INJ
INTERNATIONAL NEUROUROLOGY JOURNAL
pISSN 2093-4777 eISSN 2093-6931
Original Article
Volume 19 | Number 2 | June 2015 pages 131-210
INTERNATIONAL NEUROUROLOGY JOURNAL
Int Neurourol J 2015;19:246-258 http://dx.doi.org/10.5213/inj.2015.19.4.246 pISSN 2093-4777 · eISSN 2093-6931
Official Journal of Korean Continence Society / Korean Society of Urological Research / The Korean Children’s Continence and Enuresis Society / The Korean Association of Urogenital Tract Infection and Inflammation
einj.org 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 18 yr and agreed to postoperative follow-up
Women with SUI as diagnosed by clinical evaluation and urodynamics
Women with SUI as diagnosed by clinical evaluation and urodynamics
All patients in whom SUI could be objectified during clinical and/or urodynamic examination
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
www.einj.org Russia
Israel
Korea
Brazil
Brazil
Canada
Portugal
Canada
Italy
Italy
Sweden
USA
USA
Czech Republic
China
34
98
12
Huang, et al. • Efficacy and Safety of TVT-Secur for Female SUI
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
Int Neurourol J 2015;19:246-258
Neuman et al. (2011) [13]
TVT-Secur
Therapy in Therapy in experimental group control group
Tommaselli et al. (2010) [16]
Study
Table 1. Study and patient characteristics
INJ
250 www.einj.org A A A A A A A A A A A A A A A A
Wang et al. (2011) [18]
Masata et al. (2012) [19]
Hota et al. (2012) [20]
Barber et al. (2012) [21]
Andrada Hamer et al. (2013) [22]
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]
Neuman et al. (2011) [13]
Pushkar et al. (2011) [29]
A
A
B
A
A
A
A
A
A
A
A
A
A
A
A
A
B
Allocation concealment
A
B
B
A
A
A
A
A
B
B
A
A
B
A
A
A
A
Blinding
3
6
0
7
5
6
0
2
34
9
4
14
6
0
6
34
9
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
t-test, chi-square test or Fisher exact test and the McNemar test
t-test, chi-square test or Fisher exact test and McNemar test
Student t-test, chi-square test, and Fisher exact test
Mann-Whitney U-test, Student t-test, Fisher exact test
Mann-Whitney U-test, Student t-test, Fisher exact test
Fisher exact test, Mann-Whitney U test and t-test
Fisher exact test
Chi-square test, Kruskal-Wallis test, Wilcoxon test, and Fisher exact test
Mann-Whitney test, Wilcoxon test, or chi-square test
Mann-Whitney test, Wilcoxon test, or chi-square test
Chi-square test, Wilcoxon test, Mann-Whitney test or Kruskal-Wallis test
Paired t-test, Wilcoxon rank-sum test
t-test, Mann-Whitney U-test, or chi-square test
Fisher exact test
Paired t-test, chi-square test
Mann-Whitney test, chi-square test
Student t-test, Shapiro-Wilk test
Statistical analysis
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
A
B
B
A
A
A
A
A
B
B
A
A
B
A
A
A
B
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.
A
Hinoul et al. (2011) [17]
Allocation sequence generation
Tommaselli et al. (2010) [16]
Study
Table 2. Quality assessment of individual study
INJ Huang, et al. • Efficacy and Safety of TVT-Secur for Female SUI
Int Neurourol J 2015;19:246-258
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)
INJ
Postoperative complications: Seven RCTs represented 780 participants (392 in the TVT-Secur group and 388 in the TVTO 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 0.67, and the 95% CI was 0.48 to 0.95 (P=0.03). This result suggests that TVT-Secur showed a significant decrease in the rate of postoperative complications compared with TVT-O. De novo urgency: Eight RCTs represented 874 participants (439 in the TVT-Secur group and 435 in the TVT-O group) (Fig. 5). 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 0.78, and the 95% CI was 0.50 to 1.91 (P=0.25). This result suggests that TVT-Secur showed no significant difference in the rate of de novo urgency compared with TVT-O. Reoperation for SUI: Four RCTs represented 471 participants (229 in the TVT-Secur group and 242 in the TVT-O group) (Fig. 5). 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 4.96, and the 95% CI was 2.37 to 10.35 (P
INTERNATIONAL NEUROUROLOGY JOURNAL
pISSN 2093-4777 eISSN 2093-6931
Original Article
Volume 19 | Number 2 | June 2015 pages 131-210
INTERNATIONAL NEUROUROLOGY JOURNAL
Int Neurourol J 2015;19:246-258 http://dx.doi.org/10.5213/inj.2015.19.4.246 pISSN 2093-4777 · eISSN 2093-6931
Official Journal of Korean Continence Society / Korean Society of Urological Research / The Korean Children’s Continence and Enuresis Society / The Korean Association of Urogenital Tract Infection and Inflammation
einj.org 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 18 yr and agreed to postoperative follow-up
Women with SUI as diagnosed by clinical evaluation and urodynamics
Women with SUI as diagnosed by clinical evaluation and urodynamics
All patients in whom SUI could be objectified during clinical and/or urodynamic examination
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
www.einj.org Russia
Israel
Korea
Brazil
Brazil
Canada
Portugal
Canada
Italy
Italy
Sweden
USA
USA
Czech Republic
China
34
98
12
Huang, et al. • Efficacy and Safety of TVT-Secur for Female SUI
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
Int Neurourol J 2015;19:246-258
Neuman et al. (2011) [13]
TVT-Secur
Therapy in Therapy in experimental group control group
Tommaselli et al. (2010) [16]
Study
Table 1. Study and patient characteristics
INJ
250 www.einj.org A A A A A A A A A A A A A A A A
Wang et al. (2011) [18]
Masata et al. (2012) [19]
Hota et al. (2012) [20]
Barber et al. (2012) [21]
Andrada Hamer et al. (2013) [22]
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]
Neuman et al. (2011) [13]
Pushkar et al. (2011) [29]
A
A
B
A
A
A
A
A
A
A
A
A
A
A
A
A
B
Allocation concealment
A
B
B
A
A
A
A
A
B
B
A
A
B
A
A
A
A
Blinding
3
6
0
7
5
6
0
2
34
9
4
14
6
0
6
34
9
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
t-test, chi-square test or Fisher exact test and the McNemar test
t-test, chi-square test or Fisher exact test and McNemar test
Student t-test, chi-square test, and Fisher exact test
Mann-Whitney U-test, Student t-test, Fisher exact test
Mann-Whitney U-test, Student t-test, Fisher exact test
Fisher exact test, Mann-Whitney U test and t-test
Fisher exact test
Chi-square test, Kruskal-Wallis test, Wilcoxon test, and Fisher exact test
Mann-Whitney test, Wilcoxon test, or chi-square test
Mann-Whitney test, Wilcoxon test, or chi-square test
Chi-square test, Wilcoxon test, Mann-Whitney test or Kruskal-Wallis test
Paired t-test, Wilcoxon rank-sum test
t-test, Mann-Whitney U-test, or chi-square test
Fisher exact test
Paired t-test, chi-square test
Mann-Whitney test, chi-square test
Student t-test, Shapiro-Wilk test
Statistical analysis
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
A
B
B
A
A
A
A
A
B
B
A
A
B
A
A
A
B
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.
A
Hinoul et al. (2011) [17]
Allocation sequence generation
Tommaselli et al. (2010) [16]
Study
Table 2. Quality assessment of individual study
INJ Huang, et al. • Efficacy and Safety of TVT-Secur for Female SUI
Int Neurourol J 2015;19:246-258
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)
INJ
Postoperative complications: Seven RCTs represented 780 participants (392 in the TVT-Secur group and 388 in the TVTO 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 0.67, and the 95% CI was 0.48 to 0.95 (P=0.03). This result suggests that TVT-Secur showed a significant decrease in the rate of postoperative complications compared with TVT-O. De novo urgency: Eight RCTs represented 874 participants (439 in the TVT-Secur group and 435 in the TVT-O group) (Fig. 5). 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 0.78, and the 95% CI was 0.50 to 1.91 (P=0.25). This result suggests that TVT-Secur showed no significant difference in the rate of de novo urgency compared with TVT-O. Reoperation for SUI: Four RCTs represented 471 participants (229 in the TVT-Secur group and 242 in the TVT-O group) (Fig. 5). 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 4.96, and the 95% CI was 2.37 to 10.35 (P
