R EVI E W A R T IC L E BJUI Mid-urethral synthetic slings for female stress urinary incontinence BJU INTERNATIONAL Eva D.M. Fong and Victor W. Nitti Department of Urology, New York University Langone Medical Center, New York, NY, USA Accepted for publication 9 March 2010 • Mid-urethral synthetic slings (MUSS) have grown in acceptance and popularity to gain a foremost position in stress urinary incontinence (SUI) surgery. • There are numerous studies that provide a large amount of Level 1 and 2 evidence that support the concept of a sling placed at the level of the mid-urethra. • Long-term follow-up has been published for the original tension-free vaginal tape (TVT) procedure with the most recent publication providing Level 2 evidence with mean follow-up of 11.5 years of 69/91 (77%) of patients from the original series. There was objective cure was in 90% of women and 77% considered themselves subjectively cured, based on the Patient Global Impression of Improvement. • Level 1 evidence with long-term follow-up has been provided comparing colposuspension to TVT at 2 and 5 years. At 5 years for the primary efficacy variable of a negative 1 h stress pad test, there was no difference in success (81% vs 90%). • Two recent meta-analyses provide Level 1 evidence comparing outcomes for retropubic vs transobturator MUSS. One included 18 studies, randomized and cohort: cohort studies had a 12.3% failure rate for transobturator and 13.7% failure for the retropubic approach, randomized studies showed 5.7% failure in the transobturator vs 7.8% in the retropubic group. The other meta-analysis included 11 studies published 2008–2009, which found that the shortterm cure rate was borderline inferior for the transobturator tape group (odds ratio 0.62; 95% confidence interval 0.37–1.00), nearly reaching statistical significance (P = 0.05). • This review details further comparator evidence and evidence for use in specific patient groups (elderly, obese, intrinsic sphincter deficiency, mixed UI). KEYWORDS stress urinary incontinence, mid-urethral synthetic sling, tension-free vaginal tape, transobturator tape, outcomes, complications INTRODUCTION Since Ulmsten [1] described the tension-free vaginal tape (TVT, Gynecare, Ethicon, Somerville, NJ, USA) procedure in 1995, ‘An ambulatory surgical procedure under local anaesthesia for treatment of female urinary incontinence.’, mid-urethral synthetic slings (MUSS) have grown in acceptance and popularity to gain a foremost position in stress urinary incontinence (SUI) surgery. They have become the new ‘gold standard’ for the surgical treatment of female SUI, not only because of their simplicity for both the surgeon and the patient, but also because of very positive surgical outcomes and low morbidity. There are numerous studies, both randomized controlled trails (RCTs) and well-designed prospective studies, which provide a large amount of Level 1 and 2 evidence that support the concept of a sling placed at the level of the mid-urethra. In addition, there is increasing evidence regarding how different approaches for placing a MUSS (retropubic and transobturator) can be applied to specific patient groups. The evidence base will be reviewed to help resolve clinical dilemmas concerning which type of sling to use in specific situations. In this review, we will discuss the anatomical basis and techniques of MUSS, examine their indications and outcomes, describe some of the newer ‘less invasive’ techniques, and discuss the management of problems and complications that can occur after MUSS placement. 596 © JOURNAL COMPILATION © 2010 THE AUTHORS 2 0 1 0 B J U I N T E R N A T I O N A L | 1 0 6 , 5 9 6 – 6 0 8 | doi:10.1111/j.1464-410X.2010.09544.x MID-URETHRAL SYNTHETIC SLINGS FIG. 1. Integral theory for stress incontinence from Petros and Ulmsten, 1998 [4] (see text). FIG. 2. Hammock theory for stress incontinence from DeLancey, 1997 [5] (see text). and ‘top-to-bottom’ approaches using minor modifications of MUSS material and surgical instrumentation. Transobturator • the anterior vaginal wall, • the endopelvic fascia between the arcus tendineus facia pelvic on each side, • and pelvic floor muscles (Fig. 2) [5]. DEVELOPMENT OF THE MUSS Mechanism of action The theoretical basis for the MUSS is the ‘Integral theory of female urinary continence’ based on a series of anatomical studies of the female urethral closure mechanism performed by Petros and Ulmsten in the 1990s [2]. An important alternate theory advanced by DeLancey in 1994 [3] in his description of the ‘hammock’ theory. Both of these theories strive to explain how urethral pressure can be maintained above vesical pressure during increased intra-abdominal pressure. In the ‘Integral’ theory this is explained by opposing forces; the pelvic floor muscles act through their vaginal attachments to stretch the vaginal hammock against the pubourethral ligaments, shutting the urethra off from behind. Weakness in the pubourethral ligaments would lead to similar forces opening the urethra (Fig. 1) [4]. The hammock theory proposes that both urethral support and constriction are important. In this model, the support is provided by the layers outside the urethra on which it rests: © With increased intra-abodominal pressure, the urethra remains shut against this backboard, as long as it is intact. When the backboard is not intact, urethral hypermobility and/or SUI may result. It has been shown by ultrasound studies that placement of a sling at the mid-urethra causes a dynamic kinking of the urethra with stress and thus can cure SUI without affecting position or urethral mobility [6]. Anatomical approaches Retropubic The original TVT procedure placed a polypropylene sling at the level of the midurethra via a ‘bottom-to-top’ approach. This involved the passage of a trocar from a mid-urethral vaginal incision through the endopelvic fascia and the retropubic space to a suprapubic exit point. The ‘top-to-bottom’ technique was developed in 2001 [7] with the introduction of the Suprapubic Arc system (SPARC, American Medical Systems, Inc., Minnetonka, MN, USA) sling. This technique involves passage of the trocar from a suprapubic incision (lateral to the midline) to a subepithelial vaginal dissection. Subsequently, there have been several different modifications of the ‘bottom-to-top’ The transobturator approach was introduced by Delorme [8] in 2001 to avoid trocar passage in the retropubic space/pelvis addressing concerns over bladder, bowel and major vessel injury and voiding dysfunction after TVT. Anatomical studies have shown that in this method the synthetic sling is entirely outside the pelvis (and also retropubic space), within the foremost extension of the ischiorectal fossa [9]. In this approach, the vaginal dissection is as per the retropubic approach. Both types of transobturator approach involve trocar passage between the vaginal incision, through the obturator membrane and obturator internus muscle to a groin incision below the adductor muscle insertion. The original transobturator tape (TOT) operation was described as an ‘outside-in’ technique with the tape being passed from the thigh into the vaginal incision (Uratape, PorgesMentor, Le Plessis, Robinson, France). In 2003, De Leval [10] further modified the technique as an ‘inside-out’, approach, with a vaginal incision through the obturator foramen and out through the inner thigh as the TVTObturator (TVT-O, Ethicon). Types of mesh Several different synthetic materials have been used as slings. Both monofilament and multifilament materials have been tried. The ideal sling material should be inert, nonallergenic and relatively resistant to inflammation and infection. Synthetic meshes are divided into four groups: 2010 THE AUTHORS JOURNAL COMPILATION © 2010 BJU INTERNATIONAL 597 FONG and NITTI Name TVT Advantage SPARC Lynx Prefyx PPS Monarc ObTryx Aris TVT-O MiniArc TVT-Secur Type Retropubic ‘bottom–top’ Retropubic ‘bottom–top’ Retropubic ‘top–bottom’ Retropubic ‘top–bottom’ Pre-pubic ‘bottom–top’ Transobturator ‘outside–in’ Transobturator ‘outside–in’ Transobturator ‘outside–in’ Transobturator ‘inside–out’ Single Incision Single Incision Manufacturer Ethicon Boston Scientific AMS Boston Scientific Boston Scientific AMS Boston Scientific Coloplast Ethicon AMS Ethicon TABLE 1 Some commonly used commercially available type I mesh slings slings (adapted from Rapp and Kobashi, 2008 [14]) AMS, American Medical Systems, Minnetonka, MN, USA; Ethicon Inc., Somerville, NJ, USA; Boston Scientific Inc., Maple Grove, MN, USA; Coloplast A/S, Copenhagen, Denmark. • Type 1, macroporous, monofilament • Type 2, microporous • Type 3, macroporous, multifilament • Type 4, submicronic, coated biomaterials with pore sizes of <1 µm. ‘all 598 Since the introduction of the MUSS, it has become clear that slings made from type 1 mesh are better than other slings, predominately because they are relatively resistant to infection and inflammation. Slack et al. [11] showed in an in vivo study that type 1 mesh had an early and sustained filling with fibrous connective tissue and capillaries, showing that macroporous meshes promote tissue host in-growth with resultant integration, allowing anchoring of the mesh within the tissue. The inflammatory response provokes decreases markedly with time thus reducing the risk of infection. Both type 2 and 3 meshes had a much more marked inflammatory response without as much fibrous in-growth. ObTape in particular had barely any fibrous tissue or capillary ingrowth. These findings are in concordance with commercially available MUSS are now made several other studies that support type 1 from type I, uncoated mesh’ mesh as having optimal qualities for use in sub-urethral slings [11]. The largest trial comparing monofilament and multifilament slings was published by Meschia et al. [12] with 190 patients randomized to TVT or intravaginal slingplasty. At the 24-month follow-up only vaginal erosion was significantly more common after intravaginal slingplasty than TVT. In 2005, Domingo et al. FIG. 3. Final position of the TVT in situ, Bullock et al. [15]. [13] reported a 13.8% extrusion rate for the ObTape. Based on the above animal and clinical studies, all commercially available MUSS are now made from type I, uncoated mesh (Table 1) [14]. Surgical technique Currently available commercial slings and their approaches are listed in Table 1 [14]. Figures 3 and 4 [15] show the final positions of the TVT and transobturator slings. For details of technique refer to: • • • • TVT, Ulmsten and Petros 1995 [1] SPARC, Deval et al. 2003 [7] TOT, De Lorme et al. 2003 [8] TVT-O, de Leval 2003 [10]. © JOURNAL COMPILATION © 2010 THE AUTHORS 2010 BJU INTERNATIONAL MID-URETHRAL SYNTHETIC SLINGS FIG. 4. Final position of the transobturator sling in situ, Bullock et al. [15]. publication provides Level 2 evidence with a mean follow-up of 11.5 years of 69/91 (77%) of the patients in their original series. Objective cure, defined in this group as negative cough test on examination or a 24-h pad test of <8 g, was found in 90% of women. Subjectively, 77% considered themselves cured based on the Patient Global Impression of Improvement (PGI-I). Intermediate-term data are now available for the TOT. Liapis et al. [17] recently reported follow-up at 4 years for TVT-O with a cure rate of 82.4% in 74 patients and Waltergny et al. [18] reported 3 years follow-up of the original TOT series described by DeLeval [10] with a cure rate of 88.4%. or very satisfied (91% vs 90%). Hospital-stay was significantly shorter for the TVT group. However, there was no difference in the chance of re-operation, although patients who had colposuspension were more likely to require prolapse surgery (7.5% vs 1.8%). The authors did note that identifying true durability of cure was somewhat hampered by loss to follow-up across both groups as only 119 of the original 377 patients had full 5year subjective and objective data sets. A subanalysis of the trial by Manca et al. [23] showed that TVT was more cost effective than Burch colposuspension with greater gains in quality-adjusted life years gained. INDICATIONS AND OUTCOMES FOR MUSS Most of the early series on MUSS were done on very select patients with urethral hypermobility, pure urodynamic SUI (no urgency UI [UUI] or detrusor overactivity [DO]) and no prior surgery (the index patient). In this population, results of both retropubic and transobturator approaches are very favourable and include many studies with solid Level 1 and 2 evidence (see below). Over the years, applications have been extended to include patients with more complex SUI (minimal hypermobility, low leak-point or urethral-closure pressure, mixed UI). Furthermore the MUSS has been successfully performed in ‘special populations’ such as obese and elderly patients, women undergoing simultaneous repair of pelvic organ prolapse and women with failed prior surgery. Based on the data, we think that it can now be said for the index patient (and perhaps some others as well), that the MUSS is the gold standard for the treatment of SUI. Results of MUSS Comparisons of outcomes in UI surgery are hampered by variations in definition of success. Definitions of cure may be subjective where the patient reports absence of SUI, preferably by a validated questionnaire or instrument, or objective where the absence of SUI is proven by a negative cough or pad test. In addition, various levels of subjective and objective improvement may constitute success depending upon the study protocols. Also, long- and intermediate-term data are now available from several MUSS trials that provides Level 2 evidence for durability of treatment. Long-term outcomes have been published for the original TVT procedure from Nilson et al. [16]. Their most recent © Perhaps the best way to describe the results of The Cochrane review found nine RCTs comparing MUSS to traditional slings. MUSS is to look at the Level 1 and 2 evidence of various RCTs and comparator trials. These MUSS had a shorter operating time (35 vs trials compare MUSS to other surgical 87 min) and shorter hospital stays (relative procedures for SUI as well as comparing different MUSS and approaches to each other. risk [RR] 0.5). Different health-related qualityof-life (HRQL) measures were used in each There have been several high-quality recent study; however, all HRQL measures showed reviews of the large amount of literature similar outcomes for traditional vs synthetic reporting on synthetic slings. A recent slings [19]. For open colposuspension vs slings Cochrane review by Ogah and Rogerson [19] nine RCTs were included. Objective cure rates found 62 randomized trials including at 12 months (N = 729) were 79% for synthetic slings. These included comparisons synthetic slings vs 82% for colposuspension. between synthetic slings and traditional sling For laparoscopic colposuspension vs slings, operations or colposuspension, retropubic ‘top–down’ vs ‘bottom–up’ approach, ‘Comparisons of outcomes in UI surgery are transobturator hampered by variations in definition of success’ ‘outside-in’ vs ‘inside-out’ and the combined results of six RCTs showed no retropubic vs transobturator route. Before significant difference in patient-reported this Novara et al. [20] had reviewed the outcomes within 12 months; 80% for slings complications rates in a meta-analysis vs 74% for colposuspension. By clinician published in 2008. assessment there was a significant difference in favour of synthetic slings, 89% vs 78% [19]. Comparison trials of MUSS with other surgical procedures for SUI Comparator trials for retropubic MUSS Initial Level 1 evidence for TVT comes from the A Cochrane review found three trials reported Ward and Hilton trial [21], a multicentre RCT on patient-reported cure (defined as absence of TVT vs Burch colposuspension. In the of leakage on stress) showing a significant original publication, the authors showed TVT and colposuspension have equivalent efficacy difference in favour of ‘bottom–top’ vs ‘top– bottom’ at 12 months (85% vs 77%) [24]. The (based on very strict criteria with lost to combined analysis of objective cure rate (by follow-up considered failures) with 51% cure pad test or stress test) also favoured bottomfor TVT vs 63% for Burch colposuspension. to-top by a smaller margin, 92% vs 87%. The authors also reported 5-year follow-up data on 117 patients [22]. For the primary Comparator trials for transobturator MUSS efficacy variable of a negative 1-h stress pad test, there was no difference in success There are four randomized studies that (81% vs 90%). Furthermore, there were no directly compare ‘outside-in’ to ‘inside-out’ differences in the secondary variables of cure transobturator slings [25–28]. These report of stress leakage (63% vs 70%), and satisfied 2010 THE AUTHORS JOURNAL COMPILATION © 2010 BJU INTERNATIONAL 599 FONG and NITTI equivalent cure rates over the short- and medium-term; objective cure rates range from 83% to 98% for outside-in and 87% to 90% for inside-out. By subjective measures, most often PGI-I, inside-out ranged from 83% to 90.7% and outside-in from 77% to 88.7%. statistical significance (P = 0.05). The authors commented that this could be due to inclusion of the Schierlitz et al. [31] study of women with intrinsic sphincter deficiency (ISD). We will discuss the comparison of approaches in ISD in more detail in a separate section on ISD. Similarly in the meta-analysis by Latthe et al. [24] of transobturator slings, indirect comparison of TVT-O and TOT showed equivalent cure rates. In a recent Cochrane review, Ogah and Rogerson [19] reviewed 24 trials that compared retropubic and transobturator approaches of MUSS placement. Subjective cure was reported in 10 trials with a total of 1281 participants and showed no statistically significant difference between routes. Comparison of retropubic and transobturator approaches Two meta-analyses compared retropubic with transobturator slings. Sung et al. [29] found 18 eligible studies, both randomized and cohort, in 2007. In all, 492 patients were in randomized and 2099 were in cohort studies. They were ‘indirect comparison of TVT-O and TOT showed unable to assess a equivalent cure rates’ pooled estimate for objective cure as only one randomized study reported this and the four cohort studies used different definitions for reporting. The cohort studies had 12.3% failure rate for the transobturator approach and 13.7% failure for the retropubic approach. The pooled odds ratio (OR) for subjective failure in five of six randomized studies reporting this, was 0.85 (95% CI 0.38– 1.92), 5.7% failure in the transobturator group vs 7.8% in the retropubic group. These results did not change when only patients with >1 year follow-up were analysed. Results from the pooled subjective outcomes from cohort studies were similar with an OR of 0.73. This led these authors to conclude that there was no statistically significant difference in subjective outcomes between the two approaches. However, they do caution that this does not mean that there is not one, simply that, the data available to them did not show one. Long et al. [30] provided a meta-analysis of the more recent literature (after the Sung study [29]), January 2008 to March 2009, comparing approaches. They found 11 studies: six RCTs and five cohort studies. Again, outcome reported differed between studies, three RCTs reported on objective cure, one on subjective cure and two on changes in HRQL or re-operation rate. The short-term cure rate was borderline inferior for the TOT group (OR 0.62, 95% CI 0.37–1.00), nearly reaching 600 In 17 trials, with 2434 participants, women were slightly less likely to be cured when using the obturator route (84%) compared with the retropubic route (88%); RR for objective cure rates 0.96 (95% CI 0.93–0.99) at 12 months, although there was no significant difference in subjective cure rates (83% in both groups; RR 1.01, 95% CI 0.96– 1.05). Sung et al. [29] in a review of six RCTs and 11 cohort studies in 2591 women showed no difference in subjective failure between the two routes; 5.7% for transobturator vs 7.8% for retropubic in RCTs and 15.4% for transobturator vs 12.8% for retropubic in the cohort studies. However, they did note a lower risk of complications and de novo irritative voiding symptoms for the transobturator group. They concluded that it would take a RCT of 30 000 women to demonstrate superiority of one approach over the other. Similarly Latthe et al. [32] found 14 trials comparing either TVT-O or TOT to TVT, showing no difference in subjective cure rate. Based on these studies we believe that for the index patient transobturator and retropubic MUSS offer similar efficacy, with perhaps a slight advantage to the transobturator approach for intraoperative and long-term complications. RESULTS OF MUSS IN SPECIAL POPULATIONS Mixed UI With any SUI operation in the patient with mixed symptoms, there are always concerns about lower cure rates for the stress component and persistent urgency and UUI for the overactive bladder component. For cure of SUI, studies on MUSS have shown favourable results. Duckett and Tamilselvi [33] © JOURNAL COMPILATION © 2010 THE AUTHORS 2010 BJU INTERNATIONAL MID-URETHRAL SYNTHETIC SLINGS studied 51/344 women undergoing TVT who had both DO and urodynamic SUI. They found that SUI was cured in 92% with objective cure of DO in 47% and resolution of UUI in ≈ 60%. Similarly the update of the original Nilsson and Kuuva [34] series in 2001 included 59 (of 161) patients with mixed UI, but no DO. At a mean follow-up of 16.7 months, the cure rate for patients with mixed UI was 81.4% and this was not statistically different from those with pure SUI at 88%. Two studies by Paick et al. [35,36] reported on patients with mixed UI. The first, which reported on 73/274 with mixed UI who underwent TVT with ≥6 months follow-up, showed that the mixed UI group had the same cure rate for SUI as the SUI-only group. They also found that 16.4% of the mixed UI group had persistent UUI, so that the overall UI cure rate was lower for the mixed UI than the SUI group, but still quite favourable (78.1% vs 95.5%). In their second study, they reported on 144 women with mixed UI. The cure rates for SUI-only showed no statistical difference for TVT, SPARC and TOT at 95.8%, 90.9% and 94%, respectively [36]. Results were also not statistically different for total cure (incorporating UUI) with TVT, SPARC and TOT showing rates of 81.9%, 77.3% and 78%, respectively. There were no risk factors for cure of SUI, but DO on urodynamic studies (UDS) was a risk factor for treatment failure of UUI. There was one notable difference between preoperative characteristics between groups, patients that had TOT had significantly less severe UI than those in both the SPARC and TVT groups. To further stratify patients with mixed UI, a study of 1113 patients compared those who presented with predominant SUI, equal SUI and UUI, and predominant UUI [37]. Preoperative urodynamic variables, including DO, were not reported in this study. Overall outcomes in these mixed UI populations were good, 87.3% and 82.7% were stress-test dry at 7 and 38 months of follow-up. These authors had strict standards for cure; for subjective cure this was both being very satisfied and having SUI and UUI indices of ≤2 on standardized questionnaires, whilst objective cure had to include a negative SUI test (pad test of <10 g). There was no difference in rates of ‘stress-test dry’ at 7 and 38 months between groups, although there was a trend to lower cure rates for predominant UUI at 38 months (75.3% vs 84.7% for predominant SUI). However, there were statistically significant differences between objective cure, subjective cure, pad © test-dry and patient satisfaction for patients with predominant SUI vs predominant UUI at 7 and 38 months, with patients with predominant UUI worse in all variables assessed. Also, these authors found that rates of UUI compared with preoperative status, deteriorated between 7 and 38 months. Holmgren et al. [37] also showed deterioration over time, in 2–8 years followup. Women with pure SUI maintained a cure rate of 82% to 8 years, whereas women with mixed UI had a lower cure rate, 60% to 4 years with a further decline to 30% in patients at 4– 8 years after surgery. Elderly The affect of age on outcomes of MUSS is relatively undefined. There are several confounding variables such as a higher rate of DO and ISD in the elderly. Also, the definition of elderly varies between studies. At best, we can say that there is conflicting evidence regarding age and its impact on MUSS outcomes. Liapis et al. [40] showed a cure rate of 76.4% in 55 patients with a mean age of 75.4 years. Pugsley et al. [41] reported a cure rate of 77% for women aged >70 years compared to 92% for those aged <70 years undergoing TVT and colposuspension; however, there was considerable disparity in numbers with only 22 in the older group vs 100 in the younger group. Sevestre et al. [42] Overall, these results suggest that women with mixed UI can do well with sling surgery for SUI; however, they should be carefully counselled that urge symptoms can persist with ‘women should not be excluded for MUSS significant impact surgery based on the presence of UUI or on patient urgency symptoms’ satisfaction. We think that women should not be excluded for MUSS surgery reported a cure rate of 67% in 76 patients based on the presence of UUI or urgency with a mean age of 76 years. Hellberg et al. symptoms. [39] also analysed their results for TVT in the ‘very old’ vs other patients finding a reduced cure rate of 56% for those aged >75 years Obesity compared with 80% for those aged <75 years. Conversely, Gordon et al. [43] reported similar There are no prospective randomized cure rates between younger (mean age 57.8 studies that have examined obesity as an years, n = 208) and older (mean age 74.9 independent variable across different surgical years, n = 123) patients undergoing TVT at 12 procedures to treat SUI. There are six months by absence of persistent SUI at 6% published studies that have shown that there and 7%, respectively. A significant difference is no decrease in cure after TVT, and one that between these groups was the frequency of reported a difference [38]. Most recently a concomitant prolapse repair, 81% of older retrospective study by Killingsworth et al. women and 67% of younger women. Two 2009 [38], reviewed outcomes in TVT at 1 year other studies also showed equivalence in TVT by PGI-I, Urogenital Distress Inventory-6 and [44,45] Campeau et al. [46] compared Incontinence Impact Questionnaire-7, finding immediate to 6 month delayed placement of no differences in satisfaction, improvement in TVT in 69 women aged >70 years. At 6 HRQL and complications between three months, the sling group had improved HRQL groups of patients: those of ‘normal’ body and patient satisfaction compared to the mass index (BMI; <25 kg/m2) overweight (25– delayed group. 30 kg/m2) and obese (>30 kg/m2) women. A Perioperative morbidity and complications are single study by Hellberg et al. [39] where 970 also a consideration in older patients with women after TVT insertion were telephone several authors reporting higher rates in surveyed (mean follow-up 5.6 years), showed elderly patients. In the study of Gordon et al. significant differences in cure from 81.2% in [43], the risk of de novo urge was 18% at 1 those with a BMI of <25 kg/m2 to 52.1% cure year in older vs 4% in younger patients. Also, in those with a BMI of >35 kg/m2. However, in the elderly group there were two cases of this study did not control for preoperative pulmonary embolism, two cases of cardiac symptom severity and did not use a arrhythmia, one case of severe pneumonia, standardized questionnaire. There is no data and one case of deep vein thrombosis vs the specifically reporting outcomes for younger group where none of these occurred transobturator slings in obese women. 2010 THE AUTHORS JOURNAL COMPILATION © 2010 BJU INTERNATIONAL 601 FONG and NITTI except one cardiac arrhythmia. Pugsley et al. [41] showed that there was higher rates of patients requiring intermittent selfcatheterization, UTI and division of tape (OR 29). Campeau et al. [46] reported significant perioperative complications: bladder perforation (22.6%), urinary retention (12.9%), UTI (3.2%) and de novo urgency (3.2%). At present there are no studies that report on transobturator slings specifically in an elderly population. RECURRENT SUI ‘there is Several studies specifically address surgery for recurrent SUI after failed transobturator, retropubic or mini-slings. Liapis et al. 2009 [47], recently published a series of 31 such patients. conflicting evidence regarding age and its They found the overall cure rate impact on MUSS outcomes’ when placing a TVT in patients with recurrent SUI was 74%. However, it was best (>80%) in those who had urethral hypermobility and no ISD. Success was reduced but satisfactory (63%) with low urethral mobility (<30 °) and no ISD and was low (40%) with both ISD and a fixed urethra, 40%. Meschia et al. [48] included 25/301 patients with previous anti-UI procedures in their series using TVT in which they reported a lower cure rate of 72% for recurrent vs 89% for primary treatment. Biggs et al. [49] showed successful use of a transobturator sling in women with failed prior surgery for SUI. In a series of 27 women with urethral hypermobility who underwent TVT-O there was an 80% success rate assessed by PGI-I (‘very much better’ or ‘much better’) at mean follow-up of 25.7 months. Stav et al. [50] recently showed that repeat placement of a MUSS resulted in a lower subjective cure rate than primary placement, 62% vs 86%. They also showed that a repeat retropubic was more successful than a repeat transobturator sling, 71% vs 48%. Both of these results may in part be due to the higher rate of ISD in repeat candidates (31% vs 13%). Also of note, the rates of de novo urgency (30% vs 14%) and de novo UUI (22% vs 5%) were higher in the repeat group. CONCOMITANT PROLAPSE SURGERY/HYSTERECTOMY Groutz et al. [51] published their series of 100 clinically continent women with occult SUI 602 with prolapse reduction. At mean follow-up of 27 months, results were comparable with ‘index’ patients. Only two patients had symptomatic SUI at 1 year. In addition, perioperative morbidity was low with only two patients requiring catheterization for >7 days and de novo urgency in 8%, which is comparable with sling-only series. Liang et al. [52] reported a series of patients undergoing hysterectomy and prolapse repair who underwent pessary reduction of the prolapse during preoperative UDS. Patients with a positive pessary test (occult SUI) were randomized to TVT or no TVT. The rate of postoperative subjective SUI was significantly lower in those who had a TVT placed (10% vs 65%). No patients with a negative pessary test (none had a sling) had postoperative SUI. A previous prospective trial with 3 years followup by Meltomaa et al. [53] found that concomitant vaginal surgery did not affect outcome of TVT; however, there was an increased rate of complications such as infection, bladder perforation and transient retention after TVT. Ballert et al. [54] used UDS to decide which patients should have a MUSS placed with prolapse repair. Patients who had UDS-confirmed SUI and occult SUI (with the prolapse reduced, SUI confirmed during UDS) had a MUSS placed. There is an ongoing trial addressing prophylactic sling placement, the ‘OPUS’ trial [55]. Based on the currently available literature, it would appear that MUSS is a good choice to treat concomitant SUI and prolapse and may also be effective in reducing the risk of postoperative SUI in women with occult SUI. ISD ISD represents the portion of SUI that is not due to a support defect or urethral mobility. ISD is difficult to quantify and even more difficult to diagnose in patients who also have urethral mobility. Most of the published data has used a definition of an abdominal leakpoint pressure (ALPP) of <60 cmH2O or a maximum urethral closure pressure (MUCP) of <20 cmH2O. While we would agree that these lower resistance urethras are probably more difficult to treat, it is difficult to say that the lower resistance is due to ISD rather than a support defect (except in the fixed urethra). Nevertheless, the literature has made that distinction and for the purpose of this review, we will accept that as support defect ISD (SDISD). Fortunately, more recently ISD and urethral hypermobility have been viewed as a © JOURNAL COMPILATION © 2010 THE AUTHORS 2010 BJU INTERNATIONAL MID-URETHRAL SYNTHETIC SLINGS TABLE 2 Comparison of retropubic and transobturator slings in patients with ISD N 253 145 164 Cure rates, % TVT TOT 87 35 97 84 79 55 Araco et al. [62] Constantini et al. [57] Gungorduk et al. [63] 201 (not all ISD) 145* 300 100 72 78.3 66 68 52.1 100 Comments Pubovaginal sling 87 Nine in TOT require repeat surgery for SUI Small numbers with ISD % De Noro Urgency Reference Jeon et al. [60] Miller et al. [61] Schierlitz et al. [31] FIG. 5. De novo urgency frequency by duration since TVT surgery (P = 0.65) from Holmgren et al. 2007 [73]. 80 60 40 20 0 2 3 4 5 6 Year after TVT 7-8 *50 < 60 cmH20; TOT only combined results of ISD and urethral hypermobility. spectrum of disease with overlap. Thus, recent research examines the contributions of ISD and urethral hypermobility to outcomes. Retropubic MUSS have been shown to be effective in treating this group of patients. Rezapour et al. [56] reported on their longterm results in patients with ISD (defined as MUCP of <20 cmH20) at 2 years, with cure rates of 74%, 12.5% improved and 12% no change. These results compare favourably with their and other author’s results for all patients with SUI. There are five studies (one cohort, one retrospective review and three randomized trials) that favour retropubic over transobturator MUSS and one RCT (Constantini et al. [57]) showing equivalence in patients with ISD (variably defined as MUCP of <20 cmH20, Constantini et al. [57] defined ISD as ALPP of <60 cmH2O. Fritel et al. [58] showed that TVT was most effective in treating the hypermobile urethra but had acceptable success rates for the relatively fixed urethra. Success rates at 9 months were 97% with Q-tip test >60 °, 86% for Q-tip test of 30–60 ° and 70% for Q-tip test of <30 °. There was no difference in success based on an MUCP > or <20 cmH2O. A recent small study (n = 65) by Haliloglu et al. [59] of urethral hypermobility (Q-tip test of ≥30 °) and ISD (ALPP of <60 cmH2O) with TOT reported cure rates at 24 months (defined as a negative cough test) of: urethral hypermobility, no ISD in 96.4% (n = 31); urethral hypermobility and ISD in 87.5% (n = 18); no urethral hypermobility and ISD in 66.7% (n = 16). They concluded that a lack of urethral hypermobility may be a risk factor for TOT failure and suggested that even in the presence of low ALPP suggestive of ISD, the coexistence of urethral hypermobility still indicates likely good outcomes with transobturator MUSS. © Based on the available data (Table 2 [31,57,60–63]), it would appear that MUSS, retropubic or transobturator work well in cases of low urethral resistance with hypermobility. The literature suggests that patients with ISD may do better with retropubic MUSS but the evidence is not strong enough to support a high-level recommendation. In cases of a more fixed urethra, there is more data to support the retropubic approach over transobturator, but again the level of recommendation would be relatively low. MINI-SLINGS Although the retropubic and transobturator MUSS are relative minimally invasive procedures, there have been more recent ‘MUSS is a good developments to make the procedures even less invasive. The minislings or single-incision slings are designed to be placed via a small vaginal incision (like the traditional MUSS) but without any exit incisions. These slings can be place like a ‘hammock’ (mimicking the transobturator slings) or like a ‘U’ (mimicking retropubic slings). The two currently available singleincision slings are the TVT-Secur (Ethicon) and the Miniarc (American Medical Systems). The TVT-Secur can be placed into the endopelvic fascia in a U-form or into the obturator internus muscle in a hammock-form, while the Miniarc is placed only as a hammock. To date there is a paucity of peer-reviewed publications in this emerging area, thus far there are mixed results, some studies report equivalent cure rates to transobturator and retropubic approaches, others show less favourable results; the results are summarized in Table 3 [64–73], Fig. 5. There are no peer-reviewed published Level 1 comparative trails for single-incision slings comparing them to traditional MUSS yet to establish their place in evidence-based practice. In theory these procedures could offer a quicker recovery, but that is yet to be shown. Notably, there have been case reports of complications despite the extremely minimally invasive nature. Masata et al. [74] described severe bleeding from the internal obturator muscle following TVT-Secur with 1 L of bleeding requiring repeat surgical exploration. We think that single-incision slings hold promise for the treatment of female SUI are choice to treat concomitant SUI and prolapse ’ they rely on the same principles as other MUSS. However, to date follow-up has been short and outcomes are mixed, making these slings, in our opinion, a technology that still must be proven to have an advantage over traditional retropubic and transobturator MUSS. COMPLICATIONS OF MUSS Complications of MUSS are shown in Table 4 [19,20,24,30,73,75–80], categorized as intraoperative complications (bladder, urethral, viscus and vessels injury), immediate postoperative complications (voiding dysfunction, groin pain, infection, necrotizing fasciitis) and chronic problems (de novo urgency, sling erosion/extrusion). 2010 THE AUTHORS JOURNAL COMPILATION © 2010 BJU INTERNATIONAL 603 FONG and NITTI TABLE 3 Mini-slings No. of studies/no. of subjects 120 Sling name Contasure needleless Reference Navazo et al. (2009) [69] Miniarc Gauruder-Burmester et al. (2009) [64] 97 Moore et al. (2009) [70] Debodinance and Delporte (2009) [72] Neuman (2008) [68] 61 72 100 Martan et al. (2009) [66] Oliveira et al. (2009) [71] 85 107 Meschia et al. (2009) [67] 91 Golero et al. (2009) [65] 15 TVT secur Novara et al. [20] performed a meta-analysis of TVT complications vs other treatments. Technique Forceps penetrates obturator foramen, grasps pocket. No needles. Self fixating tips in obturator membrane Results (%) Cure (84) Failure (8) Complications (%) Vaginal erosion (2.5) Urinary retention (1.7) Negative cough test (83.1) (77) at 12 months De novo urge (36.8) Bladder perforation (1) Haematoma (1) Urinary retention (1.6) Erosion 1 De novo urge 1 Vaginal perforation (8) in 1st 50 + vaginal trimming (12) Failure at 3 months De novo urge (5.6) Vaginal erosion 1 Cure rate physician and patient (94) 2 months: (76) cure 1 year: (69.1) cure ‘Learning curve:’ (80) for 1st 50,then (92) for 2nd 50 (88.6–92) selfreport continence at 12 months Negative cough test (62) Negative cough test (71) 1 year: Subjective cure(78) Objective cure (81) UDS cure rate at: 3 months (80) At 6 months (87) by cough test. It is especially important to document the relationship of symptom onset to surgery. If patients report symptoms of voiding dysfunction, ‘mini-slings or single-incision slings are designed to a free flow rate should be measured. be placed via a small vaginal incision’ The necessity of UDS They showed that in analysis of nonin this setting is controversial and evidence randomised data, TOT was statistically less lacking. We would not consider them likely to cause perforation than retropubic necessary in the setting of classic obstructive slings. symptoms, retention or high postvoid residual urine volume (with normal preoperative Voiding dysfunction is reported at varying postvoid residual urine volume; unpublished levels after sling surgery, the Cochrane review data). However, video UDS would be useful in found that transobturator slings had lower patients with irritative symptoms to incidence (4% in pooled data) vs 7% for determine whether obstruction is present at retropubic slings [19]. Patients may present the level of the sling. Patients with irritative early, with retention, or late with obstructive symptoms should also be warned that in a voiding symptoms: feeling of incomplete study of 44 patients undergoing sling emptying, straining or hesistancy, needing to takedown or urethrolysis; two thirds of lean forward or stand, partial or complete patients with preoperative irritative urinary retention, or symptoms suggesting symptoms still had them postoperatively. Only overflow UI. 14 patients with sub-urethral synthetic slings (all TVT) were included in this study, so the Symptoms of de novo urge may be secondary numbers may not be sufficient to draw to urethral obstruction but are not indicators conclusions from this study alone [81]. in themselves of voiding dysfunction; they Conservative management includes should be taken in context with obstructive observation for irritative symptoms and clean symptoms. intermittent self-catheterization for high 604 postvoid residual urine volume and retention. In synthetic slings, we favour the alternative approach of early tape loosening for obstructive symptoms. We consider this for patients who have retention or near retention at 1–2 weeks. For early intervention, sling loosening in the office or operating room can be considered. Nguyen [82] published his series of 10 women who underwent tape loosening (under anaesthesia) at 3–10 days with all spontaneously voiding after this and no recurrence of obstruction or SUI at 1 year follow-up. Price et al. [83] recently published their series of 33 women who had early sling loosening (mean 7.7 days) under general anaesthesia. This was successful in 29 women, with four requiring tape division at 4–8 months. All patients had resolution of voiding symptoms, with one of the four patients that had tape division having the only recurrence of SUI. We perform this procedure in a similar fashion under local anaesthesia in the office and have found this to be well tolerated. Animal studies have shown fibroblast infiltration of the tape at 1 week, which supports observation of Price et al. [83] that tapes cannot be loosened after 2 weeks. For persistent voiding dysfunction beyond this, a formal transvaginal sling lysis or © JOURNAL COMPILATION © 2010 THE AUTHORS 2010 BJU INTERNATIONAL MID-URETHRAL SYNTHETIC SLINGS TABLE 4 Complications of MUSS Complication Intraoperative Bladder perforation Urethral injury Major vessel injury Meta-analyses/registry/reviews (year) Comparisons Novara et al. (2008) [20] TVT/SPARC Ogah et al. (2009) [19] Latthe et al. (2009) [24] TVT/SPARC Retropubic vs TO TOT TVT-O vs TVT Morton et al. (2009) [75] TO vs retropubic Deng et al. (2007) [76] Deng et al. (2007) [76] Retropubic Retropubic + TO N = 26 N = 36 (USA) Four [77,78] National registries: French, Finnish, Austrian, Netherlands Deng et al. (2007) [76] Retropubic 0–0.1 Retropubic N = 38 Bowel injury Early postoperative Voiding Ogah et al. (2009) [19] dysfunction 3.4 1.03 0.88 Retropubic vs TO 7 4 Johnson et al. (2003) [79] Flam et al. (2009) [80] Retropubic vs TO 2 2 Groin pain Latthe et al. (2009) [24] Retropubic vs TO 0.9 12 Chronic De novo urgency Holmgren et al. (2007) [73] TVT 14.5 Long et al. (2009) [30] Retropubic vs TO Long et al. (2009) [30] All slings Latthe et al. (2009) [24] Retropubic vs TOT vs TVT-O 1.1 3.0 4.7 Latthe et al. (2009) [24] Retropubic TOT TVT-O 2 2.6 1.1 Bladder/urethral erosion urethrolysis will be required. This is also approached through the midline incision. Identification of the sling is the key in this procedure. Using a cystoscope or urethral dilator may aid in identifying a tight band where the sling lies. The sling should be outside the peri-urethral fascia (if placed correctly), so that there is minimal danger to Symptoms/signs Management Cystoscopy, bleeding Remove and replace tape Retention, obstruction, UI Removal of sling, urethral reconstruction 3 deaths Ligation, embolization OR 0.55 for TVT vs SPARC 5.5 vs 0.3 OR 0.15 0.11 Infection Necrotizing fasciitis Vaginal erosion © Incidence, % 6 deaths (see text) Analgesia, steroid injection, sling removal Frequency consistent from 2 to 8 year follow-up 3.2 2.7 <3 the urethra itself during dissection. The sling is grasped with an Allis clamp or similar, a right-angle clamp is passed beneath and it is divided. There should be an appreciable loss of tension. The ends of the sling are then grasped and dissected back towards the vaginal fornix and freed up. A portion should be sent for pathology, to document sling lysis. Sling division, excision, oestrogen cream Removal of mesh Several small series now suggest that early intervention should be favoured, as delayed intervention may lead to irreversible bladder symptoms. Leng et al. [84] published a series of 21 patients who underwent sling lysis. When they stratified patients by their postoperative symptoms or absence of, there was a statistically significant difference in 2010 THE AUTHORS JOURNAL COMPILATION © 2010 BJU INTERNATIONAL 605 FONG and NITTI mean time to sling lysis, 9 months in the no symptom vs 31 months in the persistent symptom group. 8 CONCLUSIONS MUSS have transformed anti-UI surgery for patient morbidity, durable cure and ease of performance. The surgical techniques continue to develop, with the emergence of the transobturator technique and more recently the development of mini-slings. 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Nitti, Department of Urology, New York University Medical Center, 150 E 32nd Street 2nd floor New York, NY 10016, USA. e-mail: victor.nitti@nyumc.org Abbreviations: MUSS, mid-urethral synthetic slings; (S)(U)UI, (stress) (urgency) urinary incontinence; TVT(-O), tension-free vaginal tape (-obturator); DO, detrusor overactivity; PGI-I, Patient Global Impression of Improvement; TOT, transobturator tape; RR, relative risk; RCT, randomized controlled trail; HRQL, health-related quality-of-life; OR, odds ratio; ISD, intrinsic sphincter deficiency; UDS, urodynamic studies; BMI, body mass index; ALPP, abdominal leak-point pressure; MUCP, maximum urethral closure pressure. © JOURNAL COMPILATION © 2010 THE AUTHORS 2010 BJU INTERNATIONAL