Clinical trials

The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.

This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.