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inflated were determined to provide an
erection suitable for intercourse. This
assessment of device function does
not include the following information
regarding device malfunctions: Of the
140 devices found to be functioning
properly on or after 18 months, 2 required
revision surgery prior to this evaluation to
correct a mechanical malfunction. These
and other cases of revision surgery are
discussed further in the next section.
Surgical Revisions:
The incidence of revisions was evaluated
in the 141 patients with follow-up out to
at least 18-months, and an additional 6
patients who were explanted prior to 18
months and subsequently discontinued
from the study. (A revision is considered
any urogenital surgical intervention that is
related to the function, placement or site
reaction to the implanted device.) Of these
147 patients, 14 (9.5%) experienced a total
of 15 revision surgeries, and 133 (90.5%)
have not been revised.
The average time to the first revision
surgery was 12 months (ranging from 0
to 50 months). Of the fifteen (15) revision
surgeries, there were six (6) revisions due
to "Mechanical Malfunction"; five (5) due
to "Infection"; one (1) due to "Migration/
Extrusion" (pump migration and cylinder
aneurysm/bulging/extrusion); one (1) due
to "Malposition"; one (1) due to "Phimosis";
and one (1) due to "Patient Dissatisfaction".
Patient Evaluation of Quality of Life,
Self-esteem, Psychological and Sexual Well-
Being
No decline in overall patient quality of
life, self-esteem, psychological well being,
sexual functioning or sexual satisfaction
was demonstrated during this clinical trial.
The psychological well being of these
patients, as judged by the Brief Symptom
Inventory (BSI) was determined to be
equivalent to the pre-implant state. The
self-esteem of the patients, as evaluated by
the Rosenberg Self-Esteem Scale, was also
equivalent to the pre-implant state. The
sexual functioning and sexual satisfaction
did improve from the pre-implant state,
as measured by the Sexual History Form
(SHF).
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