The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.
Winter Park Urology
Orlando, Florida, United States
RECRUITINGWinter Park Urology
Orlando, Florida, United States
RECRUITINGNorth Fulton Urology
Roswell, Georgia, United States
Time to Re-Treatment
Time to re-treatment will be estimated using Kaplan Meier estimation techniques. The re-treatment rate at years 1 through 5 will be estimated and 95% confidence intervals obtained, and the median time to re-treatment will be estimated. Subjects who receive re-treatment will be classed as treatment failures. Subjects who are lost to follow-up will be considered as re-treated at their last known study visit. In addition, a missing at random (MAR) analysis will be performed.
Time frame: 5 years
Change from Baseline in American Urological Association (AUA) Total Score at 5 years
Measured based on the number of subjects who worsened, had no change (1-29%), had a 30% or greater improvement or who are missing, based on the change in AUA total score compared to individual baseline for each follow-up evaluation. A responder analysis will also be done on peak flow rate (PFR) with the following categories: the number of subjects who worsened, had no change (1-19%), had a 20% or greater improvement or who are missing, based on the change in PFR compared to individual baseline for each follow-up evaluation.
Time frame: 5 years
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Regional Urology
Shreveport, Louisiana, United States
RECRUITINGMerrimack Urology Associates PC
Chelmsford, Massachusetts, United States
RECRUITINGAlbany Medical College Division of Urology
Alabany, New York, United States
RECRUITINGMidtown Urologic Trials, PC
New York, New York, United States
RECRUITINGMobley Research Center
Houston, Texas, United States
RECRUITING