Ejaculation sparing of classic and minimally invasive surgical treatments of LUTS/BPH.

BACKGROUND: The surgical landscape for Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH) has evolved with the introduction of Minimally Invasive Surgical Therapies (MISTs), recognizing the impact of sexual function on patients' well-being, and prioritizing ejaculation-sparing approaches. METHODS: This systematic review explored ejaculation sparing after classic endoscopic procedures and MISTs (iTind, Rezum, Urolift, Aquablation, and TPLA) and a literature search yielded 41 studies. RESULTS: While all procedures demonstrated efficacy in improving LUTS/BPH symptoms (IPSS, QoL, Qmax), a subset of studies evaluated ejaculatory function. Positive outcomes were noted, challenging the historical association of BPH surgeries with ejaculatory dysfunction. Variations in study design, patient cohorts, and limited long-term data present challenges. Notably, the lack of baseline specificity, use of alpha-blockers, and non-specific sexual function assessments underscore potential biases. CONCLUSIONS: Despite limitations, the review tentatively concluded that MISTs, including iTind, Rezum, Urolift, Aquablation, and TPLA, appear comparable in sparing ejaculation. Long-term studies are essential to validate sustainability, and comparative research should assess trade-offs between MISTs and traditional surgeries. Incorporating patient-reported outcomes and quality of life assessments will enhance future investigations, refining MISTs as standard therapeutic options for LUTS/BPH.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

How I Do It: Optilume BPH catheter system.

Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting aging men which has a significant impact on quality of life. The Optilume BPH Catheter System (Optilume BPH) is a prostatic dilation system that combines balloon dilation with a localized transfer of paclitaxel to maintain long term patency. Optilume BPH can be deployed using standard rigid cystoscopy without general anesthesia in an office setting. Prospective data indicate that Optilume BPH has favorable functional and sexual patient outcomes. Readers will familiarize themselves with Optilume BPH, significant historical studies and the technique for deploying Optilume BPH.

Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study.

PURPOSE: To evaluate the safety and efficacy of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: This open-label, single-arm study enrolled eighty subjects with LUTS secondary to BPH who were treated with the Optilume BPH Catheter System. Symptoms were recorded utilizing the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPH-II). Functional improvement was measured utilizing peak urinary flow rate (Qmax) and post-void residual urine volume (PVR). Adverse events were systematically captured and reported at each follow-up visit. RESULTS: Subjects treated with the Optilume BPH Catheter System experienced a significant improvement in LUTS from baseline through 2 years of follow-up, as measured by IPSS (22.3 vs 8.2, p < 0.001) and BPH-II (6.9 vs 2.3, p < 0.001). Functional improvement was also significant, with Qmax improving from an average of 10.9 mL/s at baseline to 17.2 mL/s at the 2-year follow-up and PVR improving from 63.1 to 45.0 mL. Treatment-related adverse events were typically minor, with none occurring between 1- and 2-year post-treatment. CONCLUSIONS: The Optilume BPH Catheter System is a unique minimally invasive surgical therapy that combines mechanical and pharmaceutical aspects for the treatment of BPH. The functional and symptomatic improvements seen after treatment are significant and have been sustained through 2 years in this early feasibility study. REGISTRATION: NCT03423979, registered February 6, 2018.

Functional and oncological outcomes after radical prostatectomy in patients with history of surgery for lower urinary tract symptoms related to benign prostatic enlargement: A systematic review with meta-analysis.

BACKGROUND: Outcomes of radical prostatectomy (RP) in men with history of lower urinary tract symptoms related to benign prostatic enlargement (LUTS/BPE) surgery represents a controversial issue. We performed an updated systematic review and meta- analysis evaluating oncological and functional outcomes of RP in this subset of patients. METHODS: Eligible studies were identified from MEDLINE, Web of Science and the Scopus databases. The following outcomes were evaluated: incidence of positive surgical margins (PSM), incidence of biochemical recurrence (BCR), 3-mo and 1-year urinary continence (UC) rates, incidence of nerve-sparing (NS) procedures, 1-year erectile function (EF) recovery rates. We estimated pooled Odds ratios (OR) and 95% confidence intervals (CI) using random effects models. Sub-analyses were performed according to the type of RP and LUTS/BPE surgery. RESULTS: Twenty-five retrospective studies including 11,101 patients undergoing RP were included in the analysis (2113 with history of LUTS/BPE surgery, and 8898 controls). PSM rate was significantly higher in patients with history of LUTS/BPE surgery (OR 1.39, 95% CI 1.18-1.63, p < 0.001). No statistically significant difference in terms of BCR emerged between patients with or without history of LUTS/BPE surgery (OR 1.46, 95% CI 0.97-2.18, p = 0.066). Three-months and 1-year UC rates were significantly lower in patients with previous LUTS/BPE surgery (OR 0.48, 95% CI 0.34-0.68, p < 0.001 and OR 0.44, 95% CI 0.31-0.62, p < 0.001; respectively). Although not statistically significant differences between the two groups emerged in terms of adoption of NS procedures (OR 0.59, 95% CI 0.32-1.12, p = 0.107), 1-year EF recovery was significantly lower in patients with history of LUTS/BPE procedures (OR 0.60, 95% CI 0.40-0.89, p = 0.010). CONCLUSIONS: In conclusions, RP in patients with history of previous LUTS/BPE surgery is associated with increased incidence of PSM, lower UC rates at both 3-months and 1-year follow-up as well as lower rates of EF recovery at 1-year follow-up.