Prospective multi-center study elucidating patient experience after prostatic urethral lift.

INTRODUCTION: The prostatic urethral Lift (PUL) procedure offers a novel treatment for men with lower urinary tract obstructive symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Most patients who seek LUTS/BPH treatment choose the intervention that offers the expectations of a significant improvement in quality of life and the least chance of short or long term morbidity. We report the results of a prospective, non-randomized study designed to further characterize the perioperative subject experience with the PUL procedure. MATERIALS AND METHODS: The PUL procedure employs permanent implants to mechanically pull the prostatic lateral lobes apart. Subjects were ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥ 12, peak flow rate ≤ 12 mL, and prostate volume between 30 cc and 80 cc. Subject experience through 1 month was characterized by validated instruments designed to assess quality of recovery, work productivity, activity impairment, symptom response, quality of life, flow rate and sexual function. RESULTS: Fifty-one subjects were treated without any serious adverse events. No case was abandoned or postponed due to subject discomfort. By 1 month, 86% of subjects achieved high quality recovery as measured by a score of ≥ 80 on the Quality of Recovery Visual Analog Scale. Ninety percent of subjects reported improvement in their condition and 75% of subjects would recommend the procedure to a friend. Symptom response, flow rate improvement, and sexual function preservation were comparable to published studies. CONCLUSIONS: The PUL procedure was tolerated under local anesthesia, rarely required postoperative catheterization, and offered rapid LUTS relief with minimal associated morbidity. The study further allows urologists to advise patients regarding post-procedural expectations and side effects, inclusive of symptomatic benefit.

Efficacy of National Comprehensive Cancer Network Guidelines in Identifying Pathogenic Germline Variants Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial.

BACKGROUND: Prostate cancer (PCa) patients with pathogenic/likely pathogenic germline variants (PGVs) in cancer predisposition genes may be eligible for U.S. Food and Drug Administration-approved targeted therapies, clinical trials, or enhanced screening. Studies suggest that eligible patients are missing genetics-informed care due to restrictive testing criteria. OBJECTIVE: To establish the prevalence of actionable PGVs among prospectively accrued, unselected PCa patients, stratified by their guideline eligibility. DESIGN, SETTING, AND PARTICIPANTS: Consecutive, unselected PCa patients were enrolled at 15 sites in the USA from October 2019 to August 2021, and had multigene cancer panel testing. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Correlates between the prevalence of PGVs and clinician-reported demographic and clinical characteristics were examined. RESULTS AND LIMITATIONS: Among 958 patients (median [quartiles] age at diagnosis 65 [60, 71] yr), 627 (65%) had low- or intermediate-risk disease (grade group 1, 2, or 3). A total of 77 PGVs in 17 genes were identified in 74 patients (7.7%, 95% confidence interval [CI] 6.2-9.6%). No significant difference was found in the prevalence of PGVs among patients who met the 2019 National Comprehensive Cancer Network Prostate criteria (8.8%, 43/486, 95% CI 6.6-12%) versus those who did not (6.6%, 31/472, 95% CI 4.6-9.2%; odds ratio 1.38, 95% CI 0.85-2.23), indicating that these criteria would miss 42% of patients (31/74, 95% CI 31-53%) with PGVs. The criteria were less effective at predicting PGVs in patients from under-represented populations. Most PGVs (81%, 60/74) were potentially clinically actionable. Limitations include the inability to stratify analyses based on individual ethnicity due to low numbers of non-White patients with PGVs. CONCLUSIONS: Our results indicate that almost half of PCa patients with PGVs are missed by current testing guidelines. Comprehensive germline genetic testing should be offered to all patients with PCa. PATIENT SUMMARY: One in 13 patients with prostate cancer carries an inherited variant that may be actionable for the patient's current care or prevention of future cancer, and could benefit from expanded testing criteria.

Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities.

PURPOSE: This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. MATERIALS AND METHODS: The Spanner was placed for 3 cycles of 30 days in catheter-dependent men with comorbid conditions, confirmed detrusor contractility, and catheter-associated discomfort. At each visit, postvoid residual, maximum flow rate, international prostate symptom score, quality of life, and adverse events were assessed. Voiding success was defined as PVR ≤ 150 ml at all visits. RESULTS: One hundred seven men were enrolled at 8 US sites; 82/107 (76.6%) completed the trial, and 79/107 (73.8%) successfully maintained PVR ≤ 150 ml for the trial duration. Patients were 77.1 ± 10.6 years old; 63/107 (58.9%) were dependent on Foley and 40/107 (37.4%) on intermittent catheterization for 36.0 ± 39.3 days and 30.2 ± 45.8 days, respectively. 25/107 (23.4%) discontinuations were primarily due to voluntary patient withdrawal 9/107 (8.4%), investigator-initiated withdrawal 8/107 (7.5%), or lack of effectiveness 4/107 (3.7%). During Spanner use, the mean Q max was 11.2 ± 6.6, mean IPSS was 7.5 ± 6.4, and mean QOL was 2.0 ± 1.6. The most prevalent device-related adverse events were asymptomatic bacteriuria 25/107 (23.4%), discomfort 10/107 (9.4%), and urinary urgency 8/107 (7.5%). No device-related serious AEs were reported. CONCLUSIONS: This study demonstrates that catheter-dependent men with sufficient bladder contractility can achieve volitional voiding and successful bladder drainage using The Spanner Temporary Prostatic Stent for extended periods of time.

Levofloxacin versus ciprofloxacin in the treatment of chronic bacterial prostatitis: a randomized double-blind multicenter study.

OBJECTIVES: To compare the safety and efficacy of levofloxacin with that of ciprofloxacin for the treatment of chronic bacterial prostatitis. METHODS: In a multicenter, double-blind, active-control trial, 377 men with a history of chronic bacterial prostatitis, current clinical signs and symptoms, and laboratory evidence of prostatitis were randomized to treatment with levofloxacin 500 mg once daily or ciprofloxacin 500 mg twice daily for 28 days. The primary endpoint was microbiologic efficacy in the microbiologically assessable population. The Meares-Stamey "four-glass" procedure was used to obtain prostatic secretions and urine for culture. RESULTS: A total of 377 subjects received the study drug. The clinical success rates, including cured plus improved patients, were similar (75% for levofloxacin and 72.8% for ciprofloxacin; 95% confidence interval for the difference in the success rates: -13.27 to 8.87), as were the microbiologic eradication rates (75% for levofloxacin and 76.8% for ciprofloxacin; 95% confidence interval for the difference -8.98 to 12.58). Enterococcus faecalis and Escherichia coli were the most common isolates. The 6-month relapse rates were similar for both regimens. Both levofloxacin and ciprofloxacin were well tolerated, with similar rates of adverse events. CONCLUSIONS: Levofloxacin 500 mg once daily for 28 days is as effective as ciprofloxacin 500 mg twice daily for 28 days for the treatment of chronic bacterial prostatitis. Isolation of a high proportion of gram-positive organisms, as well as gram-negative pathogens, underscores the necessity of choosing an antimicrobial agent with broad-spectrum activity.