WASHINGTON -- Implantation of a temporary prostatic urethra expander resulted in sustained improvements of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH), results from the sham-controlled trial showed.
Men who had the Urocross Expander System implanted had an average reduction in their International Prostate Symptom Score (IPSS) of 49% at 12 months -- 6 months after removal of the device -- which continued to improve up to 30 months (55.2% reduction), reported Kevin McVary, MD, of Loyola University Medical Center in Chicago, at the American Urological Association (AUA) annual meeting.
This group had a responder rate (defined by the FDA as an improvement of at least a 30% in IPSS at 12 months) of 74.4%.
The expander system, which was cleared in March, consists of a sterile, single-use, nitinol-based implant that is designed to remain inserted for up to 6 months and retrieved through standard cystoscopy, with the idea that it will "remodel the prostate," allowing for long-term LUTS relief, McVary explained.
Clearance was based on data from the current trial (Expander-2) and was supported by the 12-month data presented here at AUA. Though no significant difference was observed for the study's primary efficacy endpoint -- at 3 months, the expander group had an average IPSS reduction of 25.7% compared with a reduction of 24.2% for the sham group -- the intervention provided symptom relief.
