Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023.

PURPOSE: The purpose of this American Urological Association (AUA) Guideline amendment is to provide a useful reference on the effective evidence-based management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH). MATERIALS AND METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies relevant to the management of BPH. The guideline was updated in 2023 to capture eligible literature published between September 2020 and October 2022. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. RESULTS: The BPH amendment resulted in changes to statements/supporting text on combination therapy, photoselective vaporization of the prostate (PVP), water vapor thermal therapy (WVTT), laser enucleation, and prostate artery embolization (PAE). A new statement on temporary implanted prostatic devices (TIPD) was added. In addition, statements on transurethral needle ablation (TUNA) and transurethral microwave thermotherapy (TUMT) were removed and information regarding these legacy technologies was added to the background section. References and the accompanying treatment algorithms were updated to align with the updated text. CONCLUSION: This guideline seeks to improve clinicians' ability to evaluate and treat patients with BPH/LUTS based on currently available evidence. Future studies will be essential to further support these statements to improve patient care.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Impact of Body Mass Index on Outcomes Following Anatomic GreenLight Laser Photoselective Vaporization of the Prostate.

Introduction: Obesity can lead to increased risk of perioperative complications in surgical patients, but evidence is lacking regarding the impact of obesity on bladder outlet surgery outcomes. We sought to assess the safety and efficacy of GreenLight photoselective vaporization of the prostate (PVP) in obese patients by comparing functional outcomes and complications in men, stratified according to the body mass index (BMI). Materials and Methods: A retrospective analysis was undertaken of 424 men who underwent 180W GreenLight PVP between 2012 and 2016 at two tertiary medical centers. Patients were stratified based on the World Health Organization (WHO) classification of obesity as determined by BMI. Normal weight men had BMI <25 kg/m2, overweight men had BMI between 25 and 30 kg/m2, and obese men had BMI greater than 30 kg/m2. Primary endpoints examined were differences in intraoperative outcomes and incidence of intraoperative and postoperative complications between BMI groups. Secondary endpoints were improvements in the International Prostate Symptom Score, quality of life score, and the uroflowmetry variables, maximum urinary flow rate and postvoid residual. Results: The BMI groups did not differ regarding operative time or lasing time after matching for prostate volume, but overweight patients in the matched cohort still required higher mean energy use than normal weight men (258.6 kJ vs 233.9 kJ; p = 0.017). No significant differences between BMI groups were observed for intraoperative complications, postoperative complications, or readmission rates. All functional parameters were significantly improved at 24 months for each group, with no differences in improvement between groups. On multivariable analysis, BMI was not a significant predictor for outcomes following PVP. Conclusions: Increased BMI has a negligible effect on intraoperative parameters and does not affect postoperative complication rates or functional outcomes. GreenLight XPS 180W PVP is a safe and effective procedure in overweight and obese men.