UroLift System TOlerability and ReCovery When Administering Local Anesthesia

Status:	Completed
Conditions:	Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:	Hematology, Nephrology / Urology
Healthy:	No
Age Range:	50 - Any
Updated:	3/22/2019
Start Date:	April 2013
End Date:	September 4, 2018

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:

- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia
(BPH)

Exclusion Criteria:

- Size, volume,length of prostate

We found this trial at

sites

Carolina Urologic Research Center

823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572

(843) 449-1010 ext.268