Early Experience with the First Pre-connected 3-Piece Inflatable Penile Prosthesis: The Mentor Alpha-1

Abstract

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.

AMS Three–Piece Inflatable Implants for Erectile Dysfunction: A Long–Term Multi–Institutional Study in 200 Consecutive Patients

“…Most of the penile implants series published to date come from highly reputable centers for this type of surgery and results reported in these studies may not be easily reproduced in everyday general urological practice. For this reason, to obtain long–term results regarding the reliability of prosthesis implantantion in patients with erectile dysfunction [4, 5], reports from multicenter studies are extremely important in this field. This paper describes a multi–institutional long–term follow–up experience involving 200 consecutive patients suffering from erectile dysfunction and treated by placement of American Medical Systems (AMS) three–piece penile implants.…”

Penile prosthesis implantation: past, present and future

“…The Mentor Alpha 1 prosthesis was the designation for this device after the cylinders were supplied preconnected to the pump. 46,47 …”

Antimicrobial activity of antibiotic-soaked, Resist™-coated Bioflex®

“…1 A major concern for urologists who implant penile prostheses is the risk of infection, which occurs in 0.89-8.9% of cases with an overall incidence of approximately 2%. [2][3][4][5][6][7][8][9][10] It is a customary practice to soak a penile prosthesis in antibiotic solutions for 5-10 min before implantation. This antibiotic application in theory may wash off any superficial microbes and provide shortterm protection against infection.…”