L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.
The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.
Inclusion Criteria:
Exclusion Criteria: