Eric A. Hurtado MD, Rebecca J. McCrery MD, Rodney A. Appell MD

Scott Department of Urology, Baylor College of Medicine, Houston, TX

Material and Methods: The charts of all adult male patients who received Ethylene Vinyl Alcohol (EVA) copolymer between 2005 and 2006 were reviewed for demographics, physical examination findings, urodynamic findings, outcomes, and complications. Patients receiving other intra-urethral agents, children, or use of bulking agents not placed intra-urethrally were excluded. Erosions were defined as the presence of bulking agent passing through the urethral mucosa. Efficacy was reported on a subjective scale from 0% to 100% improved an was used to determine if other injection sessions were required.

Results: Seventeen of 18 males 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 upon injection of the material. Urethral erosion was associated with pain, frequency, urgency, and/or passage of material resulting in worsening stress incontinence symptoms. Subjective improvement of at least 50% was reported by 41.1% of patients. Ten of 17 patients reported 10% or less improvement in their stress incontinence symptoms after treatment. The mean follow-up period was 4.2 months.

Conclusions: Intra-urethral bulking agents are meant to be a minimally invasive procedure with lower complication rates than alternative procedures 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 number of adverse events. Urethral erosion was the most common complication creating severe dysuria, frequency, and loss of benefit with passage of material. Additionally, urethral erosion precluded further injection in the affected area often rendering sub-optimal bulking. Currently, the long-term effects of persistent material exposure in relation to voiding dysfunction and urethral compliance are unknown at this time. Furthermore, EVA used as an off-label intra-urethral bulking agent may be significantly less efficacious than the FDA data reported in women, especially with prior use of intra-urethral bulking agents. A long-term prospective study involving serial cystoscopy needs to be performed with EVA compared to a standard agent, such as collagen, in men before further off-label use of EVA in the treatment of male stress incontinence can be recommended.

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