BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia

BPH-6: A UroLift® System Post Market Multi-Center Randomized Study

The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects.

Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Inclusion Criteria:

• Men >50 years old with moderate-severe BPH

Exclusion Criteria:

• Size, width of prostate
• Other medical condition or co-morbidity contraindicative for TURP or UroLift