Report of a Multicenter Clinical Evaluation of the Dura-II Penile Prosthesis

AbstractPurpose: Information was collected during the first 2 years of an ongoing, prospective, multi-institutional evaluation of the Dura-II [dagger] penile prosthesis. Evaluation included data on clinical outcomes and a patient satisfaction survey, and will continue for 5 years after implantation for each patient.[dagger] Dacomed Corp., Minneapolis, Minnesota.Materials and Methods: To date 196 patients have been evaluated. Surgical data, adverse events and information from satisfaction surveys are reported.Results: At a followup of 13.4 plus/minus 8.4 months postoperatively, adverse events occurred in 8.2 percent of the patients, resulting in reoperation in 5.1 percent. There have been no mechanical failures. Overall satisfaction rates were 85 percent at 3 months, 83 percent at 1 year and 91 percent 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 si...