european urology 51 (2007)

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1 european urology 51 (2007) available at journal homepage: Female Urology Incontinence One-Year Follow-up of Tension-free Vaginal Tape (TVT) and Trans-obturator Suburethral Tape from Inside to Outside (TVT-O) for Surgical Treatment of Female Stress Urinary Incontinence: A Prospective Randomised Trial Marzio Angelo Zullo a, *, Francesco Plotti b, Marco Calcagno b, Elettra Marullo a, Innocenza Palaia b, Filippo Bellati b, Stefano Basile b, Ludovico Muzii a, Roberto Angioli a, Pierluigi Benedetti Panici b a Department of Obstetrics and Gynecology, Campus Bio-medico University of Rome, Rome, Italy b Department of Obstetrics and Gynecology, La Sapienza University of Rome, Rome, Italy Article info Article history: Accepted October 26, 2006 Published online ahead of print on November 7, 2006 Keywords: Female stress urinary incontinence TVT TVT-O Abstract Objectives: To compare tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of stress urinary incontinence (SUI) for complications (primary end point) and success rate (secondary end point). Methods: Seventy-two consecutive patients, with a mean age of 53.2 yr (range: yr) and affected by SUI, were included in this randomised controlled trial. After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. Operative time, perioperative complications, and hospital stay were prospectively recorded. Cure of SUI was defined as no leakage of urine during the stress test at urodynamic testing at the 12-mo evaluation. The Wilcoxon signed rank sum test, Mann-Whitney U test, McNemar test, and Fisher exact test were used to verify statistical significance, set at p < Results: All patients were evaluable at the 12-mo follow-up. The characteristics of patients were well balanced between groups after randomisation. The mean operative time was significantly shorter in the TVT-O group. Perioperative complications were significantly more common after the retropubic approach (5% and 27% in TVT-O and TVT groups, respectively, p < 0.04). The groups did not differ significantly in intraoperative blood loss, hospital stays, and time to return to normal activities. Sixty-five patients (90%) were successfully treated for SUI 12 mo after the operation (89% and 91% for TVT-O and TVT groups, respectively). Conclusions: Both techniques appear to be equally effective in the surgical treatment of SUI. However, TVT-O had a shorter operative time and lower overall perioperative complication rate. # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Marzio Angelo Zullo, MD, Department of Obstetrics and Gynecology, University of Rome Campus Bio-medico, Via Longoni, 83, 00155, Rome, Italy. Tel ; Fax: address: m.zullo@unicampus.it (M.A. Zullo) /$ see back matter # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 european urology 51 (2007) Introduction Since the report by Ulmsten and Petros in 1995 [1], the tension-free vaginal tape (TVT) technique has been the most commonly used surgical treatment for stress urinary incontinence (SUI) thanks to its advantages such as minimal surgical trauma, shorter postoperative stay, and long-term high cure rate, ranging from 81% to 95% [2,3]. Nevertheless, TVT has been associated with various perioperative complications, including bladder perforation, injuries to retropubic organs, pain, urinary infection, urinary retention, and de novo detrusor overactivity [4 6]. More recently, several suburethral tape insertion procedures have been described such as tension-free trans-obturator tape either from outside to inside or inside to outside [7 10]. If compared with the TVT procedure, these techniques are equally effective in the treatment of SUI and the trans-obturator route seems to be safer than the classic retropubic route [11 13]. Avoiding the intrapelvic and retropubic passage, the transobturator route enables the paravesical space to be preserved, limiting the risks of vesical, visceral, and vascular injuries [14]. This prospective randomised trial compared use of TVT and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of SUI in terms of complications (primary end point)and short-term success rate (secondary end point). 2. Patients and methods From July 2004 to May 2005, consecutive patients affected by SUI were included in the study. The internal review board approved the study. Inclusions criteria included SUI with no contraindications to vaginal surgery and signed informed consent. Exclusion criteria included urogenital prolapse greater than stage 1, detrusor overactivity, symptoms of overactive bladder (OAB), intrinsic urethral sphincter deficiency, urinary retention, previous anti-incontinence surgery, neurologic bladder, and psychiatric disease. Preoperative assessment included history and general assessment, urinalysis, urogynaecologic clinical examination, and urodynamic evaluation (as recommended by the International Consultation on Incontinence [ICI]). During the urogynaecologic interview a 10-cm grade visual analogue scale (VAS) was used to subjectively quantify the patient perception of SUI symptom severity by a standardised question ( Can you quantify the influence of urinary incontinence on your daily life? ). During the urogynaecologic examination, the degree of vaginal defects was evaluated using the pelvic organ prolapse quantification (POP-Q) system [15]. All patients underwent cough stress testing in the supine and standing positions at 300 ml bladder filling. Urethrovesical junction hypermobility was evaluated using the cotton swab test. Urodynamic evaluations were performed in accordance with criteria established by the International Continence Society (ICS) [16]. The present study was not blinded although all follow-up examinations were performed by physicians not involved in the study protocol (masked). Maximum urethral closure pressure <20 cm H 2 O was considered an indicator of intrinsic sphincter deficiency. After preoperative assessment, patients who signed informed consent were randomly allocated to undergo a TVT or TVT- O procedure by using a predetermined computer-generated randomisation code. Surgical procedures were performed by the same two experienced surgeons (P.B.P. and M.A.Z.) according to the original techniques by Ulmsten and Patros [1] and De Leval [9]. Cystoscopy was routinely performed only in the TVT group. A short-term antibiotic prophylaxis was performed 2 h prior to surgery (cefazolin 2 g). All surgical procedures for both groups were performed under lumbar epidural anaesthesia. When bladder injury occurred, an indwelling catheter was placed for 48 h. If postoperative postvoid residual was >100 ml, the patient carried out intermittent self-catheterisation at home until a postvoid residual <80 ml on two consecutive measurements was obtained. Operative time, perioperative complications, spontaneous voiding, postoperative complications, and hospital stay were prospectively recorded in all patients. At 1, 6, and 12 mo after surgery, patients were asked to answer urogynaecologic standardised questions addressing urinary symptoms; in addition physical examination was performed. Severity of incontinence was evaluated with the VAS scale. The urodynamic assessment was performed at the 12-mo evaluation. Classification of surgical complication was performed using the Dindo classification [17]. Success rate was assessed at 12 mo postoperatively. Cure of SUI was defined as no leakage of urine during the stress test at urodynamic testing. Urinary frequency was defined as a repeated voiding of a small volume of urine (>8 times/d) in short intervals. Urgency was defined as a strong desire to void accompanied by fear of leakage or fear of pain; nocturia was defined as the need to awake more than twice a night to void. Bladder outlet obstruction was measured with a pressure flow study according to the Blaivas and Groutz nomogram [18]. Severe pain was defined as presence of pain requiring analgesic therapy still 1 wk after surgery. We believed that the incidence of intraoperative and postoperative complications would be 39% (higher value reported in literature) [19] in the TVT group and 7% in the TVT-O group. Based on 0.9 power to detect a significant difference ( p = 0.05, 2-sided), 35 patients were required for each study group. To compensate for nonevaluable patients (estimated 10%), we planned to enroll 38 patients per group. The Wilcoxon signed rank sum test was used for comparison within groups. The Mann-Whitney U test was used for comparison between the groups. The change from baseline of the urinary symptoms was analysed using the McNemar test, with the Fisher exact test being used for analysis between the groups. Statistical significance was set at p < Results A total of 112 patients affected by SUI were assessed for eligibility. Seventy-two patients who met the

3 1378 european urology 51 (2007) Fig. 1 CONSORT trial flow diagram for patients who were accrued into the trial. TVT = tension-free vaginal tape; TVT-O = tension-free vaginal tape-obturator from inside to outside. inclusion criteria and signed informed consent were enrolled. All 72 patients were treated on an intention-totreat basis; 37 had the TVT-O procedure (TVT-O group) and 35 had the TVT procedure (TVT group; Fig. 1). Patient characteristics are shown in Table 1 and appear well balanced between the treatment groups after randomisation. The intraoperative and postoperative details are shown in Table 2. The mean operative time was significantly shorter in the TVT-O group ( p < 0.01). The two groups did not differ significantly in intraoperative blood loss, length of hospital stay, and time to return to normal activities. The incidence of overall perioperative complications was significantly higher after the retropubic approach (2 [5%] and 9 [26%] patients in TVT-O and TVT groups, respectively; p < 0.04; Table 2). Major perioperative complications occurred in only one (3%) patient (TVT group). This patient developed a retropubic haematoma with drop of haemoglobin level that required laparotomic surgical revision. Classification of surgical Table 1 Patient characteristics Variable TVT-O group (37 patients) TVT group (35 patients) p Age, yr ns Body mass index, kg/m ns Parity, n ns Menopausal status, n 8 (22%) 6 (17%) ns Hormone replacement therapy, n 3/8 (36%) 3/6 (50%) ns Previous hysterectomy, n 5 (14%) 4 (11%) ns POPQ system Stage 0 11 (30%) 9 (26%) ns Stage 1 24 (65%) 25 (71%) ns Values are given as mean standard deviation (SD). TVT-O = tension-free vaginal tape-obturator from inside to outside; TVT = tension-free vaginal tape; ns = not significant.

4 european urology 51 (2007) Table 2 Intraoperative and postoperative details in 72 patients Variable TVT-O group (37 patients) TVT group (35 patients) p Operative time, min <0.001 Blood loss, ml ns Operative complications, n 0 4 (11%) ns Bladder injury, n 0 2 Vascular injury, n 0 0 Bowel injury 0 0 Neurologic injury, n 0 0 Vaginal perforation, n 0 1 Retropubic haematoma, n 1 Obturator haematoma, n 0 Postoperative complications, n 2 (5%) 5 (14%) ns Wound infection, n 0 0 Fever, n 0 2 Urinary tract infection, n 1 2 Severe pain, n 1 0 Urinary retention, * n 0 1 Tape erosion, y n 0 0 Postoperative hospital stay, d ns Time to return to normal activities, wk ns Values are given as mean standard deviation (SD). TVT-O = tension-free vaginal tape-obturator from inside to outside; TVT = tension-free vaginal tape; ns = not significant. * Duration of catheterization >7 d. y 12-mo follow-up. complications is shown in Table 3. No patients were lost at follow-up. Median follow-up time was 16 mo (range: mo). Overall, 65 of 72 patients (90%) were cured of SUI 12 mo after the operation with no significant differences found between groups (33 [89%] and 32 [91%] patients for TVT-O and TVT groups, respectively). No tape erosions were observed. The comparison between groups concerning urinary symptoms is shown in Table 4. There was no significant difference for OAB symptoms between groups at each follow-up visit. At the 12-mo follow-up visit, OAB symptoms were present only in three (9%) patients in the TVT group. The values of Table 3 Classification of surgical complications based on Dindo et al [17] TVT-O group (37 patients) TVT group (35 patients) Grade I 3 (8%) 5 (14%) ns Grade II 1 (3%) 2 (6%) ns Grade III a 0 0 b 0 1 (3%) ns Grade IV a 0 0 ns b 0 0 ns Grade V 0 0 ns TVT-O = tension-free vaginal tape-obturator from inside to outside; TVT = tension-free vaginal tape; ns = not significant. p cotton swab testing, positive stress testing, and peak flow showed a significant reduction in both groups from baseline to the 12-mo follow up visit ( p < 0.01; Table 5). For the other urodynamic data, no statistically significant differences were found between groups and within groups from baseline to the 12-mo follow-up (Table 5). There was no significant difference between groups concerning bladder outlet obstruction (Table 4). When comparing VAS values concerning the severity of urinary incontinence at baseline and at the 12-mo evaluation, we found a statistically significant difference within both groups (preoperative and postoperative mean severity of urinary loss perception: vs ; vs in TVT-O and TVT groups, respectively; p < 0.01), but there were no significant differences between groups. 4. Discussion Several authors have claimed TVT is a safe and effective surgical treatment for SUI with a good continence rate over time [2,3,20,21]. Nevertheless, TVT is associated with various perioperative complications including bladder perforation ( %), perioperative bleeding (4%), haematoma ( %), persistent urinary retention (0.5 20%), urinary infections (0.7 22%), and de novo detrusor overactivity (2.5 25%) [4 7]. Recently, several suburethral tape insertion procedures have been described such as

5 1380 european urology 51 (2007) Table 4 Comparison between groups in relation to urinary symptoms Frequency Urgency Nocturia DO TVT-O TVT p TVT-O TVT p TVT-O TVT p TVT-O TVT p Baseline 0 0 ns 0 0 ns 0 0 ns 0 0 ns 1 mo 2 (5%) 4 (11%) ns 3 (8%) 6 (17%) ns 1 (3%) 1 (3%) ns 1 (3%) 1 (3%) ns 6 mo 1 (3%) 3 (9%) ns 2 (5%) 4 (11%) ns 1 (3%) 1 (3%) ns 1 (3%) 1 (3%) ns 12 mo 0 2 (6%) ns 0 3 (9%) ns 0 0 ns 0 0 ns Some patients had more than one symptom. Values are numbers of patients with percentages. TVT-O = tension-free vaginal tape-obturator from inside to outside; TVT = tension-free vaginal tape; DO = detrusor overactivity; ns = not significant. tension-free trans-obturator tape (TOT) either from outside to inside or inside to outside [7 9]. One retrospective comparative study, investigating Table 5 Preoperative and 12-mo postoperative urogynaecologic clinical examination and urodynamic evaluation Clinical and urodynamic data Preoperative At 12 mo p Cotton swab test, 8 TVT-O <0.001 TVT <0.001 Positive stress testing, n TVT-O 37 (100%) 4 (11%) <0.001 TVT 35 (100%) 3 (9%) <0.001 Peak flow, ml/s TVT-O <0.001 TVT <0.001 Flow time, ml/s TVT-O ns TVT ns Postvoid residual, ml TVT-O ns TVT ns First voiding desire, ml TVT-O ns TVT ns Maximum cystometric capacity, ml TVT-O ns TVT ns Detrussor pressure at peak flow, cm H 2 O TVT-O ns TVT ns MUCP, cm H 2 O TVT-O ns TVT ns UFL, mm TVT-O ns TVT ns Values are given as mean standard deviation (SD). TVT-O = tension-free vaginal tape-obturator from inside to outside; TVT = tension-free vaginal tape; ns = not significant; MUCP = maximum urethral closure pressure; UFL = urethral functional length. retropubic and outside-in trans-obturator sling, demonstrated that these procedures are equally efficacious to treat SUI with a cure rate of 90% versus 84% for TOT and TVT, respectively [11]. The only clinical trial comparing TVT and TVT-O in a randomised setting showed that objective cure rates were 89% and 90% for TVT and TVT-O groups, respectively, at a 12-mo follow-up. Nevertheless, the mean operative time was significantly shorter in the TVT-O group compared to the TVT group [13]. The present study confirms the high continence rates achieved by these procedures at a short-term follow-up. Moreover, the present study confirms that the mean operative time was significantly shorter in the TVT-O group. This difference is mainly due to the cystoscopy carried out after the TVT procedure. Cystoscopy is mandatory after all retropubic anti-incontinence procedures due to the high risk of bladder perforation reported by literature ( %) [5,6]. By using the trans-obturator route the risk of bladder injury is very low. At the beginning of their experience, Dargent et al reported no bladder injury verified by cystoscopy after TOT procedures in the first 71 patients [22]. However, few cases of bladder injury (0.5%) have been reported in the past literature [11,23], although frequently in patients with an associated cystocele [23,24]. Indeed, authors do not recommend a cystoscopy during the trans-obturator procedure when it is performed in normal conditions. Concerning intraoperative complications, Liapis et al [13] reported three (6.5%) and no bladder perforations in TVT and TVT-O procedures, respectively. In the present series, bladder perforation occurred in only two patients (6%) in the TVT group. However, the safety of a surgical procedure is analysed considering both intraoperative and postoperative complications. Liapis et al in their randomised trial reported that, overall, the perioperative complication rate was 24% versus 5% for TVT and TVT-O, respectively, but all were minor complications [13]. The present study showed that, overall, the perioperative complications rate was significantly higher after the TVT procedure,

6 european urology 51 (2007) although most were minor complications; only one patient in the TVT group required surgical revision for retropubic haematoma (grade IIIb complication using the Dindo [17] classification; Table 3). Indeed, bleeding is a complication that can be encountered penetrating the Retzius space, as reported in past series [11]. Some explanations for the lower incidence of intraoperative complications (mostly bleeding) during a trans-obturator procedure can be based on the anatomic studies performed by Bonnet et al [25]. They observed that the pelvic region is completely outside of the dissection field. The devices passed in a virtual space located in the most anterior part of the ischiorectal fossa. Our data are in keeping with those reported by Liapis et al [13] supporting the higher safety of the inside outside trans-obturator route (no intraoperative complications), although no statistical difference was reached when this technique was compared with the classical retropubic approach. Concerning postoperative complications, Liapis et al reported an incidence of 17% (8 patients) and 5% (2 patients) for TVT and TVT-O, respectively. The more common complication was urinary retention (4 [9%] vs. 1 patient for TVT and TVT-O groups, respectively). In the present series five (15%) and two (6%) patients developed early postoperative complications in the TVT and TVT-O group, respectively, but the difference was not significant. Nevertheless, in the present study we observed a low rate of urinary retention (a single patient in the TVT group); however, its incidence reported in literature is % [4 6]. Several studies showed that TVT induces a dynamic obstruction with a compressive process due to the kinking of urethra on the sling [26]. Thus, at the present time, most investigators have stopped using the intraoperative cough stress test because it led to excessive compression and subsequent obstruction. Mellier et al [27] presented a hypothesis on the place of the tape and its consequence. With the obturator route, the tape is inserted at a 458 angle to the vertical and horizontal planes, giving a 908 angle, which is wider than the angle obtained in the TVT. The reported incidence of de novo OAB symptoms after the TVT procedure ranges from 3% to 26% in different series [4 7]. The present series supports the fact that there are no significant differences between groups in terms of OAB symptoms. On the other hand, the incidence of de novo urinary frequency increased in each group during the first month after surgery. After 12 mo, the rate of de novo frequency was 0% and 6% in TVT-O and TVT groups, respectively ( p = ns). Concerning urgency, a similar trend was noted, with the incidence of de novo urgency after 1 mo 9% and 18% in the TVT-O and TVT groups, respectively; however, at the 12-mo follow-up evaluation, urgency persisted only in three patients (9%) in TVT group ( p = ns). De novo OAB symptoms could be due to the obstructive effect of the sling, and the degree of bladder outlet obstruction may be correlated with the degree of detrusor overactivity; however, our urodynamic data suggest that no obstruction of the bladder outlet was present after the surgical procedure. Some authors believe that the reason for de novo OAB may be that the Prolene tape could induce changes in the paraurethral collagen metabolism with potential sclerosis [28]. In addition, menopausal status seems to increase the rate of OAB syndrome in patients having the TVT procedure [28]. In the present series the three patients who developed OAB syndrome were all in menopausal status. However, the severity of urinary incontinence (evaluated by VAS) showed a significant improvement within both groups after 12 mo, even if no statistically significant differences between the two groups were observed. Although this is actually a subjective evaluation, patient satisfaction is an important parameter to consider to establish the success of a procedure designed just to improve the quality of life. A more precise evaluation of subjective outcomes could have possibly been obtained if validated questionnaires such as the Urinary Distress Inventory (UDI), International Consultation on Incontinence Questionnaire (ICI-Q), Urinary Incontinence Questionnaire (UIQ), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) had been used. 5. Conclusions In conclusion, both techniques appear to be equally effective for the surgical treatment of SUI after 1 yr of follow-up. However, TVT-O had a shorter operative time, no absolute need of routine cystoscopy, and lower overall complication rate. Moreover, one patient in the TVT group required surgical revision. More prospective randomised trials including larger series of patients and long-term follow-up are necessary to obtain definitive conclusions. References [1] Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29: [2] Nilsson CG, Falconer C, Rezapour M. Seven year followup of the tension-free vaginal tape procedure for

7 1382 european urology 51 (2007) treatment of urinary incontinence. Obstet Gynecol 2004;104: [3] Jomaa M. A seven-year follow up of tension free vaginal tape (TVT) for surgical treatment of female stress urinary incontinence under local anaesthesia. Int Urogynecol J 2003;14:S69 (abstract). [4] Schraffordt Koops SE, Bisseling TM, Heintz APM, et al. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol 2005;193: [5] Abouassaly R, Jordan R, Steinberg R, et al. Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int 2004;94: [6] Nilsson CG, Kuuva N. The tension-free vaginal tape procedure is successful in the majority of women with indications for surgical treatment of urinary stress incontinence. BJOG 2001;108: [7] Niknejad K, Plzak LS, Staskin DR, et al. Autologous and synthetic urethral slings for female incontinence. Urol Clin North Am 2002;29: [8] Delorme E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11: [9] De Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 2003;44: [10] Deval B, Ferchaux J, Berry R, et al. Objective and subjective cure rates after trans-obturator tape (OBTAPE 1 ) treatment of female urinary incontinence. Eur Urol 2006; 49: [11] Fischer A, Fink T, Zachmann S, Eickenbusch U. Comparison of retropubic and outside-in transobturator sling systems for the cure of female genuine stress urinary incontinence. Eur Urol 2005;48: [12] Roumeguere T, Quackels T, Bollens R, et al. Trans-obturator vaginal tape (TOT 1 ) for female stress incontinence: one year follow-up in 120 patients. Eur Urol 2005;48: [13] Liapis A, Bakas P, Giner M, et al. Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. Gynecol Obstet Invest 2006;62: [14] Delmas V. Anatomical risks of transobturator suburethral tape in the treatment of female stress urinary incontinence. Eur Urol 2005;48: [15] Auward W, Freeman RM, Swift S. Is the pelvic organ prolapse quantification system (POPQ) being used? A survey of members of the International Continence Society (ICS) and the American Urogynecologic Society (AUGS) Int Urogynecol J Pelvic Floor Dysfunct 2004;15: [16] Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-Committee of the International Continence Society. Neurourol Urodyn 2002;21: [17] Dindo D, Dematrtines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and result of a survey. Ann Surg 2004;240: [18] Blaivas JG, Groutz A. Bladder outlet obstruction nomogram for women with lower urinary tract symptomatology. Neurourol Urodyn 2000;19: [19] Ward K, Hilton P, United Kingdom and Ireland Tensionfree Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325: [20] Rafii A, Paoletti X, Haab F, Levardon M, Deval B. Tensionfree vaginal tape and associated procedures: a case control study. Eur Urol 2004;45: [21] Munir N, Bunce C, Gelister J, Briggs T. Outcome following TVT sling procedure: a comparison of outcome recorded by surgeons to that reported by their patients at a London district general hospital. Eur Urol 2005;47: [22] Dargent D, Bretones S, George P, et al. Insertion of a suburethral sling through the obturating membrane for treatment of female urinary incontinence. Gynecol Obstet Fertil 2002;30: [23] Krauth JS, Rasoamiaramanana H, Barletta H, et al. Suburethral tape treatment of female urinary incontinence morbidity assessment of the trans-obturator route and a new tape (I-STOP 1 ): a multi-centre experiment involving 604 cases. Eur Urol 2005;47: [24] Hermieu JF, Messas A, Delmas V, et al. Bladder injury after TVT transobturator. Prog Urol 2003;13: [25] Bonnet P, Waltregny D, Reul O, et al. Transobturator vaginal tape inside out for the surgical treatment of female stress urinary incontinence: anatomical considerations. J Urol 2005;173: [26] Valentini F, Pigné A, Nelson P. Comparison at short follow-up of the changes in the voiding phase induced by sub-urethral tapes (TVT and TVT-O). Progr Urol 2004;14: [27] Mellier G, Benayed B, Bretones S, et al. Suburethral tape via the obturator route: is the TOT a simplification of the TVT? Int Urogynecol J Pelvic Floor Dysfunct 2004;15: [28] Zullo MA, Plotti F, Calcagno M, et al. Vaginal estrogen therapy and overactive bladder symptoms in postmenopausal patients after a tension-free vaginal tape procedure: a randomized clinical trial. Menopause 2005;12:

8 european urology 51 (2007) Editorial Comment Massimo Lazzeri, Department of Urology, Casa di Cura Santa Chiara, p.zza indipendenza 11, Firenze, Italy The tools to report outcomes after surgery are often unsettled. Most surgical interventions have to face this uncertainty, but this issue may become extremely significant for interventions designed to decrease the impact of specific signs and symptoms such as those found with urinary incontinence. Without established and generally accepted criteria, the quality of study outcomes reporting for urinary incontinence will never develop to the level seen for other symptom or disease states such as oncologic outcomes. Zullo and colleagues reported a well-designed, randomised, prospective, controlled study to compare tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for the treatment of stress urinary incontinence (SUI). The investigators concluded that both techniques appear to be equally effective in the surgical treatment of SUI but TVT-O has a shorter operative time and a lower overall perioperative complication rate. A potential critique is that minimal requirements for reporting of results include not only certain specified elements with which to assess the procedure outcomes, such as perioperative complications and hospital length of stay, but also longevity of data follow-up. In this study the follow-up remains short and we cannot forget the individual s response to the surgical intervention for the treatment of SUI and the impact that follow-up has on a single outcome criterion. Despite the enthusiasm of doctors and patients for new minimally invasive therapies for the treatment of SUI, the level of evidence for efficacy and grade of recommendation for new products remain low. Recently, industry developed several new devices for the minimally invasive treatment of SUI and used an army of salespeople to sell them before another new product appeared on the market. This strategy ignores the fact that the longterm outcome and the cost benefit ratio are often not known until that procedure has been applied to hundreds of patients and compared, by welldesigned studies, with the existing standard of excellence. Every new device for the treatment of SUI seems to produce a dramatically beneficial clinical effect, which is far more effective than any existing options, and has few unwanted effects. Unfortunately, history shows that most of the new techniques and new devices fall short of this ideal. To avoid misinterpretation, we need high-quality studies such as this one by Zullo et al. Health care providers, however, have to allocate some of their time for rigorous evaluation of new techniques before simply introducing them into practice and all providers must find in their daily clinical practice valuable data on efficacy and safety of the new techniques. Editorial Comment Konstantinos Hatzimouratidis, 2nd Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Greece kchatzim@med.auth.gr The retropubic placement of suburethral tensionfree vaginal tape (TVT) has revolutionised treatment of female stress incontinence being a minimally invasive procedure associated with high efficacy rates. The trans-obturator approach (TVT-O) has been proposed to have several advantages over the retropubic approach. It is associated with similar efficacy rates but avoids the need for cystoscopy (the main reason for operative time reduction) while major complications (retropubic haematomas and bladder, vascular, or bowel injuries) are extremely rare [1]. However, long-term data are still lacking. Only a few studies included a head-to-head direct comparison of the two procedures [2 5]. Comparative trials are extremely important before suggesting one method over the other. In this prospective, randomised, clinical trial, the authors compared the classic TVT to the relatively new TVT-O approach (inside-out) with a 12-mo follow-up. No major complications (bladder and vascular injury or haematomas) were recorded in the TVT-O group compared to TVT. However, there were no significant differences in terms of blood loss, complications, hospital stay, and time to return to normal activities between the two groups. The TVT-O procedure was clearly superior to TVT in terms of operative time. Efficacy rates were similar. Nevertheless, the authors assessed cure rates using a visual analogue scale instead of adapting validated

9 1384 european urology 51 (2007) questionnaires such as the Incontinence Impact Questionnaire (IIQ-7), the Urogenital Distress Inventory (UDI-6), or the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). This study shows that both procedures are equally efficacious in the short term, but the trans-obturator approach is simpler, quicker, and safer. Efficacy in the long term remains to be established. More studies including larger series of patients as well as long-term efficacy data are necessary to confirm these facts. If this is the case, the classic retropubic approach may be removed from the urologic armamentarium. References [1] Roumeguere T, Quackels T, Bollens R, et al. Transobturator vaginal tape (TOT 1 ) for female stress incontinence: one year follow-up in 120 patients. Eur Urol 2005;48: [2] Andonian S, Chen T, St-Denis B, Corcos J. Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results. Eur Urol 2005;47: [3] Liapis A, Bakas P, Giner M, Creatsas G. Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. Gynecol Obstet Invest 2006;62: [4] Morey AF, Medendorp AR, Noller MW, et al. Transobturator versus transabdominal mid urethral slings: a multiinstitutional comparison of obstructive voiding complications. J Urol 2006;175: [5] David-Montefiore E, Frobert JL, Grisard-Anaf M, et al. Perioperative complications and pain after the suburethral sling procedure for urinary stress incontinence: a French prospective randomised multicentre study comparing the retropubic and transobturator routes. Eur Urol 2006;49:133 8.