Degree of Plaque Calci
f
cation
Co-primary endpoint results by degree of plaque calci
f
cation
at baseline (no calci
f
cation, non-contiguous stippling, and
contiguous calci
f
cation that did not interfere with the
injection) are shown in Table 2. At baseline, 447 patients had
no calci
f
cation (
n
=
287 for CCH and
n
=
160 for placebo),
103 patients had non-contiguous stippling (
n
=
76 for CCH
and
n
=
27 for placebo), and 62 patients had contiguous
calci
f
cation that did not interfere with injection (
n
=
38 for
CCH and
n
=
24 for placebo).
For both mean percent penile curvature deformity and PD
symptom bother, signi
f
cant improvements were observed in
CCH-treated patients compared with placebo in the no
calci
f
cation group only (both
P
<
0.001). Differences between
CCH and placebo for the non-contiguous stippling (
P
=
0.110
and
P
=
0.342, respectively) and contiguous calci
f
cation that
did not interfere with the injection groups were not
statistically signi
f
cant (
P
=
0.231 and
P
=
0.985, respectively).
Erectile Function Severity
Results for the co-primary endpoints in patients with varying
baseline IIEF-erectile function severity are shown in Table 3.
At baseline, 22 patients were in the IIEF score 1
–
5 (no sexual
activity) group, 106 were in the 6
–
16 (low IIEF-erectile
function) group, and 480 were in the
≥
17 (high IIEF-erectile
function) group. Mean percent improvements in penile
curvature deformity in CCH-treated patients strati
f
ed by
baseline IIEF-erectile function severity were not statistically
signi
f
cant compared with placebo in any but the largest
group of patients (
P
<
0.001 for the
≥
17 [high IIEF-erectile
function] group). For the 1
–
5 (no sexual activity) and 6
–
16
(low IIEF-erectile function) groups, no statistically signi
f
cant
differences emerged.
Table 1
Change in penile curvature and Peyronie
’
s disease symptom bother from baseline to week 52 (last observation carried forward), strati
f
ed by
duration of disease.
Duration of PD
1
–
2 years
>
2to
≤
4 years
>
4 years
CCH (
n
=
134)
Placebo (
n
=
67)
CCH (
n
=
136)
Placebo (
n
=
76)
CCH (
n
=
131)
Placebo (
n
=
68)
Mean
Æ
SD
penile curvature,
°
Baseline
49.4
Æ
14.4
50.6
Æ
14.8
51.6
Æ
14.7
50.4
Æ
13.3
49.2
Æ
14
46.9
Æ
13.7
Week 52
35.1
Æ
16.8
38.0
Æ
16.3
34.3
Æ
17.7
41.9
Æ
17.4
29.7
Æ
15.2
40.0
Æ
14.7
Change
À
14.3
Æ
14.9
À
12.6
Æ
15.1
À
17.3
Æ
15.0
À
8.5
Æ
13.9
À
19.5
Æ
14.1
À
7.0
Æ
10.9
% Change
À
28.9
Æ
31.4
À
23.8
Æ
31.9
À
33.8
Æ
27.7
À
17.1
Æ
31.3
À
39.6
Æ
27.6
À
14.0
Æ
23.5
P
0.28
<0.001
<0.001
Mean
Æ
SD
PDQ PD symptom bother score
Baseline
8.3
Æ
3.7
7.6
Æ
3.9
7.5
Æ
3.4
8.6
Æ
3.5
6.5
Æ
3.3
7.0
Æ
3.4
Week 52
5.4
Æ
3.9
5.6
Æ
4.2
4.9
Æ
4.2
6.9
Æ
4.2
3.6
Æ
3.1
5.4
Æ
3.6
Change
À
2.9
Æ
4.1
À
2.0
Æ
4.1
À
2.6
Æ
3.6
À
1.8
Æ
3.2
À
3.0
Æ
3.5
À
1.6
Æ
3.4
P
0.14
0.07
0.01
PD, Peyronie
’
s disease; CCH, collagenase Clostridium histolyticum; PDQ, Peyronie
’
s Disease Questionnaire. Bolded text indicates statistical signi
f
cance.
Table 2
Change in penile curvature and Peyronie
’
s disease symptom bother from baseline to week 52 (last observation carried forward), strati
f
ed by
plaque calci
f
cation.
No calci
f
cation
Non-contiguous stippling
Contiguous calci
f
cation*
CCH (
n
=
287)
Placebo (
n
=
160)
CCH (
n
=
76)
Placebo (
n
=
27)
CCH (
n
=
38)
Placebo (
n
=
24)
Mean
Æ
SD
penile curvature,
°
Baseline
50.3
Æ
14.3
49.8
Æ
14.2
49.8
Æ
16.0
46.2
Æ
15.0
49.1
Æ
11.9
49.6
Æ
11.2
Week 52
33.0
Æ
16.8
40.9
Æ
16.1
32.1
Æ
17.2
34.7
Æ
16.9
35.5
Æ
15.6
40.5
Æ
15.7
Change
À
17.2
Æ
16.8
À
8.9
Æ
13.9
À
17.7
Æ
14.0
À
11.6
Æ
13.1
À
13.6
Æ
13.2
À
9.2
Æ
11.8
% Change
À
34.3%
Æ
29.8
À
16.8%
Æ
29.4
À
35.9%
Æ
27.1
À
25.5%
Æ
33.0
À
28.0%
Æ
28.7
À
19.5%
Æ
24.3
P
<0.001
0.110
0.231
Mean
Æ
SD
PDQ PD symptom bother score
Baseline
7.5
Æ
3.6
7.9
Æ
3.6
7.5
Æ
3.5
7.2
Æ
3.5
7.1
Æ
3.5
7.9
Æ
4.1
Week 52
4.6
Æ
3.7
6.2
Æ
4.1
5.0
Æ
4.4
5.4
Æ
4.3
4.4
Æ
3.5
5.2
Æ
3.4
Change
À
2.9
Æ
3.8
À
1.7
Æ
3.5
À
2.6
Æ
3.6
À
1.8
Æ
3.9
À
2.7
Æ
3.7
À
2.7
Æ
3.5
P<
0.001
0.342
0.985
PD, Peyronie
’
s disease; CCH, collagenase Clostridium histolyticum; PDQ, Peyronie
’
s Disease Questionnaire. Bolded text indicates statistical signi
f
cance. *Contiguous calci
f
cation
that did not interfere with injection.
© 2015 The Authors
BJU International © 2015 BJU International
653
Ef
f
cacy of collagenase
Clostridium histolyticum
in Peyronie
’
s disease