Effect of Transperineal Versus Transrectal Prostate Biopsy on the Quality of Hydrogel Spacer Placement in Men Prior to Radiation Therapy for Prostate Cancer.

OBJECTIVE: To determine whether prostate biopsy type affects spacer placement quality using a large sample of patients treated in the ambulatory setting. METHODS: A retrospective cohort study was conducted on patients diagnosed with prostate cancer who underwent hydrogel spacer placement before primary radiation treatment between 2018 and 2023 after transperineal (TP) or transrectal (TR) prostate biopsy. Study outcomes were Spacer Quality Score (SQS) (0-2, with greater values indicating better placement), Rectal Wall Infiltration (RWI) (0-3, with lower values indicating lack of RWI), and the occurrence of other hydrogel complications. RESULTS: A total of 395 patients were included. A pre-hydrogel TR biopsy was performed in 273 patients (69.1%), while TP biopsy was performed in 122 (30.9%). A SQS ≥1 occurred in 308 (77.9%) patients. A greater proportion of TP patients had a favorable SQS (≥1) compared to those who underwent TR (87.7 vs 73.5%, P <.002). An RWI score ≥2 was found in 180 (45.6%) patients. The proportion of patients with an unfavorable RWI score (≥2) did not differ significantly by type of biopsy performed. Patients who had an interval of >70 days between biopsy and hydrogel placement had significantly decreased odds of an RWI score ≥2 (odds ratio = 0.42, 95% confidence interval: 0.21-0.83). Only one infection was found after hydrogel placement. CONCLUSION: The quality of hydrogel placement was significantly better in men who had undergone TP biopsy. Rectal wall infiltration was more common than previously reported but did not differ between TP and TR biopsies.

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device.

Purpose: To document the effect of the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. Materials and Methods: Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. Results: We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared with baseline. Men in the iTind arm without erectile dysfunction at baseline showed an improvement in total IIEF score of +6.07 ± 21.17 points (p = 0.034) at 12 months, in addition to an improvement in ejaculatory function. SHIM scores remained unchanged in all groups, regardless of age, prostate volume, or baseline erectile function. Conclusion: No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function. Clinicaltrials.gov: NCT02506465.

Role of Prophylactic Antibiotics in Transperineal Prostate Biopsy: A Systematic Review and Meta-analysis.

CONTEXT: Transperineal prostate biopsy is associated with a significantly lower risk of infectious complications than the transrectal approach. In fact, the risk of infectious complications with transperineal prostate biopsy is so low that the utility of administering periprocedural antibiotics with this procedure has come under question. OBJECTIVE: To perform a systematic review and meta-analysis to assess for differences in the rates of infectious complications (septic, nonseptic, and overall) after performing transperineal prostate biopsy with and without the administration of periprocedural antibiotic prophylaxis. EVIDENCE ACQUISITION: Three electronic databases (PubMed, Embase, and MEDLINE) were searched, and studies were included if they included patients who underwent transperineal prostate biopsy, were published after January 2000, included information on periprocedural antibiotic administration, and reported postbiopsy complications. Preferred Reporting Items for Systematic Reviews and Meta-analyses and Agency for Healthcare Research and Quality guidelines were utilized. EVIDENCE SYNTHESIS: A total of 106 unique studies describing 112 cohorts of patients were identified, of which 98 (37 805 men) received antibiotic prophylaxis and 14 (4772 men) did not receive it. All patients were included in the analysis of septic complications. In total, there were 19/37 805 (0.05%) episodes of sepsis in the group of men who received antibiotics, which was similar to the no antibiotic group with 4/4772 (0.08%) episodes (p = 0.2). For overall infections (septic plus nonseptic), there were 403/29 880 (1.35%) versus 58/4772 (1.22%) events among men with evaluable data who received and did not receive antibiotic prophylaxis, respectively (p = 0.8). Restricting our analysis to studies with a comparable low number of biopsy cores (<25 cores), there remained no difference in the rates of sepsis between groups, but there was a small, statistically significant lower risk of infectious complications with antibiotic administration-67/12 140 (0.55%) versus 58/4772 (1.22%; p < 0.01). CONCLUSIONS: The likelihood of septic infections after transperineal prostate biopsy is low with and without antibiotic prophylaxis. The omission of periprocedural antibiotics with this procedure stands to benefit patients by avoiding potential drug reactions. Furthermore, this practice is in line with calls throughout the medical community for improved antibiotic stewardship. PATIENT SUMMARY: In a large systematic review and meta-analysis, we evaluated infectious complications after transperineal prostate biopsy with or without the administration of prophylactic antibiotics. We conclude that prophylactic antibiotics do not decrease the rate of postbiopsy sepsis but may have a small benefit in terms of preventing less serious infections.

Natural history of lower urinary tract symptoms among men undergoing stereotactic body radiation therapy for prostate cancer with and without a Rectal Hydrogel Spacer.

PURPOSE: Stereotactic body radiation therapy (SBRT) is increasingly used for prostate cancer, but has morbidity as both the bladder and rectum are radiated during treatment. Our goal was to document and compare lower urinary tract symptoms (LUTS) among men who underwent SBRT with and without SpaceOAR hydrogel (Augmenix, Inc., Bedford, MA). METHODS: We performed a retrospective analysis of 87 men (50 SpaceOAR and 37 non-SpaceOAR) who underwent SBRT. Primary outcomes were patient reported symptoms during radiation therapy, pharmacotherapy usage, and urologic and bowel survey scores up to 6-months post-SBRT. RESULTS: 78% of men were on α-inhibitors at the end of SBRT, an increase from 27.6% baseline usage (p < 0.001). Post-SBRT urinary frequency was more common in the non-SpaceOAR group versus the SpaceOAR group (68% versus 38%, p = 0.006), as was nocturia (35% vs. 8%, p = 0.002). Acute gastrointestinal symptoms did not differ. 58.8% of men were on α-inhibitors at 6-months of follow-up post-SBRT, an increase from 27.6% baseline usage (p < 0.001). Importantly, there was a difference of α-inhibitor use between non-SpaceOAR and SpaceOAR groups at the end of SBRT and at 1.5-, 3-, and 6-months follow up (86% vs. 53% [p = 0.002], 83% vs. 53% [p = 0.005], 72% vs. 49% [p = 0.038], respectively). CONCLUSION: LUTS after SBRT remains a significant problem for men undergoing treatment for prostate cancer. LUTS affects men during and up to 6-months following SBRT. Owing to these increased LUTS, preemptive minimally invasive solutions and their mechanisms of protection, including the SpaceOAR, should be further investigated.

Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes.

INTRODUCTION: Half of men aged > 60 years will develop benign prostatic hyperplasia (BPH) with 40% of these men having moderate-to-severe lower urinary tract symptoms (LUTS). There is limited knowledge on a head-to-head comparison of prostatic urethral lift (UroLift) and convective water vapor ablation (Rezum) for the treatment of LUTS secondary to BPH. We sought to compare randomized controlled trials with 3-year clinical outcome data. MATERIALS AND METHODS: After a thorough literature search, two multicenter sham-controlled double-blind randomized trials for UroLift and Rezum were identified and compared. Both studies had similar designs, baseline characteristics, reported outcomes, and low risks of bias. RESULTS: Rezum and UroLift resulted in significant improvement of International Prostate Symptom Score (IPSS) at 3 months (51.4% and 49.9%, respectively) and 50% reduction of IPSS Quality of Life that was durable across all time points. At 24 and 36 months, there was a statistically significant difference in IPSS between groups, favoring Rezum (-11.2 ± 7.3 versus -9.13 ± 7.62, p = 0.04, and -11.0 ± 7.1 versus -8.83 ± 7.41, p = 0.04, respectively). While Rezum had greater improvement in Qmax at 3 months (6.4 ± 7.2 versus 4.29 ± 5.16, p < 0.01), there was no difference in improvement from 12-36 months between treatments. Only UroLift experienced improvements of Men's Sexual Health Questionnaire- Ejaculatory Dysfunction (MSHQ-EjD) function from baseline and was better than Rezum at all time points (p < 0.01). Rezum failed to significantly reduce the MSHQ-EjD bother at 3 months, while UroLift demonstrated a significant reduction of 27.56% (p < 0.01). Both systems offered equal improvements in the bother score by 12-36 months. Surgical re-treatment rates favored Rezum over Urolift (4.4% vs. 10.7%, respectively). CONCLUSIONS: Rezum achieved a greater improvement in symptom relief compared to UroLift. Improvement in ejaculatory dysfunction in patients treated with UroLift was greater than Rezum.

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.

OBJECTIVE: To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS: A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION: Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

Persistent Discordance in Grade, Stage, and NCCN Risk Stratification in Men Undergoing Targeted Biopsy and Radical Prostatectomy.

OBJECTIVE: To elucidate the accuracy of MRI and MRI-ultrasound fusion guided targeted biopsy (TBx) on risk stratification in men who underwent subsequent radical prostatectomy (RP). MATERIALS AND METHODS: A single-center, retrospective study was performed in men at risk for prostate cancer who (n = 140) underwent TBx and RP between November 2012 and August 2018. Comparisons were made between patients clinically staged by preoperative MRI and TBx Gleason grade group (GGG) and stage after RP. Multivariable regression was performed to identify factors associated with MRI and TBx compared to RP grading, staging, and consistency with National Comprehensive Cancer Network (NCCN) risk stratification. RESULTS: There was an increase in NCCN risk stratification in 47 men (33.6%) and a decrease in 17 men (12.1%) compared to the resected prostate. GGG upgrading and downgrading occurred in 35 (25.0%) and 31 men (22.1%), respectively. Upstaging occurred in 41 men (29.3%). In adjusted analysis for age, BMI, PSA Density (PSAD), median maximal diameter of the regions of interest, and PIRADS, men with PIRADS 4 were less likely to be upgraded (OR 0.26, 95% CI 0.08-0.81, P = .020) than PIRADS 3. PSAD ≥ 0.15 ng/mL/cc was associated with upstaging (OR 3.92, 95% CI 1.60-9.62, P = .003). CONCLUSION: Accurate risk stratification is critical for disease management, mandated by the increasing use of active surveillance, partial gland ablation, and androgen deprivation therapy with radiation therapy for men with unfavorable intermediate and high-risk prostate cancer. This study confirms the need for advances in imaging and biomarker to increase the accuracy of pretreatment staging.

Mechanical Thrombectomy for Submassive Pulmonary Embolism in an Adult with Duodenal Adenocarcinoma and Brain Metastases.

A 52-year-old African American man with small bowel adenocarcinoma metastatic to the brain and leptomeninges was found to have an acute pulmonary embolism while hospitalized for acute lower limb weakness, bowel, and urinary incontinence. He had an elevated troponin, echocardiographic findings concerning for right heart failure, and bilateral segmental and subsegmental pulmonary artery perfusion deficits with right pulmonary artery thrombus on CT angiography. Given the laboratory and radiographic findings with normotensive blood pressure, the patient was diagnosed with a submassive pulmonary embolism.  After deliberation with interventional radiology and hematology, the patient underwent mechanical thrombectomy and was treated with therapeutic anticoagulation. Mechanical thrombectomy revealed substantial clot burden in the central pulmonary arteries and yielded a significant improvement in hypoxia and dyspnea.  This case was an excellent exercise in therapeutic decision-making amidst a dynamic disease process that required integration of numerous clinical and diagnostic data points, including empiric anticoagulation with high clinical suspicion of acute pulmonary embolism, review of contraindications to anticoagulation and thrombolysis in metastatic malignancy, and the decision to pursue mechanical thrombectomy in the setting of contraindications to catheter-directed thrombolysis.

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

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

Data on the quality and methods of studies reporting healthcare costs of post-prostate biopsy sepsis.

This data article presents the supplementary material for the review paper "Healthcare Costs of Post-Prostate Biopsy Sepsis" (Gross et al., 2019). A general overview is provided of 18 papers, including the details about year and journal of publication, country of dataset, data population characteristics, cost basis, and potential for bias evaluation. Quality assessment and the risk of bias of the 18 papers are detailed and summarized.

Feasibility of a Mobile Health Application To Monitor Recovery and Patient-reported Outcomes after Robot-assisted Radical Prostatectomy.

A mobile application (app) designed on the basis of a literature review and interviews with urologic oncologists was created to help streamline robot-assisted radical prostatectomy care and in compliance with quality indicators. Use of the app was limited to English-speaking men with iPhones; 20 of 43 men approached (47%) agreed to participate. Lack of an iPhone was the most common reason for non-enrollment (52%). Preoperatively, men received daily push notifications to perform Kegel exercises and 19 men (95%) completed an Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire using the app. After hospital discharge, men completed a postoperative pain questionnaire and received push notifications to ambulate and increase their fluid intake. After catheter removal, daily notifications to perform Kegel exercises and complete weekly EPIC-CP surveys were pushed to monitor recovery of functional outcomes. EPIC-CP and postoperative pain assessment response rates were 75% and 90%, respectively. 85% of the men complied with notifications to ambulate, hydrate, and perform Kegel exercises. The 15 men (75%) who completed the satisfaction survey found the app easy to use and understand, which suggests that mobile apps can be easily implemented perioperatively. Mobile apps have the potential to improve compliance with perioperative instructions and allow more frequent capture of patient-reported outcomes with minimal resource utilization. Patient summary: We examined the use of a mobile application designed to capture patient-reported outcomes and guide postoperative care after major urologic surgery. Mobile apps can be implemented with relative ease and high patient satisfaction.

Healthcare Costs of Post-Prostate Biopsy Sepsis.

Sepsis following transrectal prostate biopsy occurs in 2%-5% of cases and the risk is increasing. We performed a comprehensive literature search for the cost of post-prostate biopsy sepsis to define the potential cost savings of reducing infectious complications. Reporting of cost is varied and presents a challenge to interpretation. Length of hospitalization ranged from 1.1 to 14 days and the percent admitted to an ICU ranged from 1.1% to 25%. The estimated cost of sepsis post-prostate biopsy, adjusted for inflation, ranged from $8,672 to $19,100. Healthcare costs of treating post-biopsy infection are substantial. Our findings should guide payers and policymakers, especially in value-based care models.

The influence of age and other prognostic factors associated with survival of ovarian immature teratoma - A study of 1307 patients.

OBJECTIVE: To determine impact of age and other prognostic factors on the survival of ovarian immature teratoma (IT) patients. METHODS: Data obtained from the SEER database between 1973 and 2012. Kaplan-Meier methods and multivariate Cox regression models were used for statistical analyses. RESULTS: Of 1307 patients (median: 24years; range: 0-93), 78%, 5%, 13%, 4% were stages I, II, III and IV, respectively. 25%, 35%, and 40% had grades 1, 2, and 3. Whites were less likely to be diagnosed, and Asians had a nearly 3-fold higher proportion of IT compared to the proportion of Asians in the U.S. census. The 5-year disease-specific survival (DSS) was 91.2%. Those with stages I, II, III and IV disease had survivals of 99.7%, 95%, 81%, and 71.8% (p<0.001) and grades 1, 2, and 3 had DSS of 98.7%, 95.8%, and 91% (p<0.001), respectively. Of those who underwent fertility-preserving surgery, the DSS was 98.8%. Over time from 1973 to 1986, to 1987-1999, to 2000-2012, the survivals were 76.4%, 92.8%, and 94.7% (p<0.001). Of stage I patients, no patient <18years (n=214, used as adult cutoff) and 2 of 283 patients >18years died of cancer, with corresponding 5years DSS of 100% vs. 99.6% (p>0.05). Older age (by year, HR: 1.05; 95% CI: 1.04-1.06; p<0.0001) and higher stage (HR: 11.52; 95% CI: 4.08-32.48; p<0.0001) were independent factors indicating poorer survival. CONCLUSION: The outcome of patients with stage I disease was excellent at 99.7%, with children and adults having corresponding survivals of 100% and 99.6%.