Twelve month data of MedLift Study in patients with benign prostatic hyperplasia.- Neotract

NeoTract, a wholly owned subsidiary of Teleflex Incorporated focused on addressing unmet needs in the field of urology, announced the publication of 12-month data from the multi-center prospective MedLift Study of the UroLift System treatment for Benign Prostatic Hyperplasia (BPH) in patients with an obstructive median lobe. Results were published in Prostate Cancer and Prostatic Diseases, a Nature Publishing Group journal.

The MedLift Study provided clinical evidence to support the safety and efficacy of the UroLift System treatment for BPH, or an enlarged prostate, involving a median lobe obstruction. Median lobe obstructions are present in a subset of men with BPH. Results from this study led to the recent U.S. Food and Drug Administration ( FDA ) clearance of an expanded indication for the UroLift System, making patients who have an obstructive median lobe eligible to receive the UroLift System treatment for BPH symptoms.

Data published from the MedLift Study show that patients who were treated for obstructive median lobe with the UroLift System experienced significant improvements in IPSS (International Prostate Symptom Score), Qmax (peak flow rate), and QoL (quality of life) scores: Mean IPSS improved from baseline by at least 13.5 points (p<0.0001). quality of life and bph impact index scores were improved>60 and >70 percent, respectively at 3, 6, and 12 months, p<0.0001). mean qmax improvement ranged from 90-129 percent p><0.0001). at 1 month 80 percent of men 95 ci 66- 89 percent reported being much or very much better and 89 percent 95 ci 76-95 percent would recommend the procedure. bother due to ejaculatory function improved rapidly and remained modestly improved at 1 year p="0.001)." no patient reported de novo sustained ejaculatory or erectile dysfunction.>

The outcomes from this study were consistent with those found in the five-year pivotal L.I.F.T study of the UroLift System for patients with lateral lobe enlargement, demonstrating rapid, significant, and sustained improvements in symptoms and quality of life for patients who have an enlarged median lobe, while also preserving their sexual function with no instances of new, sustained erectile or ejaculatory function. No differences were observed in symptom relief based on the size of median lobe protrusion, and the majority of patients required only one additional UroLift permanent implant in the median lobe to achieve lasting relief from BPH symptoms.

See: "Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study" Daniel Rukstalis et al. Prostate Cancer and Prostatic Diseases 12 December 2018 https://doi.org/10.1038/s41391-018-0118-x