Effectiveness of convective water vapor energy therapy versus prostatic urethral lift for symptomatic benign prostatic hyperplasia: a systematic review and indirect comparison.

PURPOSE: To synthesize the evidence from randomized controlled trials of prostatic urethral lift (PUL) and convective water vapor thermal energy therapy (WAVE) for minimally invasive treatment of men with benign prostatic hyperplasia. METHODS: A systematic search of databases was performed to identify trials comparing WAVE or PUL to either an active or sham surgery control in subjects with symptomatic benign prostatic obstruction. A controlled indirect treatment comparison based on the approach of Bucher was performed for outcomes including International Prostate Symptom Score and maximum urinary flow rate (Qmax). The durability of treatment response was assessed by life-table analysis of freedom from retreatment through 4 years. RESULTS: Two multicenter sham-controlled trials (Rezum II Study, NCT01912339: LIFT Study, NCT01294150) were identified. The trials employed a common sham procedure and were similar with respect to their designs and subjects' baseline characteristics. Comparisons on the treatment effect in excess of sham response found non-significant differences between WAVE and PUL for symptom score [mean difference (MD): - 1.7 points; 95% confidence interval (CI): - 4.8, 1.4] but Qmax improvements favored WAVE [MD: 3.4 ml/sec; CI: 1.2, 5.6]. The proportion free of retreatment through 4 years was 89.1% for WAVE versus 75.4% for PUL [log-rank P = 0.004]. CONCLUSIONS: PUL and WAVE provide similar subjective improvements but flow-rate improvement and durability of response seem greater for WAVE. The confirmation of these findings in a randomized trial is warranted.

Low Interrater Reliability of Videourodynamic Diagnosis of Detrusor External Sphincter Dyssynergia.

OBJECTIVES: Complex bladder dysfunction requires urodynamic testing, often under fluoroscopy termed videourodynamic study (VUDS), to assist the diagnosis and management. Videourodynamic study is an objective tool with high interrater reliability (IRR) for identifying detrusor overactivity. However, IRR has not been validated with disorders associated with neurogenic bladder (NGB). We aim to investigate the IRR of VUDS to diagnose detrusor external sphincter dyssynergia (DESD) among NGB patients and hypothesize a high IRR to DESD diagnosis on VUDS. METHODS: Videourodynamics tracings with fluoroscopic images were rated either positive or negative for evidence of DESD by 4 raters (2 neurourologists, neurourology fellow, and urology postgraduate year 2 resident), in patients who underwent VUDS from 2013 to 2017. The study population had known NGB without previous bladder reconstruction. The IRR was determined using percent agreement and κ values. RESULTS: The experts had a percent agreement of 82.1% (κ = 0.26). Expert 1 and expert 2 had a percent agreement of 63.6% (κ = 0.1497) and 68.9% (κ = 0.2967), respectively, when compared with the fellow. Sensitivity and specificity ranged from 28% to 75% and 64% to 93%, respectively. The negative predictive values ranged from 90% to 95%. CONCLUSIONS: The IRR to diagnose DESD on VUDS was much lower than expected, even among experts, and was likely multifactorial and partially owing to lack of clinical context and lack of standardized VUDS interpretation of the electromyogram. A high negative predictive value was found among all participants. Further research is needed to evaluate factors contributing to the low reproducibility of DESD diagnosis on VUDS.

Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy: A Meta-analysis of Oncologic, Perioperative, and Complication-related outcomes.

Robot-assisted radical cystectomy (RARC) is increasingly being used to treat muscle-invasive bladder cancer in an attempt to improve functional outcomes and complication rates over open radical cystectomy (ORC). We performed a meta-analysis of randomized controlled trials (RCTs) to compare patient outcomes between RARC and ORC. The primary outcome measure was a composite of recurrence-free survival (RFS) or progression-free survival (PFS). As a secondary measure, we examined other surrogate oncologic endpoints, perioperative outcomes, and complications. We found no difference between RARC and ORC with respect to RFS/PFS (hazard ratio 0.89, 95% confidence interval 0.64-1.24), surgical margin rates, or lymph node dissection yield. Analysis of patterns of recurrence for (pelvic) versus distant/abdominal sites indicated a significant difference between RARC and ORC (p=0.04). This analysis represents a combination of post hoc analyses using RCT data and inconsistent between-study definitions of recurrence sites, and must be interpreted with caution. Lastly, RARC was associated with an advantage in estimated blood loss, but a longer operative time, with no difference in hospital length of stay or complication rates. These data support the oncologic safety of RARC; however, further research is required to assess potential differences in recurrence patterns. PATIENT SUMMARY: We synthesized data from recent randomized controlled trials to examine differences in cancer control between minimally invasive, robot-assisted radical cystectomy and traditional, open radical cystectomy. Our study shows that cancer control outcomes are comparable between robotic and open techniques, supporting the safety of minimally invasive surgery. Blood loss was lower in robotic surgery, but the robotic procedure was longer and did not have lower complications rates after surgery.

Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc).

Between September and December 2017, 82 men with moderate-to-severe lower urinary tract symptoms due to benign prostatic hyperplasia LUTS/BPH and prostate volume of 80-150 cc underwent Aquablation in a prospective multicenter clinical trial in the United States. Baseline patient and clinical demographics and standardized postoperative parameters were collected and tabulated in a central independently monitored database. Adverse events through 3 months were adjudicated by an independent clinical events committee. Mean pre-treatment prostate volume was 108 ± 21.1 cc. Mean operative time was 38.2 ± 14.4 min and mean Aquablation resection time was 7.7 ± 3.3 min. Additional electrocautery for hemostasis was not needed in any patient following Aquablation. The average length of stay following the procedure was 1.6 ± 1.0 days. Mean pre- and 3 months post-treatment IPSS scores were 23.7 ± 6.4 and 7.1 ± 5.1, -16.6, p < 0.01. Mean pre- and 3 months post-treatment Qmax were 9.2 ± 3.3 ml/s and 19.5 ± 13 ml/s, + 10.8 ml/s, p < 0.01. Mean pre- and 3 months post-treatment post-void residuals were 120.6 ± 119.1 cc and 50.6 ± 61.6 cc, -72.0 cc, p < 0.01. The observed Clavien-Dindo grade 2 or higher event rate at 3 months was 34.1%. Aquablation is a safe and effective treatment option for men with large prostates (80-150 cc) suffering from LUTS/BPH.

Complications associated with single-dose, perioperative mitomycin-C for patients undergoing bladder tumor resection.

OBJECTIVES: To better understand the risk of short-term complications associated with perioperative intravesical mitomycin-C (MMC) therapy for patients undergoing endoscopic management of non-muscle invasive bladder cancer. METHODS AND MATERIALS: Using an institutional database of patients with bladder cancer, we performed a retrospective case-control study of patients receiving perioperative MMC after tumor resection (2008-2012). MMC cases were matched by clinical stage to controls receiving endoscopic resection alone. Demographic information, clinicopathologic details, and outcomes were compared between groups. Outcomes of interest included overall, genitourinary, and major complications. Chi-square tests and multivariable logistic regression were used to evaluate associations among patient characteristics, clinical factors, exposure to MMC, and outcomes of interest. RESULTS: One-hundred sixteen patients treated with MMC were matched to 116 controls. Patients receiving MMC were younger (P = 0.04) and more likely to have invasive disease (i.e. T1 or greater) (23% vs. 15%, P = 0.02). Complications were more frequent among patients who were treated with MMC (34.5% vs. 19.8%, Odds Ratio 2.89, 95% Confidence Interval 1.43-5.81). The most common complication among MMC patients that required medical management was dysuria (17%). Major complications were more common among MMC patients (5.2% vs. 0.9%), but this difference did not reach statistical significance (P = 0.11). CONCLUSIONS: Use of MMC is associated with a greater odds of complications compared with controls. Patients should be counseled regarding both the benefits and potential risks of perioperative intravesical MMC. Continued research is required to understand the safety implications associated with the use of perioperative, intravesical MMC.

Efficient delivery of radical cystectomy after neoadjuvant chemotherapy for muscle-invasive bladder cancer: a multidisciplinary approach.

BACKGROUND: Cystectomy delay >90 days after a diagnosis of muscle-invasive bladder cancer (MIBC) adversely affects pathologic stage and survival outcomes in patients who undergo primary surgery. After neoadjuvant chemotherapy (NAC), the impact of the timing of cystectomy delivery on these outcomes is uncertain. Poor communication between urologic and medical oncologists can result in cystectomy delay after systemic treatment. The authors of this report hypothesized that a delay in cystectomy delivery after NAC is associated with adverse survival outcomes. METHODS: An eligible cohort of 153 patients with MIBC received NAC and underwent radical cystectomy between 1990 and 2007. At the authors' institution, the genitourinary team strives to schedule patients for surgery at the time of initial evaluation or after their first chemotherapy cycle. Clinicopathologic characteristics, including timing of cystectomy, chemotherapy delivery, vital status, and reasons for excessive surgical delay, were analyzed retrospectively using an institutional database. A Cox proportional regression model was used to test the association between the timing of cystectomy delivery and survival. RESULTS: The median follow-up for all patients was 3.6 years. The median time to cystectomy was 16.6 weeks and 6.9 weeks from the first and last day of NAC, respectively. In multivariate analyses, the timing of cystectomy delivery from the termination of NAC did not significantly alter the risk of survival. The most common reason for cystectomy delivery beyond 10 weeks (28 patients; 18%) was procedural scheduling. CONCLUSIONS: Cystectomy delivery within 10 weeks after NAC did not compromise patient survival and, thus, provided a reasonable window for patient recovery and surgical intervention.

Metabolomic profiling reveals potential markers and bioprocesses altered in bladder cancer progression.

Although alterations in xenobiotic metabolism are considered causal in the development of bladder cancer, the precise mechanisms involved are poorly understood. In this study, we used high-throughput mass spectrometry to measure over 2,000 compounds in 58 clinical specimens, identifying 35 metabolites which exhibited significant changes in bladder cancer. This metabolic signature distinguished both normal and benign bladder from bladder cancer. Exploratory analyses of this metabolomic signature in urine showed promise in distinguishing bladder cancer from controls and also nonmuscle from muscle-invasive bladder cancer. Subsequent enrichment-based bioprocess mapping revealed alterations in phase I/II metabolism and suggested a possible role for DNA methylation in perturbing xenobiotic metabolism in bladder cancer. In particular, we validated tumor-associated hypermethylation in the cytochrome P450 1A1 (CYP1A1) and cytochrome P450 1B1 (CYP1B1) promoters of bladder cancer tissues by bisulfite sequence analysis and methylation-specific PCR and also by in vitro treatment of T-24 bladder cancer cell line with the DNA demethylating agent 5-aza-2'-deoxycytidine. Furthermore, we showed that expression of CYP1A1 and CYP1B1 was reduced significantly in an independent cohort of bladder cancer specimens compared with matched benign adjacent tissues. In summary, our findings identified candidate diagnostic and prognostic markers and highlighted mechanisms associated with the silencing of xenobiotic metabolism. The metabolomic signature we describe offers potential as a urinary biomarker for early detection and staging of bladder cancer, highlighting the utility of evaluating metabolomic profiles of cancer to gain insights into bioprocesses perturbed during tumor development and progression.

Overactive bladder: recognition requires vigilance for symptoms.

Overactive bladder (OAB) is a prevalent condition in both men and women that imposes significant burdens on the patient and his or her quality of life. Nevertheless, only a small percentage of patients with OAB receive diagnosis and treatment. The identification of OAB is well within the scope of the primary care provider, as it is symptom-based and does not generally require specialized testing. The treatment of OAB relies on behavioral modification and/or pharmacologic options, primarily antimuscarinic therapy. Better identification of OAB symptoms in the primary care setting should reduce the number of patients suffering from untreated OAB.