The aim of this clinical investigation was to obtain preliminary treatment outcome data concerning the Mentor Alpha-1, the first 3-piece inflatable penile prosthesis with pre-connected tubing between the pump and the penile cylinders. The study was designed to be the first multi-institutional treatment outcome report for any clinically available penile prosthesis with data analysis to be independent of the participating surgeons. A total of 12 board-certified urologists of mixed surgical training backgrounds and practices implanted the Alpha-1 device in 112 consecutive patients. With a mean of 27 +/- 5 months of followup the surgical complication rate included a 4% mechanical malfunction, 2% infection rate and 9% reoperation rate. Patient experience with the implanted device was computed from information on 96 of the 112 patients who returned a questionnaire. Of the patients 82% stated that the device fulfilled expectations as a treatment for impotence and 83% had improved sexual intercourse by 8 weeks after implantation. Patient satisfaction was computed on a scale of 12 equally weighted interrelated variables. Of the patients 77% recorded 9 or more cumulative satisfaction points. Patient and physician questionnaire data were analyzed for their relation to the cumulative prosthesis satisfaction score. A significant difference in cumulative scores was found for physician reported long-term postoperative problems (mean satisfaction score 8.1 for patients with problems versus 10.2 for patients without problems, p = 0.018). The Alpha-1, with its feature of pre-connected tubing, is a reliable 3-piece inflatable penile prosthesis associated with a high level of patient satisfaction.

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The rat was used as an animal model to examine the effect of foreign bodies and long term infection (24 weeks) on bladder epithelium. Stainless steel wire implants and multiple injections of Escherichia coli were compared to control rat bladders by gross observation, light microscopy and scanning electron microscopy. Hyperplastic alterations, (papilloma, von Brunn's nests), dysplasia (squamous metaplasia, microvilli) and early lesions consistent with neoplasia occurred in rats with bladder implants and multiple bacterial injections but not in controls. Epithelial changes were not associated with sterile bladder implants. Bladder papillomata could be observed as early as 2 weeks in rats having both an implant and an infection, but the majority of hyperplastic and early neoplastic-like changes occurred after 6 weeks. Long-term infections, both with and without a bladder implant, can lead to lesions consistent with neoplasia in bladder epithelium.

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