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Table 20 – Mean Prostate Volume at Baseline and Follow-up of
Patients Age ≥ 80 Years
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Among the subset of patients with prostate size larger than 90g, baseline
characteristics were similar to those of the entire Composite group, other
than gland volume.
Table 21 – Baseline Characteristics of Patients with Prostate Size ≥
90g
Characteristic
Age (years)
IPSS
Quality of life
Prostate volume (gms)
PSA (ng/mL)
* 12 of 95 patients (12.6%) had indwelling bladder catheters at baseline
Symptoms improved in this cohort post embolization at all time points,
and a minimum 3-point reduction and drop of at least one symptom
category in IPSS was achieved by 96% and 89% of patients respectively.
Table 22 – Mean IPSS at Baseline and Follow-up of Patients with
Prostate Size ≥ 90g
Time Window
Baseline
1 to 3 months f/u
9 to 16 months f/u
Table 23 – Proportion of Patients with Prostate Size ≥ 90g Achieving
≥ 3 Point IPSS Improvement
Time Window
Proportion (95% CI)
1 to 3 months f/u
0.955 (0.873-0.991)
9 to 16 months f/u
0.961 (0.865-0.995)
Table 24 – Proportion of Patients with Prostate Size ≥ 90g Achieving
≥ 1 IPSS Category Improvement
Time Point
Proportion (95% CI)
1 to 3 months f/u
0.870 (0.767-0.939)
9 to 16 months f/u
0.889 (0.774-0.958)
Mean quality of life scores also improved and prostate size demonstrated
a reduction at each evaluation point, consistent with the reduced lower
urinary tract symptoms.
Table 25 – Mean Quality of Life at Baseline and Follow-up of Patients
with Prostate Size ≥ 90g
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Table 26 – Mean Prostate Size at Baseline and Follow-up of Patients
with Prostate Size ≥ 90g
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
The difference in size of the prostates relative to the entire Composite
group did not impact technical success of embolization. Over 90% of
patients underwent bilateral embolization.
Mean ± SD
n
78.1 ± 37.1
34
55.1 ± 22.5
16
64.6 ± 20.6
10
Mean ± SD
n
68.4 ± 9.0
95
19.8 ± 6.8
87
4.6 ± 0.8
53
124.2 ± 35.5
95
7.4 ± 5.5
88
Mean ± SD
n
19.8 ± 6.8
87
5.0 ± 4.6
69
4.6 ± 4.1
54
Mean ± SD
n
4.6 ± 0.8
53
1.1 ± 0.9
49
1.2 ± 0.9
40
Mean ± SD
n
124.2 ± 35.5
95
85.9 ± 27.2
70
91.0 ± 27.8
44
Table 27 – Unilateral versus Bilateral Embolization of Patients with
Prostate Size ≥ 90g
Embolization
Unilateral
Bilateral
No data
Patients with indwelling catheters at baseline tended to be older than the
Composite population as a whole, and the catheters led to unhappy to
quality of life scores categorized as terrible.
Table 28 – Baseline Characteristics of Patients with Indwelling
Catheters at Baseline
Characteristic
Age (years)
Quality of life
Prostate volume (gms)
PSA (ng/mL)
Baseline IPSS data were not analyzed for patients with indwelling catheters
because their acute urinary retention made questions about urination
habits moot. Consequently, no analyses of the proportions of patients
whose symptoms improved from baseline could be conducted.
Post embolization, patients went from inability to answer IPSS questions
to being only mildly symptomatic, and quality of life scores improved
from categorization of unhappy to terrible at baseline to pleased after
treatment.
Table 29 – Mean IPSS During Follow-up of Patients with Indwelling
Catheters at Baseline
Time Window
1 to 3 months f/u
9 to 16 months f/u
Table 30 – Mean QOL at Baseline and Follow-up of Patients with
Indwelling Catheters at Baseline
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Mean prostate size was reduced at all follow-up points, with over 80% of
patients having received bilateral embolization.
Table 31 – Mean Prostate Size at Baseline and Follow-up of Patients
with Indwelling Catheters at Baseline
Time Point
Baseline
1 to 3 months f/u
9 to 16 months f/u
Table 32 – Unilateral versus Bilateral Embolization of Patients with
Indwelling Catheters at Baseline
Embolization
Unilateral
Bilateral
No data
Table 33 – Adverse Events
Event
Congenital, familial and genetic disorders
Hydrocele
Ear and labyrinth disorders
Ear pain
Endocrine disorders
Hypogonadism
Gastrointestinal disorders
8
Patients (%)
6 (6.3)
87 (91.6)
2 (2.1)
Mean ± SD
n
73.8 ± 8.4
54
5.8 ± 1.0
16
79.0 ± 33.5
45
6.3 ± 5.4
39
Mean ± SD
n
6.0 ± 4.8
22
5.9 ± 4.3
22
Mean ± SD
n
5.8 ± 1.0
16
1.0 ± 0.8
25
1.0 ± 1.0
23
Mean ± SD
n
79.0 ± 33.5
45
64.3 ± 32.4
21
54.3 ± 19.1
20
Patients (%)
9 (16.7)
44 (81.5)
1 (1.8)
PAE
1 (0.3%)
1 (0.3%)
2 (0.7%)
2 (0.7%)
1 (0.3%)
1 (0.3%)
33 (11.5%)
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