european urology 53 (2008)

european urology 53 (2008) 288 309 available at www.sciencedirect.com journal homepage: www.europeanurology.com Review Incontinence Complication Rates of Tension-Free Midurethral Slings in the Treatment of Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing Tension-Free Midurethral Tapes to Other Surgical Procedures and Different Devices Giacomo Novara a,b, Antonio Galfano a, Rafael Boscolo-Berto a, Silvia Secco a, Stefano Cavalleri a, Vincenzo Ficarra a, Walter Artibani a, * a Department of Oncological and Surgical Sciences, Urology Clinic, University of Padua, Italy b I.R.C.C.S. Istituto Oncologico Veneto (IOV), Italy Article info Article history: Accepted October 30, 2007 Published online ahead of print on November 8, 2007 Keywords: Burch colposuspension Pubovaginal sling Stress urinary incontinence Tension-free vaginal tape Transobturator tape Please visit www.eu-acme.org/ europeanurology to read and answer questions on-line. The EU-ACME credits will then be attributed automatically. Abstract Objectives: To evaluate the complication rates of tension-free midurethral slings compared with other surgical treatments for stress urinary incontinence, including other tension-free midurethral slings. Methods: A systematic review of the literature using MEDLINE, EMBASE, and Web of Science was performed in January 2007. Meta-analysis was conducted by using the Review Manager software 4.2. Results: Our search identified 33 randomized controlled trials reporting data on complication rates. Our meta-analysis showed that complication rates were similar after tension-free vaginal tape (TVT) and Burch colposuspension, with the exclusion of bladder perforation, which was more common after TVT ( p = 0.0001), and reoperation rate, which was significantly higher after Burch colposuspension ( p = 0.02). TVT and pubovaginal sling were followed by similar complication rates. With regards to the comparisons among retropubic tapes, TVT and intravaginal slingplasty had similar complication rates, whereas suprapubic arc sling (SPARC) was complicated by higher rates of voiding lower urinary tract symptoms () ( p = 0.02) and reoperations ( p = 0.04). Comparing retropubic and transobturator tapes, the occurrence of bladder perforations ( p = 0.007), pelvic haematoma ( p = 0.03), and storage ( p = 0.01) was significantly less common in patients treated by transobturator tapes. Conclusions: Tension-free slings were followed by lower risk of reoperation compared with Burch colposuspension, whereas pubovaginal sling and tension-free midurethral slings had similar complication rates. With regards to different tension-free tapes, voiding and reoperations were more common after SPARC, whereas bladder perforations, pelvic haematoma, and storage were less common after transobturator tapes. The quality of many evaluated studies was limited. # 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Oncological and Surgical Sciences, Urology Clinic, University of Padua, Monoblocco Ospedaliero, IV Floor, Via Giustiniani 2, 35128 Padua, Italy. Tel. +39 049 8212720; Fax: +39 049 8218757. E-mail address: walter.artibani@unipd.it (W. Artibani). 0302-2838/$ see back matter # 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2007.10.073

european urology 53 (2008) 288 309 289 1. Introduction Stress urinary incontinence (SUI) is a high prevalent symptom that has been estimated to be among the top 10 medical problems of adult women [1]. Although not life-threatening, SUI may seriously impair the physical, psychological, and social wellbeing of the affected patients [2]. Several procedures have been proposed for the surgical treatment of SUI. Since the first reports from Ulmsten and Petros [3] in a 1995 group, midurethral tension-free vaginal tape (TVT) has gained large popularity owing to the ease of the procedure and its effectiveness; to date, it is estimated that more than 1 million cases have been performed worldwide [4]. After the success of TVT, several devices, including suprapubic arc (SPARC) sling, intravaginal slingplasty (IVS) sling, transobturator slings, prepubic TVT, were introduced on the market to make the midurethral sling procedures even less invasive and to reduce the complications [5]. Published series [6 8] with long follow-up shows good continence rates after TVT placement, ranging from 70% to 80%, and a recently published metaanalysis [9] showed that TVT outperformed both Burch colposuspension and other retropubic tensionfree midurethral slings in terms of continence rates. Complication rates following placement of TVT are usually considered low. With regards to the intraoperative complications, bladder perforations have been reported to occur in 2.5 11.7% of cases, whereas significant bleedings are less common (0.5 2.5%). Postoperative complications included urinary tract infections (0.4 31.5%), de novo urgency (3.1 29%), transient or persistent voiding dysfunction (2.8 38%), vaginal and/or bladder erosions (0.6 5.4%), and so on [10]. Indeed, data on complications at follow-up as long as 10 yr are still unknown. Despite those encouraging figures, some cases of major complications have been reported, including bowel, vascular, and nerve injuries, necrotizing fasciitis, ischiorectal abscess, sepsis, and patient deaths. Owing to the presence of so many different surgical techniques and several similar devices, however, the literature on tension-free midurethral slings is really hectic. The purpose of the present meta-analysis is to evaluate the complication rates of TVT in comparison with the other surgical treatments for SUI, including the other currently available tension-free midurethral retropubic and transobturator slings. 2. Materials and methods The systematic review of the literature was performed in January 2007 by searching MEDLINE, EMBASE, and Web of Science. The MEDLINE search employed a complex search strategy including both MeSH (Medical Subject Heading) and free text protocols. Specifically, the MeSH search was conducted by combining the following terms retrieved from the MeSH browser provided by MEDLINE: Urinary Incontinence, Stress, and Suburethral Slings. Multiple free text searches were performed by applying singularly the following terms through the fields title and abstract of the records: Urinar*incont*, TVT, Tension-free vaginal tape*, Tension-free vaginal sling*, Transobturator tape*, Transobturator sling*, TVT-Obturator, TVT-O ; TOT, suprapubic arc sling*, SPARC sling*, intravaginal slingplasty, IVS sling, Uratape, ObTAPE, Prepubic sling*, Prepubic TVT, Prepubic tape*, PelviLace, Aris, In- Fast, and BioArc. Subsequently, the searches were pooled and the following limits were employed: Humans, gender (female), Language (English). No temporal limits were used. The searches on EMBASE and Web of Science used only the free-text protocol, with the same keywords. Subsequently, the queries were pooled without applying any limits. In addition, other significant studies cited in the reference lists of the selected papers were considered. Four hundred seventy-one records were retrieved by searching MEDLINE, 399 EMBASE, and 384 Web of Sciences. Three of the authors reviewed their full texts to select the papers relevant to the review topic. Specifically, all the studies including complication rates of tension-free midurethral slings were selected. Two authors collected separately data from studies in an electronic database, whereas another author verified the accuracy of data extraction and collection. All the relevant studies identified in the systematic search were included in the analysis. The selected papers were distinguished according to the grade of evidence: meta-analyses of randomized clinical trials (RCTs) constitute the highest evidence (level 1a), followed by an adequately sampled single RCT (level 1b), systematic review of cohort studies (level 2a), and low-quality RCT or observational studies (level 2b). Lower grade of evidence was provided by surgical series (level 4) [11]. The quality of the retrieved RCTs was assessed through the Jadad score [12]. A numerical score between 0 to 5 was assigned as a rough measure of study design and reporting quality, 0 being the weakest and 5 the strongest. The author suggested assigning one point if the trial was either randomized or doubleblinded, or in the case of an accurate description of the dropout patients. Moreover, further points were given if randomization and blinding procedures were appropriate, whereas, points were subtracted in the case of inappropriate descriptions of the same procedures. An overall score equal to or higher than 3 indicated a good-quality study [12]. Meta-analysis was conducted with the use of the Review Manager software, version 4.2 (The Cochrane Collaboration, Oxford, United Kingdom). Statistical heterogeneity was tested through the chi-square test. A p value < 0.10 was used to indicate heterogeneity. In case of lack of heterogeneity, fixed-effects models were used for the meta-analyses. For dichotomous data, results of each study were expressed as an odds ratio with 95% confidence intervals (CIs).

290 Table 1 Randomized controlled trials comparing retropubic tension-free midurethra slings to Burch colposuspension as primary treatment for stress urinary incontinence complication rates Reference Cases Follow-up (mo) Level of evidence Bladder/vaginal perforation Haematoma Bladder erosions Vaginal erosion UTI Storage Voiding CIC Reoperation rate Liapis 2002 [13] TVT 36 24 2b 11% 0 NR 13.8% 33% NR 0 NR Colposuspension 35 0 5.7% NR 5.7% 17.1% NR NR NR Persson 2002 [14] TVT 38 12 2b 3% NR NR NR NR 6% NR NR Lap colposuspension 32 0 NR NR NR NR 9% NR NR Ward 2002 * [15] TVT 175 6 1b 12% 2% 1% 22% 32% 21% NR NR Colposuspension 169 2% 0 NR 32% 79% 12% NR NR Ustun 2003 [16] TVT 23 11.3 2b 8.6% 2 NR NR NR NR 4.3% 8.6% NR NR Lap colposuspension 23 13.5 4.3% 1 4.3% NR NR NR NR NR NR NR Paraiso 2004 [17] TVT 36 12 1b 5.4% 2.7% 0 2.7% NR 19.3% 15.2% NR 5.4% Lap colposuspension 36 0 2.7% 0 0 NR 6.2% 14.7% NR 5.4% Valpas 2004 [18] TVT 70 12 1b NR NR NR NR NR NR NR NR Lap colposuspension 51 NR NR NR NR NR NR NR NR Ward 2004 [19] TVT 175 24 1b NR NR NR 5.9% 33% 10% 0 1.8% Colposuspension 169 NR NR NR 2.1% 34% 13% 2.7% 8.2% Bai 2005 [20] TVT 31 12 2b NR NR NR NR NR 12.9% NR NR Colposuspension 33 NR NR NR NR 9% 3% NR NR El-Barky 2005 [21] TVT 25 3 6 2b 8% NR NR 20% 8% 20% 20% NR Colposuspension 25 0 NR NR 12% 12% 12% 12% NR european urology 53 (2008) 288 309 Foote 2006 [22] SPARC 49 6 2b 10% NR NR NR 15.9% 0 NR NR Lap colposuspension 48 2% NR NR NR 6.9% 0 NR NR UTI, urinary tract infection;, lower urinary tract symptoms; CIC, clean intermittent catheterisation; TVT, tension-free vaginal tape; NR, not reported; lap, laparoscopic. * Same randomized clinical trial; published at different follow-up intervals.

european urology 53 (2008) 288 309 291 The presence of publication bias was evaluated through a funnel plot, which is scatter plots of the treatment effect estimated by individual studies versus a measure of study size or precision. In this graphical representation, larger and more precise studies are plotted at the top, near the combined effect size, whereas smaller and less precise studies will show a wider distribution below. If there were no publication bias, the studies would be expected to be symmetrically distributed on both sides of the combined effect size line. In case of publication bias, the funnel plot may be asymmetrical, since the absence of studies would distort the distribution on the scatter plot. 3. Results Once duplicate publications were excluded, papers evaluating technical variants of the classical TVT procedure, studies evaluating the treatment of persistent SUI after TVT procedure, and those including only urodynamic data, 169 studies were the object of the present review. Among these, we identified 33 randomized controlled trials reporting data on complication rates. Fig. 1 Forest plots of complication rates after transvaginal tape (TVT) and Burch colposuspension. (a) Bladder/vaginal perforations; (b) pelvic haematoma; (c) urinary tract infections; (d) storage lower urinary tract symptoms (); (e) voiding ; (f) reoperation rate. SUI, stress urinary incontinence OR, odds ratio; CI, confidence interval.

292 european urology 53 (2008) 288 309 Fig. 1. (Continued). 3.1. Randomized controlled studies comparing retropubic tension-free midurethral tapes to Burch colposuspension To date, 9 RCTs [13 21] comparing TVT to Burch colposuspension reported data on complication rates. A further study [22] compared SPARC with laparoscopic Burch colposuspension (Table 1). The most valuable RCT was published by Ward and Hilton [15] on behalf of the UK and Ireland Tension-free Vaginal Tape trial group. The authors reported data on 344 patients with SUI, who were randomized to TVT or Burch colposuspension. With regards to complication rates, at 24-mo follow-up, TVT was followed by higher rates of intraoperative complications (mainly bladder and vaginal perforations), whereas operation times, blood loss, analgesic requirements, postoperative complications, and catheterisation were greater in the colposuspension group [19]. Pelvic organ prolapse occurred differently in the two study arms. TVT was more commonly followed by cystocoele and cystouretrocoele (49.1% vs. 25.7%, p = 0.0003), whereas cervical prolapse, vault prolapse, and enterocoele were more

european urology 53 (2008) 288 309 293 Fig. 2 Forest plots of complication rates after transvaginal tape (TVT) and pubovaginal sling. (a) Voiding lower urinary tract symptoms (); (b) clean intermittent catheterization. SUI, stress urinary incontinence; OR, odds ratio; CI, confidence interval. frequent after Burch colposuspension (22.5% vs. 39.8%). Reoperation rates for urinary incontinence were similar in both arms (1.8% after TVT vs. 3.4% after colposuspension, p = 0.48), but surgical procedures for pelvic organ prolapse were more common after colposuspension (0% vs. 4.8%, p = 0.0042) [15,19]. The study should be regarded as a high quality trial, in spite of the lack of blinding procedures, because of appropriate randomization technique, accurate selection of outcomes, and subjective and objective tools to evaluate the patients (Jadad score 3). The data at 2-year followup, however, is not sufficient to assess the long-term complications; long-term results are still awaited. Fig. 1 shows the forest plots concerning the meta-analyses of complication rates. TVT and Burch colposuspension were followed by similar complication rates, with the exclusion of bladder perforation, which was more common after TVT (odds ratio [OR] = 5.35; 95%CI OR, 2.27 12.63; p = 0.0001). Indeed, the reoperation rate was significantly higher after Burch colposuspension (OR, 0.29; 95%CI OR, 0.10 0.80; p = 0.02) (Fig. 2a f). Sensitivity analyses evaluating only the three high-quality RCTs [15,17 19] showed overlapping figures for all the assessable complications (forest plots not shown). A further RCT [22] compared another retropubic tape, the SPARC sling, to laparoscopic colposuspension. The inclusion of this study in all the meta-analyses did not significantly modify the above-reported figures (forest plots not shown). 3.2. Randomized controlled studies comparing TVT tapes to pubovaginal slings Four RCTs provided data on complication rates after TVT or pubovaginal sling (Table 2) [20,23 25]. Three studies compared the efficacy of TVT to autologous slings [20,23,25], although all the RCTs were small, low-quality studies. In the study with longer follow-up (36 mo), Abdel-Fattah et al [24] reported on 142 patients randomized to TVT (68 cases) or porcine dermal sling (Pelvicol TM implant [Bard]; 74 cases). In both arms of the studies, no major complications occurred, although the percentages of minor complications were slightly higher in the Pelvicol group. Specifically, pelvic haematoma was slightly more frequent after Pelvicol implant (4.1% vs. 2.9%), as well as storage (17.6% vs. 15%) and voiding lower urinary tract symptoms () (8.3% vs. 5.9%). Moreover, few patients needed clean intermittent self-catheterisation for voiding (3.4% after TVT and 1.4% after Pelvicol), with sling releasing

294 Table 2 Randomized controlled trials comparing TVT to pubovaginal sling as primary treatment for stress urinary incontinence complication rates Reference Cases Follow-up (mo) Level of evidence Bladder perforation Haematoma Bladder erosions Vaginal erosion Storage Voiding CIC Reoperation rate Arunklalaivanan 2003 * [23] TVT 68 12 1b 0 2.9% 0 0 NR 1.5% 3.4% 4.4% Pelvicol 74 0 4.1% 0 0 NR 8.1% 1.4% 9.5% Abdel-Fattah 2004 * [24] TVT 68 36 1b 0 2.9% 0 0 15% 5.9% 3.3% 4.4% Pelvicol 74 0 4.1% 0 0 17.6% 8.3% 2.9% 9.5% Bai 2005 [20] TVT 31 12 2b NR NR NR NR NR 12.9% 12.9% NR Rectus fascia sling 28 NR NR NR NR NR 7.1% 7.1% NR Wadie 2005 [25] TVT 25 6 2b 8% NR NR NR NR NR NR NR Rectus fascia sling 28 3.5% NR NR NR NR NR NR NR TVT, tension-free vaginal tape;, lower urinary tract symptoms; CIC, clean intermittent catheterisation; NR, not reported. * Same randomized clinical trial; published at different follow-up intervals. Table 3 Randomized controlled trials comparing TVT to IVS as primary treatment for stress urinary incontinence complication rates Reference Cases Follow-up (mo) Level of evidence Bladder perforation Haematoma Bladder erosions Vaginal erosion UTI Storage Voiding CIC Reoperation rate european urology 53 (2008) 288 309 Rechberger 2003 [26] TVT 50 13.5 2b 4% 4% 0 0 0 16% 20% NR NR IVS 50 8% 2% 0 0 2% 8% 4% NR NR Lim 2005 [27] TVT 61 1.5 3 2b 1.6% 0 3.3% NR 6.6.% 3.3% NR NR IVS 60 3.3% 0 1.7% NR 8.3% 3.3% NR NR Meschia 2006 [28] TVT 95 24 2b 3.3% 1.1% 0 0 13% 9% 5% NR NR IVS 95 3.4% 3.4% 0 9% 14% 11% 5% NR NR TVT, tension-free vaginal tape; IVS, intravaginal slingplasty; UTI, urinary tract infection;, lower urinary tract symptoms; CIC, clean intermittent catheterisation; NR, not reported.

european urology 53 (2008) 288 309 295 being performed in 2.9% of the patients who had undergone TVT and in 6.8% of the Pelvicol group. The RCT was, however, a low-quality study, owing to the lack of blinding procedures, inappropriate randomization technique (Jadad score 1), and use of a nonvalidated questionnaire to assess the outcome. Fig. 2 shows the forest plots concerning the metaanalyses of complication rates after TVT and pubovaginal slings. Both procedures were followed by similar complication rates (Fig. 2), assessable in terms of voiding (OR, 1.57; 95%CI OR, 0.54 4.61; p = 0.77) and need of clean intermittent catheterisation (OR, 1.79; 95%CI OR, 0.50 6.40; p = 0.91). 3.3. Randomized controlled studies comparing TVT to other retropubic tension-free midurethral slings Three RCTs [26 28] compared TVT to IVS, a midurethral sling produced by Tyco, designed to be implanted in the retropubic space downside-totop (Table 3). The main difference between the two devices is determined by the texture of the polypropylene fibers constituting the mesh, with IVS being multifilament and having a denser texture and smaller pores (55 65 mm), resulting in a more rigid mesh. Rechberger et al [26] were the first to report a randomized controlled trial in which classic TVT was compared with an IVS device. Specifically, the study Fig. 3 Forest plots of complication rates after transvaginal tape (TVT) and intravaginal slingplasty (IVS). (a) Bladder perforation; (b) pelvic haematoma/bleeding; (c) bladder/vaginal erosions; (d) urinary tract infection; (e) storage lower urinary tract symptoms (); (f) voiding. SUI, stress urinary incontinence; OR, odds ratio; CI, confidence interval.

296 european urology 53 (2008) 288 309 Fig. 3. (Continued). included 50 patients in each arm, who were evaluated at 13.5-mo follow-up. Complication rates were quite similar, with the exception of postoperative acute urinary retention, which was significantly more common among the patients who had TVT placement. The study should be considered a poor-quality RCT owing to the lack of appropriate randomization and blinding procedures (Jadad score 1). The largest trial was recently published by Meschia et al [28], who reported on 190 patients randomized 1 to 1 to TVT or IVS. The study was quite well designed and presented an acceptable 24-mo follow-up. The complication rates were similar in both arms, with the exclusion of vaginal erosion, which was significantly more common after IVS (9% vs. 0 in the TVT arm, p = 0.009). Fig. 3 shows the forest plots concerning the metaanalyses of complication rates. Similar figures were observed in both TVT and IVS in all the assessable parameters (Fig. 3a f). Interestingly, the rate of erosions was lower in those patients having TVT, although only a nonstatistically significant trend was observed (OR, 0.26; 95%CI OR, 0.06 1.03; p = 0.06) (Fig. 3c). Four RCTs [27,29 31] compared TVT with the SPARC TM Sling System (American Medical Systems U.K. Ltd, Brentford, UK), which was developed to be implanted topside-to-down (Table 4). In the study with the longest median follow-up (25 mo), Tseng et al [30] compared the efficacy and complication rates of TVT and SPARC in 62 patients. Specifically, the authors reported similar complication rates in all the assessable parameters. However, although the differences were not statistically significant, frequency, urgency, urge incontinence, and incomplete voiding were more common among

european urology 53 (2008) 288 309 297 Table 4 Randomized controlled trials comparing TVT to SPARC as primary treatment for stress urinary incontinence complication rates CIC Reoperation rate Voiding UTI Storage Vaginal erosion Haematoma Bladder erosions Bladder perforation Level of evidence Reference Cases Follow-up (mo) Andonian 2005 [29] TVT 43 12 2b 23% 0 0 0 NR NR 9.3% NR 4.6% SPARC 41 24% 2.4% 0 2.4% NR NR 4.9% NR 4.8% Lim 2005 [27] TVT 61 1.5 3 2b 1.6% 0 3.3% NR 6.6% 3.3% NR NR SPARC 61 6.6% 0 13.1% NR 10% 3.3% NR NR Tseng 2005 [30] TVT 31 25 1b 0 16.1% 29% NR 25.9% 25.9% NR 3.2% SPARC 31 12.9% 9.7% 9.6% NR 48.3% 54.9% NR 0 Lord 2006 [31] TVT 147 2 1b 0.7% 4.1% NR NR NR 40.5% 23.1% 1.4% 0 SPARC 154 1.9% 2.6% NR NR NR 42.4% 32.4% 1.9% 6.5% TVT, tension-free vaginal tape; UTI, urinary tract infection;, lower urinary tract symptoms; CIC, clean intermittent catheterisation; NR, not reported. the patients treated with SPARC. The study was a good-quality RCT (Jadad score 3). Similar figures were reported by Lord et al [31] in the largest published RCT, enrolling 147 patients randomized to TVT and 154 to SPARC. However, the short follow-up of the study (6 8 wk) limits the relevance of the data. Despite the currently available inadequate followup duration, the trial was methodologically accurate (Jadad score 3). Fig. 4 shows the forest plots concerning the metaanalyses of complication rates. Voiding (OR, 0.61; 95%CI OR, 0.40 0.93; p = 0.02) and reoperations (OR, 0.30; 95%CI OR, 0.10 0.94; p = 0.04) were significantly less common after TVT. No statistically significant differences between TVT and SPARC were identified in the other evaluated complications. However, nonstatistically significant trends were identified in favour of TVT for the occurrence of bladder perforations (OR, 0.51; 95%CI OR, 0.24 1.10; p = 0.08) and, on the other hand, in favour of SPARC for the occurrence of storage (OR, 1.30; 95%CI OR, 0.75 2.26; p = 0.35) (Fig. 4). Sensitivity analyses, which excluded the study from Lord et al [31] from the meta-analysis owing to the very short follow-up, showed no difference in the risk of voiding (OR, 0.56; 95%CI, 0.26 1.24; p = 0.15) and reoperations (OR, 1.37; 95%CI, 0.26 7.18; p = 0.71) (forest plots not shown). Further sensitivity analyses evaluating only the two high-quality RCTs [30,31] showed overlapping figures for all the assessable complications (forest plots not shown). 3.4. Randomized controlled studies comparing retropubic to transobturator tension-free midurethral slings Excluding the paper by DeTayrac et al [32] (retracted for major violation of the ethical standards for conducting human research), six trials compared TVT TM and TVT-O TM (Gynecare; a macroporous polypropylene mesh, to be inserted inside-to-out through the obturator foramen) [33 38]; three RCTs [39 41] compared TVT with transobturator outsideto-in tape; a further study [42] compared TVT with Monarc TM (American Medical Systems), a knitted macroporous polypropylene mesh to be placed outside-to-in through the transobturator route. Two studies [43,44] compared SPARC with Monarc; two further RCTs [45,46] reported on a series of patients in which I-Stop (CL. Medical), a macroporous monofilament polypropylene mesh, was implanted through a retropubic or a transobturator route [45,46] (Table 5). With the exclusion of three recently published studies by Laurikainen et al [34], Meschia et al [36], and Zullo et al [38], all the trials were methodolo-

298 european urology 53 (2008) 288 309 gically weak, owing to inaccurate randomization and blinding procedures, were underpowered for most of the end points, and had short follow-up durations. Further, some of them were published only as congress abstracts [33,36,37,39 41,43]. Laurikainen et al randomized 267 patients to TVT or TVT-O, and evaluated them at 2-mo follow-up. Postoperative groin pain was significantly more common in the TVT-O group than in the TVT group ( p < 0.001), whereas no major intraoperative complications were reported. Minor complications included a single case of retropubic haematoma after TVT and urinary tract infections (8% after TVT and 13% after TVT-O). De no storage were reported in about 2% of the patients in each arm, whereas only 2 patients who had undergone TVT-O experienced self-catheterisation for voiding (1.5%). The study has to be considered a goodquality RCT owing to methodological considerations (appropriate randomization procedure, no patients lost to follow-up) (Jadad score 3); the currently available follow-up is poor. Zullo et al randomized 70 patients to TVT or TVT-O and evaluated them at 16-mo follow-up. Complication rates were slightly higher in the TVT arm, although all the differences were not statistically significant. Although the study has to be considered a good-quality RCT according to methodological considerations (appropriate randomization procedure, blinding data collection, no patients lost to follow-up) (Jadad score 3), the Fig. 4 Forest plots of complication rates after transvaginal tape (TVT) and SPARC. (a) Bladder perforation; (b) pelvic haematoma/bleeding; (c) bladder/vaginal erosions; (d) storage lower urinary tract symptoms (); (e) voiding ; (f) reoperation rate. SUI, stress urinary incontinence; OR, odds ratio; CI, confidence interval.

european urology 53 (2008) 288 309 299 Fig. 4. (Continued). currently available follow-up is only modest. A third consistent RCT was presented by Meschia et al at the 2006 annual meeting of the International Urogynecological Association; to date, the full text of the study has not been published. Bladder perforations were more common after TVT (4% vs. 0%), whereas the rate of early postoperative urinary retention and voiding difficulty were similar for both groups At a median follow-up of 6 mo, voiding, recurrent urinary tract infection, and vaginal erosions had similar prevalence rates in the two arms [36]. Fig. 5 shows the forest plots concerning the metaanalyses of complication rates. Owing to the lack of several data, the paper by Na et al [43] was not included in the meta-analysis. Comparing retropubic and transobturator tapes, bladder perforations (OR, 2.33; 95%CI OR, 1.26 4.32; p = 0.007) (Fig. 5a), pelvic haematoma (OR, 4.83; 95%CI OR, 1.22 19.15; p = 0.03) (Fig. 5b), and storage (OR, 1.81; 95%CI OR, 1.13 2.91; p = 0.01) (Fig. 5e) were significantly less common in the patients treated by transobturator tapes. Vice versa, the performances of retropubic and transobturator tapes were similar for all the other evaluable parameters (vaginal erosions, urinary tract infections, reoperation rates). Sensitivity analyses were performed and included only the trials in which TVT was the retropubic tape [39 42]. The figures reported above were not significantly modified, with the exception of the occurrence of pelvic haematoma (OR, 5.02; 95%CI

300 Table 5 Randomized controlled trials comparing retropubic to transobturator tapes as primary treatment for stress urinary incontinence complication rates Reference Cases Follow-up (mo) Level of evidence Bladder/vaginal perforations Haematoma Bladder erosions Vaginal erosion UTI Storage Voiding CIC Reoperation rate Mansoor 2003 [39] TVT 54 NR 2b 9.2% 0 NR NR NR 19% 9.2% NR 9.2% TOT 48 0 0 3% 2.1% 2.1% David-Montefiore 2005 * [45] Enzelsberger 2005 [42] Retropubic I-Stop 42 1 2b 9.5% 4.8% NR NR NR 23.8% NR 0 NR Ttransobturator I-Stop 46 10.9% 0 NR NR NR 19.6% NR 0 NR TVT 52 15 2b 7.6% 5.7% 1.9% 5.7% 9.6% 7.6% NR 1.9% Monarc 53 0 0 1.8% 5.6% 11.2% 5.6% NR 1.8% Na 2005 [43] SPARC 65 3 2b N.R N.R 0 0 N.R N.R 7.7% N.R N.R Monarc 65 N.R N.R 0 0 N.R N.R 6.2% N.R N.R Porena 2005 [44] TVT 47 13.4 2b 2.1% 4.2% NR 0 NR 10.6% 6.4% NR 0 TOT 43 0 0 4.8% 2.4% 2.4% 4.8% Ryu 2005 [33] TVT 40 NR 2b 0 0 NR 0 NR NR NR NR NR TVT-O 40 0 0 NR 0 NR NR NR NR NR Liapis 2006 [35] TVT 46 12 2b 6.5% 0 NR 2.1% 6.5% NR NR NR 2.1% TVT-O 43 0 0 NR 0 2.3% NR NR NR 0 Meschia 2006 [36] TVT 114 9 1b 4% NR NR 0 7% NR 10.5% NR NR TVT-O 117 0 0.8% 4.3% 6% Oliveira 2006 [37] TVT 17 10 2b NR NR NR 5.9% 11.8% 21.4% NR NR 5.9% TVT-O 28 3.7% 17.8% 28.6% 0 Riva 2006 [41] TVT 66 >12 2b 1.5% 0 NR 1.5% NR NR 1.5% 1.5% 0 TOT 65 0 0 3.1% 0 3.1% 3.1% Wang 2006 [44] SPARC 29 9 1b 3.4% 3.4% NR 3.4% NR 41.3% 55.1% NR NR Monarc 31 12.9% 0 NR 0 NR 25.8% 22.6% NR NR european urology 53 (2008) 288 309 Darai 2007 * [46] Retropubic I-Stop 42 10 2b 9.5% 4.8% NR NR NR 20.8% NR NR NR Ttransobturator I-Stop 46 10.9% 0 NR NR NR 17% NR NR NR Laurikainen 2007 [34] TVT 136 2.1 1b 2.2% 0.7% NR NR 8% 2.2% NR 0 NR TVT-O 131 2.3% 0 13% 2.3% 1.5% Zullo 2007 [38] TVT 35 16 1b 11% 2.8% 0 0 5,6% 9% NR NR NR TVT-O 37 0 0 0 0 2.5% 0 NR NR NR UTI, urinary tract infection;, lower urinary tract symptoms; CIC, clean intermittent catheterisation; TVT, tension-free vaginal tape; NR, not reported; TOT, transobturator tape. * Same randomized clinical trial; published at different follow-up intervals.

european urology 53 (2008) 288 309 301 Fig. 5 Forest plots of complication rates after retropubic and transobturator slings. (a) Bladder/vaginal perforation; (b) pelvic haematoma; (c) vaginal erosions; (d) urinary tract infections; (e) storage lower urinary tract symptoms (); (f) voiding ; (g) clean intermittent catheterisation; (h) reoperation rate. SUI, stress urinary incontinence; OR, odds ratio; CI, confidence interval.

302 european urology 53 (2008) 288 309 Fig. 5. (Continued). OR, 0.86 29.23; p = 0.07), where the difference in favour of transobturator tapes did not reach a statistical significance. Further sensitivity analyses evaluated only high-quality RCTs [34,36,38,44]: Only nonstatistically significant trends in favour of transobtuarator tapes were identified with regards to bladder/vaginal perforations (OR, 1.82; 95%CI OR, 0.75 4.40; p = 0.18), pelvic haematoma (OR, 3.10; 95%CI OR, 0.32 30.37; p = 0.33), and storage (OR, 1.96; 95%CI OR, 0.85 4.54; p = 0.12). All the other outcomes were overlapping (forest plots not shown). 3.5. Publication bias Funnel plots of the studies used in this metaanalysis were generated for all the evaluated comparisons. Only two studies [30,44] lay outside the

european urology 53 (2008) 288 309 303 Fig. 5. (Continued). 95%CI with an even distribution about the vertical, suggesting little evidence of publication bias (plots not shown). 3.6. Evidence from nonrandomized studies Owing to the limited follow-up of most of the evaluated randomized clinical trials, we elected to analyse the nonrandomized studies available in the literature with acceptable follow-up durations (longer than 24 mo). Table 6 summarises the data from available papers regarding complication rates. Summarising all the data available on the complications after placement of TVT in studies with follow-up longer than 24 mo, the cumulative rates were 1.7% for pelvic haematoma, 3.4% for bladder perforations, 1.1% for vaginal erosion, 0.8% for bladder erosion, 9.7% for urinary tract infections, 15.6% for storage, 16.1% for voiding, 4% for clean intermittent catheterisation, and 3.2% for reoperations. 4. Discussion Following the initial report by Ulmsten et al [3] on a new surgical procedure to treat SUI, Gynaecare s TVT gained worldwide diffusion owing both to miniinvasivity and high success rates. With the aim of making sling procedures even less invasive, and, sometimes, only for patent issues, other devices to be implanted retropubically, such as SPARC, IVS sling, I-Stop, and others have been placed on the market. More recently, to reduce the risk of complications in the retropubic space, the transobturator route has been used for placing the sling, both with outside-in (Monarc; Obtape TM [Mentor- Porges]; Obtryx TM, [Boston Scientific]; a transobturator tape, Uratape TM, [Mentor-Porges]) and inside-out approaches (TVT-O TM, Gynaecare). Although a meta-analysis [47] comparing retropubic and transobturator tapes has been published recently, the present paper is the first published meta-analysis assessing extensively the complication rates after placement of tension-free midurethral tapes in SUI in comparison with other surgical treatments for SUI. Our meta-analysis showed that complication rates were similar after TVT and Burch colposuspension (with the exclusions of bladder perforation and reoperation rate), whereas TVT and pubovaginal sling were followed by similar complication rates. With regards to the comparisons among retropubic tension-free tapes, SPARC was complicated by higher rates of voiding and reoperations, whereas, in comparisons of retropubic

304 Table 6 Nonrandomized studies evaluating TVT with follow-up durations longer than 24 mo complication rates Reference Cases Follow-up (mo) Haematoma Bladder perforations Bladder erosion Vaginal erosion UTI Storage Voiding CIC Reoperation rate Jeffry 2001 112 25 0.9% 11.6% NR NR 10.7% 25.9% 12.5% 8.9% NR Nilsson 2001 90 56 3.3% 1.1% NR NR 7.8% 5.9% NR NR NR Rezapour 2001 49 48 NR 2% NR NR NR NR 22.4% 10.2% NR Rezapour 2001 34 48 NR 2.9% NR NR NR NR 41.2% NR NR Rezapour 2001 80 48 8% 1.2% NR NR NR NR 20% 20% 1.2% Darai 2002 40 25 NR 15% NR NR 15% 7.5% 7.5% NR NR Debodinance 2002 63 36 0 9.5% NR NR 3.2% 22% NR % NR NR Radin 2002 245 38 1.6% 3.2% NR 0.4% NR 36.3% 6.1% NR 3.7% Rafii 2003 86 27 NR 12.7% NR NR 9.3% NR 15.1% NR NR Rafii 2003 62 27 NR 9.6% NR NR 8% NR 12.9% NR NR Rafii 2003 39 27 NR 2.5% NR NR 7.6% NR 25.6% NR NR Sevestre 2003 76 24.6 NR NR NR 1.3% NR 18.4% 85% NR NR Abdel-Fattah 2004 68 36 NR 3.6% NR NR NR NR 11% NR 2.9% Allahdin 2004 162 36 0.6% NR NR 1.2% NR 5% 9% 2.4% NR Glavind 2004 61 60 NR NR NR 1.6% NR NR NR NR NR Groutz 2004 100 27 NR 1% NR 0 NR 8% NR NR NR Nilsson 2004 80 91 NR NR NR NR 7.5% 6.3% NR NR NR Paick 2004 60 35 NR 10% NR NR NR 4% 18.3% 5% NR Rafii 2004 100 24.5 NR NR NR NR NR NR 16.2% 7% 4% Rafii 2004 40 24.5 NR NR NR NR NR NR 12.5% NR Rafii 2004 46 24.5 NR NR NR NR NR NR 10.8% NR Tsivian 2004 55 55 NR 5.45% 1.8% 3.8% NR NR 11.5% NR 3.8% Wang 2004 600 60 NR 0.8% NR NR NR NR NR NR NR Al-Singary 2005 120 26 1.1% 0 0 NR NR NR NR NR NR Gordon 2005 303 30 NR 1.3% NR 1.9% 14% 18% 1.6% 2.5% NR Meschia 2005 61 31 1.6% 4.9% NR 1.6% NR NR NR NR NR Meschia 2005 204 31 1.5% 3.9% NR 1.5% NR NR NR NR NR Aniulene 2006 57 36 1.8% 1.8% NR NR 7% 8.8% 15.8% NR NR Ankardal 2006 707 60 1% 1.7% NR NR 9.3% NR NR 10% NR Doo 2006 134 67 3.7% NR NR NR 1.5% 15.4% NR 0.7% NR Huang 2006 75 25 0 0 1.3% NR NR 13.3% 12% 4% NR Kuuva 2006 129 72 NR NR NR NR 9.3% 4.7% 17% NR 1.6% Neuman 2006 566 68 NR NR NR NR NR NR NR NR NR Sergent 2006 60 36 NR NR NR NR NR 10.3% NR NR NR Overall figures N.A. >24 mo 1.7% 3.4% 0.8% 1.1% 9.7% 15.6% 16.1% 4% 3.2% european urology 53 (2008) 288 309 UTI, urinary tract infection;, lower urinary tract symptoms; CIC, clean intermittent catheterisation; NR, not reported. All studies provide level IV evidence. See the Appendix for full reference citations of the papers included in this table.

european urology 53 (2008) 288 309 305 and transobturator tapes, the occurrence of bladder perforations, pelvic haematoma, and storage were significantly less common in patients treated by transobturator tapes, although sensitivity analyses based on high-quality RCTs showed only nonstatistically significant trends. Although our systematic review fulfilled most of the criteria of the Overview Quality Assessment Questionnaire to be considered a good-quality review [48], the overall value of the meta-analysis is impaired by major limitations of the studies included. Specifically, most of the trials were low-quality studies, having Jadad scores lower than 3, and were underpowered to detect statistically significant differences in complications rates. Clinically speaking, moreover, the mean follow-up of many trials was clearly insufficient to assess the long-term complications of surgical procedures for SUI (only two studies [24,30] reported data at follow-up longer than 24 mo), and some potentially interesting variables such as patients comorbidities, effect of the learning curve, timing of complications, and presence of complication-related symptoms were impossible to evaluate. Moreover, data on reoperation rates due to complications of the primary procedure were reported in only a few cases and were almost certainly underestimated, considering the short follow-up. Owing to some of these issues, some figures coming from nonrandomized studies with longer follow-up might be considered more reliable data. The figures of our meta-analysis on the most frequent complications sound acceptable. However, storage and voiding, as frequent as 15.6% and 16.1%, respectively, according to the data of our review, can be considered clinically significant issues. With regards to major complications, bowel, vascular, and nerve injuries, necrotizing fasciitis, ischiorectal abscess, sepsis, and patients deaths have been reported after placement of retropubic and transobturator tapes. Those conditions are extremely uncommon and very hard to be identified in randomized controlled trials. However, Deng et al [4], in a review on more than 11,800 published cases, totaled only 86 major complications (0.7%). In the same paper, moreover, the authors provided the results of a search of the Food and Drug Administration s Manufacturer and User facility Device Experience (MAUDE) database, which monitors voluntary reporting of complications involving the use of a device; they reported 32 cases of vascular injuries, 33 bowel injuries, and 8 patient deaths after TVT placement, which let hypothesise that major complications might be underreported in the literature, suggesting the need to create large national registries to record major complications. 5. Conclusions The figures of the published literature summarised in our meta-analysis showed that complication rates were similar after TVT and Burch colposuspension, with the exception of bladder perforation (more common after TVT) and reoperation rates (significantly higher after Burch colposuspension). Similarly, TVT and pubovaginal sling were followed by similar complication rates. In comparisons of different retropubic devices, TVT and IVS had overlapping complication rates, whereas the SPARC sling had higher rates of voiding and reoperations compared with TVT. Comparison of retropubic and transobturator tapes showed that occurrence of bladder perforations, pelvic haematoma, and, notably, storage were significantly less common in patients treated by transobturator tapes, although sensitivity analyses on high-quality RCTs did not reconfirm those figures. Considering the overall quality of the trials included, most of the studies were of limited methodological and clinical quality, which limits the strengths of the recommendations derived by their meta-analysis. High-quality studies with long-term follow-up duration would be highly desirable. Conflicts of interest The authors have nothing to disclose. Appendix A. Nonrandomized studies included in the meta-analysis Abdel-Fattah M, Barrington JW, Arunkalaivanan AS. Pelvicol TM pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence: a prospective randomized three-year follow-up study. Eur Urol 2004;46:629 35. Al-Singar W, Arya M, Patel HRH. Tension-free vaginal tape: avoiding failure. Int J Clin Pract 2005;59:522 5. Allahdin S, McKinley CA, Mahmood TA. Tension free vaginal tape: a procedure for all ages. Acta Obstet Gynecol Scand 2004;83:937 40. Aniuliene R, Bariliene S. New surgical technique for the treatment of urinary incontinence in

306 european urology 53 (2008) 288 309 Clinic of Obstetrics and Gynecology of Kaunas University of Medicine. Medicina (Kaunas) 2006;42:725 31. Ankardal M, Heiwall B, Lausten-Thomsen N, Carnelid J, Milsom I. Short- and long-term results of the tension-free vaginal tape procedure in the treatment of female urinary incontinence. Acta Obstet Gynecol Scand 2006;85:986 92. Darai E, Jeffry L, Deval B, Birsan A, Kadoch O, Soriano D. Results of tension-free vaginal tape in patients with or without vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2002;103:163 7. Debodinance P, Delporte P, Engrand JB, Boulogne M. Tension-free vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 years experience involving 256 operations. Eur J Obstet Gynecol Reprod Biol 2002;105:49 58. Doo CK, Hong B, Chung BJ, et al. Five-year outcomes of the tension-free vaginal tape procedure for treatment of female stress urinary incontinence. Eur Urol 2006;50:333 8. Glavind K, Sander P. Erosion, defective healing and extrusion after tension-free urethropexy for the treatment of stress urinary incontinence. Int Urogynecol J 2004;15:179 82. Gordon D, Gold R, Pauzner D, Lessing JB, Groutz A. Tension-free vaginal tape in the elderly: is it a safe procedure? Urology 2005;65:479 82. Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Tension-free vaginal tape (TVT) for the treatment of occult stress urinary incontinence in women undergoing prolapse repair: a prospective study of 100 consecutive cases. Neurourol Urodyn 2004;23:632 5. Huang KH, Kung FT, Liang HM, Chen CW, Chang SY, Hwang LL. Concomitant pelvic organ prolapse surgery with TVT procedure. Int Urogynecol J Pelvic Floor Dysfunct 2006;17:60 5. Jeffry L, Deval B, Birsan A, Soriano D, Darai E. Objective and subjective cure rates after tensionfree vaginal tape for treatment of urinary incontinence. Urology 2001;58:702 6. Kuuva N, Nilsson CG. Long-term results of the tension-free vaginal tape operation in an unselected group of 129 stress incontinent women. Acta Obstet Gynecol Scand 2006;85:482 7. Meschia M, Pifarotti P, Buonaguidi A, et al. Tension-free vaginal tape (TVT) for treatment of stress urinary incontinence in women with lowpressure urethra. Eur J Obstet Gynecol Reprod Biol 2005;122:118 21. Neuman M. Transvaginal suture placement for bleeding control with the tension-free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct 2006;17:176 7. Nilsson CG, Kuuva N, Falconer C, et al. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(suppl 2):S5 8. Nilsson CG. Latest advances in TVT tension-free support for urinary incontinence. Surg Technol Int 2004;12:171 6. Paick JS, Ku JH, Kim SW, Oh SJ, Son H, Shin JW. Tension-free vaginal tape procedure for the treatment of mixed urinary incontinence: significance of maximal urethral closure pressure. J Urol 2004;172:1001 5. Rafii A, Daraï E, Haab F, Samain E, Levardon M, Deval B. Body mass index and outcome of tensionfree vaginal tape. Eur Urol 2003;43:288 92. Rafii A, Paoletti X, Haab F, Levardon M, Deval B. Tension-free vaginal tape and associated procedures: a case control study. Eur Urol 2004;45: 356 61. Rardin CR, Rosenblatt PL, Kohli N, Miklos JR, Heit M, Lucente VR. Release of tension-free vaginal tape for the treatment of refractory postoperative voiding dysfunction. Obstet Gynecol 2002;100: 898 902. Rezapour M, Falconer C, Ulmsten U. Tension-free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD) a long-term follow-up. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(suppl 2):S12 4. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in women with recurrent stress urinary incontinence a long-term follow up. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(suppl 2):S9 11. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in women with mixed urinary incontinence a long-term follow-up. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(suppl 2):S15 8. Sergent F, Popovic I, Grise P, Leroi AM, Marpeau L. Three-year outcomes of the tension-free vaginal tape procedure fortreatment offemale stress urinary incontinence with low urethral closure pressure. Gynecol Obstet Fertil 2006;34:692 700. Sevestre S, Ciofu C, Deval B, Traxer O, Amarenco G, Haab F. Results of the tension-free vaginal tape technique in the elderly. Eur Urol 2003;44:128 31. Tsivian A, Mogutin B, Kessler O, Korczak D, Levin S, Sidi AA. Tension-free vaginal tape procedure for the treatment of female stress urinary incontinence: long-term results. J Urol 2004;172:998 1000. Wang AC. The techniques of trocar insertion and intraoperative urethrocystoscopy in tension-free vaginal taping: an experience of 600 cases. Acta Obstet Gynecol Scand 2004;83:293 8.

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