Clinical Studies - Boston Scientific AMS Ambicor Mode D'emploi

Clinical Studies

A clinical trial was undertaken to
demonstrate that the AMS Ambicor
Inflatable Penile Prosthesis provides an
erection that is suitable for intercourse and
has acceptable rates of surgical revision
and of significant clinical events associated
with the implantation and use of these
devices. This trial was also designed to
demonstrate the implantation of these
devices does not negatively impact the
sexual satisfaction, psychological well
being, self-esteem or quality of life of
patients who receive these devices. It was
a prospective, multi-center cohort trial in
which the patients served as their own
control.
One hundred and seventy-nine (179)
male patients, over 21 years of age, were
enrolled and implanted in this study. All
patients with diagnosed organic erectile
dysfunction were eligible for enrollment,
if they did not present with a history of
allergy/sensitivity to silicone, preexisting
autoimmune or connective tissue diseases
or active urogenital infection.
All safety-related data, diagnoses and
health status evaluations were captured
on detailed case report forms. The
Investigators' professional evaluation
of the erections provided by the IPPs
after implantation and their suitability
for intercourse was the primary efficacy
endpoint. The number of surgical
revisions performed and reported by
the Investigators was the primary safety
endpoint. Patient self-evaluations on four
validated outcome instruments were the
secondary efficacy endpoints (concerning
quality of life, self-esteem, and sexual
satisfaction and functioning).
This clinical trial provided the following
results through the 18-month evaluation
for the first 141 patients to reach this post-
surgical follow-up. Some patients were
studied for longer than 18 months.
Physician Assessment of Device Function:
The function of 141 implanted devices was
evaluated on or after the 18-month follow-
up exam. Of these 141 devices, 140 could
be inflated (99.3%). The device that could
not be inflated was surgically replaced. All
of the 140 devices that were successfully
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