative catheterization may reduce the occurrence of AUR.

Introduction: We aimed to evaluate the success of bladder neck injections of triamcinolone at the time of transurethral bladder neck incision (BNI) for prevention of recurrent vesicourethral anastomotic stenosis (VUAS) following prostate cancer treatment. Methods: This is a retrospective cohort study examining patients with recurrent VUAS post-RP ± radiation treated with triamcinolone injections at the time of BNI. VUAS was diagnosed by symptoms followed by cystoscopy or urethrography. The outpatient procedures were done under general anesthesia. Cold knife incisions were made at the three, nine, and 12 o’clock BN positions, followed by triamcinolone injections (4 mg/mL) into the three and nine o’clock incision sites. Treatment outcomes were determined with cystoscopy. Results: Eighteen men underwent 25 procedures over a four-year period. Median age at diagnosis of VUAS was 65 (interquartile range [IQR] 61–68); median time to VUAS from RP was eight months (IQR 5–12). Fourteen patients (78%) had radiation treatment. The cohort had 128 unsuccessful VUAS treatments, with a median of five failed treatments per patient (IQR 3–10). Failed treatments included BN dilation, BNI, BN injection of mitomycin C, and urethral stent placement. Success rate after a mean of 16.3 months (standard deviation [SD] 8.1) from the time of triamcinolone injection was 83% (15/18). Six patients went on to have successful incontinence surgery. Five patients (28%) had treatment complications (bleeding, urinary tract infection, pain, and urinary extravasation). The three non-responders are stable and awaiting re-treatment with triamcinolone injection. Conclusions: Triamcinolone bladder neck injections for post-RP VUAS are a useful and safe treatment for recurrent stenosis.

Introduction: We sought to assess seven-day and 30-day complications following renal mass biopsy (RMB), including mortality, hospitalizations, emergency department (ED) visits, and operative and non-operative complications and compare these to rates in population matched controls. Methods: We performed a population-based, matched, retrospective cohort study of patients undergoing RMB following consultation with a urologist and axial imaging from 2003–2015 in Ontario, Canada. Data on seven-day and 30-day rates of mortality, operative and non operative complications after RMB were reported. The seven-day and 30-day rates of mortality, operative and non-operative interventions, hospitalizations, and ED visits were compared to matched controls using multivariable logistic regression. Results: Among 6840 patients who underwent RMB in the study period, 24 (0.4%) and 159 (2.3%) died within seven and 30 days, respectively, of their biopsy. Seven- and 30-day operative intervention rates were 79 (1.2%) and 236 (3.4%), respectively. Seven- and 30-day non-operative intervention rates were 227 (3.3%) and 529 (7.7%) respectively. Thirty-day mortality (odds ratio [OR] 8.1; 95% confidence interval [CI] 5.1–13.0), hospitalizations (OR 12.6; 95% CI 10.6–15.2), and ED visits (OR 3.8; 95% CI 3.4–4.3) were more common among patients who underwent RMB than the matched controls (p

Introduction: With the cessation of non-urgent clinical office visits due to the coronavirus, there has been a rapid shift to telephone and other virtual visits in outpatient practice. We conducted a survey to evaluate patients’ perspective of telephone visits during the COVID-19 pandemic. Methods: Patients receiving a scheduled telephone call, as a virtual visit, from urologists at our clinic were asked to participate in a three-minute, self-administered, online questionnaire. After verbal permission was obtained, the survey was emailed to each participant. The outcomes evaluated were telephone visit satisfaction and preference for type of appointment. Non-parametric tests were used to analyze the results. The study was approved by the Sunnybrook Research Ethics Board. Results: A total of 102 participants were included; 96% of participants assessed the telephone visit as a positive experience in every survey question, while 45% expressed no preference. In those who expressed a preference, this was evenly divided between in-office visits and phone visits (p=0.0614). Participants who lived more than 75 km from the hospital were less likely to prefer an in-office visit compared to those residing locally (U=433; p=0.006; odds ratio 0.29; 95% confidence interval 0.106–0.779; p=0.0142). Conclusions: In this survey, most participants assessed the telephone visit positively. Almost half had no preference and a similar proportion expressed a preference for in-office and telephone visits. Patients who resided farther from the hospital were more likely to prefer the telephone visit. This is the first study that we know of to assess patients’ preferences regarding remote encounters in urology.

INTRODUCTION AND OBJECTIVE:Regulatory warnings for mesh-based stress urinary incontinence (SUI) and pelvic organ prolapse (POP) procedures have led to an unsupported claim that mesh directly stimul...

Introduction: Benign prostatic obstruction (BPO) due to histologic benign prostatic hyperplasia is highly prevalent among older men. Despite widespread use of medical therapy, surgical treatment remains a mainstay in the management of BPO. We sought to characterize trends in the surgical management of BPO in Ontario, Canada. Methods: We performed an interrupted time-series analysis using segmented regression among men aged 18 years and older undergoing surgical treatment for BPO between January 1, 1994 and December 31, 2014 in Ontario, Canada. The passage of time was considered the primary exposure. The primary outcome was the proportion of all BPO surgeries performed using each of the following modalities: transurethral resection of the prostate (TURP), endoscopic laser prostatectomy, open/laparoscopic prostatectomy, and others. Results: We identified 136 459 men who underwent BPO surgery between 1994 and 2014. The annual age-adjusted rate of BPO surgery declined significantly over time (24 to 10 per 10 000 population in 1994 and 2014, respectively). From 1994 to 2001, there were no significant changes in the distribution of BPO surgical modalities with TURP, the most common throughout (97.2% and 97% in 1994 and 2001, respectively). From 2002 to 2014, there was a significant decline in the use of TURP (92.1% to 76.9%; p=0.027) with a corresponding increase in the use of endoscopic laser prostatectomy (3.5% to 21.9%; p=0.0008). Conclusions: This study demonstrates a shift in the management of BPO, with increasing use of endoscopic laser prostatectomy, beginning in 2002. However, TURP remains the most common treatment modality.

Background: The causal association between radiation and chemotherapy treatment and the development of secondary sarcoma is well known, but the contemporary risk has not been well characterized for patients with cancers of the abdomen and pelvis. Methods: We conducted a population–based retrospective cohort study examining the risk of sarcoma among patients with localized cancer of the prostate, bladder, colorectal, cervical, uterine, and testis between 2002–2016. The primary outcome was the development of sarcoma. Cox proportional hazard analysis was used to estimate the risk of sarcoma after treatment combinations with radiation, chemotherapy, or surgery. Findings: We identified 173,580 patients. Most patients had genitourinary (51∙4%) or colorectal cancer (39∙9%). Overall, 332 (0∙2%) sarcomas developed over a median of 5∙7 years (IQR: 2∙2–8∙9). Compared to a reference group of patients who had surgery alone, the greatest risk for sarcoma was found for patients who underwent a combination of radiation and chemotherapy (HR=4∙1,95%CI:2∙8–6∙0,p

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.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.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.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.

The artificial urinary sphincter is a common treatment of male urinary incontinence. We sought to characterize long-term rates of artificial urinary sphincter revision/removal and reimplantation, and associated risk factors.We performed a population based, retrospective study using the Ontario Health Insurance Plan database of all male patients who underwent artificial urinary sphincter implantation from 1994 to 2013. Hospital, diagnostic and billing codes were used to identify patients. The Kaplan-Meier method and multivariable Cox proportional hazards models were applied to examine the cumulative incidence of artificial urinary sphincter reimplantation and revision/removal, and identify risk factors, respectively.A total of 1,632 male patients underwent initial implantation of an artificial urinary sphincter. The 10-year revision/removal and reimplantation rates were 34% and 27%, respectively. There was no difference between high and low volume hospitals or between community and academic hospitals in terms of revision/removal. A high level of comorbidity was associated with an increasing risk of removal/revision. The reimplantation rate was significantly lower in patients who underwent insertion at hospitals with the highest volume of surgery (HR 0.55, 95% CI 0.37-0.82, p0.01). A high level of comorbidity was not associated with an increasing risk of reimplantation. Preimplantation radiotherapy was not significantly associated with the risk of reimplantation (p = 0.17) or revision/removal (p = 0.95). Other factors were not significantly associated with reimplantation or revision/removal.Most men who undergo artificial urinary sphincter placement still have a device without repeat surgery 10 years following insertion. Radiotherapy does not increase the risk of repeat surgery. A high level of comorbidity was associated with an increasing risk of removal/revision.

AIMS To report the recommendations of the 6th International Consultation on Incontinence (ICI) on post-prostatectomy urinary incontinence. METHODS The 6th ICI committee on surgical treatment of urinary incontinence in men assessed and reviewed the outcomes of surgical therapy and updated the prior recommendations published in 2013. Articles from peer-reviewed journals, abstracts from scientific meetings, and literature searches by hand and electronically formed the basis of this review. The resulting guidelines were presented at the 2016 ICI meeting in Tokyo, Japan. RESULTS Voiding diary and pad tests are valuable for assessing quantity of leakage. Cystoscopy and/or urodynamics may be useful in guiding therapy depending on the type of incontinence and presumed etiology. Artificial Urinary Sphincter (AUS) is the preferred treatment for men with moderate to severe stress urinary incontinence (SUI) after RP. Male slings are an acceptable approach for men with mild to moderate SUI. Much discussion centers on the definition of moderate SUI. Injectable agents have a poor success rate in men with SUI. Options for recurrent SUI due to urethral atrophy after AUS implantation include changing the pressure balloon, downsizing the cuff and increasing the amount of fluid in the system. Infection and/or erosion demand surgical removal or revision of all or part of the prosthesis. CONCLUSIONS Although there are several series reporting the outcomes of different surgical interventions for PPUI, there is still a need for prospective randomized clinical trials. Recommendations for future research include standardized workup and outcome measures, and complete reporting of adverse events at long-term.

Background The long-term potential of solifenacin and mirabegron combination treatment for patients with overactive bladder (OAB) has not been previously assessed. Objectives To evaluate the safety and efficacy of solifenacin succinate 5mg plus mirabegron 50mg tablets (combination treatment) versus solifenacin or mirabegron monotherapy in patients with OAB over 12 mo. Design, setting, and participants Randomised, double-blind, multicentre, phase 3 trial (SYNERGY II) of patients with "wet" OAB symptoms (urinary frequency and urgency with incontinence) for ≥3 mo. The study was conducted from March 2014 to September 2016; with 1829 patients randomised. The full analysis set was comprised of 1794 patients. Outcome measurements and statistical analysis The primary objective was safety, measured as treatment-emergent adverse events (TEAEs). Efficacy was measured as the change from baseline to the end of treatment in the mean number of incontinence episodes/24h and micturitions/24h. Results and limitations The median age was 60 yr (range 19–86 yr) and 1434 patients (80%) were female. Overall, 856 patients (47%) experienced ≥1 TEAE. TEAE frequency was slightly higher in the combination group (596 patients, 49%; mirabegron 126 patients, 41%; solifenacin 134 patients, 44%). Serious TEAEs were reported by 67 patients (3.7%); one was considered possibly treatment-related (mirabegron group, atrial fibrillation). Dry mouth was the most common TEAE (combination 74 patients, 6.1%; solifenacin 18 patients, 5.9%; mirabegron 12 patients, 3.9%). Combination therapy was statistically superior to mirabegron and solifenacin for the number of incontinence episodes (vs mirabegron: adjusted mean difference [AMD] −0.5, 95% confidence interval [CI] −0.7 to −0.2, p Conclusions Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 mo and led to efficacy improvements over each monotherapy. This innovative combination is a treatment option that could become widely used in the clinic. Patient summary This study looked at the safety and efficacy of a combination of solifenacin succinate 5mg plus mirabegron 50mg tablets over 12 mo in patients with the overactive bladder (OAB) symptoms of increased urination frequency, heightened urgency to urinate, and unintentional passing of urine. We compared this treatment with solifenacin succinate 5mg or mirabegron 50mg alone, and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms. This novel combination could be an improved treatment option in the clinical setting for patients with OAB. This study is registered at ClinicalTrials.gov as NCT02045862.

Introduction We hypothesize that optimal management of interstitial cystitis/bladder pain syndrome requires more personalized data than obtained with symptom questionnaires and standard urological assessment. We used a qualitative approach to develop a best evidence series of questions to explore the total clinical picture in the patient with interstitial cystitis/bladder pain syndrome. Methods The methodology of this project included preliminary focus groups, individual patient interviews, content development and validity analyses to develop a series of questions of value to patients with interstitial cystitis/bladder pain syndrome. A new convenience sample of patients with this syndrome completed the series of questions exploring not only pain and urination symptoms, but also other biopsychosocial parameters noted to be of relevance to these patients. Results Content of final series of questions addressed pain, urination symptoms, flares and the 10 most important domains impacted by interstitial cystitis/bladder pain syndrome. Further questions addressed thoughts or feelings, attitudes and suicidal ideation. A series of questions addressed how patients cope with and manage their condition. A total of 32 patients with interstitial cystitis/bladder pain syndrome completed the finalized series of questions. Bladder pain and urination symptoms were primary concerns of patients but other domains related to associated nonurological conditions (poor sleep/persistent fatigue, irritable bowel syndrome-like symptoms, low back and general muscle pain, interference/impact [eg sleep, diet, travel, activities, sexual functioning], positive and negative beliefs/attitudes, and coping mechanisms) make up the total clinical picture for each patient. Conclusions The biopsychosocial information provided by our patients will better inform the health care professional on how to develop personalized treatment strategies and also individualized patient directed outcomes independent of bladder pain and urination symptoms.

There have been concerns that treatment of overactive bladder with β3 -adrenoceptor agonists may potentially have detrimental cardiovascular (CV) side effects. We evaluated the CV safety of mirabegron, a β3 -adrenoceptor agonist, alone and in combination therapy with the antimuscarinic agent solifenacin. The SYNERGY trial was a multinational, multicenter, randomized, double-blind, parallel-group, placebo and active-controlled phase 3 trial. Patients were randomized to receive solifenacin 5 mg + mirabegron 50 mg (combination 5 + 50 mg), solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg monotherapy, mirabegron 25 mg monotherapy, mirabegron 50 mg monotherapy, or placebo for a 12-week double-blind treatment period. A total of 3398 patients were included in the study. Mean changes from baseline to the end of therapy in ECG parameters were similar across treatment groups, although there was an increase in heart rate of 1 beat/minute in the mirabegron treatment groups. There were no clinically meaningful differences in change from baseline in QTcF between monotherapies and placebo and between monotherapies and combination therapy. There were very few major CV events: 1 of 853 (0.1%) with a nonfatal myocardial infarction in the combination 5 + 25 mg group, 2 of 848 (0.2%) with a nonfatal stroke in the combination 5 + 50 mg group, and no events in the other groups. This CV safety analysis of the combination of mirabegron and solifenacin showed rates of CV events comparable with those for monotherapy treatments based on assessments of vital signs, electrocardiograms, and adjudicated CV events.

Background The PREFER study was an assessment of medication tolerability, treatment preference and symptom improvement during treatment with mirabegron (M) and tolterodine (T) extended release (ER) in patients with overactive bladder (OAB). In this analysis of PREFER, patient-reported outcomes (PROs) were assessed during treatment. Methods PREFER was a two-period, 8-week crossover, double-blind, phase IV study (NCT02138747) of treatment-naïve adults with OAB ≥3 months randomized to 1 of 4 treatment sequences (M/T; T/M; M/M; T/T), separated by a 2-week washout. Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks. At each visit, PROs related to treatment satisfaction, quality of life and symptom bother were assessed using the OAB Satisfaction (OAB-S; 3 independent scales/5 single-item overall assessments), OAB-q (total health-related QoL [HRQoL] and subscales [Sleep, Social, Coping, Concern] and Symptom Bother scale) and Patient Perception of Bladder Condition (PPBC) questionnaires. Responder rates were reported for OAB-q subscales based on a minimal important difference (MID; ≥ 10-point improvement) and OAB-S Medication Tolerability score ≥ 90. Results In total, 358 randomized patients received ≥1 dose of double-blind study medication and completed ≥1 post-baseline value (OAB-S scale, OAB-q, PPBC): M/T (n = 154), T/M (n = 144), M/M (n = 30) or T/T (n = 30). At end of treatment (EoT), mirabegron and tolterodine ER were associated with similar mean improvements in 7 of the 8 OAB-S scores investigated, OAB-q scales and PPBC. A higher percentage of patients achieved clinically relevant improvements (MID) in OAB-q scales and OAB-S Medication Tolerability score during treatment with mirabegron than tolterodine ER. Conclusions On average, patients with OAB experienced improvements in treatment satisfaction, HRQoL and symptom bother that were of a similar magnitude during treatment with mirabegron or tolterodine ER. However, during mirabegron treatment, patients were more likely to achieve clinically relevant improvements in tolerability and HRQoL (as measured by the MID for the OAB-q or an OAB-S Medication Tolerability score ≥ 90) than during tolterodine ER treatment. Trial registration NCT02138747; registered May 13, 2014.

Up to 10% of men after radical prostatectomy will experience persistent bothersome urinary incontinence. Multichannel urodynamics is often utilized in the preoperative assessment of men with post-prostatectomy incontinence. However, the routine use of this expensive and invasive diagnostic modality in post-prostatectomy incontinence is debatable. This review highlights the evidence either supporting or refuting the routine use of multichannel urodynamic assessment in the preoperative workup of post-prostatectomy urinary incontinence. Stress urinary incontinence symptoms elucidated on history appears to accurately reflect findings on urodynamic assessment with a positive and negative predictive value of >95 and 100%, respectively. Up to half of men with post-prostatectomy incontinence may have some element of bladder dysfunction (decreased compliance, overactivity, decreased bladder capacity, etc); however, numerous studies have failed to demonstrate an impact of preoperative bladder dysfunction on post-surgical treatment outcomes. The available evidence demonstrates that a thorough history accurately reflects findings on urodynamic assessment. Further, bladder dysfunction, regardless of type, does not appear to impact on post-surgical treatment outcomes in men with post-prostatectomy incontinence. These findings argue against the routine use of multichannel urodynamic assessment in the preoperative assessment. However, unlike female incontinence, large randomized controlled trials testing the impact of preoperative urodynamic findings on surgical treatment outcomes are lacking.

Objective\ud \ud To assess the hypothesis that patients receiving placebo in overactive bladder (OAB) trials who experience less benefit from “treatment” continue with behavioral modifications such as fluid restriction, whereas those on active treatment adopt more normal drinking patterns. This may manifest itself as a reduction in micturition frequency (MF).\ud \ud Materials and Methods\ud \ud We interrogated a large integrated database containing pooled patient data from 4 randomized, placebo-controlled phase III OAB solifenacin studies. A statistical correction was applied to MF to remove the influence of fluid intake.\ud \ud Results\ud \ud Pooled analysis using patient-level data from 3011 patients and accounting for the studies within the models showed that all patients voided progressively less total urine per 24 hours during treatment than at baseline. However, reduction in total urine volume voided per 24 hours was larger in patients receiving placebo vs those on solifenacin; with a substantial decrease in 24-hour urine output in the placebo group from baseline to week 4, which was not the case in active groups. After correcting MF for volume voided for each patient using the statistical correction and averaging the corrected MF per treatment arm, the placebo effect almost disappeared. Patients on solifenacin voided less often, with a statistically significant increase in volume voided each time they voided, vs placebo.\ud \ud Conclusion\ud \ud Assuming volume voided is a good surrogate measure for fluid intake, this analysis shows that fluid restriction almost completely explains the reduction in MF in the placebo group. In contrast, patients receiving active treatment adopt more normal drinking patterns once they start to perceive improvement in their OAB symptoms.

In this double-blind, randomized study we compared the efficacy and safety of onabotulinumtoxinA or solifenacin vs placebo in patients with overactive bladder who had urinary incontinence and an inadequate response to or were intolerant of an anticholinergic. Post hoc analysis was done to compare the effects of onabotulinumtoxinA vs solifenacin.Solifenacin naïve patients were randomized to onabotulinumtoxinA 100 U, solifenacin 5 mg, (which could escalate to 10 mg at week 6 according to predefined criteria) or placebo. Patients could request treatment 2 (open label onabotulinumtoxinA) after fulfilling prespecified criteria. End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co-primaries, other urinary symptoms and quality of life, all at week 12, and adverse events.The change from baseline in incontinence episodes per day was significantly greater with onabotulinumtoxinA or solifenacin vs placebo (-3.19 or -2.56, respectively, vs -1.33, both p0.001). The incontinence reduction was significantly greater for onabotulinumtoxinA vs solifenacin (p = 0.022). At week 12, 33.8% (vs placebo p0.001), 24.5% (vs placebo p = 0.028) and 11.7% of patients receiving onabotulinumtoxinA, solifenacin and placebo, respectively, were dry. After treatment 2, which was open label onabotulinumtoxinA, 43.2%, 37.6% and 41.9% of patients in the onabotulinumtoxinA, solifenacin and placebo groups, respectively, were dry. Significant improvements in other urinary symptoms and quality of life were observed for both active treatments. Urinary tract infection in 25.5% of cases and urinary retention in 6.9% were more common with onabotulinumtoxinA.The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.

Introduction and hypothesis The objective of this study was to assess the tolerability and treatment preference in patients with overactive bladder (OAB) treated with mirabegron or tolterodine. Methods This was a two-period, 8-week crossover, double-blind, phase IV study (PREFER; NCT02138747) in treatment-naive adults with OAB for 3 months or longer randomized to one of four treatment sequences in a 5:5:1:1 ratio (mirabegron/tolterodine, tolterodine/mirabegron, mirabegron/mirabegron, or tolterodine/tolterodine), separated by a washout period of 2 weeks. The primary endpoint was drug tolerability using the Medication Tolerability scale of the OAB Treatment Satisfaction (OAB-S) questionnaire at end of treatment (EoT). Period-by-treatment interactions were analyzed to determine any effect of drug order. Patient preference, change from baseline in OAB symptoms, and treatment-emergent adverse events (TEAEs) were assessed. Results A total of 358 randomized patients completed the OAB-S Medication Tolerability scale questionnaire at one or more visits after the baseline evaluation. The mean (95% CI) OAB-S Medication Tolerability scores were significantly higher (better tolerability) for mirabegron (86.29 [83.50, 89.08]) than for tolterodine (83.40 [80.59, 86.20]; p = 0.004). The period-by-treatment interaction was not significant (p = 0.955). Improvements in OAB-S Medication Tolerability scores at EoT were more evident in women, patients aged ≥65 years, and in patients without baseline incontinence, and were greater with mirabegron than with tolterodine extended release. There were no significant differences in patient preference or improvements in OAB symptoms. Significant differences in favor of mirabegron were observed for anticholinergic TEAEs (20.4% vs. 27.4%; p = 0.042) and specifically for gastrointestinal disorders (14.7% vs. 22.5%; p = 0.015). Conclusions Tolerability of mirabegron was significantly higher than that of tolterodine, and patient preference and improvements in OAB symptoms were comparable. Both treatments were well tolerated; however, anticholinergic side effects were higher with tolterodine. Electronic supplementary material The online version of this article (doi:10.1007/s00192-017-3377-5) contains supplementary material, which is available to authorized users.

ObjectivesTo examine the complication rates after benign prostatic enlargement (BPE) surgery and the effects of age, comorbidity and preoperative medical therapy.DesignA retrospective, population-based cohort study using linked administrative data.SettingOntario, Canada.Participants52 162 men≥66 years undergoing first BPE surgery between 1 January 2003 to 31 December 2014.InterventionMedical therapy preoperatively and surgery for BPE.Primary and secondary outcome measuresThe primary outcome was overall 30-day postoperative complication rates. Secondary outcomes included BPE-specific event rates (bleeding, infection, obstruction, trauma) and non-BPE specific event rates (cardiovascular, pulmonary, thromboembolic and renal). Multivariable analysis examined the association between preoperative medical therapy and postoperative complication rates.ResultsThe 30-day overall complication rate after BPE surgery was 2828 events/10 000 procedures and increased annually over the study period. Receipt of preoperative α-blocker monotherapy (relative rate (RR) 1.05; 95% CI 1.00 to 1.09; p=0.033) and antithrombotic medications (RR 1.27; 95% CI 1.22 to 1.31; pConclusionsThirty-day complication rates after BPE surgery have increased annually between 2003 and 2014. Preoperative medical therapy with alpha blockers or antithrombotics was independently associated with higher rates of complications. Over this time, the duration of conservative therapy also increased.

INTRODUCTION AND OBJECTIVES:In men, overactive bladder (OAB) symptoms commonly overlap with those of benign prostatic hyperplasia (BPH), but limited data are available on the use of OAB medications...

INTRODUCTION AND OBJECTIVES:Renal mass biopsy (RMB) in the evaluation of renal masses for assessment of renal cancer is not widely adopted. Data to date are limited to single-institutional case ser...

INTRODUCTION AND OBJECTIVES:Patients with neuropathic bladder dysfunction associated with spina bifida are typically diagnosed and initially treated by pediatric specialists. Abrupt transition of c...

Background The majority of patients with overactive bladder (OAB) are aged >65yr. There has been no prospectively designed study assessing treatment efficacy with the β3-adrenoreceptor agonist, mirabegron, specifically in this age group. Objective A phase IV study comparing flexibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence. Design, setting, and participants Community-dwelling patients aged ≥65yr with OAB for ≥3mo. Intervention Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/24h were randomised 1:1 to double-blind 25mg/d mirabegron or matched placebo, for 12wk. After week 4 or 8, the dose could be increased to 50mg/d mirabegron/matched placebo based on patient and investigator discretion. Outcome measurements and statistical analysis Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24h and incontinence episodes/24h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24h, mean volume voided/micturition, and mean number of urgency episodes/24h. Stratified rank ANCOVA was used for the mean numbers of incontinence episodes/24h and urgency incontinence episodes/24h. Results and limitations Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Safety and tolerability were consistent with the known mirabegron safety profile. Conclusions Mirabegron efficacy, safety, and tolerability over 12 wk were confirmed in patients aged ≥65yr with OAB and incontinence. Patient summary We examined the effect of mirabegron compared with placebo in people aged 65yr or older with overactive bladder and incontinence. Mirabegron improved the symptoms of overactive bladder compared with placebo. Side effects were similar to those already known for mirabegron.

To examine the impact of androgen deprivation therapy (ADT) and primary treatment modality on cardiovascular and skeletal-related events and to investigate potential effect modification in a contemporary cohort of patients treated for clinically localized prostate cancer.We conducted a retrospective cohort study using Surveillance, Epidemiology, and End Results-Medicare linked databases for men aged 65-79 years who underwent radical prostatectomy or radiotherapy for cT1 or cT2 prostate cancer from 2000 to 2008. We categorized treatment according to primary therapy and receipt of ADT. We described the cumulative incidence of cardiovascular and skeletal-related events.Among 60,156 men, 14,403 underwent surgery and 45,753 underwent radiotherapy. Median follow-up was 6.0 years. After adjusting for baseline differences, treatments with radiotherapy (adjusted hazard ratios [aHR] 1.16-1.28, P .0001-.04) and ADT (aHR 1.18-1.32, P .0001-.008) were each independently associated with increased risk of coronary heart disease, sudden cardiac death, fracture, and fracture requiring hospitalization. Radiotherapy was associated with an increased risk of myocardial infarction (aHR 1.20, P = .02), whereas ADT was not (P = .5). We did not identify a significant statistical interaction between primary and hormonal treatment.Care for cardiovascular and skeletal-related events is an important part of the survivorship phase for a significant proportion of patients with localized prostate cancer. Increasing use of ADT for patients with localized disease undergoing radiotherapy and the observed higher prevalence of these events in these patients should be considered when discussing the risks and benefits of treatment for localized prostate cancer and when formulating a survivorship plan.

Purpose: We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron 50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg.Materials and Methods: Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were randomized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg, or solifenacin 5 or 10 mg for 12 weeks. The mirabegron dose was increased from 25 to 50 mg after week 4. Symptom bother, health related quality of life and patient perception of bladder condition were assessed by OAB-q (Overactive Bladder Questionnaire) and the PPBC (Patient Perception of Bladder Condition) questionnaire, respectively. Responder rates were based on a 50% reduction in daily incontinence, zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC.Results: Overall 2,174 patient...

Context To date, there is no Level 1 evidence comparing the efficacy of radical prostatectomy and radiotherapy for patients with clinically-localized prostate cancer. Objective To conduct a meta-analysis assessing the overall and prostate cancer-specific mortality among patients treated with radical prostatectomy or radiotherapy for clinically-localized prostate cancer. Evidence acquisition We searched Medline, EMBASE, and the Cochrane Library through June 2015 without year or language restriction, supplemented with hand search, using Preferred Reporting Items for Systematic Reviews and Meta-Analysis and Meta-analysis of Observational Studies in Epidemiology guidelines. We used multivariable adjusted hazard ratios (aHRs) to assess each endpoint. Risk of bias was assessed using the Newcastle-Ottawa scale. Evidence synthesis Nineteen studies of low to moderate risk of bias were selected and up to 118 830 patients were pooled. Inclusion criteria and follow-up length varied between studies. Most studies assessed patients treated with external beam radiotherapy, although some included those treated with brachytherapy separately or with the external beam radiation therapy group. The risk of overall (10 studies, aHR 1.63, 95% confidence interval 1.54–1.73, p 2 =0%) and prostate cancer-specific (15 studies, aHR 2.08, 95% confidence interval 1.76–2.47, p 2 =48%) mortality were higher for patients treated with radiotherapy compared with those treated with surgery. Subgroup analyses by risk group, radiation regimen, time period, and follow-up length did not alter the direction of results. Conclusions Radiotherapy for prostate cancer is associated with an increased risk of overall and prostate cancer-specific mortality compared with surgery based on observational data with low to moderate risk of bias. These data, combined with the forthcoming randomized data, may aid clinical decision making. Patient summary We reviewed available studies assessing mortality after prostate cancer treatment with surgery or radiotherapy. While the studies used have a potential for bias due to their observational design, we demonstrated consistently higher mortality for patients treated with radiotherapy rather than surgery.

Study Objective A variety of surgical procedures exist to correct stress urinary incontinence (SUI). Mid-urethral slings are currently considered the gold standard. Recent FDA warnings regarding mesh use in pelvic organ prolapse surgeries may have caused negative perceptions towards mesh-based procedures. The objective of this study is to review the outcomes and complications associated with the different surgical procedures performed for SUI. Design A retrospective chart review of patients undergoing SUI surgery from 2013–2018 was performed and included: Mid-urethral sling (MUS), laparoscopic polypropylene mesh sling (Lap mesh sling), laparoscopic Burch (Burch) and autologous fascial sling (AFS). Setting Tertiary care academic center. Patients or Participants Patients were identified from our center's operating room database and verified with office charts from the involved 6 surgeons. Interventions N/A Measurements and Main Results Patient demographics, pre/intra/post-operative measures and surgical outcomes (up to 2 years post-surgery) were reviewed. Of 649 charts, 32% (209/649) had MUS, 31% (200/649) had lap mesh sling, 25% (161/649) had Burch and 12% (79/649) had AFS. 408/649 (62.9%) had concomitant procedures with the most common being posterior vaginal repair (274/408). Intra/post-surgical complication rates were: DVT/PE (0/649), transfusion (0/649), re-operation for hemorrhage (2/649), bladder injury (9/649), bowel injury (4/649), readmission (32/649). Post-op urinary retention rates (and mean duration of catheter use) were: MUS 22.5% (8.4 days), Lap mesh sling 52.0% (11.2 days), Burch 61.5% (5.7 days) and AFS 93.7% (15.9 days). Overall, 232/649 (35.7%) and 124/649 (19%) had information available for the 1- and 2-year follow-up visits. At 1-year post-operatively, SUI was cured in 89% (79/89) of MUS, 82% (63/77) of Lap mesh sling, 92.0% (23/25) of Burch and 58.5% (24/41) of AFS. Conclusion The 2 most common surgical procedures for SUI at our center involve the use of permanent mesh: MUS and laparoscopic mesh sling. Overall, there are low complication rates and good 1-year cure rates for all surgeries except AFS.