The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Status:	Completed
Conditions:	Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:	Hematology, Nephrology / Urology
Healthy:	No
Age Range:	50 - Any
Updated:	9/7/2018
Start Date:	February 2011
End Date:	July 5, 2017

Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms

The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System
when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will
be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and
safety will be reviewed based on pertinent adverse events.

The randomized portion of the study is a prospective, multicenter, multinational, 2:1
randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment
group to the IPSS of the control group at the 3 month follow-up. Subjects in the active
treatment group undergo UroLift system treatment. Subjects in the control group undergo a
cystoscopy procedure.

All subjects will be followed through 12 months, and through 5 years for those that receive
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

Pinellas Urology Inc

Saint Petersburg, Florida 33710

from

Saint Petersburg, FL