Teleflex announces publication of a large real-world study confirming results from controlled clinical studies of the UroLift System

Teleflex Incorporated announced the publication of positive results from a multi-center study reaffirming the safety and effectiveness of the minimally invasive UroLift System for the treatment of benign prostatic hyperplasia (BPH) in real-world patient populations. This is the largest, most comprehensive study to examine a minimally invasive BPH procedure in a real-world setting. Results were published in the Journal of Endourology.

The Real-World Retrospective study was designed to evaluate the safety and effectiveness of the UroLift System in a real-world setting and to determine whether clinical outcomes are consistent with those found in controlled studies. The multi-center, retrospective study examined the results of 1,413 consecutive patients who received the UroLift System treatment over two years across 14 sites in North America and Australia.

The randomized L.I.F.T. clinical trial demonstrated that treatment with the UroLift System provides patients rapid and durable symptom relief.The minimally invasive procedure, which works without cutting, heating, or removing prostate tissue, demonstrates an excellent safety profile and preserves sexual function. Unlike BPH thermal therapies such as the most recent steam treatment, the real-world results for the UroLift System treatment showed complication rates and a patient experience that were consistent with controlled clinical trials.

Data published from the study show that patients from multiple subgroups treated with the UroLift System experienced improvements in IPSS (International Prostate Symptom Score) and QoL (Quality of Life) score: Consistent with the L.I.F.T. study, symptoms improved significantly from baseline at all follow up time points through two years, and most perioperative adverse events were mild to moderate, resolving by four weeks. In a cohort-matched comparison to L.I.F.T. study patients with moderate-severe symptoms (IPSS ?13), symptom improvement was similar at all time points. Of the 165 patients in retention at baseline, 83% became catheter-free by one-month post-procedure and 87% were catheter-free by the end of the study; IPSS scores were similar to non-retention patients In the 73 patients with prior prostate cancer treatment, mean IPSS improved at all time points with no significant difference in adverse events of interest compared to other patients. IPSS improvement was similar regardless of prostate volume (< 30cc; 30cc to <80cc; ?80cc).

Findings from this large, multi-center study support the application of the UroLift System in the broader BPH population, including challenging patients such as those in retention and those who have been treated for prostate cancer. Individuals with lower prostate volumes (<30cc) experienced significant symptomatic relief with a favorable safety profile, highlighting the unique benefits of the UroLift System for these patients. Unlike some BPH thermal therapies, the indication for the UroLift System has no lower limit on prostate volume.

See - Population Health Management Vol. 16, No. S2- "Optimizing Population Health and Economic Outcomes: Innovative Treatment for BPH"- Transcribed and adapted for publication by Janice L. Clarke Published Online:10 Dec 2013https://doi.org/10.1089/pop.2013.1691.