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pISSN 2093-4777
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Original Article
INTERNATIONAL
NEUROUROLOGY JOURNAL
Official Journal of
Korean Continence Society / Korean Society of Urological Research / The Korean Childrens Continence
and Enuresis Society / The Korean Association of Urogenital Tract Infection and Inflammation
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Mobile Web
Efficacy and Safety of Tension-Free Vaginal Tape-Secur MiniSling Versus Standard Midurethral Slings for Female Stress
Urinary Incontinence: A Systematic Review and Meta-Analysis
Wei Huang1,2, Tao Wang1,2, Huantao Zong1,2, Yong Zhang1,2
Urology Department, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Neurourology Research Division, China National Clinical Research Center for Neurological Disease, Beijing, China
1
2
Purpose: To assess the efficacy and safety of tension-free vaginal tape (TVT)-Secur for stress urinary incontinence (SUI).
Methods: A literature review was performed to identify all published trials of TVT-Secur. The search included the following
databases: MEDLINE, Embase, and the Cochrane Controlled Trial Register.
Results: Seventeen publications involving a total of 1,879 patients were used to compare TVT-Secur with tension-free obturator tape (TVT-O) and TVT. We found that TVT-Secur had significant reductions in operative time, visual analog score for
pain, and postoperative complications compared with TVT-O. Even though TVT-Secur had a significantly lower subjective
cure rate (P <0.00001), lower objective cure rate (P < 0.00001), and higher intraoperative complication rate, compared with
TVT-O at 1 to 3 years, there was no significant difference between TVT-Secur and TVT-O in the subjective cure rate (odds
ratio [OR], 0.49; 95% confidence interval [CI], 0.221.08; P=0.08), objective cure rate (OR, 0.49; 95% CI, 0.221.09; P=0.08),
or complications at 3 to 5 years. Moreover, TVT-Secur had significantly lower subjective and objective cure rates compared
with TVT.
Conclusions: This meta-analysis indicates that TVT-Secur did not show an inferior efficacy and safety compared with TVTO for SUI in 3 to 5 years, even though displaying a clear tread toward a lower efficacy in 1 to 3 years. Considering that the safety is similar, there are no advantages in using TVT-Secur.
Keywords: Urinary Incontinence, Stress; Suburethral Slings; Randomized Controlled Trial
Fund Support: This study was supported by the Capital Characteristic Clinical Project of China.
Conflict of Interest: No potential conflict of interest relevant to this article was reported.
INTRODUCTION
The International Continence Society defines stress urinary incontinence (SUI) as the complaint of involuntary urine leakage
during effort, exertion, sneezing, or coughing [1]. It results
from hypermobility of the urethra and functional insufficiency
of the urethral sphincter. SUI affects 4% to 35% of women, and
Corresponding author: Yong Zhang http://orcid.org/0000-0001-9737-2553
Urology Department, Beijing Tian Tan Hospital, Capital Medical University, No.
6 Tiantan Xi Li, Dong cheng District, Beijing 100050, China
E-mail: doctorzhy@126.com / Tel: +86-10-6709-8393 / Fax: +86-10-6709-6611
Wei Huang
http://orcid.org/0000-0002-1338-4213
Submitted: August 5, 2015 / Accepted after revision: September 7, 2015
the prevalence increases with age [2]. Ten percent of middleaged women report daily or severe incontinence and at least
one-third report leakage at least weekly [3].
SUI management is based on surgical options in case of failure of noninvasive therapies. Placement of a suburethral sling is
the gold standard treatment for management of SUI associated
with urethral hypermobility [4]. Tension-free vaginal tape
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/
by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Fig. 1. The flow diagram of the study selection. RCT, randomized controlled trial.
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Data Extraction
Data extracted from each eligible study included the name of
the clinical trial, number of patients in each group, the therapy
that the patients received, and the country in which the study
was conducted. Data including operative time, subjective cure
rate, objective cure rate, visual analog score (VAS) for pain,
bleeding greater than 100 mL, intraoperative complications,
postoperative complications, reoperation for SUI, and de novo
urgency were also extracted.
Statistical Analysis
The meta-analysis of comparable data was carried out with Review Manager 5.1.0 (The Cochrane Collaboration, London,
UK). Due to the large number of plots, we combined 6 forest
plots into 1 plot by using Adobe Photoshop CS (Adobe Systems, San Jose, CA, USA).
RESULTS
Characteristics of Individual Studies
The database search and reference lists of retrieved studies
found 267 potential articles for our meta-analysis. Based on the
inclusion and exclusion criteria, 194 articles were excluded after
reading the titles and abstracts of the articles; 38 articles were
not randomized controlled trials (RCTs), and 18 articles lacked
useful data. In all, 17 articles [11,12,16-29] with 18 RCTs that
compared TVT-Secur with standard MUS (TVT, TVT-O) were
included in the analysis. The baseline characteristics of the
studies included in our meta-analysis are listed in Table 1.
Quality of Individual Studies
All 18 RCTs were blinded, and all described the randomization
processes that they had used. All included a power calculation
to determine the optimal sample size (Table 2). The level of
quality of each identified study was A to B (Table 2). The funnel
plot provided a qualitative estimation of publication bias of the
studies, and no evidence of bias was found (Fig. 2).
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TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
TVT-Secur
Masata et al.
(2012) [19]
Hota et al.
(2012) [20]
Barber et al.
(2012) [21]
Tommaselli et al.
(2013) [11]
Tommaselli et al.
(2015) [23]
Maslow et al.
(2014) [24]
Oliveira et al.
(2011) [25]
Ross et al.
(2014) [26]
Bianchi-Ferraro et al.
(2013) [27]
Bianchi-Ferraro et al.
(2014) [12]
Jeong et al.
(2010) [28]
50
73
33
56
56
34
30
50
77
77
69
127
44
68
32
12
36
12
24
12
12
12
12
63
36
12
12
12
24
12
12
Women with primary SUI or MUI with predominant stress, age >18
yr, positive CST
Adiagnosis of SUI based on the patients personal history and a positive cough test with the bladder holding 300 to 400 mL
Women with symptoms of SUI and a positive cough test, which required surgical management
Women at least 21 yr of age with SUI on multichannel urodynamics, desire for surgical treatment, concurrent surgical treatment of prolapse
Women with SUI with an impact on QoL, positive CST during urodynamics
249
45
79
31
66
66
40
30
56
77
77
64
136
43
129
34
36
12
SUI lasting for at least 2 yr as diagnosed by clinical evaluation and urodynamics and age> 40 yr
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Russia
Israel
Korea
Brazil
Brazil
Canada
Portugal
Canada
Italy
Italy
Sweden
USA
USA
Czech
Republic
China
34
98
12
TVT-O
TVT-O
TVT-O
TVT-O
TVT-O
TVT
TVT-O
TVT-O
TVT-O
TVT-O
TVT
TVT
TVT-O
TVT-O
TVT
China
97
37
TVT, tension-free vaginal tape; TVT-O, tension-free obturator tape; SUI, stress urinary incontinence; QoL, quality of life; CST, cough stress test; MUI, mixed urinary incontinence; PFMT,
pelvic floor muscle training.
TVT-Secur
Wang et al.
(2011) [18]
TVT-O
Belgium, the
Netherlands
38
Inclusion population
TVT-Secur
TVT-Secur
Wang et al.
(2011) [18]
TVT-O
Italy
Sample size
Duration of
Experimental Control treatment (mo)
Pushkar et al.
(2011) [29]
TVT-Secur
Hinoul et al.
(2011) [17]
TVT-O
Country
TVT-Secur
Neuman et al.
(2011) [13]
TVT-Secur
Therapy in
Therapy in
experimental group control group
Tommaselli et al.
(2010) [16]
Study
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A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Allocation
concealment
Blinding
34
14
34
Loss to
follow-up
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Calculation of
sample size
Statistical
analysis
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Intention-to-treat Level of
analysis
quality
A, all quality criteria met (adequate) - low risk of bias; B, one or more of the quality criteria only partly met (unclear) - moderate risk of bias; C, one or more criteria not met (inadequate or
not used) - high risk of bias.
Allocation
sequence
generation
Study
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Huang, et al. Efficacy and Safety of TVT-Secur for Female SUI
Intraoperative complications: Five RCTs represented 645 participants (325 in the TVT-Secur group and 320 in the TVT-O
group) (Fig. 6). According to our analysis, no heterogeneity was
found among the trials, and a fixed-effects model was thus chosen for the analysis. Based on our analysis, the pooled estimate
of OR was 1.98, and the 95% CI was 1.15 to 3.42 (P=0.01). This
result suggests that TVT-Secur showed significant increases in
the rate of intraoperative complications compared with TVT-O.
0
SE (log [OR])
0.2
0.4
0.6
0.8
1
0.002
0.1 1 10
500
OR
Fig. 2. Funnel plot of the studies represented in our meta-analysis. SE, standard error; OR, odds ratio.
Study of subgroup
TVT-Secur
TVT-O
Mean SD Total
Mean SD Total
Operation time
Hinoul P 2011
18.9 7.0 96
16.0 6.0 92
Masata J 2012
11.4 3.7 64
8.3 3.5 68
Masata J 2012
10.8 4.4 65
8.3 3.5 68
Tommaselli GA 2010
7.1 2.1 37
11.3 2.9 38
Tommaselli GA 2013
7.8 2.5 64
12.0 3.1 66
Wang YJ 2011
15.4 1.4 34
16.2 1.5 36
Total (95% CI)
360
368
Heterogeneity: Chi2 = 150.77, df = 5 (P < 0.00001); I2 = 97%
Test for overall effect: Z = 4.56 (P < 0.00001)
Pain VAS score
Oliveria R 2011
2.3 2.3 30
4.5 2.6 30
Tommaselli GA 2010
2.1 1.1 37
4.5 2.3 38
Tommaselli GA 2014
0.7 0.2 64
2.8 1.4 66
Total (95% CI)
131
134
Heterogeneity: Chi2 = 0.45, df = 2 (P = 0.80); I2 = 0%
Test for overall effect: Z = 13.80 (P < 0.00001)
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Weight
(%)
Mean difference
Mean difference
5.3
12.0
9.9
13.9
19.5
39.4
100
6.0
14.1
79.9
100
10 0 10 20
TVT-Secur
TVT-O
Fig. 3. Operative time, visual analog score (VAS) score (postoperative day 1) (TVT-Secur vs. TVT-O). TVT, tension-free vaginal tape;
TVT-O, tension-free obturator tape; SD, standard deviation; IV, inverse variance; Fixed, fixed effect model; CI, confidence interval; df,
degrees of freedom.
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Weight
(%)
Odds ratio
Odds ratio
56
85
68
68
50
40
36
403
11.1
16.2
20.4
16.5
16.2
9.8
9.7
100
48
82
40
28
63
63
43
25
38
31
33
56
85
44
33
68
68
50
30
40
38
36
8.2
9.3
14.2
5.5
13.2
13.3
11.1
5.8
8.8
3.4
7.2
548
100
Neuman M 2011
70
77
60
Tommaselli GA 2013
50
64
55
Total (95% CI)
141
Total events
120
115
Heterogeneity: Chi2 = 2.28, df = 1 (P = 0.13); I2 = 56%
Test for overall effect: Z = 1.77 (P = 0.08)
Objective cure in 3-5 years
60
66
126
35.5
64.5
100
60
66
32.6
67.4
Study of subgroup
TVT-Secur
TVT-O
Events Total
Events Total
Neuman M 2011
Tommaselli GA 2013
70
50
77
64
45
77
58
58
44
21
33
336
58
57
126
115
100
0.1
TVT-Secur
1 10 1,000
TVT-O
Fig. 4. Subjective and objective cure rate at 13 years and 35 years (TVT-Secur vs. TVT-O). TVT, tension-free vaginal tape; TVT-O,
tension-free obturator tape; M-H, Mantel-Haenszel method; Fixed, fixed effect model; CI, confidence interval; df, degrees of freedom.
result suggests that TVT-Secur showed a significant increase in
the rate of reoperation for SUI compared with TVT-O.
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Study of subgroup
TVT-Secur
TVT-O
Events Total
Events Total
Weight
(%)
Odds ratio
Odds ratio
65
92
68
68
60
36
389
3.0
73.8
5.6
5.7
3.3
8.6
100
44
68
68
62
242
5.1
5.5
5.6
83.8
100
2
13
56
68
4.5
23.3
0
17
1
1
0
1
20
0
0
0
9
9
65
13
68
24.7
Neuman M 2011
12
79
14
73
26.0
Oliveria R 2011
30
30
9.5
Tommaselli GA 2010
37
38
2.0
Tommaselli GA 2014
64
66
2.0
12
34
36
8.0
Wang YJ 2011
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55
435
100
0.1
TVT-Secur
10 200
TVT-O
Fig. 5. Bleeding greater than 100 mL, reoperation for stress urinary incontinence (SUI), and de novo urgency (TVT-Secur vs. TVTO). TVT, tension-free vaginal tape; TVT-O, tension-free obturator tape; M-H, Mantel-Haenszel method; Fixed, fixed effect model;
CI, confidence interval; df, degrees of freedom.
group and 126 in the TVT-O group) (Fig. 4). According to our
analysis, no heterogeneity was found among the trials, and a
fixed-effects model was thus chosen for the analysis. Based on
our analysis, the pooled estimate of OR was 0.49, and the 95%
CI was 0.22 to 1.08 (P=0.08). This result suggests that TVT-Secur showed no significant difference in subjective cure rate in
comparison with TVT-O.
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Study of subgroup
TVT-Secur
TVT-O
Events Total
Events Total
4
18
1
1
0
24
32
24
10
10
9
6
13
104
6
9
15
Weight
(%)
Odds ratio
Odds ratio
56
92
68
68
36
320
21.4
66.6
4.6
5.0
2.5
100
56
92
68
68
30
38
36
388
30.5
21.3
11.7
11.2
9.5
6.9
8.9
100
73
66
139
41.3
58.7
100
0.1
TVT-Secur
10 1,000
TVT-O
Fig. 6. Complications: intraoperative or postoperative complications at 13 years, postoperative complications at 35 years (TVT-Secur vs. TVT-O). TVT, tension-free vaginal tape; TVT-O, tension-free obturator tape; M-H, Mantel-Haenszel method; Fixed, fixed effect model; CI, confidence interval; df, degrees of freedom.
comparison with TVT-O.
Postoperative complications
Two RCTs represented 282 participants (143 in the TVT-Secur
group and 139 in the TVT-O group) (Fig. 6). According to our
analysis, no heterogeneity was found among the trials, and a
fixed-effects model was thus chosen for the analysis. Based on
our analysis, the pooled estimate of OR was 1.20, and the 95%
CI was 0.58 to 2.49 (P=0.63). This result suggests that TVT-Secur showed no significant difference in the rate of postoperative
complications compared with TVT-O.
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Study of subgroup
TVT-Secur
TVT
Events Total
Events Total
Subjective cure
Andrada Hamer M 2013
28
60
47
Barber MD 2012
72
129
77
Ross S 2014
35
37
29
Total (95% CI)
226
Total events
135
153
Heterogeneity, Chi2 = 5.87, df = 2 (P = 0.05); I2 = 66%
Test for overall effect: Z = 2.58 (P = 0.010)
Objective cure
Andrada Hamer M 2013
40
60
56
Ross S 2014
27
33
25
Wang YJ 2011
33
34
30
Total (95% CI)
127
Total events
100
111
Heterogeneity: Chi2 = 4.01, df = 2 (P = 0.13); I2 = 50%
Test for overall effect: Z = 2.84 (P = 0.004)
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Weight
(%)
Odds ratio
Odds ratio
61
127
30
218
40.8
56.3
2.8
100
61
28
32
121
76.1
20.2
3.7
100
0.1
TVT-Secur
10 1,000
TVT-O
Fig. 7. Subjective and objective cure rate (TVT-Secur vs. TVT). TVT, tension-free vaginal tape; M-H, Mantel-Haenszel method;
Fixed, fixed effect model; CI, confidence interval; df, degrees of freedom.
Study of subgroup
TVT-Secur
TVT
Events Total
Events Total
7
10
3
12
32
Weight
(%)
Odds ratio
Odds ratio
61
23.9
127
34
32
254
39.0
11.0
26.0
100
0.1
TVT-Secur
10 1,000
TVT-O
Fig. 8. Complications (TVT-Secur vs. TVT). TVT, tension-free vaginal tape; M-H, Mantel-Haenszel method; Fixed, fixed effect
model; CI, confidence interval; df, degrees of freedom.
among the trials, and a fixed-effects model was thus chosen for
the analysis. Based on our analysis, the pooled estimate of OR
was 0.33, and the 95% CI was 0.15 to 0.71 (P=0.004). This result suggests that TVT-Secur showed a significantly lower objective cure rate in comparison with TVT.
and the 95% CI was 0.65 to 1.91 (P=0.68). This result suggests
that TVT-Secur showed no significant difference in the rate of
complications compared with TVT.
Safety
Complications: Four RCTs represented 524 participants (270 in
the TVT-Secur group and 254 in the TVT group) (Fig. 8). According to our analysis, no heterogeneity was found among the
trials, and a fixed-effects model was thus chosen for the analysis. Based on our analysis, the pooled estimate of OR was 1.12,
DISCUSSION
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