ABSTRACT
INTRODUCTION AND OBJECTIVE: To report IPSS, QoL and treatment failure rate up to 79-months for the MT02 study with implantation of the temporary implantable nitinol device (iTind;Medi- Tate Ltd®, Israel) in men with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). METHODS: Three out of nine international centers consented to continue the international prospective multicenter study on patients with LUTS due to BPO (IPSS ≥10, Qmax <12ml/sec, and prostate volume <75ml) beyond 36 months following implantation of iTind. Out of the originally enrolled 81 patients, 50 were followed-up at sites in Italy, Switzerland, and Belgium. Due to Covid-19 the originally planned follow-up scheme was amended: Each patient was assessed once during a timeframe of 50-79 months post-operatively by IPSS and IPSS-QoL, change in medication and adverse events via a telephone call. Patients were analyzed in three groups according to their follow-up time point (clustered into groups from 48-59 months, 60-71 months, and 72-83 months). RESULTS: Fifty to 79 months results were available for 42 patients. Four patients were lost to follow-up and two patients deceased from reasons unrelated to the iTind device. Only two patients had treatment failures (one patient underwent TURP, the other ThuLEP), while no patient required any additional medication. IPSS average results were 12.63±8.84 (50-59m, N=24), 8.85±5.54 (60-71m, N =13) and 9.20 ±5.85 (72-79m, N=5). QoL average results were 2.21±1.69 (50-59m, N=24), 1.85±0.99 (60-71m, N=13) and 1.80±1.10 (72-79m, N=5). IPSS (-8.88, -10.31, and -9.60) and IPSSQoL (-2.04, -1.85 and -1.80) improved significantly for all groups vs. baseline, respectively (p <0.0001). Functional data is shown in Figure 1. No late post-operative complications were observed between 50 and 79 months. CONCLUSIONS: iTind for treatment of LUTS secondary to BPO is an effective and safe procedure providing significant and effective reduction in symptoms and quality of life durable up to 79 months (6.6 years) with only 4% of treatment failures after 3-year follow-up. (Figure Presented).
ABSTRACT
A gap in knowledge exists regarding drug use among drivers and other road users (pedestrians, bicyclists) who are seriously or fatally injured in crashes in the United States. This study examines the prevalence of alcohol as well as selected over-the-counter, prescription, and illegal drugs in the blood of seriously or fatally injured drivers and other crash victims near the time of their crashes before and during the COVID-19 public health emergency. Data was collected at Level 1 trauma centers and medical examiner offices. The 3,003 participants represent a convenience sample of roadway users who were seriously or fatally injured during the study period. Trauma centers and medical examiners made available small volumes of blood for toxicological analyses from the total collected during their normal clinical procedures. The results indicate drug prevalence was high among seriously and fatally injured roadway users before the public health emergency began and was even higher during, especially for alcohol, cannabinoids (active THC), and opioids. Drivers in particular showed significantly higher overall drug prevalence during the public health emergency, with 64.7% testing positive for at least one active drug, compared to 50.8% before. Drivers also showed an increase in testing positive for two or more categories of drugs going from 17.6% before to 25.3% during the public health emergency. Of particular note, active THC was more prevalent among drivers during the public health emergency than alcohol (32.7% versus 28.3%), and opioid use among drivers almost doubled from 7.5% to 13.9%. Overall, the results of this study suggest the highway safety community should be concerned about the impact of other drugs as well as alcohol. In particular, the observed cannabis and opioid prevalence rates before and during the public health emergency could be indicative of a growing problem. These findings are prevalence rates only and cannot be used to determine whether the people were impaired at the time of their crash.