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.

[Azoospermia should not be given as the result of vasectomy]. / La azoospermia no debería ofrecerse como resultado de la vasectomia.

OBJECTIVES: Vasectomy is a surgical method of male contraception. Azoospermia is offered as result of the technique and this is not always attained, resulting in legal matters. The purpose of this study is to know the number of semen samples needed to discharge a patient after intervention. To identify sperm count on semen analysis at time of discharge. METHODS: Retrospective study of men who underwent vasectomy in a 15-month period with a 2 year follow up. Consecutive semen analyses up to 5 samples were measured at 2 to 3 months interval in all men who had persistence of spermatozoa. RESULTS: 618 men were intervened, 106 did not bring semen to the laboratory (17%), 2 (0.39%) presented motile sperm and were considered a failure of the technique and excluded. 510 men completed controls. 316 (61.9%) were azoospermic in the first sperm analysis, 74 (14.5%) in the second, 27 (5.2%) in the third, 6 (1.2%) in the fourth and one (0,.%) in the fifth analysis. The remaining 86 men (16.8%) had persistence of immotile sperm in the ejaculate and were less than 100,000/ml. No pregnancy was reported during 2 years follow up or after. CONCLUSIONS: Five or more semen analysis can be made after the surgery. Persistence of immotile sperm in the ejaculate is frequent and may exist for a long period afterwards. Immotile sperm count of 100,000/ml or less should be accepted as result of the procedure. The patient should be informed about the fact that persistent immotile sperm can be found in his semen. In the informed consent azoospermia should not be a concern as it is frequent to find immotile sperm in the ejaculate and this is an acceptable issue. As with other contraceptive methods, vasectomy should be offered as a safe method although clearly stating that the possibilities of failure do exist.