Complications of Ethylene Vinyl Alcohol Copolymer as an Intraurethral Bulking Agent in Men with Stress Urinary Incontinence

Abstract

To report the short-term safety and efficacy of ethylene vinyl alcohol (EVA) copolymer (Tegress; C.R. Bard, Inc., Covington, GA) in the off-label treatment of male stress urinary incontinence. We reviewed the charts of all adult male patients who received EVA copolymer between 2005 and 2006 for demographics, physical examination findings, urodynamic findings, outcomes, and complications. A total of 17 of 18 men completed follow-up after receiving EVA during this time period. With an average of 1.4 injection sessions, 58.8% of patients experienced a complication related to the procedure, with 41.1% of these complications being urethral erosion of the material and 22% experiencing severe pain on injection. Subjective improvement of at least 50% was reported by 41.1% of patients. The mean follow-up period was 4.2 months. Intraurethral bulking agents are meant to be a minimally invasive procedure with lower complication rates than alternatives such as the artificial urinary sphincter and male sling. The off-label use of EVA in men in this case series resulted in a significant complication rate. Urethral erosion was the most common complication causing dysuria, precluding further bulking in others, and resulting in loss of benefit with passage of material. In addition, EVA used in men may be less efficacious than the Food and Drug Administration data reported in women, especially with prior injectable therapy. In December 2006, EVA was voluntarily taken off the marketplace by CR Bard owing to reports from clinicians.