Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis

Article information

Int Neurourol J. 2015;19(4):246-258

Publication date (electronic) : 2015 December 28

doi : https://doi.org/10.5213/inj.2015.19.4.246

Wei Huang^1,2, Tao Wang^1,2, Huantao Zong^1,2, Yong Zhang^,1,2

¹Urology Department, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

²Neurourology Research Division, China National Clinical Research Center for Neurological Disease, Beijing, China

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

Received 2015 August 5; Accepted 2015 September 7.

Abstract

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 the prevalence increases with age [2]. Ten percent of middle-aged 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 (TVT) and tension-free obturator tape (TVT-O) are widely used for this indication, with a high success rate and few complications [5]. Nevertheless, neither is completely free of complications, mainly due to the blind course of the introducer devices. The TVT course may perforate the bladder, whereas TVT-O passage is associated with vaginal perforation and neurologic impairment, leading to protracted thigh pain and upper leg weakness [6]. Both routes occasionally are associated with life-threatening complications, including bowel perforation, major vessel disruption, and perineal gangrene [7]. In addition, voiding dysfunction and vaginal mesh exposures may also complicate midurethral slings (MUS) [8].

Single-incision slings (SIS) were optimized to overcome these complications. TVT-Secur was the first single-incision device, and was developed in 2006. This device can be placed using a retropubic or “U” approach, or a transobturator-like “hammock” approach [9]. The innovation was based on the use of shorter polypropylene laser-cut tape (8 cm×1 cm) through a single vaginal incision in order to avoid the retropubic space, obturator foramen, or groin muscles, and their related nerves and blood vessels.

Moreover, TVT-Secur seemed to cause less postoperative pain and reduced operative time [10], but its effectiveness seemed to be lower in comparison with traditional MUS [11,12]. However, a number of studies reported satisfactory results, including at midterm [13]. The anchoring mechanism of TVT-Secur has been critically evaluated, with studies demonstrating a deterioration over time of the efficacy of this SIS, and calling for long-term studies of the surgical treatment of SUI [14]. Following these contrasting results, TVT-Secur was withdrawn from clinical practice by the manufacturer.

The goal of the present study was to perform a meta-analysis to evaluate the safety and efficacy of TVT-Secur compared with standard MUS in treating SUI, making the evidence available for the many women who had a TVT-Secur device implanted.

MATERIALS AND METHODS

Inclusion Criteria and Trial Selection

Article selection proceeded according to the search strategy based on Preferred Reporting Items for Systematic Reviews and Meta-analysis criteria (Fig. 1). Only studies comparing TVT-Secur and standard MUS were included for further screening. Cited references from the selected articles retrieved in the search were also assessed for significant papers. Conference abstracts were not included because they were not deemed to be methodologically appropriate. Two independent reviewers completed this process, and all disagreements were resolved through consensus.

Fig. 1.

The flow diagram of the study selection. RCT, randomized controlled trial.

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.

Table 1.

Study and patient characteristics

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).

Table 2.

Quality assessment of individual study

Fig. 2.

Funnel plot of the studies represented in our meta-analysis. SE, standard error; OR, odds ratio.

TVT-Secur Compared With TVT-O at 1 to 3 Years

Efficacy

Operative time (minute): Six RCTs represented 728 participants (360 in the TVT-Secur group and 368 in the TVT-O group) (Fig. 3). Based on our analysis, the pooled estimate of standardized mean difference (SMD) was –0.99, and the 95% confidence interval (CI) was –1.42 to –0.57 (P<0.00001). This result suggests that TVT-Secur showed significant reductions in the mean operative time compared with 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.

Subjective cure rate: Seven RCTs represented 791 participants (388 in the TVT-Secur group and 403 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 odds ratio (OR) was 0.38, and the 95% CI was 0.27 to 0.54 (P<0.00001). This result suggests that TVT-Secur showed a significantly lower subjective cure rate in comparison with TVT-O.

Fig. 4.

Subjective and objective cure rate at 1–3 years and 3–5 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.

Objective cure rate: Eleven RCTs represented 1,076 participants (528 in the TVT-Secur group and 548 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 0.26, and the 95% CI was 0.19 to 0.37 (P<0.00001). This result suggests that TVT-Secur showed a significantly lower objective cure rate in comparison with TVT-O.

Safety

VAS pain score (postoperative day 1): Three RCTs represented 265 participants (131 in the TVT-Secur group and 134 in the TVT-O group) (Fig. 3). 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 SMD was –2.15, and the 95% CI was –2.45 to –1.84 (P<0.00001). This result suggests that TVT-Secur showed significant reductions in the VAS score compared with TVT-O.

Bleeding greater than 100 mL: Six RCTs represented 791 participants (402 in the TVT-Secur group and 389 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 1.78, and the 95% CI was 0.98 to 3.22 (P=0.06). This result suggests that TVT-Secur showed no significant difference in the rate of bleeding greater than 100 mL compared with TVT-O.

Fig. 5.

Bleeding greater than 100 mL, reoperation for stress urinary incontinence (SUI), and de novo urgency (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.

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.

Fig. 6.

Complications: intraoperative or postoperative complications at 1–3 years, postoperative complications at 3–5 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.

Postoperative complications: Seven RCTs represented 780 participants (392 in the TVT-Secur group and 388 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 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<0.0001). This result suggests that TVT-Secur showed a significant increase in the rate of reoperation for SUI compared with TVT-O.

TVT-Secur Compared With TVT

Efficacy

Subjective cure rate: Three RCTs represented 444 participants (226 in the TVT-Secur group and 218 in the TVT group) (Fig. 7). 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 0.59, and the 95% CI was 0.39 to 0.88 (P=0.01). This result suggests that TVT-Secur showed a significantly lower subjective cure rate in comparison with TVT.

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.

Objective cure rate: Three RCTs represented 248 participants (127 in the TVT-Secur group and 121 in the TVT group) (Fig. 7). 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 0.33, 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.

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, 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.

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.

DISCUSSION

As a third-generation device, TVT-Secur was first used in 2006. The new so-called minimally invasive devices have been developed to limit groin pain after sling placement while aiming at comparable success results. TVT-Secur minimizes operative dissection and risk of injury of periurethral elements and pelvic organs, as well as the risk of nerve or adductor muscle damage. However, TVT-Secur was withdrawn from clinical practice by the manufacturer due to poor efficacy.

Our study reveals that there was no evidence of significant differences between TVT-Secur and TVT-O for bleeding greater than 100 mL or de novo urgency. There were also no significant differences between TVT-Secur and TVT in complication rates. However, our study found that TVT-Secur has a higher reoperation rate for SUI and intraoperative complication rate compared with TVT-O. Some reports highlighted the risk of severe bleeding following TVT-Secur positioning [30,31]. Larsson et al. [31] recently reported an injury of the corona mortis, an anomaly of the vessels combining the obturator and epigastric arteries passing over the superior pubic ramus. Both cases required surgical intervention to remove clots, identify the site of bleeding, and perform hemostasis. Another report [16] thought that the severe blood loss (approximately 400 mL) experienced by one patient undergoing TVT-Secur was probably from the internal obturator muscle, and was treated conservatively by immediate compression of the muscle with vaginal packing. These data suggest that severe bleeding for TVT-Secur positioning is possible. In the TVT-Secur group, the main postoperative complication was de novo urgency, which may be related to tension difficulties with this kind of device. Higher de novo urgency rates (5%–35%) have been published [18,21], but were not significantly different from the rate observed in the TVT-O group.

Thigh pain is one of the most frequent complications of TVT-O, and TVT-Secur was associated with less postoperative pain [17]. Although we observed a statistical difference in postoperative pain, both groups presented average pain scores<3, which are considered mild according to the VAS [32]. TVT-Secur was associated with less thigh pain than TVT-O, possibly due to absence of involvement of the nerve or adductor muscles. However, all women were free from this symptom within a month following surgery. Moreover, operative time was significantly reduced in the TVT-Secur group.

Our meta-analysis indicated that TVT-Secur had significantly worse subjective and objective outcomes than standard MUS at 1 to 3 years. However, at 3 to 5 years, we found that there was no significant difference in subjective or objective cure rates in comparison with TVT-O. The subjective and objective cure rate of TVT-Secur is 69.7% and 70% at 1 to 3 years, and 59.7% and 78% at 3 to 5 years, respectively. Tommaselli et al. [23] recently reported that subjective success (63.8%) and objective cure rates (68.4%) over 5 years were lower for TVT-Secur than TVT-O, but not significantly. The reason may be that many patients with TVT-Secur who failed at 1 to 3 years may have had other operations, which were not included at 3 to 5 years of follow-up. Moreover, in comparison with the 36-month follow-up, TVT-Secur showed a greater decrease in subjective cure rate than TVT-O [23]. These data seem to indicate that the subjective cure rate of TVT-Secur decreases over time more than that of TVT-O, although not significantly. Indeed, a limitation of our study is the sample size of patients. With a larger sample size, the study may demonstrate a difference in outcomes between TVT-Secur and TVT-O at 3 to 5 years. As for objective cure rate, this discrepancy may be explained by the fact that objective evaluation may not reflect normal daily activities, and thus underestimates the incidence of recurrent SUI. The fact that TVT-Secur has been associated with lower cure rates deserves some consideration. The failure at 1–3 years is mainly linked to an incorrect positioning or early failure of the sling, and recurrences are probably due to insufficiency of the tape in avoiding SUI. As for the many women who had a TVT-Secur device implanted, reoperation is a problem. The clinical relevance of the decline of the efficacy of TVT-Secur, and the limited advantages of this device in the long-term, in particular, suggest that TVT-O may be a better choice, when all factors are considered.

In summary, TVT-Secur failed to demonstrate high clinical efficacy for SUI. Indeed, only 70.8% of patients treated with TVT-Secur remained cured, whereas 90.7% of patients treated with TVT-O remained cured after a median follow-up of 32 months. These results are influenced by previous incontinence surgery and a cystocele grade ≥2 [33]. Multivariate analysis also showed that only low Valsalva leak point pressure<60 cm H₂O was associated with a lower cure rate [34]. Therefore, these factors should be carefully evaluated when choosing a TVT-Secur procedure, to provide sufficient information to patients. TVT-O or TVT are still the first-line treatments for female SUI.

This meta-analysis includes studies in which all findings are from randomized double-blind, placebo-controlled trials. According to the quality-assessment scale that we developed, the quality of the individual studies in the meta-analysis was conforming. The results of this analysis acquire great importance from a scientific standpoint, but also for daily clinical practice. However, the number of included studies was not large. Longer-term safety, efficacy, and stability of TVT-Secur cannot be extrapolated from this article, as the sample size is limited. In addition, unpublished data were not included in the analysis. Besides, there is a discrepancy in the number of parameters used in comparing the procedures. Nine parameters were evaluated for the analysis of TVT-Secur compared with TVT-O at 1 to 3 years. As the data were limited, a carefully structured analysis comparing TVT-S with TVT-O at 3 to 5 years could not be done, and only 3 parameters were evaluated. This may compromise the value of the study results, and these factors may have resulted in bias. More high-quality trials with larger samples are proposed to learn more about the efficacy and safety of the therapy for female SUI.

In conclusion, this meta-analysis indicates that TVT-Secur did not show an inferior efficacy and safety compared with TVT-O 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.

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