Early experience with the first pre-connected 3-piece inflatable penile prosthesis: the Mentor Alpha-1.
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.
Goldstein
I
I
Department of Urology, Boston University School of Public Health, Massachusetts.
Bertero
E B
EB
Kaufman
J M
JM
Witten
F R
FR
Hubbard
J G
JG
Fitch
W P
WP
Geller
R A
RA
McKay
D L
DL
Krane
R J
RJ
Borges
F D
FD
D003625:Data Collection; D007172:Erectile Dysfunction / Q000453:epidemiology / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D015917:Penile Prosthesis / Q000523:psychology / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome