TVT-O for the Treatment of Pure Urodynamic Stress Incontinence: Efficacy, Adverse Effects, and Prognostic Factors at 5-Year Follow-up

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1 EUROPEAN UROLOGY 63 (2013) available at journal homepage: Platinum Priority Female Urology Incontinence Editorial by David Waltregny on pp of this issue TVT-O for the Treatment of Pure Urodynamic Stress Incontinence: Efficacy, Adverse Effects, and Prognostic Factors at 5-Year Follow-up Maurizio Serati a, *, Ricarda Bauer b, Jean Nicolas Cornu c, Elena Cattoni a, Andrea Braga a, Gabriele Siesto d, Daphné Lizée c, François Haab c, Marco Torella e, Stefano Salvatore f a Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy; b Department of Urology, University Hospital Grosshadern, Munich, Germany; c Department of Urology, Tenon Hospital, University Paris 6, Paris, France; d Department of Gynecology, IRCCS Humanitas Clinical and Research Center, Rozzano, Milan, Italy; e Department of Obstetrics and Gynecology, 2nd Faculty, Naples, Italy; f Department of Obstetrics and Gynecology, IRCCS San Raffaele Hospital, Milan, Italy Article info Article history: Accepted December 10, 2012 Published online ahead of print on December 20, 2012 Keywords: Overactive bladder Sling Stress urinary incontinence Tape TVT-O Urinary incontinence Urodynamic stress incontinence Abstract Background: Inside-out tension-free vaginal transobturator tape (TVT-O) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI), but data reporting long-term outcomes are scarce. Objective: To evaluate the efficacy and safety of TVT-O 5-yr implantation for management of pure SUI in women. Design, setting, and participants: A prospective observational study was conducted in four tertiary reference centers. Consecutive women presenting with urodynamically proven, pure SUI treated by TVT-O were included. Patients with mixed incontinence and/ or anatomic evidence of pelvic organ prolapse were excluded. Intervention: TVT-O implantation without any associated procedure. Outcome measurements and statistical analysis: Data regarding subjective outcomes (International Consultation on Incontinence-Short Form [ICIQ-SF], Patient Global Impression of Improvement, patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Multivariable analyses were performed to investigate outcomes. Results and limitations: Of the 191 women included, 21 (11.0%) had previously undergone a failed anti-incontinence surgical procedure. Six (3.1%) patients were lost to follow-up. The 5-yr subjective and objective cure rates were 90.3% and 90.8%, respectively. De novo overactive bladder (OAB) was reported by 24.3% of patients at 5-yr follow-up. Median ICIQ-SF score significantly improved from 17 (interquartile range [IQR]:16 17) preoperatively to 0 (IQR: 0 2) ( p < ). Failure of a previous anti-incontinence procedure was the only independent predictor of subjective recurrence of SUI (hazard ratio [HR]: 4.4; p = 0.009) or objective (HR: 3.7; p = 0.02). No predictive factor of de novo OAB was identified. Conclusions: TVT-O implantation is a highly effective option for the treatment of women with pure SUI, showing a very high cure rate and a low incidence of complications after 5-yr follow-up. # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Obstetrics and Gynecology, Urogynecology Unit, University of Insubria, Piazza Biroldi 1, Varese, Italy. Tel ; Fax: address: mauserati@hotmail.com (M. Serati) /$ see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

2 EUROPEAN UROLOGY 63 (2013) Introduction Retropubic and transobturator tension-free midurethral slings represent the most effective and popular procedures for the surgical treatment of stress urinary incontinence (SUI) and they are currently considered the gold standard [1]. According to the latest European Association of Urology (EAU) guidelines, midurethral slings (MUS) are the first-line surgical option for female SUI management after failure of conservative measures [2]. Several studies comparing retropubic and transobturator insertion of MUS showed that there is no significant difference in terms of objective and subjective cure rates at 12 mo [3 5]. Although some recently published studies evaluated the long-term efficacy and safety of tension-free vaginal tape (TVT) and demonstrated long-lasting benefits [6 8], the retropubic route appears to be associated with higher complication rates. Thus far, however, only very few data on the outcomes of transobturator MUS are available at medium- to long-term follow-up. Life expectancy is significantly increasing in Western countries; therefore, data regarding the long-term durability of anti-incontinence procedures, such as tension-free vaginal transobturator tape (TVT-O), need to be addressed. To date, the available evidence is limited to three publications that evaluated a total of 192 patients with 5-yr follow-up [9 11]. In two of these papers, the authors also included women with overactive bladder (OAB) symptoms or with a urodynamically proven detrusor overactivity (DO) [10,11].In the third paper, Angioli et al. presented their outcomes of TVT-O considering only pure urodynamically proven urodynamic stress incontinence (USI) in a female population; however, they had only 31 patients in their 5-yr follow-up study [9]. The aim of the present multicenter study, the largest available in the literature, is to report the medium-term objective and subjective outcomes of women implanted with TVT-O for pure SUI with a follow-up of at least 5 yr to assess the efficacy and the safety of this procedure in case of pure SUI. 2. Methods This was a multicenter, prospective evaluation in four tertiary reference centers in three countries. From January 2006, we have enrolled all consecutive women who complained of pure SUI symptoms with urodynamically proven USI. All patients recommended for surgery were scheduledfor atvt-o procedure (Gynecare TVT Obturator System; Ethicon Inc., Somerville, NJ, USA). Exclusion criteria were as follows: women with previous history of radical pelvic surgery, psychiatric and neurologic disorders, concomitant vaginal prolapse greater than stage 1 according to the pelvic organ prolapse quantification (POP-Q) system [12], OAB symptoms, urodynamically proven DO, and postvoid residual >100 ml [8]. Preoperative evaluation included medical history, physical examination, a voiding diary, urinalysis, and complete urodynamic testing. Physical examination was performed with the patient in the lithotomy position and POP was described during a maximal Valsalva maneuver according to the POP-Q system [12]. All women were evaluated with urodynamic studies as previously described [13] (including uroflowmetry, filling cystometry, Valsalva leak-point pressure [VLPP] measurement, and pressure/flow study) by a trained urogynecologist, using a standardized protocol in accordance with the good urodynamic practice guidelines of the International Continence Society [14]. Urethral hypermobility was defined by a Q-tip test >308. Patients were included regardless of Q-tip test and VLPP values. All methods, definitions, and units were updated in agreement with the last version of the International Continence Society standardization of terminology [15]. All patients also completed the International Consultation on Incontinence Questionnaire-Short Form ICIQ-SF questionnaire [16]. All the TVT-O procedures were performed according to the technique originally described by de Leval [17]. General or spinal anesthesia was used in accordance with the anesthesiologic requirements and/or the patient s preference, as previously reported [18]. Postoperative evaluations were mandatory at 12 mo and 60 mo in all centers and intermediate visits were scheduled at the physician s discretion. Every follow-up visit included medical history, physical examination, voiding diary, stress test, and evaluation of subjective satisfaction. A stress test was performed in the lithotomy and upright positions with a full bladder (ultrasonographic measurement 400 ml). Objective cure was defined as the absence of urine leakage during the stress test. To define the subjective outcomes at 1 and 5 yr, all patients completed the ICIQ-SF, the PGI-I Scale (a 7-point scale, with a range of responses from 1, very much improved, through 7, very much worse ) [19], and a patient-satisfaction scale (a single, self-answered, Likert-type scale of 0 10 that grades the patient s degree of satisfaction regarding continence: 0 represents not satisfied, and 10, satisfied ) [20]. Subjective success was indicated both by very much improved or much improved (PGI-I 2) and by a patient-satisfaction score 8, as previously described in 2011 by Abdel-Fattah et al. [21]. The Declaration of Helsinki was followed, and preoperative written informed consent for TVT-O implantation was obtained from all patients in this observational prospective evaluation Statistical analysis Statistical analysis was performed with SPSS v.17 for Windows (IBM Corp, Armonk, NY, USA). Continuous variables were reported as median and interquartile range (IQR). Chi-square and Fisher exact tests were used to analyze proportions, as appropriate. The log-rank test was used for univariate analysis of variables that had the potential to affect the risk of SUI recurrence (subjective, and objective). For this purpose, continuous variables were arbitrarily dichotomized according their definition (elderly: aged 65 yr, obese: body mass index 30 kg/m 2, multiparous for two or more vaginal deliveries, urethral hypermobility for Q-tip test >308, and intrinsic sphincter deficiency for VLPP <60 cm H 2 0). All nominal variables were dichotomized as yes versus no. All the covariates presenting significant correlation or a tendency towards association ( p 0.20) in univariable analysis with the outcomes of interest (subjective and objective SUI recurrence) were entered into the multivariate analysis using the Cox proportional hazard model to select independent predictors. Finally, univariate and multivariate analyses were performed to investigate factors affecting the risk of de novo OAB development. All the covariates were dichotomized according to the same criteria described earlier. All the covariates for which p 0.20 in univariable analysis were entered into the multivariate model using a binomial logistic regression to select independent predictors. Statistical significance was considered achieved when p < Results 3.1. Patient characteristics During the study period, a total of 191 patients meeting the inclusion criteria were submitted to TVT-O and included in

3 874 EUROPEAN UROLOGY 63 (2013) Table 1 Baseline characteristics N = 191 Age, yr, median (IQR) 60 (52 68) BMI, kg/m 2, median (IQR) 25 ( ) Obese * 33 (17.3) Sexually active 167 (87.4) Menopausal 152 (79.6) HRT 39 (40.1) Recurrent UTI 32 (16.8) Smoking habits 19 (9.9) Previous vaginal deliveries, median (IQR) 2 (1 2) Macrosome (4000 g) 48 (25.1) Operative delivery (vacuum/forceps) 38 (19.9) Cesarean section 33 (17.3) Previous hysterectomy 3 (1.6) Previous POP surgery 5 (2.6) Previous anti-incontinence procedures 21 (11.0) IQR = interquartile range; BMI = body mass index; HRT = hormonal replacement therapy; UTI = urinary tract infections; POP = pelvic organ prolapse. Data are expressed as absolute number (%) unless otherwise indicated. * BMI 30 kg/m 2. the present study by the four enrolling departments. Baseline characteristics of the study group are summarized in Table 1. Preoperative median ICIQ-SF was 17 (IQR: 16 17). Urethral hypermobility (Q-tip test >308) was recorded in 137 women (71.7%) and 26 (13.6%) had VLPP <60 cmh 2 O. Of the 167 patients (87.4%) who were sexually active before surgery, 30 (18.0%) complained of coital incontinence and 21 (15.3%) complained of superficial and deep dyspareunia. Among our study population, 21(11%) women had undergone a prior, failed anti-incontinence surgical procedure (10 Burch colposuspension, 6 retropubic MUS, 3 periurethral bulking agents, and 2 pubovaginal fascial sling). TVT-O was positioned by an expert urogynecologist in 89% of cases; 21 (11.0%) procedures were performed by a resident under supervision of an expert urogynecologist Intraoperative and early postoperative complications Bladder perforation occurred intraoperatively only in one case (0.5%). There were no other intraoperative complications. Eleven (5.8%) women reported early postoperative voiding dysfunction, but only in one case was TVT-O revision necessary Late postoperative complications Three (1.6%) women developed de novo recurrent UTI. One patient had undergone improper positioning of the sling (just below the bladder neck); this woman remained uncured at 1-yr follow-up and the sling was therefore removed. Vaginal erosion was recorded 12 mo after TVT-O in two cases and one of these also required sling removal. The other patients were totally asymptomatic. Nineteen (9.9%) patients complained of groin pain 24 h after surgery. One month after surgery, six (3.1%) women complained of groin pain and this symptom remained in two (1.0%) even 1 yr after surgery ( p for trend <0.0001). At 5-yr follow-up, no cases of groin pain remained Objective and subjective outcomes At 12-mo examination, 4 women out of 191 (2.1%) were lost to follow-up. Objective cure with a negative stress test was recorded for 170 of 187 patients (90.9%). Similarly, 171 of 187 patients (91.4%) considered themselves to be subjectively satisfied. Overall, at 5-yr follow-up, 6 of the cohort of 191 women (3.1%) were lost to follow-up. Objective cure with a negative stress test was recorded for 168 of 185 patients (90.8%). Similarly, 167 of 185 patients (90.3%) considered themselves to be subjectively satisfied (Table 2). At 5-yr, the median ICIQ-SF score was 0 (IQR: 0 2), a significant improvement in comparison with the scores recorded at inclusion (Wilcoxon paired t test, p < ). Table 3 reports univariable and multivariable analyses of all factors potentially involved in the risk of subjective and objective SUI recurrence during the follow-up. Age >65 yr, two or more vaginal deliveries, menopausal status, and history of failure of previous anti-incontinence procedures were associated with subjective recurrent SUI in univariable analyses ( p 0.20 for all). On multivariable analysis, the history of failure of previous anti-incontinence procedures (HR: 4.4; p = 0.009) was the only independent predictor of subjective failure (6 of 21 cases of failure). This last item also represented the only independent predictor of objective recurrence of SUI (HR: 3.7; p = 0.02) on multivariable analysis (5 of 21 cases of failure). There was no statistically significant difference between surgery naïve and previously operated patients in terms of urethral hypermobility, VLPP, or other urodynamic characteristics. Table 2 Cure rates at 12-mo and 5-yr follow-up visit Cured at 1 yr, % Cured at 5 yr, % Subjective outcomes Women with data available at 1 yr and 5 yr 91.4 (171/187) 90.3 (167/185) Assuming all missing data (withdrawals and lost) are failures 89.5 (171/191) 87.4 (167/191) Assuming all missing data (withdrawals and lost) are cured 91.6 (175/191) 90.5 (173/191) Objective outcomes Women with data available at 1 yr and at 5 yr 90.9 (170/187) 90.8 (168/185) Assuming all missing data (withdrawals and lost) are failures 89 (170/191) 87.9 (168/191) Assuming all missing data (withdrawals and lost) are cured 91.0 (174/191) 91.0 (174/191)

4 EUROPEAN UROLOGY 63 (2013) Table 3 Uni- and multivariable analyses of variables potentially involved in the risk of failure of TVT-O Subjective failure Objective failure Univariable analysis a Multivariable analysis b Univariable analysis a Multivariable analysis b Variable Elderly (aged 65 yr) 0.4 ( ) ( ) ( ) ( ) 0.97 Obese (BMI 30 kg/m 2 ) 1.8 ( ) ( ) 0.48 No. of vaginal deliveries (n 2) 0.4 ( ) ( ) ( ) 0.77 Macrosome (4000 g) 0.7 ( ) ( ) 0.53 Operative delivery 2.1 ( ) ( ) 0.56 Cesarean section 0.04 ( ) ( ) 0.36 Menopausal 0.2 ( ) ( ) ( ) ( ) 0.95 HRT 1.5 ( ) ( ) 0.71 Recurrent UTI 1.4 ( ) ( ) 0.48 Smoking habits 0.45 ( ) ( ) ( ) 0.15 Previous anti-incontinence 4.3 ( ) ( ) ( ) ( ) 0.02 procedures Surgeon s skill (resident vs expert) 0.4 ( ) ( ) 0.46 Urethral hypermobility 1.3 ( ) ( ) 0.35 (Q-tip test >308) VLPP <60 cm H 2 O 1.3 ( ) ( ) ( ) 0.18 CI = confidence interval; BMI = body mass index; HRT = hormone replacement therapy; UTI = urinary tract infection; VLPP = Valsalva leak-point pressure. a Univariate Cox proportional hazard model. b Cox proportional hazard model full enter mode. The onset of de novo OAB symptoms was reported by 24% (45 of 187) and 19.5% (36 of 185) patients at 1- and 5-yr follow-up, respectively. Eighteen of 19 women with de novo OAB received antimuscarinic therapy (one woman refused these drugs). Nine women with OAB treated with antimuscarinics (50%) were subjectively cured 12 wk later and they continued this treatment for 6 mo. In the other patients with de novo OAB symptoms, we prescribed onabotulinumtoxina injections or percutaneous tibialnerve stimulation. Univariable and multivariable analyses were performed to evaluate variables predicting the risk of de novo OAB after TVT-O, but no clinically significant data were found (Table 4). Table 4 Uni- and multivariable analyses of variables potentially involved in the risk of onset of de novo overactive bladder symptoms Persistent de novo OAB (dry) 5 yr after TVT-O Persistent de novo OAB (wet) 5 yr after TVT-O Univariable analysis a Multivariable analysis b Univariable analysis a Multivariable analysis b Variables Elderly (aged 65yr) 1.3 ( ) ( ) ( ) 0.11 Obese (BMI 30 kg/m 2 ) 1.7 ( ) ( ) 0.77 No. of vaginal deliveries (n 2) 1.02 ( ) > ( ) 0.64 Macrosome (4000 g) 1.1 ( ) ( ) >0.99 Operative delivery 1.9 ( ) ( ) >0.99 Cesarean section 0.2 ( ) ( ) ( ) 0.22 Menopausal 1.4 ( ) ( ) ( ) 0.66 HRT 1.6 ( ) ( ) ( ) 0.08 Recurrent UTI 0.4 ( ) ( ) ( ) 0.09 Smoking habits 1.4 ( ) ( ) 0.69 Coital incontinence 1.08 ( ) > ( ) ( ) 0.08 Previous anti-incontinence procedures 1.6 ( ) ( ) ( ) 0.18 Surgeon s skill (resident vs expert) 0.3 ( ) ( ) ( ) 0.73 Sling-related complications 1.02 ( ) > ( ) 0.03 Urethral hypermobility 1.1 ( ) > ( ) 0.66 (Q-tip test >308) VLPP <60 cm H 2 O 0.2 ( ) ( ) ( ) 0.53 Postoperative temporary voiding symptoms 1.01 ( ) ( ) 0.77 OAB = overactive bladder; TVT-O = tension-free vaginal transobturator tape; CI = confidence interval; BMI = body mass index; HRT = hormone replacement therapy; UTI = urinary tract infection; VLPP = Valsalva leak-point pressure. a Fisher exact test. b Binary logistic regression with forward stepwise analysis.

5 876 EUROPEAN UROLOGY 63 (2013) Discussion This study reports the combination of subjective and objective outcomes of TVT-O at 5-yr follow-up. We found TVT-O to be a highly effective and safe procedure, with a long-lasting effectiveness. In our study, the 5-yr objective and subjective cure rates were 90.8% and 90.3%, respectively, meaning that TVT-O seems to stand the test of time. In the last decade, several publications have demonstrated the efficacy of the retropubic MUS at 10 yr [6 8,22], but recent meta-analysis, review, and original articles and the latest EAU guidelines showed that compared with TVT-O, retropubic slings present similar short-term cure rates but with a statistically significant higher rate of intraand postoperative complications [2]. However, very few data with >3-yr follow-up are available on TVT-O, and longer-term follow-up is mandatory to compare outcomes between TVT-O and retropubic procedures for the treatment of female SUI (eg, TVT) because this is crucial for its management. In this series, the efficacy of TVT-O was not affected in the medium term either, and even though current evidence concerning this topic is still very limited, our data are more favorable than the majority of those currently available in literature [9,10]. In 2010, in a 5-yr follow-up, randomized study comparing TVT and TVT-O in 72 women with pure SUI, Angioli et al. reported objective and subjective cure rates of 73% and of 62%, respectively, in their TVT-O group [9]. These 5-yr outcomes were relatively less satisfying if compared with those previously reported at 1, 3, and 4 yr by the majority of other authors [4,23,24] and also with our present data. Similar to our study, Angioli et al. [9] evaluated subjective outcomes using patient-satisfaction scales rather than a quality of life (QoL) questionnaire; however, a limitation of their interesting randomized study could be the very limited sample size that probably influenced the reported cure rates. Indeed, in the TVT-O group, only 31 patients completed the 5-yr follow-up, with a significant proportion of patients lost to follow-up (16%). Similarly, Groutz and colleagues found at a 5-yr cure rate of 74% in a group of 61 women who had undergone TVT-O [10]. However, the authors did not exclude women with mixed urinary incontinence; furthermore, every patient with surgical failure already complained of preoperative OAB symptoms. This is a considerable bias that strongly influences the TVT-O outcome, decreasing cure rates and patient satisfaction ( p = 0.001) [25,26]. Finally, Cheng and Liu evaluated a large population of women 5 yr after the TVT-O procedure. Even though they reported a very encouraging cure rate of 87.4%, it must be taken into account that patients with preoperative OAB symptoms had not been excluded; on the contrary, 60% of them reported a wet OAB syndrome before surgery [11]. The authors stated that complete disappearance of SUI occurred in nearly 90% of patients, but this is not at all relevant if the authors do not report the OAB symptom s persistence or de novo appearance rates. For the first time in the published literature, we present a subjective and clinically objective 5-yr follow-up after TVT-O, which only includes a large population of patients with pure SUI and USI. It is noteworthy that our findings show a 5-yr cure rate that is definitely comparable to those reported by several papers with a much shorter follow-up [22,23]. We have also considered several preoperative, demographic, anamnestic, and clinical data to identify which factors could be involved in the risk of failure and, for the first time, we have also included the surgeon s skill in this analysis. No homogeneous data are available in the literature on the different possible factors (obesity, VLPP, maximum urethral closure pressure [MUCP], fixed urethra, previous anti-incontinence surgery) [8,27] predictive of sling failure. In our population, history of failure of previous anti-incontinence procedures was the only independent predictor for objective and subjective 5-yr TVT-O failure, confirming, therefore, the first anti-incontinence surgical treatment as the most effective. The onset of de novo OAB symptoms, together with their progression and possible treatment, is one of the most clinically significant and largely debated postoperative complications of midurethral slings. Previous studies have reported de novo urgency rates ranging from 4% to 33% after retropubic TVT [8,28], but very few medium-term data are available on the relation between TVT-O and de novo OAB symptom onset. Moreover, in the long run, a certain percentage of women may naturally develop age-related OAB symptoms, and this could play a confounding role. In our series, however, we recorded a considerable prevalence of de novo OAB, especially in the early postoperative period. Indeed, despite patient ageing, our findings seem to show a reduction of this rate over time. In this population, we also evaluated antimuscarinic efficacy in this particular type of OAB, recording a lower cure rate (50%) compared to our previous data [29] and to the data reported by other papers [30], which are similar to our efficacy data in cases of de novo OAB symptoms after retropubic TVT. At present, it is difficult to define the real efficacy of antimuscarinic treatment in this type of OAB; however, since the onset of this condition may negatively affect the QoL of women submitted to MUS, we feel that this crucial clinical issue deserves further investigation. We have also attempted to identify which independent factors could be involved in the risk of developing de novo OAB, but no significant predictor was found. Points of strength of this study are (1) a highly homogeneous study population with the exclusion of women with mixed incontinence, DO, and/or any other associated surgical procedure; (2) the subjective and objective outcomes obtained by the use of validated tools; and (3) the very low rate of loss to follow-up. Conversely, we acknowledge that a limitation of this study could be that formal, validated, QoL questionnaires were not used because, unfortunately, no validated QoL questionnaire exists in Italian. We used the standardized and validated ICIQ-SF and two validated patient-satisfaction scales to evaluate results of the classic retropubic TVT and of TVT-O [6,7,9,21]. Finally, we did not consider MUCP, which may be considered questionable, but we do not

6 EUROPEAN UROLOGY 63 (2013) consider this to be a real limitation as it is not yet a standardized urodynamic parameter. 5. Conclusions The 5-yr results of this study showed that TVT-O is a highly effective option for the treatment of female SUI. Indeed, we recorded both very high objective and subjective cure rates. The persisting postoperative onset of de novo OAB symptoms could be the most significant clinical issue related to TVT-O. Author contributions: Maurizio Serati had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Serati. Acquisition of data: Serati, Cattoni, Braga, Bauer, Cornu, Lizée, Torella. Analysis and interpretation of data: Serati, Siesto. Drafting of the manuscript: Serati, Cattoni, Bauer, Cornu. Critical revision of the manuscript for important intellectual content: Serati, Salvatore, Haab. Statistical analysis: Siesto, Serati. Obtaining funding: None. Administrative, technical, or material support: None. Supervision: None. Other (specify): None. Financial disclosures: Maurizio Serati certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None. Funding/Support and role of the sponsor: None. References [1] Serati M, Salvatore S, Uccella S, et al. Surgical treatment for female stress urinary incontinence: what is the gold-standard procedure? Int Urogynecol J Pelvic Floor Dysfunct 2009;20: [2] Lucas MG, Bosch RJL, Burkhard FC, et al. EAU guidelines on surgical treatment of urinary incontinence. Eur Urol 2012;62: [3] Porena M, Costantini E, Frea B, et al. 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