Supplemental Table 1 – Data for the use of botulinum toxin A in neurogenic detrusor overactivity*
No
pts
F/U
Apostolidis et al. 16
[1]
6wk
Study
Chen and Kuo
[2]
/Dose
Ehren et al. [4]
% Δ daily
catheterisation
%Δ
MCC
%Δ
RV
% Δ MDP
LE
1
-35
62
-5
19
Botox/50
-29
64
-38
21
Botox/100
-37
136
-54
17
Botox/200
-55
86
-52
Botox/200
77
-42
Botox/300
43
-64
38
6mo
92
Placebo
-36
2.6
15
92
Botox/200
-67
63
-55
91
Botox/300
-62
64
-64
Dysport /500
60
-74
Placebo
0
-22
75
-40
17
6wk
26wk
10
Giannantoni et
al. [5]
%Δ daily
leak
Placebo
34
Cruz et al. [3]
Preparation
12
6mo
Botox/300
-71
-23
1
1
1
1
Ginsberg et al.
[6]
Hershorn et al.
[7]
149
Placebo
-31
6
-4.7
135
Botox/200
-65
60
-68
132
Botox/300
-73
66
29
Placebo
13
-11
18
Botox/300
-57
75
46
Placebo
-7
-2
18
21
19
Botox/200
-52
-22
72
38
19
Botox/300
-54
-2
58
5
Botox/300
-52
66
60
-42
Botox/200
detrusor & 100
trigone
-81
68
83
-42
-40
25
6wk
6wk
27
Schurch et al.
[8] [9]
Abdel-Meguid
et al. [10]
21
18
6wk
8wk
18
Grosse et al.
[11]
28
3mo
Botox/200, 300,
400
32
55
11
3.8mo
Dysport/500
9
8
Dysport/750
20
61
9
1
1
1
2
2
8
Grise et al. [12]
39
30d
38
Krhut et al. [13]
32
3mo
32
Dysport/1000
34
77
Dysport/500
79
98
Dysport/750
134
126
2
Botox/300
-92
-28
89
-63
Botox/300
-94
-18
96
-51
2
Akbar et al. [14]
25
3-6mo
Dysport/750
47
-52
3
Alloussi et al.
[15]
64
6wk
Dysport/500
119
-72
3
Alvares et al.
[16]
22
4wk
Botox/300
84
Bagi et al. [17]
15
6wk
Botox/300
31
Chen et al. [18]
108
6wk
Botox/300
Chen et al. [19]
38
3mo
Botox/200
D’ancona et al.
[20]
28
24wk
Botox/300
DeffontainesRufin et al. [21]
71
3mo
Del Popolo et al.
[22]
199
3-6mo
-34
150
78
120
3
-59
3
-26
3
86
-86
3
168
-62
3
Botox/300
37
41
3
Dysport/500,
750, 1000
80
3
Gaillet et al. [23] 31
2mo
Botox/300
-84
Game et al. [24]
30
6wk
Botox/300
-91
Game et al. [25]
109
4wk
Botox/300
Ghalayini et al.
[26]
14
6wk
Dysport/500
56
Ghalayini et al.
[27]
12
6wk
Dysport/500
52
86
Dysport/1000
61
96
10
-21
81
60
3
52
-26
3
3
Giannantoni et
al. [28]
40
6mo
Botox/300
-77
-26
54
Giannantoni et
al. [29]
23
1mo
Botox/300
-66
-13
78
Giannantoni et
al [30]
17
4mo
Botox/300
-50
-35
38
Gomes et al.
[31]
21
12wk
Botox/200, 300
103
Hikita et al. [32]
11
8wk
Botox/300
Jia et al. [33]
41
3mo
Lanzhou
BTX/300
-88
-26
3
3
-73
3
62
-69
3
26
-59
3
96
18
42
3
3
-49
3
Kalsi et al. [34]
63
4wk
Botox/300
-62
310
-26
3
Kalsi et al. [35]
32
4wk
Botox/300
-88
240
-58
3
Kalsi et al. [36]
43
4wk
Botox/300
-91
156
-48
3
Kalsi et al. [37]
16
4wk
Botox/300
-91
Karsenty et al.
[38]
17
1-5mo
Botox/300
-100
Khan et al. [39]
137
4wk
Botox/300
Kulaksizoglu et
al. [40]
16
3mo
Dysport/500
62
Kuo [41]
24
1mo
Botox/200
93
Kuo and Liu [42]
33
3mo
Botox/200
99
Mascarenhas et
al. [43]
21
8wk
Botox/300
44
Mouttalib et al.
[44]
42
Mehnert et al.
[45]
12
6wk
Botox/100
Pannek et al.
[46]
27
4wk
Botox/300
3
43
71
-62
3
3
3
91
34
-33
3
-45
3
-42
3
Botox/300
3
Dysport/750
-50
28
49
-57
3
-58
3
Patki et al. [47]
37
3mo
Dysport/1000
Popat et al. [48]
44
4wk
Botox/300
Reitz et al. [49]
200
12wk
Botox/300
54
Reitz et al [50]
20
45d
Botox/300
131
Ruffion et al.
[51]
45
1mo
Dysport/500
11
102
-56
3
131
-57
3
70
-51
3
79
– 83
3
75
-20
3
Dysport/1000
82
-49
-92
Schulte-Baukloh
et al. [52]
16
4wk
Botox/300
35
75
-45
3
Schurch et al.
[53]
19
6wk
Botox/200, 300
62
93
-46
3
Tow et al. [54]
15
6wk
Botox/300
62
139
-68
3
Neel et al. [55]
23
Botox/12u/kg
-34
2
Pascali et al.
[56]
24
Botox/10u/kg
24
Botox/10u/kg
30
Dysport/ 10u/kg
-82
-12
Children
Safari et al. [57]
70
2
39
-53
2
30
Dysport 8u/kg &
2u/kg sphincter
43
-63
Akbar et al. [14]
19
3-6mo
Dysport/ 20u/kg
61
-29
3
Altaweel et al.
[58]
20
3mo
Unreported/
5u/kg
41
-64
3
Horst et al. [59]
11
3mo
Botox/10u/kg
33
-17
3
Kajbafzadeh et
al. [60]
15
1mo
Dysport/10u/kg
119
-52
3
Kroll et al. [61]
65
2wk
Dysport/50u/kg
Le neu et al.
[62]
8
5-8wk
Botox/12u/kg
Marte et al. [63]
47
6wk
Botox/10u/kg
Riccabona et al.
[64]
15
3mo
Unreported/
10u/kg
Schulte-Baukloh
et al. [65]
17
4wk
Botox/ 12u/kg
Schulte-Baukloh
et al. [66]
20
4wk
Botox/ 12u/kg
LE = level of evidence.
3
70
-65
3
3
-39
54
314
-46
3
57
112
-32
3
35
84
-41
3
* Study end points are reported as %Δ daily leak: % change in daily incontinence episodes from baseline; %Δ daily catheterisation: % change from baseline
in need for catheterisation per day; %Δ MCC: % change in maximum cystometric capacity; %Δ RV: % change in volume at which first detrusor overactivity
occurred; %Δ MDP: % change in maximum detrusor pressure.
Supplemental Table 2 – Data for the use of botulinum A in overactive bladder*
Study
Altaweel et al.
[67]
No
pts
F/U
11
3mo
15
3mo
28
Chapple et al.
[69]
Denys et al.
[70]
Dmochowski
271
% Δ daily
urgency
% Δ daily
leak
%Δ
MCC
%Δ
MDP
% Δ QoL
LE
Botox/100
-47
-60
-45
24
-28
UDI-6=-50 IIQ7=-42
1
Botox/200
-49
-59
-32
51
-27
UDI=-41 IIQ7=-44
/Dose
11
Brubaker et al.
[68]
%Δ daily
frequency
Preparation
-5
Botox/200
-85
1
Placebo
-7
-12
-25
IQOL=19
277
Botox/100
-18
-45
-62
IQOL=73
29
Placebo
-9
-31
-31
10
49
IQOL=30
21
Botox/50
-11
-16
-51
8
51
IQOL=38
22
Botox/100
-30
-34
-54
8
37
IQOL=96
27
Botox/150
-32
-53
-56
17
50
IQOL=110
19
5
KHQ= -7
43
6wk
Placebo
12wk
Placebo
1
1
1
et al. [71]
Flynn et al.
[72]
56
Botox/50
19
16
KHQ= -11
55
Botox/100
28
-4
KHQ= -19
50
Botox/150
39
-22
KHQ= -21
52
Botox/200
33
-21
KHQ= -20
55
botox/300
48
-4
KHQ= -19
7
6wk
15
Gousse et al.
[73]
30
6wk
30
Jabs et al. [74]
10
37
35
-7
9
UDI-6=7.4 IIQ7=0
Botox
200/300
-12
-58
UDI-6=-38 IIQ7=-67
Botox/100
1
1
Botox/150
6mo
11
Kuo [75]
Placebo
3mo
Placebo
6
8
-21
UDI-6=-18 IIQ7=-7
Botox/100
-26
-67
13
UDI-6=-49 IIQ7=-50
Botox/100
-15
0.8
-57
21
-16
-17
-6
-59
17
-7
1
1
33
Nitti et al. [76]
280
6wk
277
Sahai et al.
[77]
18
4wk
16
Tincello et al.
[78]
98
6wk
87
Cohen et al.
[79]
22
12wk
22
Kanagarajah et 32
al. [80]
3mo
32
Kuo [81]
15
15
3mo
-20
-7
-28
27
-15
Placebo
-1.1
-13
-24
Botox/100
-15
-35
-64
Placebo
-7
-18
-19
-15
-4
UDI-6=-5 IIQ7=-28
Botox/ 200
-49
-79
-62
72
-55
UDI-6=-48 IIQ7=-67
Placebo
-10
-20
-14
IQOl= 32
Botox/200
-22
-67
-95
IQOL= 127
Botox/100
-31
-61
VAS= -60
150
-52
-71
VAS= -60
1
Botox/100
UDI-6=-60
Botox/150
UDI-6=-60
Botox/100
(Detrusor)
-48
-34
27
(Suburotheli
-24
-28
51
1
1
2
2
2
al)
(bladder
base)
15
Manecksha et
al. [82]
11
6wk
-40
-50
12
Dysport/500
11
Alloussi et al.
[15]
64
Bauer et al.
[83]
56
Chen et al.
[84]
174
Dowson et al.
[85]
6wk
Dysport/500
51
-73
87
-74
91
-31
2
IPSS QOL=-58
3
Botox/
dysport
3
3mo
Botox/100
3
100
4wk
Botox/200
3
Game et al.
[25]
42
4wk
Botox/200
UDI-6= -52 IIQ- 3
7 = -65
Ghalayini and
el ghazzo [26]
16
6wk
Dysport/500
-56
Granese et al.
[86]
68
1mo
Botox/100
-64
47
-84
-72
65
-26
3
3
Hegele et a.
[87]
31
3mo
Dysport/500
Irwin et al.
[88]
73
6wk
Dysport/250
Jackson et al.
[89]
94
3mo
Botox/200
-44
-78
Jeffery et al.
[90]
25
3mo
Dysport/500
-27
-56
19
Kalsi et al. [34]
38
4wk
Botox/200
-30
-41
-51
85
-32
Kalsi et al. [35]
16
4wk
Botox/200
-43
-79
-96
111
-29
UDI-6/ IIQ-7=70
3
Karsenty et al.
[91]
11
6wk
Botox/200
-33
-25
128
-20
V8 OAB= -26
3
Ke at al. [92]
174
3mo
Botox/100
Khan et al.
[93]
74
4wk
Botox/200
UDI-6
3
Khan et al.
[94]
81
4wk
Botox/200
UDI-6=-54 IIQ7=-64
3
Krhut et al.
[95]
16
1mo
Botoxinstillation
not
3
-34
OABSS=-35
IPSS-QOL=-39
-37
3
3
VAS= -40
3
3
3
-14
-28
-50
6
-4
3
injection/
200
Kuo [96]
20
3mo
Botox/200
84
Kuo [97]
174
3mo
Botox/
100,150,200
31
Kuo et al. [98]
217
Kuschel et al.
[99]
11
2yrs
Botox/100
LahdesVasama et al.
[100]
13
6wk
Botox/50100
Lucioni et al.
[101]
40
3wk
Botox/ 300
Lie et al. [102]
19
3mo
Botox/200
Maovey et al.
[103]
85
Mohanty et al.
[104]
35
Mohee et al.
[105].
268
-42
3
3
Botox/100
3
-17
34
67
-81
3
-30
-53
3
IIQ-7=-26 UDI6=-24
3
IPSS QOL= -34
3
Botox/150200
3mo
Botox/ 200
-58
-46
-44
37
-38
3
3
Okamura et al.
[106]
17
4wk
Botox/100
Onyeka et al.
[107]
56
2mo
Botox/200
Petrou et al.
[108]
21
1mo
Botox:DMSO
/300:50
Popat et al.
[48]
31
4 wk
Botox/ 200
Rajkumar et
al. [109]
15
6wk
Botox/ 300
Rapp et al.
[110]
35
3wk
Botox/ 300
Ravindra et al.
[111]
101
3mo
Botox/200
-40
-100
Dysport/500,
300
-44
-100
106
-15
-18
-55
63
3
3
UDI-6=-50 IIQ7=-54
-50
-43
-63
-91
96
-50
32
3
3
KHQ=-32
3
UDI-6=-24 IIQ7=-28
3
3
Sahai et al.
[112]
65
4wk
Botox/ 200
Schmid et al.
[113]
100
4wk
Botox/ 100
-51
59
Schulte-
44
4wk
Botox/ 200-
-15
30
78
-50
3
3
-16
UDI-6=-30,
3
Bauloh et al.
[114]
300 + 50-100
in sphincter
SSI=-20 SII=-30
Werner et al.
[115]
26
4wk
Botox/ 100
-41
White et al.
[116]
21
1mo
Botox/ 200
-55
Blackburn et
al. [117]
27
5mo
Dysport/400500
Hoebke et al.
[118]
15
Marte et al.
[119]
21
Mcdowell et
al. [120]
57
60
3
3
Children
6mo
3
Botox/ 100
62
Unreported/
12.5u/Kg
38
Dysport/12u
/kg
3
-38
3
3
LE = level of evidence.
* Study end points are reported as %Δ daily frequency: % change in daily voiding episodes from baseline; %Δ daily urgency: %change from baseline in
urgency episodes per day; %Δ daily leak: % change in daily incontinence episodes; %Δ MCC: % change in maximum cystometric capacity; %Δ MDP: % change
in maximum detrusor pressure; %Δ QoL: % change in quality-of-life scores.
Supplemental Table 3 – Data for the use of botulinum toxin A in detrusor sphincter dyssynergia*
Study
No
pts
F/U
Preparation/
Dose
Method of
administration
De Seze et
al. [121]
5
1mo
Botox/100
Transperineal
8
1mo
Lidocaine/
0.5%
45
1mo
Botox/100
41
1mo
Placebo/
Chen et al.
[123]
18
1mo
Botox/100
Kuo [124]
33
3mo
Kuo [125]
20
Petit et al.
[126]
Schurch et
al. [127]
Gallien et
al. [122]
%Δ PVR
% Δ max urethral
pressure
%Δ
MVP
LE
1
-60
-29
3.2
-16
9
5
-15
-17
-22
-5
-4
6
Transperineal
-39
-25
-12
3
Botox/100
Transurethral
-33
-53
3
1mo
Botox/ 50100
Transurethral
-44
-31
3
17
1mo
Dysport/ 150
Transurethral
-55
-21
-20
3
24
1mo
Botox/ 25u
or
Dysport/250
Transperineal/
Transurethral
-8
-19
Transperineal
1
3
Tsai et al.
[128]
18
34wk
Botox/ 100
Radojicic et
al. [129]
20
6mo
Brand not
mentioned/
50-100
-65
3
Franco et
al. [130]
16
Brand not
mentioned/
8.85u/Kg
-81
3
Transperineal
-68
-49
-42
3
Children
LE = level of evidence.
* Study end points are reported as %Δ PVRU: % change in postvoid residual; %Δ max urethral pressure: % change from baseline in maximum urethral
pressure; %Δ MVP: % change in maximum voiding pressure.
Supplemental Table 4 – Data for the use of botulinum toxin A in lower urinary tract symptoms/benign prostatic enlargement*
Study
No
pts
F/U
Preparation/
Dose
%Δ IPSS/
AUA
% Δ Qmax
% Δ prostate
volume
% Δ PSA
%Δ
PVR
LE
Arnouk et al. [131]
17
3mo
Botox/100
-64
49
-8
-18
-70
1
Botox/200
-58
33
-8
-27
-60
Botox/100
-37
25
Botox/300
-35
27
Placebo
-26
24
-11
8
95
Botox/100
-30
26
-6
0
94
Botox/200
-32
19
-8
22
97
Botox/300
-27
18
-6
14
17
Crawford et al. [132]
68
3mo
66
Marberger et al. [133]
Maria et al. [134]
Chuang et al. [135]
94
3mo
1
15
1mo
Placebo
0
0
-3
-3
-1
15
1mo
Botox/ 200
-54
84
-55
-43
-61
21
1mo
Botox/100
-48
52
-15
-44
Botox/200
-51
47
-15
-72
20
1
1
2
Kuo and Liu [136]
Park et al. [137]
Botox/ 200600 (in split
doses)
-49
21
-11
-2
10
40
alpha
blocker & 5
alpha
reductase
-33
12
-2
-32
31
26
Botox/ 100300
-24
11
-8
-8
-24
20
6mo
2
2
26
1mo
Botox and
alphablocker
-28
12
-9
-8
-30
Brisinda et al. [138]
77
1mo
Botox/ 200
-47
52
-13
-23
-13
3
Chuang et al. [139]
16
1mo
Botox/ 100
-53
62
-13
-10
-63
3
De Kort et al. [140]
15
1mo
Botox/200
-41
39 (3mo)
-2
37
-53
(3mo)
3
Hamidi et al. [141]
10
3mo
Botox/100,2
00, 300
-45
106
-27
-45
-16
3
Nikoobakht [142]
72
1mo
Dysport/
300-600
-46
117
-34
-32
-49
3
Sacco et al. [143]
64
3mo
Botox/200
-49
-33
-2.6
-80
3
Silva et al. [144]
16
1mo
Botox/200
Silva et al. [145] [146]
21
1mo
Botox/ 200
-28
29
-33
-4
-19
-3
-29
3
3
LE = level of evidence.
* Study end points are reported as %Δ IPSS/AUA: % change in International Prostate Symptom Score/American Urological Association score from baseline;
%Δ Qmax: %change from baseline in maximum flow rate; %Δ prostate volume:% change in prostate volume; %Δ PSA: % change in prostate-specific antigen
levels; %Δ PVR: % change in postvoid residual.
Supplemental Table 5 – Data for the use of botulinum toxin A in bladder pain syndrome/interstitial cystitis*
Study
No
pts
F/U
Preparation/Dose
Gottsch et
al. [147]
9
3mo
Botox/ 50
11
Kuo and
Chancellor
[148]
El-Bahnasy
et al. [149]
%Δ Daytime
frequency
%Δ
nocturia
%Δ FBC
%Δ MCC
%Δ
VAS
1
Placebo
Botox and
hydrodistension/
200
-34
-51
40
62
-55
29
Botox and
hydrodistension/
100
-25
-24
17
26
-39
23
Hydrodistension
-14
-5
9
4
-18
15
LE
3mo
16
22wk
BCG
-31
-54
16
23wk
Botox/300
-68
-100
Chung et
al. [150]
67
3mo
Botox/100 &
hydrodistension
-26
-35
Giannanton
i et al.
[151]
14
3mo
Botox/200
-56
-74
2
2
37.5
47
-39
3
46
3
Giannanton
i et al.
[152]
14
1mo
Botox/ 200
-41
-53
37
-38
3
Giannanton
i et al.
[153]
15
1mo
Botox/ 200
-48
-67
41
-35
3
Giannanton
i et al.
[154]
13
1mo
Botox/ 200
-50
-75
32
-36
3
Giannanton
i et al.
[155]
14
3mo
Botox/200
-56
-74
90
-46
3
Kuo [156]
81
3mo
Botox/100 &
hydrodistension
-23
-28
26
-30
3
Lee and
Kuo [157]
30
2yrs
Botox/100 &
hydrodistension
-37
-33
100
22
-60
3
-52
-51
130
-64
3
10
Pinto et al.
[158]
26
1mo
Botox/ 100
Ramsay et
al. [159]
11
6wk
Botox/ 200-300
Shie et al.
23
6mo
Botox/100 &
29
-27
-22
-1
3
-30
3
[160]
hydrodistension
LE = level of evidence.
* Study end points are reported as %Δ daytime frequency: % change in daytime micturition episodes from baseline; %Δ nocturia: % change from baseline in
nocturnal voiding episodes; %Δ FBC: % change in functional bladder capacity; %Δ MCC: % change in maximum cystometric capacity; %Δ VAS: % change in
visual analogue score.
Supplemental Table 6 – Risk of bias in level 1 studies for botulinum toxin A in neurogenic detrusor overactivity*
NDO
Study
Allocation
concealment
Chen &Kuo
Random
sequence
generation
Yesstratified
Yes
Cruz
Yes
Yes
Ginsberg
Yes
Hershorn
Yes
Ehren
Yes but no
details
Giannantoni
Yes
Schurch
Yes
Apostolidis
Blinding of
participants/
personnel
Blinding of
outcome
assessments
Selective
reporting/ ITT
Other Bias
Overall bias risk
Continued anticholinergics if already taking, low
recruitment
Single institution
Moderate
Yes
Selective
reporting
Selective
reporting
ITT
Low
Yes
Yes
ITT
Yes
Yes
ITT
SCI or MS, continued anticholinergics if already
taking
SCI or MS continued anticholinergics if already
taking
SCI or MS, Discontinued anticholinergics but could
be resumed, last observation carried forward
method for missing data
MS and SCI, discontinued anticholinergics but
could be resumed, single institution, low
recruitment
Patients asked to decrease anticholinergics by 15
days, single institution, low recruitment, not all
patients incontinent
Majority SCI, patients advised to discontinue
anticholinergics
Yes
Yes
Yes
Yes
Yes
ITT
ITT= intention to treat; MS = multiple sclerosis; SCI = spinal cord injury.
* Overall bias risk <1 = high risk of bias; 2–3 = moderate risk of bias; >4 = low risk of bias (after subtraction of other bias score).
Moderate
Low
Low
High
High
Low
Supplementary Table 7 – Risk of bias in level 1 studies for botulinum toxin A in overactive bladder*
OAB
Study
Altaweel
Chapple
Denys
Gousse
Jabs
Kuo
Random
sequence
generation
Alternate
randomisation
Yes
Yes- stratified
Tincello
Brubaker
Flynn
Yes
Yes
Yes- But no
details
Yes
Yes- but no
details
Yes
Yes
Yes
Sahai
Yes
Nitti
Rovner
Allocation
concealment
Blinding of
participants/
personnel
Yes
Yes
Yes
Yes
Yes
Yes
Single blind
Yes
Yes
Yes
Blinding of
assessment
outcomes
Other Bias
Overall bias risk
Single institution, OAB
High
Low
Low
ITT
ITT
OAB
IDO, last observation carried forward method for missing
data
OAB, Single centre
OAB, single institution, low recruitment
IDO, single institution
Yes
ITT
ITT
OAB
OAB
Low
Moderate
ITT
OAB, women only
IDO
OAB, single institution, Placebo group only blinded to 6
weeks, unblinded if complications
OAB, single institution
Low
Moderate
Low
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Selective
reporting/ ITT
ITT
Selective
reporting
ITT
Selective
reporting
IDO = idiopathic detrusor overactivity; ITT = intention to treat; OAB = overactive bladder.
* Overall bias risk <1 = high risk of bias; 2–3 = moderate risk of bias; >4 = low risk of bias (after subtraction of other bias score).
High
Moderate
High
Low
Supplemental Table 8 – Risk of bias in level 1 studies for botulinum toxin A in detrusor sphincter dyssynergia*
DSD
Study
De Sèze
Gallein
Random
sequence
generation
Yes
Yesstratified
Allocation
concealment
Yes
Yes
Blinding of
participants/
personnel
Yes
Yes
Blinding of
outcome
assessments
Selective
reporting/ ITT
Other Bias
Overall bias risk
Small numbers
Moderate
Low
ITT
* Overall bias risk <1 = high risk of bias, 2–3 = moderate risk of bias; >4 = low risk of bias (after subtraction of other bias score).
Supplemental Table 9 – Risk of bias in level 1 studies for botulinum toxin A in lower urinary tract symptoms/benign prostatic enlargement*
LUTS/BPE
Study
Arnouk
Crawford
Marberger
Maria
Random
sequence
generation
Yes- But no
details
Yes
Yesstratified
Yes
Allocation
concealment
Yes
Yes
Blinding of
participants/
personnel
Blinding of
outcome
assessments
Selective
reporting
Selective
reporting
ITT
Yes
Yes
Selective
reporting/ ITT
Yes
Other Bias
Overall bias risk
High
Moderate
Route of administration changed half way through trial
Moderate
Single institution, low recruitment, primary endpoint
combination of two parameters
Moderate
ITT = intention to treat.
* Overall bias risk <1 = high risk of bias; 2–3 = moderate risk of bias; >4 = low risk of bias (after subtraction of other bias score).
Supplemental Table 10 – Risk of bias in level 1 studies for botulinum toxin A in bladder pain syndrome/interstitial cystitis*
BPS
Study
Gottsch
Random
sequence
generation
Yes- But no
details
Allocation
concealment
Blinding of
participants/
personnel
Yes
Blinding of
outcome
assessments
Yes
Selective
reporting/ ITT
Other Bias
Overall bias risk
ITT
Women only
Moderate
ITT = intention to treat.
* Overall bias risk <1 = high risk of bias; 2–3 = moderate risk of bias; >4 = low risk of bias (after subtraction of other bias score).
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