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


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 +/- 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.


CONCLUSIONS
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.
Kearse
W S
WS
Department of Urology, Wilford Hall Medical Center, San Antonio, Texas 78236-5300, USA.
Sago
A L
AL
Peretsman
S J
SJ
Bolton
J O
JO
Holcomb
R G
RG
Reddy
P K
PK
Bernhard
P H
PH
Eppel
S M
SM
Lewis
J H
JH
Gladshteyn
M
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D007172:Erectile Dysfunction / Q000209:etiology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D015917:Penile Prosthesis; D011446:Prospective Studies; D011474:Prosthesis Design; D016896:Treatment Outcome