Allium^TM Bulbar Urethral Stent: An Updated Long-Term Multi-Center Study with New Treatment Modality for Bulbar Urethral Stricture

Abstract

Objectives: To report the 2-years follow-up of patients with bulbar urethral strictures treated with the new AlliumTM Bulbar Urethral Stent (Allium BUS). Methods: The stent is a fully covered, self-expendable, large caliber metal stent specially designed for the treatment of bulbar urethral strictures. The stent is comprised of a coiled super-elastic structure covered by a polymeric coating designed to prevent mucosal hyperplasia. The indwelling time is 12 months, after which the stent should have been removed. Sixty-four patients with recurrent bulbar stricture were treated with Allium BUS in 3 worldwide centers. Results: All stents were successfully inserted with no perioperative complications. In a median follow-up of 25.5 months, the mean maximal flow rate following stent insertion was significantly higher compared to the pre-surgical flow rate (14 ml/sec vs 6.6 ml/sec, p < 0.0001). Longer indwelling time and shorter stricture length were significantly related to success rate. The main complications were stent migration, stent re-stenosis and urinary tract infections. Conclusions: The temporary placement of the AlliumTM BUS showed encouraging results with long-term failure rate of only 25%.