ProVIDE Studies Post Exit Analysis

ProVIDE Studies Post Exit Analysis

A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.

An analysis of US based subjects who exited from the ProVIDE or ProVIDE II studies.

Inclusion Criteria:

• 1. US based subjects previously enrolled in the ProVIDE Study or the ProVIDE II Bridging Study who had a ProVee device removed.
• 2. Subjects who withdrew consent or were withdrawn by site Study PI.
• 3. Subjects consented to make data available.

Exclusion Criteria:

• 1. Incomplete records available.
• 2. Subjects who exited the studies due to restarting BPH medication while they were enrolled.
• 3. Subjects who did not receive a ProVee in the ProVIDE Study or the ProVIDE II Bridging Study.
• 4. Subjects who exited the studies due to prostate cancer.