European Urology 46 (2004)

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1 European Urology European Urology 46 (2004) Surgical Treatment of Female Stress Urinary Incontinence with atrans-obturator-tape (T.O.T. 1 )Uratape 1 :ShortTerm Results of a Prospective Multicentric Study P. Costa a,*, P. Grise b, S. Droupy c, F. Monneins d, C. Assenmacher e, P. Ballanger f, J.F. Hermieu g, V. Delmas g, L. Boccon-Gibod g, C. Ortuno h a Urology Department, Academic Hospital CAREMEAU, Place du Pr DEBRE, Nîmes Cedex 09, France b Urology Department, Hospital Nicole, Rouen, France c Urology Department, Hospital Bicêtre, Le Kremlin-Bicêtre, France d Urology Department, Hospital of Gonesse, Gonesse, France e Urology Department, Saint-Elisabeth Clinic, Brussels, Belgium f Urology Department, Hospital Pellegrin, Bordeaux, France g Urology Department, Hôpital Bichat, Paris, France h Medical Clinical Research, Mentor-Porgès Company, France Accepted 10 March 2004 Available online 18 March 2004 Abstract Objective: The aim of the study was to assess the efficacy and safety of a new minimally invasive surgical procedure using the Trans-Obturator-Tape Uratape 1 to treat female stress urinary incontinence. Patients and Methods: 183 women with stress urinary incontinence (SUI) associated with urethral hypermobility, underwent the T.O.T. 1 procedure (October 2001 to March 2003). 26 patients were previously operated for incontinence. 26 patients were operated at the same time for their genital prolapse. Mean age was 56 years (29 87). 50/183 patients were having mixed incontinence. A non-elastic, polypropylene tape (UraTape 1, Mentor-Porgès) with a silicon coated central part was placed under the mid-urethra. The surgical placement technique utilises a trans-obturator percutaneous approach. All patients underwent post-operative clinical examination, cough-stress test (full bladder), uroflowmetry, and post-voiding residual assessment. Results: Mean follow-up was 7 months (1 21). At 1 year follow-up 80.5% of the patients were completely cured and 7.5% were improved. The overall peri-operative complication rate was 2.2% with no vascular, nerve or bowel injury. 6 patients (3.3%) had post-operative urinary retention. Conclusion: The present multicentric study confirms the results obtained by the instigator of the technique, E. Delorme, and allows us to consider T.O.T. 1 as an effective and safe technique for the treatment of female stress urinary incontinence, alone or in combination with prolapse repair. # 2004 Published by Elsevier B.V. Keywords: Urinary incontinence; Uratape 1 ; Surgical treatment 1. Introduction The surgical treatment of female stress urinary incontinence (SUI) due to urethral hypermobility has * Corresponding author. Tel. þ ; Fax: þ addresses: pierre.costa@chu-nimes.fr, pierre.costa@wanadoo.fr (P. Costa). been deeply changed a few years ago when Ulmsten described a new concept in 1995: the mid-urethral support without tension [1]. Since that first article, worldwide publications testified to the interest of this new surgical approach called TVT (tension-free vaginal tape). The different publications are showing cure rates of more than 80% [2 5]. Some complications have nonetheless been reported. There can be minor complications such as bladder /$ see front matter # 2004 Published by Elsevier B.V. doi: /j.eururo

2 P. Costa et al. / European Urology 46 (2004) perforations, but others, rarer, are potentially serious: vascular injuries and bowel injuries. A Finnish serie of 1455 women treated for SUI demonstrated few vascular injuries (venous lacerations were the most frequent injury reported) [6] while Zilbert and Farnell [7] reported a case of right external iliac artery injury. In addition, two deaths due to serious vascular injuries have been reported to the manufacturers [5]. Three bowel perforations have also been reported [8,9,18]. Most of these complications seem to be related to the penetration of the retro-pubic space. A new surgical approach has been imagined aiming to keep the same position under the mid-urethra as that of TVT, and its efficacy, by reducing or even eliminating the complications related to the penetration of the retro-pubic space. The original aspect of this new technique described by E. Delorme in 2001 is to place the tape between the two obturator foramen, creating a real hammock supporting the urethra instead of a urethral suspension as with TVT [10]. An open multicentric prospective study (7 centers) has been designed with three main aims: To verify that the position of the tape between the two obturator foramen is efficient in treating stress urinary incontinence. To obtain a decrease or even an elimination of the most common complications observed with the retro-pubic route. To assess the effect of this more anatomic urethral support on the voiding parameters. Seven surgical teams experienced in the retro-pubic route accepted to participate in this study. All the patients files were analysed by a centralised structure. 2. Material and methods From October 2001 to March 2003, 183 consecutive patients with proven stress urinary incontinence underwent the Trans- Obturator-Tape (T.O.T. 1 ) procedure. The study was designed as a prospective open observational study. All seven departments were using the same case report form. All patients included had been indicated for surgical treatment of their SUI with or without a combined procedure for prolapse. Main criteria for selection were: visible SUI and urethral hypermobility at the physical examination, absence of acontractile bladder or obstruction. The pre- and post-operative evaluation included the medical history, uro-gynaecologic examination, urodynamics, a stress test (cough provocation), a Marshall Test, and the assessment of postoperative efficacy and safety at 1, 6, 12, 18 and 24 months. The pre-operative urodynamic investigation consisted in a urethrocystometry, urethral pressure profiles and urine flow measurements. Peri-operative complications were also recorded on the case report form. Urethral mobility was assessed by direct visualisation at cough test during the gynaecologic examination. Cure was defined as the absence of subjective complaint of urine leakage, and the absence leakage on cough stress testing. Patients were considered improved when they had a decrease of stress incontinence. Other cases were considered as failures. 3. Patients In total 183 patients were operated on according to the T.O.T. 1 technique described by E. Delorme [11]. The T.O.T. 1 procedure was performed under spinal or general anaesthesia in 56 and 127 cases respectively. 97/183 patients suffered from genuine stress incontinence, 35/183 patients with stress incontinence reported also urgencies, and 50/183 patients had mixed incontinence (combining stress and urge leakages). Patient characteristics are shown in Table /183 (83.6%) patients have never been operated upon, 47 patients (25.7%) had undergone a previous hysterectomy and 26/183 had recurrent stress urinary incontinence (14.2%). Previous surgical procedures are described in Table 2. T.O.T. 1 was combined with other procedures in 26 patients. 15 patients had a sacrocolpopexy (laparoscopic 8, open 7), and 11 patients had a combined vaginal procedure (Marion Kelly 3, hysterectomy 1, rectocele cure 7). The physical and urodynamic pre-operative characteristics of the patients are summarised in Table 3. Table 1 Patient characteristics Age at procedure (years) 56 (29 87) Menopausal 52% Parity 2.5 (1 8) Body mass index 26.9 ( ) Previously operated for prolapse 11.5% Hysterectomy 25.7% Previously operated for incontinence 14.2% Pure stress incontinence 53% SUI and urgencies 19.1% Mixed incontinence 27.3% Values are given as median (range) or percent. Table 2 Previous surgical procedures Burch 14 TVT 6 Stamey 2 Marchall-Marchetti 1 Others 3 Number of patients

3 104 P. Costa et al. / European Urology 46 (2004) Table 3 Physical and urodynamic pre-operative characteristics Physical examination Positive Marshall test 164 Negative Marshall test 4 Missing data 15 Urodynamics No bladder overactivity 152 Bladder overactivity 22 Missing data 9 Maximum urethral closure pressure (MUCP at rest, cmh 2 O) >50 67 Missing data Surgical procedure The Trans-Obturator-Tape (T.O.T. 1 ) was carried out in patients in the lithotomy position, thighs on abdomen, and buttocks over the end of the table to free the perineum. A Foley catheter was inserted to completely empty the bladder. A 2-cm long sagittal incision was made in the vaginal wall, starting 0.5 cm from the external urethral meatus. A bilateral para-urethral dissection of the vagina was done in the direction of the ischio-pubic ramus. This dissection should allow the surgeon to introduce his index finger and to palpate the posterior part of the ischio-pubic ramus and the internal obturator muscle. Two minimal cutaneous incisions were made in the inferior internal part of the obturator foramen at the level of a horizontal passing at least 1 cm over the urethral meatus and a maximum at the level of the clitoris. The tunneller was passed through the obturator membrane and its tip was located with the index finger placed in the vaginal dissection. Then the tunneller tip was brought out into the vaginal incision using the finger to guide its path. The urethra was protected with the finger. The tape was introduced into the eye of the tunneller and exteriorised by pulling the tunneller out. An identical procedure was repeated on the other side. A cystoscopy was performed by some surgeons at the beginning of their experience but was rapidly abandoned. The tape was adjusted without any tension nor any contact with the urethra: there should be visible space between the urethra and the tape. No intra-operative cough test was performed. The excess of tape was cut N off at the obturator incisions. Vaginal incision was closed with interrupted sutures of gradually resorbable thread. Obturator incisions were closed with one resorbable suture. The Foley catheter has been left in place for 24 hours. Recovery of micturition was assessed by uroflowmetry and post-voiding residual volume ultrasonic measurement. Patients were discharged from the hospital the day after surgery. 5. Results Mean follow-up was 7 months (1 21). There were very few peri-operative complications: 1 bladder perforation, 2 urethral perforations and 1 lateral vaginal perforation (sulcus) occurred, corresponding to a complication rate of 2.2% (4/183). No bleeding, no nerve, no bowel or vascular injury was reported. Results on continence cure rates are shown in Table 4. For the women who underwent concurrent prolapse surgery (N ¼ 26), 1 was lost for follow-up, 23 (92%) were cured and 2 (8%) failed. Regarding previously operated patients for SUI, 2 among 26 were lost for follow-up, 19 (79%) were cured, 3 (12.5%) were improved and 2 (8.5%) failed. Among the 183 operated patients, 7 have been lost for follow-up and, 17 were not cured of their incontinence. Among these 17 patients: the tape had to be removed because of vaginal extrusion in 3 cases and urethral erosion in 2 cases (total of 5 cases); 4 patients were having history of multiple previous surgeries for incontinence including TVT for 3 of them. Pre-operatively 85/183 patients complained about urgencies and among them 50/85 reported urge leakages. Post-operative de novo urgency has been reported by 4 patients with 2 patients complaining of leakages (5%). On the other hand some patients with pre-operative urgencies were improved (see Table 5). Table 4 Cure rates over time Follow-up <3 months, N ¼ months, N ¼ 130 Cured 85.6% 83% Improved 7.9% 5.4% Failed 3.9% 7.7% Missing data 2.4% 3.9%

4 P. Costa et al. / European Urology 46 (2004) Table 5 Post-operative evolution of urge feelings and urge leakages Immediate post-operative voiding disorders have been reported in 7 patients, treated by immediate release of the tape in 3 (surgical 2, urethral dilatation with Hegar bougie 1), and temporary intermittent self-catheterisation in 4. Among these 7 patients 5 patients recovered a normal micturition (based on uroflowmetry) including the 3 with tape release. Comparison between pre- and post-operative data uroflowmetry showed a slight decrease in the maximum flow rate ( p < 0:05), with no changes in the voiding time and residual (see Table 6). At 1 year follow-up, two patients had voiding difficulties with residuals 100 ml. None of the patients had a maximum flow rate Q max <15 ml/s. 6. Discussion Disappearance Same Decrease Urgency Urge leakages Table 6 Comparison of uroflowmetry before and after T.O.T. 1 Uroflowmetry parameters Pre-operative, N ¼ 136 Postoperative at >12 months follow-up, N ¼ 45 Worsening Flow rate (ml/s) <0.05 Voiding time (s) NS Residual (ml) NS Data are presented as mean standard deviation; NS, not significant. E. Delorme has published two articles [10,11] reporting that T.O.T. 1 is a safe and effective surgical procedure for the treatment of female stress urinary incontinence. This paper reports, on 130 patients, a cure rate at 6 months follow-up after T.O.T. 1 of 83%, and 5.4% of improvement (Table 4). Regarding the overall population, 17 patients among 176 are considered as failures (9.6%). Among them 5 patients have seen a recurrence of their incontinence after removal of the tape due to vaginal extrusion in 3 cases and urethral erosion in 2 cases. Two urethral injuries occurred in the initial part of the training and have not been observed after. Vaginal extrusions of the tape were linked to the silicon part of the tape. Related to these complications the tape has been modified removing the silicone part (Obtape 1 ). Using Obtape 1 p the same 7 centres have operated 139 patients with less than 1% of vaginal extrusion of the tape which is equivalent to other polypropylene tapes. Moreover, 4 of the 17 failed patients were previously multiple operated, 3 with TVT Urodynamic evaluation and physical examination of these 3 patients showed a severe ISD allowing us to consider that it was not a good indication of another sub-urethral tape. Artificial urinary sphincter [13] or bulking treatment would have been more appropriate. Finally, 8 patients (4.5%) could be considered as indisputable failures of the T.O.T. 1 concept. As this registry doesn t include a quality of life questionnaire, we cannot consider that the improved patients (7.5%) are successful even if some of those patients spontaneously have claimed their satisfaction. A quality of life questionnaire has been added to the Obtape 1 registry. More detailed results on efficacy and quality of life will be provided in a future report. These results are very closed to those reported in most of the observational series of TVT and not less than the objective cure rates quoted for the randomised controlled trial of colposuspension versus TVT [19]. Indeed, two comparative studies of T.O.T. 1 versus TVT recently reported [14,15] showed no difference in efficacy. T.O.T. 1 represents an easily performed and reproducible procedure. There is no difference among the 7 centres involved in this registry and foreign teams have identical results [16]. The second major aim of this study was to confirm the hypothesis that T.O.T. 1 would dramatically reduce the intra-operative complications avoiding passing in the retro-pubic space. 183 patients are available for analysis of the intraoperative complications. The overall complication rate is 2.2% (1 bladder perforation, 2 urethral perforations and 1 vaginal lateral perforation) which is lower than the rate reported with TVT which can be up to 15% [3]. All these complications disappeared with the operative surgical training, which incorporated the use of the index finger into the vaginal incision. Since the surgeon introduces the finger in the vaginal incision in order to protect the urethra, no urethral injury has been reported. T.O.T. 1 does not expose to the risk of vascular, nerve or bowel injuries confirming the interest of the perineal approach. Regarding post-operative disorders, the obstruction seems to be linked to an excessive tension of the tape. Three patients recovered a normal micturition after the treatment of the obstruction (tape release). The other obstructed 4 patients were all previously operated and 2 of them had a significant pre-operative residual (>100 ml).

5 106 P. Costa et al. / European Urology 46 (2004) No voiding disorders has been reported in primary cases with the T.O.T. 1 implanted without any tension. In this series de novo incontinence was observed only in 2 patients (5%). De novo urgency has been reported from 0% up to 20.6% in patients operated with TVT [12]. In our patients symptoms of urgency and urge incontinence disappeared in 56.3% and 48.3% respectively (Table 5) which is in accordance with other studies using sling procedures [2,17]. Stress incontinence is frequently associated with coexisting genital prolapse, so it is important that pelvic reconstructive surgery can be done at the time of incontinence surgery. In our study 26 patients (13%) of the patients with urinary stress incontinence presented with associated anatomic defects at different vaginal sites. Thus, T.O.T. 1 was combined with a variety of pelvic reconstructive procedures without observing any difference in the cure rate. 7. Conclusion The present multicentric study confirms the results obtained by the instigator of the technique, E. Delorme, and allows us to consider that T.O.T. 1 is an effective and safe technique for the treatment of female stress urinary incontinence, alone or in combination with prolapse repair. Acknowledgements The authors thank the Mentor-Porgès company for the technical support provided for the registry. 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] Meschia M, Pifarotti P, Bernasconi F, Guercio E, et al. Tension- Free Vaginal Tape: Analysis of outcomes and complications in 404 Stress Incontinent Women. Int Urogynecol J 2001;(Suppl 2): S24 7. [3] Lebret T, Lugagne PM, Hervé JM, Barré P, et al. Evaluation of Tension-Free Vaginal Tape procedure. Eur Urol 2001;40: [4] Ulmsten U, Johnson P, Rezapour M. A three-year follow-up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obst Gynaecol 1999;106: [5] Boustead GB. Review. The tension-free vaginal tape for treating female stress urinary incontinence. BJU Int 2002;89: [6] Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 2002;81:72 7. [7] Zilbert AW, Farrell SA. External iliac artery laceration during tension-free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct 2001;12: [8] Brink DM. Bowel injury following insertion of tension-free vaginal tape. S Afr Med J 2000;90: [9] Peyrat L, Boutin JM, Bruyere F, Haillot O, et al. Intestinal perforation as a complication of Tension-Free Vaginal Tape procedure for urinary incontinence. Eur Urol 2001;39: [10] Delorme E. Trans-obturator urethral suspension: a minimally invasive procedure to treat female stress urinary incontinence. Progrès Urol 2001;11: [11] Delorme E, Droupy S, De Tayrac R, Delmas V. Trans-obturator tape Uratape 1, a new minimally invasive treatment for female urinary incontinence. Progrès Urol 2003;13: [12] Peschers UM, Tunn R, Buczkowski M, Perucchini D. Tension-free vaginal tape for the treatment of stress urinary incontinence. Clin Obstet Gynecol 2000;43: Review. [13] Costa P, Mottet N, Rabut B, Thuret R, Ben Naoum K, Wagner L. The use of an artificial urinary sphincter in women with type III incontinence and a negative Marshall test. J Urol 2001;165: [14] De Tayrac, Deffieux X, Droupy S, Chauveaud-Lambling A, Calvanèse-Benamour L, Fernandez H. A prospective randomized trial comparing tension free vaginal tape and trans-obturator suburethral tape for surgical treatment of stress urinary incontinence. Int Urogynecol J 2003;S [15] Mansoor A, Védrine N, Darcq C. Surgery of female urinary incontinence using trans-obturator tape (TOT): a prospective randomised comparative study with TVT. (Abstract of the ICS) Neurourol Urodyn 2003;22: [16] Kocjancic E, Costa P, Wagner L, Crivellaro S, Gherzi R, Gontero P, et al. Safety and efficacy of the trans-obturator tape in the treatment of stress urinary incontinence. (Abstract of the ICS) Neurourol Urodyn 2003;22: [17] Mcguire EJ. Mixed symptomatology. BJU Int 2000;85: [18] Ben Amna M, Randrianantenaina A, Michel F. Colic perforation as a complication of Tension-Free Vaginal Tape procedure. J Urol 2003; 170:2387. [19] Ward KL, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325(7355):67. Editorial Comment F. Haab, Paris, France This paper on the transobturator technique raises the interesting and crucial problem on what methodology should be chosen to evaluate surgical procedures proposed to correct stress urinary incontinence (SUI). The introduction of the TVT procedure has definitively opened a new era for surgical treatment of female SUI. Since the description of the original procedure many new techniques based on the same concept have been published. The question that has to be raised is how these new procedures should be evaluated before their widespread. Several techniques

6 P. Costa et al. / European Urology 46 (2004) of investigation and evaluation should be considered [1]. Randomized controlled trials (RCT) allowing direct comparisons in between techniques have been recommended as the gold standard. However, even RCT have their own weaknesses and limitations when the objective is to assess surgical techniques. First, is it fair from a patient perspective to be included in a randomized trial without knowing some of the results of the new procedure. Second, randomized controlled trials are very expensive and in most cases industry-dependent. Furthermore, these trials could be biased by many factors likewise heterogeneity amongst centres and modification of patient perception when they know that they are part of a medical trial. Moreover, when dealing with innovative surgical techniques sometimes the original technique could be slightly modified before the end of the trial leading to obsolete data. As an example the randomized trial that has been conducted in UK to compare TVT and Burch colposuspension demonstrates how difficult is the analysis of the data obtained [2]. In that trial even if the number of patients recruited was large and the methodology of evaluation was totally appropriate, however the overall results given by the trial were somewhat disappointing. No major difference was seen between the two techniques studied, and this was probably related to the heterogeneity of the results in between centres and to the number of drop-outs in both groups. Furthermore regarding the morbidity aspects it was almost impossible to draw valid conclusions on the most severe complications with both techniques. Registries or tracker studies are bringing very useful scientific information that are very helpful in addition to randomized trial for evaluation of surgical techniques designed for incontinence [1]. This methodology allows a continuous follow-up of the data, the results are much closer to the real life since a more representative spectrum of surgeons could be included in such research. Furthermore, this methodology is the only way to get prevalence data on rare complications or safety issues. Regarding the morbidity aspects of TVT, the nationwide analyses performed in Scandinavia or in Austria that were using a registry compilation of cases were far more informative than the randomized controlled trial performed so far [3,4]. Moreover, when a surgical technique has to be slightly modified with time, it is still possible to follow the changes and this is not possible with randomized controlled trials. However, in opposition to randomized controlled trials, registries do not allow direct comparisons between techniques. For all these reasons we consider that surgical technique in the field of urinary incontinence should be evaluated using three different types of studies. First, an explanatory trial corresponding more or less to proof of concept studies should be carried to demonstrate the safety and overall efficacy of the study. Secondly pragmatic studies should be carried out. In that context registries or eventually tracker studies could be performed to have a comprehensive and extensive evaluation of the surgical procedures considered. In that context the duty of our scientific societies will be to decide what outcome measures should be used. In parallel to this, randomized controlled trials should be conducted to compare the new technique to the previous ones for some specific aspects e.g. medico-economics, or very specific complications that may have a significant prevalence like bladder perforation rate or post operative urinary retention. These studies should probably be derived from the results obtained with the registries. References [1] Lilford R, Braunholtz J, Harris J, Gill T. Trials in surgery. Br J Surg 2004;91:6 16. [2] Ward K, Hilton P. Prospective multicentre randomized trial of tensionfree vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325(7355):67. [3] Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 2002;81(1):72 7. [4] Tamussino K, Hanzal E, Kolle D, Ralph G, Riss P. The Austrian tension free vaginal tape registry. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Suppl 2):S28 9.