L.I.F.T. Research Study

The UroLift® system is being evaluated in an FDA-approved clinical research study called the L.I.F.T. Study to support a premarketing application to FDA. The purpose of the research study is to determine the safety and effectiveness of the UroLift® system for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Study Details
The study enrollment is completed and patients are in the follow-up phase. As part of the L.I.F.T. Research Study, some patients received the UroLift system procedure while others received a “control” procedure in which the doctor (urologist) used a standard method (cystoscopy) to visualize the prostate. If you are enrolled in the research study, you were randomly assigned to have either the UroLift system or the control procedure. The randomization was 2:1, that is, you had a 2/3 chance of receiving the UroLift system procedure or a 1/3 chance of receiving the control procedure. You will not know which procedure you received until your three month follow-up visit. If at that time your symptoms persist, you find out you received the cystoscopy control procedure, and you still meet the study inclusion criteria, you will be offered the UroLift system. The procedures may be performed at the doctor’s office or in the hospital. Medications to make you comfortable for the procedure will be determined by your doctor. Afterward, your doctor will decide when you are ready to go home. You will be asked to come back for follow up visits during the first year so you can be closely monitored. If you receive the UroLift system, you will be asked to return every year for up to 5 years total.

Who is eligible?
The study enrollment is completed. It was open to men age 50 and older who were diagnosed with BPH and who had moderate-severe symptoms. Candidates were required to meet these and other detailed criteria to qualify.

Where is the study being conducted?
The L.I.F.T. Research Study is being conducted at urology practices throughout the U.S., in Canada and in Australia.

To read more about the UroLift system, click here.

CAUTION - The UroLift system is an investigational device. Limited by Federal law to investigational use.