The safety and efficacy of ethylene vinyl alcohol copolymer as an intra-urethral bulking agent in women with intrinsic urethral deficiency.

ABSTRACT

The purpose of this post-marketing case-series is to report the short-term safety and effectiveness of ethylene vinyl alcohol (EVA) copolymer (Tegress; C.R. Bard, Covington, GA, USA) in the treatment of intrinsic sphincter deficiency (ISD). The charts of all female patients who received ethylene vinyl alcohol (EVA) copolymer between 2005 and 2006 were reviewed for demographics, physical exam, urodynamic findings, outcomes and complications. Nineteen of twenty women who received EVA during this period completed follow-up. After an average of 1.4 injections, approximately 58% of the patients had a complication related to the procedure with 37% experiencing urethral erosion. Of the patients, 10.5% reported at least a 50% subjective improvement in their symptoms. Intra-urethral bulking for the treatment of SID is meant to be minimally invasive and safe with minimal reports of complications. This series of 19 patients show significant percentage of patients experiencing serious complications with Tegress. Additionally, Tegress may be less efficacious than reported in the FDA trials, especially those with prior injections. A long-term prospective study needs to be performed in women with ISD before treatment can be recommended for general use by all gynecologists and urologists.