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7
Questionnaire
and the
Rosenberg Self-esteem Questionnaire
was
evaluated at pre- and post-implant at 6, 12, 18, and 24 months.
Thirty-eight (38) patients answered the
Health Status
and
Rosenberg Self-esteem Questionnaires
at 24-month follow-up. The
self-administered
Health Status Questionnaire
2
was used to assess
non-illness specific parameters such as physical functioning,
social functioning, energy/fatigue, pain, health perception, and
emotional problems. A high score indicates that overall health
was perceived to be high. The mean score was 596 at pre-
implant and 612 at two-year follow-up. No significant difference
in health status scores was observed during the study. The
self-administered
Rosenberg Self-esteem Questionnaire
3
was used
to assess changes in patient self-esteem. The range of possible
scores is 0-6, with a score of 6 indicating high self-esteem. The
mean score at implant was 3.5 and at two-year follow-up was
4.1. The increase in mean score indicates a more positive self-
esteem following AMS 800 implant. The device did not have an
adverse effect on sexual function. Some patients with improved
continence following implant also reported increased sexual
activity. The positive impact of the device on patient’s lives
measured in the clinical study is consistent with results obtained
by other authors.
4,5,6
Surgical Revisions
A revision is a surgical intervention related to the function,
placement, or site reaction to the implanted device. For the
85 patients implanted with the device followed under the
prospective clinical study, 14 patients (16.5%) experienced a
total of 15 revisions up to 24 months following implant. One
patient had two revisions. Three (3) revisions were due to
mechanical malfunction. Two (2) revisions were due to recurrent
incontinence. Two (2) revisions were due to erosion. Two (2)
revisions were due to infection. One (1) revision each (total
= 6) was due to migration, pain, erosion/infection, persistent
incontinence/patient dissatisfaction, recurring incontinence/
malfunction, infection/pain/urethrocutaneous fistula. Multiple
reasons were provided for some revisions. Four of the 14 patients
who experienced revisions elected to have the device removed
and 10 elected to have the device replaced. The probability of
remaining revision-free 24 months following implant was 79.5%
(95% CI with 95% lower confidence bound 69.8%) based on
the prospective clinical study.
Additional data on the number of surgical revisions and their
reasons were collected under two retrospective studies. Each
of these studies are briefly described below and comparisons
of revision data of these two retro spective studies and the
prospective study are presented in Tables 2 and 3.
b. Retrospective Patient Information Form (PIF) Study
– The
PIF study was a retrospective analysis of patients implanted
(n=12,713) in the U.S during the five-year period 1995-
1999. The study examined PIF data voluntarily sent to the
manufacturer by the implanting physician for original implants
and revisions. PIF data is required to be on file with the
manufacturer in order to be eligible for product replacement.
Revision data presented in Table 2 and Table 3 below are based
on a total of 2,116 revisions reported for 2,014 patients that
required one or more revisions during the five-year period of the
study.
c. Retrospective Clinical Study
– The retrospective clinical study
was an analysis of patients implanted (n=390) in the U.S.
between 1987-1990. The study examined pre- and post-implant
medical records and follow-up data collected by questionnaires
and physician examinations. Post-implant data was available for
7