Objective and Subjective Cure Rates after Trans-Obturator Tape (OBTAPE 1 ) Treatment of Female Urinary Incontinence

european urology 49 (2006) 373 377 available at www.sciencedirect.com journal homepage: www.europeanurology.com Female Urology Objective and Subjective Cure Rates after Trans-Obturator Tape (OBTAPE 1 ) Treatment of Female Urinary Incontinence Bruno Deval a, *,Jérome Ferchaux b, Richard Berry a, Sandro Gambino a, Calin Ciofu b, Arash Rafii a, François Haab b a Service de Gynécologie, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris (AP-HP), Université Paris VII, Clichy, France b Service d Urologie, Hôpital Tenon, Assistance Publique - Hôpitaux de Paris (AP-HP), Université Paris VII, Clichy, France Article info Article history: Accepted November 16, 2005 Published online ahead of print on December 20, 2005 Keywords: Urinary incontinence Surgical treatment TOT Abstract Objective(s): To evaluate the safety and efficacy of a thermally bonded nonwoven polypropylene mesh in a transobturator suburethral tape procedure (OBTAPE 1, Mentor-Porges, Le Plessis Robinson, France) for women with stress urinary incontinence. Methods: Between January 2003 and January 2005, 129 consecutive women (mean age 57.2 years) underwent OBTAPE 1 in two academic centers. All the patients had stress urinary incontinence preoperatively. Detrusor instability was ruled out by cystometry. The women were evaluated 1, 6 and 12 months postoperatively. The objective cure rate was evaluated by clinical examination and the subjective cure rate was assessed using the KHQ and BFLUTS questionnaire. Results: Mean follow-up was 17.2 4.7 months (range 4 to 28 months). The objective and subjective cure rates were respectively 89.9% and 77.5%. Most of the patients received general anesthesia (85.3%). Urinary retention was observed in two women (1.5%), necessitating tape adjustment. Voiding difficulties were observed in 7 cases (5.4%) necessitating intermittent self-catheterization for 4.2 2.4 days (range 1 to 7 days). Seven patients developed vaginal erosion (one with vaginal extrusion, and two with an obturator abscess). Complete mesh removal was necessary in 6 patients, four of whom had recurrent stress urinary incontinence. Conclusions: Our results suggest that the OBTAPE 1 is an effective treatment for women with stress urinary incontinence. However, vaginal mesh erosion occurred in 6.2% of women, and this implies the need for careful follow-up. # 2005 Elsevier B.V. All rights reserved. * Corresponding author. Service de gynécologie, Hopital Beaujon, 100 Boulevard du Général Leclerc, 92110 Clichy, France. Tel. +33 1 40 87 52 21; Fax: +33 1 47 31 35 27. E-mail address: bruno.deval@bjn.ap-hop-paris.fr (B. Deval). 0302-2838/$ see front matter # 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2005.11.012

374 european urology 49 (2006) 373 377 1. Introduction An estimated 3 million French women suffer from stress urinary incontinence. Only a small proportion of these women (about 10 000 annually) seek surgical treatment [1]. Suburethral tapes can be placed by the retropubic or transobturator route. Tension-free vaginal taping (TVT) has a high success rate, but there are concerns over its safety (risk of injury to the bladder or major blood vessels, and voiding dysfunction) [2,3]. To avoid these complications, Delorme developed a new technique in 2001, called transobturator taping (TOT). The principle is to position the tape between the two obturator foramens, from outside to inside [4]. The results of TOT are very similar to those of TVT [5,6]. In the trials conducted by Delorme et al. [6] and Costa et al. [5], the TOT procedure was safer and caused less frequent bladder outlet obstruction. However, follow-up was short and different tapes were used [5,7]. We report the mid-term results obtained with a fusion-welded, non woven, non knitted polypropylene tape (OBTAPE 1 ) for the treatment of female stress urinary incontinence. We focused on the morbidity and efficacy of the procedure, including intraoperative and postoperative complications, objective and subjective results, and the surgeons opinion relative to existing techniques. 2. Patients and methods This longitudinal investigational device exemption study involved 129 consecutive patients with a history of stress urinary incontinence associated with urethral hypermobility. The primary objectives were to establish the safety and efficacy of the TOT procedure with OBTAPE 1 (Mentor-Porges, Le Plessis Robinson, France), as first described by Delorme et al. [8]. Patients were operated on between January 2003 and January 2005 in two French academic centers (Gynecology Unit, Beaujon Hospital; Urology Department, Tenon Hospital). All the patients received intravenous antibacterial prophylaxis (cefazolin, 2 g) at the beginning of surgery, no vaginal preparation was necessary the day before the surgery. The TOT procedure was carried out as described by Delorme et al. [8]. A Foley catheter was always inserted for 24 hours for bladder drainage, and was removed when the post-void residual volume was less than 150 ml. If the post-void residual volume was more than 150 ml, intermittent catheterization was proposed. Pre-, peri- and post-operative evaluations were done using the same protocol in the two centers. All the patients were available for post-operative evaluation (72 patients in the gynecology department, 57 patients in the urology department). Preoperative evaluations consisted of a history-taking, a physical examination, a voiding diary, a quality-of-life questionnaire and urodynamic assessments. The patients estimated the severity of their incontinence symptoms on a visual analog scale with scores ranging from 0 to 10 (0 corresponding to continence). All participants had normal neurological findings. All had clinical signs of urethral hypermobility, with an abnormal cotton swab test (greater than 30 degrees) and a bladder capacity of at least 250 ml. All procedures were performed by two surgeons (FH and BD). Postoperative fever was recorded if the temperature was more than 38 8C on two consecutive measurements at least 6 hours apart, excluding the first 24 hours. The incidence of perioperative and postoperative complications, febrile morbidity, analgesic requirements, and length of the postoperative hospital stay were recorded. Residual urine volume was evaluated after withdrawal of the Foley catheter. Voiding difficulties were defined as a residual urine volume of 150 ml or more, checked by postvoid catheterization. Early postoperative complications were defined as those occurring during the first 15 days, and late postoperative complications as those that persisted or were diagnosed more than 15 days after the operation. Only patients with a follow-up of at least 6 months were included in this analysis. Post-operative follow-up visits were routinely scheduled at 1, 6 and 12 months. Patients were considered objectively cured if they had no stress incontinence (as shown by clinical and urodynamic examinations), no incontinence during the stress provocation test, and no urinary retention (or a residual urine volume of less than 150 ml). Patients were considered objectively improved if no incontinence occurred during the stress provocation test. All other cases were recorded as objective failures. Patients were considered subjectively cured, improved or unchanged on the basis of their responses to the Kings Health Questionnaire (KHQ) [9] and the Bristol Female Lower Urinary Tract Symptom Questionnaire (BFLUTS) [10]. Statistical analysis was based on Student s t test for parametric and non parametric continuous variables, and the chi-square test or Fisher s exact test for categorical variables. p values less than 0.05 were considered to denote significant differences. This trial was not support by the industry. 3. Results 3.1. Characteristics of the patients (Table 1) The mean severity score was 8 2.5 (range 3 to 10). Thirty-two patients (24.8%) had previously had hysterectomy and 19 patients (14.7%) had previously had incontinence surgery. Those latter procedures Table 1 Characteristics of women undergoing OBTAPE 1 Characteristics Patients (N = 129) Mean age SD (y) (range) 57.1 12.6 (22 88) Mean parity SD (range) 2.2 1.2 (0 8) Body mass index >25 29 (22.5%) Body mass index >30 20 (15.5%) Stress incontinence (%) 78 (60.5%) Mixed incontinence (%) 51 (39.5%) Previous incontinence surgery (%) 20 (15.5%)

european urology 49 (2006) 373 377 375 included Burch colposuspension (7), TVT (6), Kelly plication (1) and SPARC (5). One patient had had two procedures. Seventy-eight (60.5%) patients had isolated stress incontinence, 70 (54.3%) patients also reported urinary urgency, and 51 (39.5%) patients had mixed stress and urge incontinence. The mean operating time was 9.4 1.4 minutes (range 8 to 15 min). General and spinal anesthesia were used in 109 (84.4%) and 20 (15.6%) patients, respectively. OBTAPE 1 insertion was combined with other procedures in 27 patients (20.9%): 6 patients had open sacrocolpopexy and 21 patients had a combined vaginal procedure (hysterectomy 9, rectocele 2, cystocele 4, colpocleisis 2, sacrospinofixation 4). 3.2. Complications of the OBTAPE 1 procedure (Table 2) The mean hospital stay was 2.2 1.5 days (range 1 to 9 days). One left lateral vaginal perforation occurred (intra-operative complication rate 0.6%). No bleeding and no nerve, bowel, bladder, ureteral, or vascular injuries were reported. Bladder catheterization lasted a mean of 1.3 1.1 days (range 1 to 10 days). Urinary retention was observed in two women (1.5%), necessitating tape adjustment. Voiding difficulties, with a residual volume of 150 ml or more, was observed in 7 cases (5.4%), necessitating intermittent self-catheterization for 4.2 2.4 days (range 1 to 7 days). Post-operative urinary tract infections were diagnosed in 7 women (5.4%). De novo urge symptoms occurred in 12 women (9.3%), often more than 4 weeks postoperatively. Of the 70 women with preoperative urge symptoms, 24 (34.2%) had persistent urge symptoms postoperatively. Seven patients were diagnosed with vaginal erosion, and one of these women also had vaginal extrusion (Fig. 1). None of the patients had uretral erosion. Six patients had urodynamic stress incontinence, and two had mixed urinary continence. Table 2 Complications of the OBTAPE procedure Complications T0T (N = 129) Perioperative complications Vaginal injury 1 (0.6%) Early post-operative complications Urinary tract infection 7 (5.4%) Urinary retention 2 (1.5%) Voiding difficulties lasting <15 days 7 (5.4%) Late post-operative complications De novo urge symptoms 12 (9.3%) Vaginal erosion 8 (6.2%) Obturator absess 2 (1.5%) Tape ablation 6 (4.6%) Fig. 1 Tape extrusion. Seven of these eight patients had only undergone the OBTAPE 1 procedure, while one had also had vaginal hysterectomy. None of the eight patients had relevant medical histories. Three patients had recurrent stress incontinence (TVT 2, SPARC 1), four had a vaginal discharge, one had simple perineal pain, and the patient with vaginal mesh extrusion was asymptomatic. The mean time to the onset of symptoms of vaginal erosion was 10 months (1 14 months). Nine and 17 months after the procedure, two patients developed left leg pain and oedema with purulent vaginal flow. Physical examination revealed vaginal erosion at midline, approximately 1 2 cm beneath the urethra. The tape was removed in both cases and antibiotics were prescribed. The tape was conserved in two patients and removed in six. The tape was always removed by the vaginal route. Four (66%) of these patients had a recurrence of SUI, with no change in urethral closure pressure. 3.3. Objective and subjective cure rates (Table 3, Fig. 2) Mean follow-up was 17 4.7 months (range 8 to 28 months), only patients with a follow-up of at least 6 months were included in this analysis. The overall Table 3 Objective and subjective cure rates after the OBTAPE 1 procedure Patients (N = 129) Objective cure rate Cure (%) 116 (89.9%) Failure (%) 13 (10.1%) Subjective cure rate Cure (%) 100 (77.5%) Improvement (%) 23 (18%) No change (%) 6 (4.5%)

376 european urology 49 (2006) 373 377 Fig. 2 Subjective cure rate after the OBTAPE procedure, based on a visual analog scale (VAS). The pre-/post-operative difference was statistically significant ( p < 0.0001). objective and subjective cure rates were 89.9% and 77.5%, respectively. The mean (SD) preoperative and postoperative visual analog scores were 8 2.5 and 0.9 2.2, respectively, reflecting a significant improvement ( p < 0.0001). The overall objective and subjective cure rates were significantly different ( p < 0.0001). No difference in the objective or subjective cure rates was observed between patients undergoing OBTAPE 1 alone and those who underwent additional procedures. The subjective cure rates in women with preoperative SUI and MUI were 72.2% and 80%, respectively. The objective and subjective cure rates in patients with de novo urge symptoms after surgery were 71% and 41%, respectively. 4. Discussion Since first reported by Delorme in 2001 [8], the TOT procedure has been widely adopted in France. This technique is now considered an alternative to TVT, mainly because of its high short-term success rate [5,6]. Our present results confirm the feasibility of the TOT procedure. The objective cure rate after a mean follow-up of 17 months was about 90%, in keeping with results from Delorme et al. [6] and Costa et al. [5]. Interestingly, the subjective cure rate was significantly lower than the objective cure rate, possibly owing to the use of different quality-of-life scoring systems. Indeed, most previous investigators used a modified quality-oflife assessment based mainly on visual analog scales. In contrast, the subjective cure rate was evaluated in our study by using the Kings and Bristol questionnaire covering physical effort, emotional feeling, sexual function, and personal satisfaction. We observed a high rate of vaginal erosion. This did not appear to be due to a lack of experience on the part of the two surgeons who performed the operations, or to the characteristics of the study population, but was probably related to the pore size of the TOT mesh. The reported incidence of vaginal erosion after incontinence surgery with TVT or TOT tapes ranges from 0.7% to 13.8% [7,11 13]. This wide range of values is mainly due to the use of different types of synthetic mesh. Using the TOT procedure, Costa et al. [5] and Domingo et al. [7] reported vaginal erosion rates of 3.8% and 13.8%, respectively. Both teams used URATAPE 1 (Mentor-Porges, Le Plessis Robinson, France), a synthetic mesh made of a fusion-welded, non woven, non knitted polypropylene with a 15-mm central (suburetral) siliconecoated section. A vaginal erosion rate of 6.7% was reported by But Igor. [14] with MONARC 1 polypropylene tape (American System Minneapolis, Minnesota). Using tape without silicone, we observed a vaginal erosion rate of 6.3%. This complication is probably due to subclinical infection of sling material, resulting in poor wound healing, despite antibiotic prophylaxis. Another possibility is rubbing between the mesh and the vaginal epithelium. Two vaginal erosions were complicated by obturator abscesses in our series. These infections were probably due to intra-vaginal exposure of the tape, as supported by symptom resolution after explantation. Two cases of perineal cellulitis after URATAPE 1 have been published by Caquant et al. [15]. Johnson et al. [16], while Connolly [17] described two cases of perineal cellulitis after TVT. The interval between the procedure and onset depends on the type of tape (2 and 11 days with TVT, 9 and 17 months with URATAPE 1, and 6 and 8 months in our series). Early postoperative complications in our series were related to retention (1.5%) and voiding difficulties (5.4%). Surgical treatment of stress urinary incontinence is inherently obstructive. P Costa et al. [5] and Delorme et al. [6] reported bladder outlet obstruction after TOT in 7 patients (3.8%) and 1 patient (0.6%), respectively, necessitating self-catheterization for 4 weeks. When obstruction is clinically apparent after TOT, immediate tape adjustment or release, by open vaginal incision, may be beneficial [5]. In our studies, both patients who had prolonged voiding dysfunction were successfully managed by sling adjustment, 21 and 24 days after the procedure, with no recurrence of SUI. This approach to postoperative voiding difficulties is unique to the suburetral tape procedure.

european urology 49 (2006) 373 377 377 In our study the complication with the strongest negative impact on quality of life was de novo urinary urgency, but its frequency was three times lower than reported with TVT [18]. De novo urge symptoms may be related to changes in paraurethral collagen metabolism and to sclerosis around the prolene tape. Falconer et al. [19] observed altered collagen metabolism induced by intravaginal slingplasty, and showed that this alteration was dependent on patient age and hormonal status. In conclusion, our results demonstrate that the TOT procedure with OBTAPE mesh is an effective treatment for stress urinary incontinence, and suggest that it is safer than retropubic approaches. However, it is noteworthy that 6% of patients had vaginal extrusion of the tape. Careful follow-up of these patients is important, as local complications can occur several months after the procedure. Sling explantation is recommended for extrusion or infected vaginal erosion. References [1] Deval B, El Houari Y, Rafii A, Levardon M. Pubo vaginal and sub urethral slings: review. J Gynecol Obstet Biol Reprod (Paris) 2002;31(2 Pt 1):131 43. [2] Nilsson CG, Falconer C, Rezapour M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol 2004;104(6): 1259 62. [3] Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol 2001;98(5 Pt 1):732 6. [4] Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape). A new minimally invasive method in the treatment of urinary incontinence in women. Prog Urol 2003;13(4):656 9. [5] Costa P, Grise P, Droupy S, Monneins F, Assenmacher C, Ballanger P, et al. Surgical treatment of female stress urinary incontinence with a trans-obturator-tape (T.O.T.) Uratape: short term results of a prospective multicentric study. Eur Urol 2004;46(1):102 6, discussion 106 7. [6] Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 2004; 45(2):203 7. [7] Domingo S, Alama P, Ruiz N, Perales A, Pellicer A. Diagnosis, management and prognosis of vaginal erosion after transobturator suburethral tape procedure using a nonwoven thermally bonded polypropylene mesh. J Urol 2005;173(5):1627 30. [8] Delorme E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11(6):1306 13. [9] Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 1997;104(12): 1374 9. [10] Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol 2004;191(1):73 82. [11] Leach GE, Dmochowski RR, Appell RA, Blaivas JG, Hadley HR, Luber KM, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol 1997;158(3 Pt 1):875 80. [12] Staskin DR, Choe JM, Breslin DS. The Gore-tex sling procedure for female sphincteric incontinence: indications, technique, and results. World J Urol 1997;15(5):295 9. [13] Barbalias G, Liatsikos E, Barbalias D. Use of slings made of indigenous and allogenic material (Goretex) in type III urinary incontinence and comparison between them. Eur Urol 1997;31(4):394 400. [14] But I. Vaginal wall erosion after transobturator tape procedure. Int Urogynecol J Pelvic Floor Dysfunct 2005 Jan 12. [15] Caquant F, Collinet P, Deruelle P, Lucot JP, Cosson M. Perineal cellulitis following trans-obturator sub-urethral tape Uratape. Eur Urol 2005;47(1):108 10. [16] Johnson DW, ElHajj M, EL OB-B, Miller HJ, Fine PM. Necrotizing fasciitis after tension-free vaginal tape (TVT) placement. Int Urogynecol J Pelvic Floor Dysfunct 2003;14(4): 291 3. [17] Connolly TP. Necrotizing surgical site infection after tension-free vaginal tape. Obstet Gynecol 2004;104(6):1275 6. [18] Holmgren C, Nilsson S, Lanner L, Hellberg D. Long-Term Results With Tension-Free Vaginal Tape on Mixed and Stress Urinary Incontinence. Obstet Gynecol 2005;106(1): 38 43. [19] Falconer C, Soderberg M, Blomgren B, Ulmsten U. Influence of different sling materials on connective tissue metabolism in stress urinary incontinent women. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Suppl 2):S19 23.