Report of a multicenter clinical evaluation of the Dura-II penile prosthesis.

Abstract

Information was collected during the first 2 years of an ongoing, prospective, multi-institutional evaluation of the Dura-II penile prosthesis. Evaluation included data on clinical outcomes and a patient satisfaction survey, and will continue for 5 years after implantation for each patient. To date 196 patients have been evaluated. Surgical data, adverse events and information from satisfaction surveys are reported. At a followup of 13.4 +/- 8.4 months postoperatively, adverse events occurred in 8.2% of the patients, resulting in reoperation in 5.1%. There have been no mechanical failures. Overall satisfaction rates were 85% at 3 months, 83% at 1 year and 91% at 2 years after implantation, and levels of sexual functioning were correspondingly high. A majority of patients assigned high scores to rigidity, concealability, ability to have intercourse and erection size, although satisfaction with erection size ranked lower than the other measures. The Dura-II penile prosthesis provides a satisfactory result and has an acceptable level of complications associated with its use. Further followup will assess temporal changes in satisfaction rates and sexual functioning for these patients.