european urology 51 (2007)

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1 european urology 51 (2007) available at journal homepage: Female Urology Incontinence Efficacy Analysis of Trans-obturator Tension-free Vaginal Tape (TVT-O) Plus Modified Ingelman-Sundberg Procedure versus TVT-O Alone in the Treatment of Mixed Urinary Incontinence: A Randomized Study Chi-Mou Juang a,b, *, Ken-Jen Yu a, Pesus Chou b, Ming-Shien Yen a, Nae-Fong Twu a, Huann-Cheng Horng a, Wei-Lun Hsu a a Division of Urogynecology, Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan b Department of Epidemiology, Institute of Public Health, National Yang-Ming University, Taipei, Taiwan Article info Article history: Accepted January 5, 2007 Published online ahead of print on January 16, 2007 Keywords: Denervation Mixed incontinence Trans-obturator Warning time Please visit europeanurology to read and answer questions on-line. The EU-ACME credits will then be attributed automatically. Abstract Objective: The treatment of women with mixed urinary incontinence still poses a great challenge. This study evaluated surgical outcomes of combined trans-obturator tension-free vaginal tape (TVT-O) and modified Ingelman- Sundberg (IS) procedure for the treatment of mixed urinary incontinence. Methods: A randomized controlled trial was conducted. Ninety-six women diagnosed with mixed incontinence were randomized, with 49 allocated to TVT-O plus IS and 47 to TVT-O alone. A baseline urodynamic study and evaluation of quality of life (QOL) was conducted. The primary outcome measure was objective assessment of surgical outcomes, and the secondary outcome measure was warning time. Results: Objective surgical response rate was significantly higher in the TVT-O plus IS group than in the TVT-O alone group (84.8% vs. 62.8%; p = 0.019). Furthermore, a significant increase in warning time was observed in the TVT-O plus IS group (from 3.9 to 9.4 min; p = 0.006), but the increase in warning time within the TVT-O alone group was not statistically significant (from 4.3 to 4.5 min; p = 0.695). Postoperative complications were similar in the two study groups with respect to pelvic hematoma, nerve injury, sepsis, mesh erosion, and fistula formation. However, fever occurred more frequently in the TVT-O plus IS group (30.4% vs. 20.9%; p = 0.026). Conclusions: Mixed urinary incontinence can potentially be treated with a one-step combined surgery using trans-obturator sling plus modified IS procedure. Although surgical time and blood loss were significantly increased in the TVT-O plus IS group, overall morbidity was not significantly increased. # 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. No. 201, Section 2, Shih-Pai Road, Department of Obstetrics and Gynecology, Veterans General Hospital, Taipei, Taiwan. Tel ; Fax: address: cmjuang@yahoo.com.tw (C.-M. Juang) /$ see back matter # 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 1672 european urology 51 (2007) Introduction Mixed urinary incontinence is defined by the International Continence Society (ICS) as the complaint of involuntary leakage associated with urgency and also with exertion, effort, sneezing, or coughing [1]. Urge incontinence and mixed incontinence affect 12% and 24% of women older than 40 yr, respectively [2]. Although urge incontinence is a common and disabling disorder, the etiology of this condition is still poorly understood. Anticholinergic drug use is currently the mainstay for treatment of urge incontinence with predictable side effects [3]. Mixed urinary incontinence in women poses several problems for the clinician. First, it may be difficult from the patients history to properly identify the two components of the disorder, that is, urge and stress. Second, under usual conditions, the stress component can be easily identified, whereas the urge component may consist of either detrusor overactivity, urethral relaxation, or an uninhibited premature micturition reflex [4]. Surgical results of mixed urinary incontinence treated with tension-free vaginal tape (TVT) have been reported. After TVT, the urge component resolved in 63.1% of those with preoperative symptoms of mixed incontinence and 57.7% of those who used anticholinergics preoperatively no longer needed to do so. However, de novo urge incontinence symptoms developed in 9.1% [5]. The Ingelman-Sundberg (IS) bladder denervation procedure was originally described in the 1950s by the surgeon of the same name. This procedure was initially designed to disrupt most of the innervation from the inferior hypogastric plexus to the bladder to treat refractory urgency or urge incontinence, with a cure rate of 54 64% and limited complications [6 8]. Nowadays, for treatment of urge incontinence, surgical intervention like the IS procedure presupposes failure of behavioral therapy, physiotherapy, or pharmacotherapy [9]. Although TVT has been routinely used to treat female stress urinary incontinence with a high success rate, ranging from 84% to 95%, there are concerns regarding its operative safety in relation to bowel and major blood vessel injuries, bladder and urethral perforation, and postoperative voiding difficulties [10,11]. To avoid these complications, alternate approaches with a prepubic or transobturator passage of the tape have been developed and continence rates obtained with these routes have been roughly similar to those after using the classic retropubic TVT [12]. The trans-obturator tape was introduced by Delorme to address the risks of bladder, bowel, and major vascular injuries [13]. The initial series of 16 women, together with other comparative studies [14 17], would suggest that the technique is as efficacious as, and possibly safer than, retropubic techniques. Because the trans-obturator passage of TVT and the modified IS procedure have nearly the same incisional wound and dissection plane, we designed a combined surgical procedure to simultaneously perform TVT-O (Gynecare, Ethicon, NJ) and a modified IS procedure to treat patients with mixed incontinence. 2. Material and methods 2.1. Study design and enrollment The procedures used in this study were in accordance with the guidelines of the Helsinki Declaration on human experimentation. The study was approved by the Institutional Review Board (IRB). The initial design for this randomized study was based on the assumption of a 30% increase (from 60% to 90%) in the surgical response rate for a two-tailed a = 0.05 and power (1 b) = 0.8. The choice of 60% as a baseline was from surgical results of published literature [18], and 90% was a presumptive goal for surgical outcomes. The calculated minimum number of patients for each study group was 40. From February 2004 to December 2005, 132 of 216 consecutive patients referred to the urogynecology unit at the Department of Obstetrics and Gynecology, Taipei Veterans General Hospital with a chief complaint of urinary incontinence were diagnosed as having mixed urinary incontinence, as defined by the ICS. A potential enrollee would receive antimuscarinics at first. If she had a poor response to medication, she would be invited to join the current study. After an objective evaluation, 96 eligible patients were randomized. All enrollees underwent a physical examination, urine dipstick and culture, 1-h pad test, and baseline urodynamic examinations. Urodynamic assessment of incontinence was undertaken as recommended by ICS guidelines [19]. Baseline evaluation of quality of life (QOL) was conducted using the validated Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7) [20]. Each enrollee was asked to keep a 6-d urinary diary before surgical intervention and each follow-up visit. UDI-6 is a six-item questionnaire that assesses the life impact of urinary symptoms: frequent urination, urge incontinence, stress incontinence, urinary leakage, difficulty in emptying the bladder, and pain. It has a Likert-style scale: not at all, slightly, moderately, and greatly. IIQ-7 is a seven-item questionnaire that assesses different domains of QOL impairment. The domains evaluated were traveling far from home, social activities, emotional health, entertainment activities, household chores, feelings of frustration, and physical recreation. It has a 4-point scale: 0 = not at all, 1 = slightly, 2 = moderately, and 3 = greatly; thus a composite score could be computed with a higher score indicating poorer QOL.

3 european urology 51 (2007) Ten study subjects from each study arm were randomly selected for the assessment of warning time (the period from first sensation of urgency to voluntary micturition or incontinence) at baseline. This was recorded during 4-h clinic-based monitoring periods, when subjects were instructed to delay micturition for as long as possible. At the 3-mo follow-up, warning time was recorded again. The difference of change of warning time between these two surgical procedures was compared TVT-O plus IS bladder denervation procedure In the study group, subjects underwent combined TVT-O plus modified IS procedures. All procedures were carried out using general or regional anesthesia. In a routine manner, we performed a modified IS procedure at first. The patient was positioned in the dorsal lithotomy position using Allen stirrups and a Foley catheter was placed. If necessary, diluted pitressin (1:50) was injected just beneath the vaginal mucosa to facilitate dissection and reduce blood loss. A vertical incision was made in the anterior vaginal wall. The vaginal epithelium and perivesical fascia were dissected off of the trigone. The plane of dissection was just within the serosal layer of the bladder. Lateral and posterior sharp dissection was performed to obtain more extensive division in the area of the terminal branches of the pelvic nerve. On completion of the modified IS procedure, we performed the TVT-O procedure, first on the right side, as was our routine. The needle exit points at the skin level were identified by tracing a horizontal line at the level of the urethral meatus. Due to extensive dissection of the perivesical fascia, the upper part of the ischiopubic ramus could easily be reached. The introducer was then pushed into the preformed dissection pathway until it reached and perforated the obturator membrane. The distal end of the plastic tube was mounted onto the spiral segment of the needle and the assembled device was gently slipped along the gutter of the introducer so as to pass through the obturator foramen. Once the device had perforated the obturator membrane, the plastic tube was pulled from the supporting passer, which was removed by a backwards-rotational movement, until the first centimeters of the tape became externalized. The same technique was applied to the left side. The tape was then aligned under the junction between the middle and distal urethra and the tension of the tape was adjusted by inserting a no. 4 Hegar dilator between the tape and the urethra so as not to leave a space and avoiding any tension of the tape. The plastic sheaths were then removed simultaneously. The tape ends were cut in the subcutaneous layer and the incisions were closed by simple suture TVT-O procedure The surgical procedures were nearly the same as described in the first study arm. The main difference was that subvaginal dissection was stopped once the index finger inserted through the dissection plane had contacted the internal surface of the ischiopubic bone and obturator foramen. No cystoscopy was required for the procedure unless the urine bag showed hematuria. The Foley catheter was removed the day after surgery. Once the woman was able to void and residual urine was <100 ml, she was discharged Follow-up assessment After the surgical procedures, all patients were asked to be followed up at 1, 3, 6, and 12 months. Urodynamic studies and warning time assessments were repeated at 3 months. Repeated QOL evaluations were performed at each followup visit. At each follow-up, antimuscarinics would be provisionally discontinued if frequency of voiding was less than eight times per day. If discontinuation of antimuscarinics was due to side effects, the data would be viewed as censored and excluded from analysis. At the 12-mo follow-up, the subjects received objective assessment with four levels of judgment, including cure (defined as 1-h pad test <2 g and complete discontinuation of antimuscarinic medication), improvement (defined as improvement of urine leakage on pad test or decreased dosage of antimuscarinic medication), no change, and became worse (defined as worsening of pad test or increased dosage of antimuscarinic medication) Statistical analysis The Student t test was used for all two-group comparisons of continuous measurements. The Pearson x 2 test or Fisher exact test was applied for all between-group comparisons of categoric measures. Comparisons of QOL between study groups were performed using repeated measures of analysis of variance (repeated measures ANOVA). Proportions of patients still using antimuscarinics were evaluated and plotted using Kaplan-Meier product limit method. Data were collected on standardized forms and encoded for computerized analysis with the use of SPSS 12.0 for Windows (SPSS, Chicago, IL), and figures were plotted using Sigmaplot 2001 (SPSS). Associations denoted as statistically significant were those that yielded a p < 0.05, assuming a two-sided alternative hypothesis. 3. Results Of the 96 eligible patients, 49 patients were randomly allocated, in a 1:1 ratio in balanced blocks of 10, to undergo TVT-O plus Ingelman-Sundberg procedure (TVT-O plus IS), the other 47 patients underwent TVT-O alone. Fig. 1 shows the study flowchart. Demography and baseline characteristics of the analyzed subjects in both study groups were similar (Table 1). Table 2 presents the objective assessment at the 12-mo follow-up and changes of urodynamic profile at the 3-mo follow-up. Objective surgical response rate (cure plus improvement) was significantly higher in the TVT-O plus IS group than in the TVT-O alone group (84.8% vs. 62.8%, p = 0.019). In urodynamic study, strong desire to void and sensation of maximal bladder capacity were significantly

4 1674 european urology 51 (2007) Fig. 1 Study flowchart of enrolled patients. increased in the TVT-O plus IS group than the TVT-O alone group, implying decreased bladder sensation by the IS effect. Table 3 shows blood loss, surgical time, and complications between the two study groups. No bladder, bowel, or major blood vessel injuries occurred in this study. One subject in each study group had mesh erosion. The mesh was trimmed off and the surgical wound was healing well after local hormone therapy. One subject in the TVT-O plus IS group, who presented with temporary adductor muscle weakness and a numbness sensation in the medial aspect of right thigh, was noted to have obturator nerve injury. At the 3-mo follow-up, after conservative treatment, the patient had complete relief of symptoms. About 5% of women in each study group were found to have urine retention >1 wk. After appropriate sling adjustment, none of the study subjects had urine retention lasting >2 wk. Three subjects in the TVT-O plus IS group and one subject in the TVT-O alone group, respectively, developed pelvic hematoma. The size of pelvic hematoma ranged from 4 to 10 cm. No drainage was required, and all these hematomas had resolved spontaneously at the 3-mo follow-up. Fig. 2 shows the proportions of patients who still needed antimuscarinics after the surgical procedures. At the 1-yr follow-up, about 25% of subjects in the TVT-O plus IS group still needed antimuscarinics, whereas about 45% of subjects in the TVT-O alone group still needed some kind of antimuscarinic medication. The difference was statistically significant ( p = 0.028, Kaplan-Meier product limit method). According to the above analysis, about three fourths of patients in the TVT-O plus IS group had a chance to discontinue antimuscarinics after surgery, whereas about half the patients in the TVT-O alone group still needed antimuscarinics to relieve symptoms of urge incontinence. Baseline and Fig. 2 Proportion of patients using antimuscarinics over follow-up period using Kaplan-Meier product-limit method.

5 european urology 51 (2007) Table 1 Demographic characteristics of study patients TVT-O + IS (n = 46) TVT-O alone (n = 43) p Age 53 (47 76) 57 (43 78) NS Parity 2.6 (1 6) 2.9 (0 9) NS Body mass index, kg/m ( ) 23.6 ( ) NS Detrusor overactivity 15 (42.8%) 19 (44.1%) NS Menopause 27 (79.3%) 32 (74.4%) NS Hormone replacement Systemic 12 (26.1%) 14 (32.6%) Local 3 (6.5%) 5 (11.6%) Previous surgical procedures Hysterectomy 2 3 Anterior colporrhaphy 3 1 Posterior colporrhaphy 1 1 Burch colposuspension 1 0 NS NS Baseline urodynamic profile First desire to void, ml NS Strong desire to void, ml NS Sensation of maximal capacity, ml NS Functional urethral length, cm NS MUCP, cm H 2 O NS Q max, ml/s NS ALPP, cm H 2 O NS Values were given as mean (range) or number (%). Because of rounding, not all percentages total 100. TVT-IS = trans-obturator tension-free vaginal tape plus Ingelman-Sundberg procedure; TVT-O = tension-free vaginal tape alone; MUCP = maximal urethral closing pressure; Q max = maximum flow rate; ALPP = abdominal leak-point pressure; NS = not significant. follow-up QOL scores are shown in Fig. 3. BothIIQ-7 and UDI-6 demonstrated a significant decrease at the 3-mo follow-up in the TVT-O plus IS group. Scores remained relatively stable after 3 mo of follow-up and until the end of the study. The baseline mean warning times in the TVT-O plus IS and TVT-O alone group were 3.9 and 4.5 min, respectively. After surgery, a significant increase in warning time was observed in the TVT-O plus IS group (from 3.9 to 9.4 min, p = 0.006), but the increase in warning time in the TVT-O alone group was not statistically significant (from 4.3 to 4.5 min, p = 0.695, by repeated measures ANOVA test; Fig. 4). The number of subjects with a 30% increase in Table 2 Evaluation of surgical outcomes of study patients TVT-O + IS (n = 46) TVT-O alone (n = 43) p Objective assessment * Cure 34 (73.9%) 22 (51.2%) Improvement 5 (10.9%) 5 (11.6%) No change 4 (8.7%) 12 (27.9%) Became worse 3 (6.5%) 4 (9.3%) Urodynamic profile, y % change, compared to baseline First desire to void % % NS Strong desire to void % % Sensation of maximal capacity % % Functional urethral length, cm % % NS MUCP (cm H 2 O) % % NS Q max (ml/s) % % NS ALPP, cm H 2 O % % NS Values were given as mean SD or number (%). Because of rounding, not all percentages total 100. TVT-IS = trans-obturator tension-free vaginal tape plus Ingelman-Sundberg procedure; TVT-O = tension-free vaginal tape alone; MUCP = maximal urethral closing pressure; Q max = maximum flow rate; ALPP = abdominal leak-point pressure; NS = not significant. * Evaluated at 12-mo follow-up. Statistics were performed using x 2 test, using cure and improvement as one group, and no change and became worse as the other group. y Evaluated at 3-mo follow-up.

6 1676 european urology 51 (2007) Table 3 Comparison of surgical complications TVT-O + IS (n = 46) TVT-O alone (n = 43) p Blood loss, ml Surgical time, min Intraoperative complications Vaginal fornicial puncture 2 (4.3%) 2 (4.6%) NS Bladder perforations 0 0 NS Urethral puncture 0 0 NS Bowel injury 0 0 NS Great vessel injury 0 0 NS Postoperative complications Pelvic hematoma 3 (6.5%) 1 (2.3%) NS Nerve injury 1 (2.2%) 0 NS Fever 14 (30.4%) 9 (20.9%) Sepsis 0 0 NS Mesh erosion 1 (2.2%) 1 (2.3%) NS Urine retention >7 d 2 (4.3%) 2 (4.6%) NS Vesicovaginal fistula 0 0 NS Hospital stay, d Values are given as mean SD or number (%). Because of rounding, not all percentages total 100. TVT-IS = trans-obturator tension-free vaginal tape plus Ingelman-Sundberg procedure; TVT-O = tension-free vaginal tape alone; NS = not significant. Fig. 4 Mean warning time at baseline and at 3-mo followup. Error bars denote standard deviation. * p < mean warning time was significantly higher in the TVT-O plus IS group versus TVT-O alone group (18 of 46 or 39.1% vs. 7 of 43 or 16.3%; p = 0.031). 4. Discussion Fig. 3 Distribution of quality of life (including Urinary Distress Inventory [UDI-6] and Incontinence Impact Questionnaire [IIQ-7]) over follow-up period. * p < It is evident from the results of this study that the IS procedure can potentially be added to the transobturator sling for the treatment of mixed urinary incontinence, with satisfactory outcomes and tolerable side effects. At the end of the last follow-up,

7 european urology 51 (2007) about 25% and 45% of women in the TVT-O plus IS group and the TVT-O alone group, respectively, still needed some kind of antimuscarinic medication. The QOL evaluation also revealed better improvement in the TVT-O plus IS group. Holmgren et al [18] reported that women with mixed incontinence had a persistent cure rate of 60% up to 4 yr postoperatively after TVT procedures, but the cure rate then declined steadily to 30% from 4 to 8 yr after surgery. The increased rate of incontinence was due to urgency symptoms. Moreover, a long-term follow-up study suggests that 85% of the patients with mixed incontinence were completely cured and another 4% were significantly improved [4]. However, this study lacked a controlled evaluation. Our results reveal that the objective cure rate can be up to 74% in the TVT-O plus IS group, but longer follow-up is needed to verify the durability of this combined surgery. Accumulating reports have indicated the efficacy of tension-free suburethral tapes, which are currently widely used. Retropubic TVT procedures required much less operative time and have much shorter hospitalization time, with significantly less postoperative pain and a faster return to normal daily activities than the traditional Burch colposuspension [21,22]. Nevertheless, retropubic TVT has not been free of complications, as indicated by Mickey and Sergent [23,24] in recent reviews of retropubic TVT. The following complications were observed: bladder perforation (4.5%), urethral injury (0.6%), suprapubic abscess (2%), urinary tract infection (7%), complete and lasting urinary retention (4%), expulsion of TVT (2%), de novo detrusor instability (1.5%), and voiding dysfunction (8%). About 2% of patients needed a takedown of the TVT for continued voiding dysfunction. To date, the results of three trials comparing the trans-obturator route with the retropubic route (TVT) have been published [15,25,26]. In the two trials with a longer follow-up, 81% (178 of 220) of patients and 95% (89 of 94) of patients treated with trans-obturator tape achieved continence compared with 76% (167 of 220) of patients and 91% (90 of 99) of patients treated with TVT. Overall morbidity following the trans-obturator route was 11% compared with 19% via the retropubic route. The obturator route further simplifies tape insertion, with outcomes similar to those of the retropubic route. It also prevents the potentially fatal complications that have been reported for the retropubic route. The IS procedure is an attempt at partial, peripheral denervation specific to the target organ. It is partial in the sense that sensory signals from the bladder are interrupted without disabling the motor pathways, as in sacral root transection [7]. The anatomic boundaries of the modified IS dissection decrease operative time and blood loss, while achieving comparable results [8]. Our surgical results further substantiated the efficacy of this procedure, with a mean increase in blood loss of 50 ml and surgical time of 12 minutes, as compared with the TVT-O alone group. Although the frequency of postoperative fever was significantly higher in the TVT-O plus IS group, no sepsis occurred in any patient. Furthermore, though not statistically significant, the rate of pelvic hematoma was nearly 3-fold higher in the TVT-O plus IS group. Long-term evaluation of the sequelae should be performed. Another interesting finding in our study is that warning time was significantly increased in the TVT-O plus IS group. Warning time is a novel end point for evaluating pharmacologic or surgical treatment for the symptoms of urgency or urge incontinence [27]. By increasing warning time, subjects with symptoms of urgency gain additional time in which to find a toilet. This decreases the probability of an incontinence episode, thus decreasing the risk of a socially embarrassing accident, and giving subjects renewed confidence to participate in work and activities. The weak point of the current study is that only 10 patients in each group were selected for the test of warning time, which may lead to a possible selection bias. 5. Conclusions Mixed urinary incontinence can potentially be more effectively treated with one-step combined surgery using a trans-obturator sling plus a modified IS denervation procedure, with tolerable side effects. The benefit of this combined surgery is found in the common dissection plane used for both surgical procedures. Although surgical time and blood loss were significantly increased in the combined surgery group, the overall morbidity was not statistically increased, and 75% of patients with mixed urinary incontinence were cured with this technique. Longer follow-up is needed to verify the long-term durability. Conflicts of interest The authors disclose that the current study is not a sponsored research and they have no conflicts of interests with the TVT-O manufacturer (Gynecare, Ethicon, NJ).

8 1678 european urology 51 (2007) Acknowledgements We are indebted to the research panel: Lilly Wen, MD (Catholic Cardinal Tien Hospital, Taipei), Nan-Ni Chen, MD (Municipal Hospital for Women and Children, Taipei), and Kuo-Chang Wen, MD, Wei- Min Hu, MD, Hsiao-Wen Tsai, MD, Pi-Lin Sung, MD, Wei-Lun Hsu, MD, Chih-Yu Chen, MD, Jen-Yu Huang, MD, Chia-Ming Chang, MD, Peng-Hui Wang, MD, Nae- Fong Twu, MD, Hsiang-Tai Chao, MD, and Koun- Chung Chao, MD (Veterans General Hospital, Taipei). Financial Support: Supported in part by VGHTPE References [1] 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. Am J Obstet Gynecol 2002;187: [2] Bortolotti A, Bernardini B, Colli E, et al. Prevalence and risk factors for urinary incontinence in Italy. Eur Urol 2000;37:30 5. [3] Galloway NTM. Urinary incontinence. In: Rakel, editor. Conn s current therapy. 57th ed. St Louis, MO: Saunders; p [4] Rezapour M, Ulsmsten U. Tension-free vaginal tape (TVT) in women with mixed urinary incontinence a long-term follow-up. Int Urogynecol J 2001;(suppl 2):S15 8. [5] Segal JL, Vassallo B, Kleeman S, Silva AS, Karram MM. Prevalence of persistent and de novo urge incontinence after the tension-free vaginal tape. Obstet Gynecol 2004;104: [6] Ingelman-Sundberg A. Partial denervation of the bladder: a new operation for the treatment of urge incontinence and similar conditions in women. Acta Obstet Gynecol Scand 1959;38: [7] Cespedes RD, Cross CA, McGuire EJ. Modified Ingelman- Sundberg bladder denervation procedure for intractable urge incontinence. J Urol 1996;156: [8] Westney OL, Lee JT, McGuire EJ, Palmer JL, Cespedes RD, Amundsen CL. Long-term results of Ingelman-Sundberg denervation procedures for urge incontinence refractory to medical therapy. J Urol 2002;168: [9] Dmochowski RR. Interventions for detrusor overactivity: the case for multimodal therapy. Rev In Urol 2004;4(suppl 4):S [10] 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: [11] Soulie M, Cuvillier X, Benaissa A, et al. The tension-free transvaginal tape procedure in the treatment of female urinary stress incontinence: a French prospective multicentre study. Eur Urol 2001;39: [12] Daher N, Boulanger JC, Ulmsten U. Pre-pubic TVT: an alternative to classic TVT in selected patients with urinary stress incontinence. Eur J Obstet Gynecol Reprod Biol 2003;107: [13] Delorme E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11: [14] Roumeguère 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: [15] David-Montefiore E, Frobert J-L, Grisard-Anaf M, et al. Peri-operative 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: [16] 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: [17] Duckett JR, Tamilselvi A. Effect of tension-free vaginal tape in women with a urodynamic diagnosis of idiopathic detrusor overactivity and stress incontinence. BJOG 2006;113:30 3. [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: [19] Schafer W, Abrams P, Liao L, et al. Good urodynamic practices: uroflowmetry, filling cystometry, and pressureflow studies. Neurourol Urodyn 2002;21: [20] Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn 1995;14: [21] Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:S5 8. [22] 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: [23] Mickey MK, Jeffery LS, Brett JV, Steven DK. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101: [24] Sergent F, Sebban A, Verspyck E, Sentilhes L, Lemoine JP, Marpeau L. Pre- and postoperative complications of TVT (tension-free vaginal tape). Prog Urol 2003;13: [25] 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: [26] Mellier G, Benayed B, Bretones S. Suburethral tape via the obturator route: is the TOT a simplification of the TVT? Int Urogynecol J Pelvic Floor Dysfunct 2004;15: [27] Cardozo L, Dixon A. Increased warning time with darifenacin: a new concept in the management of urinary urgency. J Urol 2005;173:

9 european urology 51 (2007) Editorial Comment on: Efficacy Analysis of Trans-obturator Tension-free Vaginal Tape (TVT-O) Plus Modified Ingelman-Sundberg Procedure versus TVT-O Alone in the Treatment of Mixed Urinary Incontinence: A Randomized Study H. Christoph Klingler, Department of Urology, Medical University of Vienna, Vienna, Austria christoph.klingler@meduniwien.ac.at This study [1] deals with a rather uncommon combination of two surgical procedures to treat mixed urinary incontinence. The authors used the Ingelberg-Sundman (IS) procedure to treat urge incontinence in an untreated patient cohort prior to other less invasive or conservative treatment options. This must be weighed against the standard of care in treatment of detrusor overactivity because the IS procedure is one to treat refractory urge incontinence and may contribute to significant complications. It should be at least recommended that prior to this setting a local detrusor infiltration with bupivacaine should be administered instead to prove efficacy in treatment of detrusor hyperactivity, as recommended by various guidelines. In addition, it must be considered that stress-induced urge incontinence may be improved by urethral tape implantation alone [2]. Consequently, it may be difficult to interpret success rates obtained in this study solely deriving from the use of the IS procedure. Likewise, it must be noted that their primary end points are limited to 10 plus 10 patients followed for a 3-mo period only. Overall, this will not improve the power of this study. Because their secondary outcome measure or end point demonstrated the risk of pelvic haematoma being 3-fold higher than TVT-O alone, this technique may, in addition, not be regarded as an overall safe procedure. In conclusion, this combined procedure may be worthwhile being investigated in future wellconduced and urodynamically controlled studies to clarify whether there is some remaining indication for the IS technique. At this stage, however, this technique should be handled with great precaution and cannot be regarded as standard of care in the treatment of mixed incontinence. References [1] Juang C-M, Yu K-J, Chou P, et al. Efficacy analysis of trans-obturator tension free vaginal tape (TVT-O) plus modified Ingelman-Sundberg procedure versus TVT-O alone in the treatment of mixed urinary incontinence: a randomized study. Eur Urol 2007;51: [2] Duckett JR, Tamilselvi A. Effect of tension-free vaginal tape in women with a urodynamic diagnosis of idiopathic detrusor overactivity and stress incontinence. Br J Obstet Gynaecol 2006;113:30 3. DOI: /j.eururo DOI of original article: /j.eururo