Clinical Studies - Boston Scientific AMS 800 Mode D'emploi

Table 3 lists the device related adverse events reported during the study.
This trial involved only devices without InhibiZone
Table 3. AMS 800 ™ Prospective Clinical Study − Device Related Adverse Events
Adverse Event Category
Impaired Device Function 7
Pain/Discomfort 6
Delayed Wound Healing 5
Bladder Spasms 2
Difficult Activation 2
Migration 3
Tissue Erosion 2
Difficult Deactivation 1
Infection 2
Recurrent Incontinence 3
Fistula Formation 1
Hematoma 1
Swelling 2
Hydrocele 1
Tissue Erosion/Infection 1
Patient Dissatisfaction 1
Positional Incontinence 1
Wound Infection 1
Urinary Retention 1
*Events may have been addressed with more than one type of intervention.
** Medical interventions included: medication, education, frequent device deactivation, dressing changes and
catheterization.
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.
Information on device revisions is described in the Clinical Studies – Males section.
Adverse Events – Males and Females
Adverse events potentially related to the implantation and use of the AMS 800 AUS
include: adhesion, allergic reaction, contracture, deep vein thrombosis, dehiscence,
dysuria, edema, erosion, exposure to biohazardous material, fibrosis, fistula, foreign body/
unretrieved device fragment, hematoma, hematuria, hemorrhage/bleeding, herniation of
the device through tissue, infection, limited urethral coaptation (may be due to device
leak, sizing, malfunction, placement, or other causes), malfunction, malposition of
components, mechanical malfunction or mechanical difficulty, migration of component,
overactive bladder, pain/discomfort, prolonged procedure, unintended surgical damage
(perforation or injury to the bladder, urethra, nerves, vessels, or other local structures),
urethral atrophy, urethral stricture, urinary retention, and urinary urgency.
Adverse Events – Males
Additional adverse events reported specifically for males include: bladder spasms,
delayed wound healing, hydrocele, and patient dissatisfaction.
Adverse Events – Females
Additional adverse events reported specifically for females with additional etiologies
include: device damage – unrelated procedure, early post-operative morbidity,
incisional hernia, phlebitis, pulmonary embolus, upper urinary tract deterioration, and
wound seroma.

CLINICAL STUDIES

Clinical Studies – Males
A prospective, multi-center, non-randomized clinical study was undertaken to
demonstrate that the AMS 800 AUS can be surgically implanted without serious
adverse sequelae, provides an acceptable level of continence, and enhances quality
of life. Each patient served as their own control. Efficacy data and safety data related
to adverse events, revision surgery, diagnoses, and health status evaluations were
captured on case report forms. Patient self-evaluations related to health status and non-
illness specific quality of life were measured on two validated outcome instruments.
Patient and physician assessments of continence were measured on a recognized,
standardized, non-validated instrument.
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Interventions*
6 4 2 2 4
5 4 3 3 1
5 5 2 3 0
2 0 0 2 0
2 2 1 1 0
3 1 2 0 1
2 2 0 0 2
1 1 0 1 0
2 2 0 0 2
3 3 1 0 2
1 1 0 0 1
1 1 0 1 0
2 2 0 2 1
1 1 0 1 1
1 1 0 0 1
1 1 0 0 1
1 0 1 0 0
1 1 0 1 0
1 1 0 1 0
Eighty-seven (87) male patients were enrolled in the study of which 85 patients were
implanted with the device during the study. The patients ranged in age from 48.5 to
96.1 years at time of enrollment. The majority of the participants were White (97.70%),
1.15% were African American, and 1.15% were Asian. Patients available at the
follow-up intervals were 6-months (n=67), 12-months (n=60), 18-months (n=55), and
24-months (n=41). Patients diagnosed with intrinsic sphincter deficiency (ISD) resulting
from prostate surgery were eligible for enrollment. Patients with a history of allergy/
sensitivity to silicone, pre-existing autoimmune or connective tissue disease, or active
urogenital infection were excluded from the study.
This trial involved only devices without InhibiZone.
Endpoints
The primary effectiveness endpoint evaluated the effect of the prosthesis on patient
quality of life using the Incontinence Impact Questionnaire, an incontinence-specific
quality of life questionnaire. The primary safety endpoint evaluated the five-year
revision-free rate using a Bayesian hierarchical model. The safety endpoint was a
five-year revision-free rate equivalent to 75% using a 10% delta with a two-sided 95%
lower bound greater than 65%.
Incontinence Impact Scores
The primary effectiveness endpoint was a reduction in the Incontinence Impact Score
from pre- to post-implant status. Incontinence impact was measured pre- and post-
implant at 6, 12, 18, and 24 months. Thirty-nine (39) patients answered the Incontinence
Impact Questionnaire (IIQ) at 24-month follow-up. The IIQ is a 30-item, self-administered
questionnaire designed to assess the impact of urinary incontinence on several
subscales including physical, emotional, and social. The IIQ used in the study was
developed from a validated instrument
higher (p<0.0001) than the mean scores at all follow-up visits. Therefore, the impact of
incontinence was reduced for patients following AMS 800 AUS implantation and the
primary objective was met.
Physician and Patient Assessment of Continence
Physician assessed continence was 63.6% dry and 34.1% required some additional
protection at one-year follow-up (n=43). At two-year follow-up (n=30), 73.3% were
dry and 23.3% required some additional protection. Patient assessed continence was
61.7% dry and 36.7% required some additional protection at one-year follow-up (n=60).
At two-year follow-up (n=41), 65.9% were dry and 31.7% required some additional
protection. No significant difference existed between the physicians' assessment and
the patients' assessment of their incontinence.
Patient Evaluation of Health Status and Self-esteem
General Quality of Life as measured by the Health Status 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 was used to assess changes in patient self-esteem. The
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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 implantation of the AMS 800 AUS. The
device did not have an adverse effect on sexual function. Some patients with improved
continence following implantation 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, and 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 retrospective studies and the prospective
study are presented in Tables 4 and 5.
These studies involved only devices without InhibiZone
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. The mean pre-implant score was significantly
1
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Black (K) ∆E ≤5.0