Abstract
Arab Journal of Urology (2013) 11, 117–126 Arab Journal of Urology (Official Journal of the Arab Association of Urology) www.sciencedirect.com URODYNAMICS/FEMALE UROLOGY REVIEW The fate of synthetic mid-urethral slings in 2013: A turning point Paholo G. Barboglio, E. Ann Gormley Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA Received 13 March 2013, Received in revised form 16 April 2013, Accepted 17 April 2013 Available online 14 June 2013 KEYWORDS Abstract Introduction: Since the introduction of the first retropubic tension-free synthetic sling to treat stress urinary incontinence (SUI), newer approaches, different Mid-urethral; techniques and new devices have been created. Transobturator and single-incision Sling; sling (SIS) techniquespara-were developed with the goal of diminishing the rate of Synthetic; complications andspeeding the recovery phase. Stress urinary inconti- Methods: For this review we searched Medline for relevant papers, with an nence; emphasis on meta-analysis and randomised controlled trials (RCTs). Specially Retropubic; selected reports were identified to address both ’index patients’ (defined as those with Transobturator tape genuine SUI and no previous anti-incontinence procedure or other genitourinary sign or symptom that might affect her SUI) and, briefly, non-index patients. Two ABBREVIATIONS authors independently reviewed papers for eligibility. DUPS, distal urethral Results: Level 1 evidence from a Cochrane review and two meta-analyses indi- polypropylene sling; cated that subjective outcomes with the mid-urethral sling (MUS) were similar to FDA, United States those from colposuspension. However, the MUS was better than colposuspension food and drug admin- when assessing objective outcomes (Level 1). MUS are equally effective as autolo- istration; gous pubovaginal slings (Level1). Two meta-analyses suggest that retropubic ISD, intrinsic sphinc- MUS (RMUS) might be better than transobturator MUS when assessing objective teric deficiency; outcomes. Five more recent RCTs with longer term outcomes showed high success MUS, Mid-urethral rates and only one reported a significant advantage for the RMUS in women with Corresponding author. Address: Dartmouth-Hitchcock Medical Center, One Medical Drive, Lebanon, NH 03766, USA. E-mail address: Elizabeth.Ann.Gormley@hitchcock.org (E. Ann Gormley). Peer review under responsibility of Arab Association of Urology. Production and hosting by Elsevier 2090-598X ª 2013 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. http://dx.doi.org/10.1016/j.aju.2013.04.005 118 Barboglio, Ann Gormley sling; intrinsic sphincteric deficiency. One meta-analysis addressing the SIS showed OR, odds ratio; inferior outcomes to the MUS (Level 1). New and improved SIS techniques have POP, pelvic organ been used, but long-term outcomes are limited and results are still controversial prolapse; when compared to the MUS. PVS, pubovaginal Conclusion: MUS are still the standard to treat the index patient as previously sling; stated by the American and European Associations of Urology. Currently data RCT, randomised are lacking to define which sling and what approach works best. Complications controlled trial; are significantly different between sling types and are dependent on technique. RMUS, retropubic ª 2013 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. mid-urethral sling; RR, relative risk; SIS, single-incision sling; SUI, stress urinary incontinence; TMUS, transobturator mid-urethral sling; TOT, transobturator tape; TVT, tension-free vaginal tape; TVT-O, TVT-obtura- tor; TVT-S, TVT-Secur; TFS, tissue-fixation mini-sling; UITN, urinary incon- tinence treatment net- work; VLPP, Valsalva leak- point pressure Introduction pubococcygeus muscle incapable of lifting the anterior vaginal wall to close the urethra against the puboure- thral ligaments. The purpose of a MUS is to reinforce The purpose of this review was to assess the current role this deficient mechanism. of mid-urethral slings (MUS) in the treatment of stress The TVT was developed as a minimally invasive pro- urinary incontinence (SUI). We reviewed data describing cedure to treat SUI by supporting the mid-urethra the historical development of MUS and its turning mechanism with a synthetic polypropylene monofila- points. We also describe the current position of the ment mesh placed by a retropubic, bottom-to-top ap- AUA and the USA Food and Drug Administration proach. The initial results showed that it was very (FDA) Notification on Vaginal Mesh. We present a con- successful (91% success, as defined by the authors, at cise literature review of the outcomes with the MUS in the 1 year) with a low complication rate that included one ‘index patient’, defined as a woman with genuine SUI and bladder perforation and voiding dysfunction affecting no previous anti-incontinence procedure or other genito- four patients from a cohort of 130 women [3]. The first urinary sign or symptom that might affect her SUI, and long-term data were from Nilsson et al. [4], who re- then comment on the role of MUS in non-index patients. ported objective and subjective cure rates of 84.7% with History of mid-urethral slings a median follow-up of 56 months. Subsequently Nilsson et al. [5] reported the longest follow-up (11 years) in a prospective observational cohort of 90 women. They The first MUS procedure, the tension-free vaginal tape showed a 90% objective and 77% subjective cure rate (TVT, Gynecare, Ethicon, Somerville, NJ, USA) was with no long-term adverse events. described by Ulmsten and Petros in 1995 [1]. The use In 2001, Andonian et al. [6] described the use of the of the TVT was based on reinforcing the pubococcygeal suprapubic arc system (SPARC, American Medical Sys- muscles at the level of the mid-urethra, as explained by tems, Inc., Minnetonka, MN, USA) using a top-to-bot- the ‘Integral Theory’, developed by Petros and Ulmsten tom retropubic approach which proved to be equally [2], which proposes that SUI results from a deficient The fate of synthetic mid-urethral slings in 2013: A turning point 119 effective as the TVT, when assessing the objective cure thral space, behind the pubic bone, with a bottom-to- data. However, when assessing adverse events, the top retropubic orientation. The H-shaped technique en- SPARC had a higher mesh erosion rate than the TVT tails introducing the sling into the obturator internus [6,7]. Given the high success rates and rapid recovery, muscle by an inside-out orientation approach, so that the retropubic MUS (RMUS) became the new standard the sling supports the urethra like a hammock. and replaced retropubic colposuspensions and the pub- This new generation of slings appears to be associ- ovaginal sling (PVS) for the surgical treatment of SUI [8]. ated with a lower risk of some complications and a As synthetic slings revolutionised the surgery for SUI, quicker recovery phase, but adverse events like vaginal they also affected the commercial market. New sling kits perforation, mesh erosion and urinary retention are using different synthetic materials, and different methods not absent. There is still debate as to whether these to introduce the sling material, were introduced (Table 1). SIS can achieve similar outcomes to the original MUS, As new sling kits were developed and marketed, surgeons given the lack of long-term outcomes and limited data introduced modifications of other surgical techniques, from randomised controlled trials (RCTs) comparing attempting to avoid the high cost of the kits. The most sig- them directly to MUS. nificant change to MUS technology was the introduction of the transobturator MUS (TMUS) in 2001 by Delorme The AUA Guideline on the surgical management of [9]. He introduced the transobturator approach to avoid female SUI the blind passage of the needle into the retroperitoneal space, which can be associated with pelvic haematoma, In 2009–2010 the AUA published a Guideline update on bladder perforation and voiding dysfunction. As origi- the surgical management of female SUI [8]. Although nally described by Delorme, the TMUS was inserted out- there was a meta-analysis of the various surgical treat- side-in and was later modified to an inside-out approach ments in this comprehensive review, significant portions by De Leval in 2003 [10]. The TMUS had comparable of the Guideline were based on the consensus of the pa- efficacy to the RMUS but with unique adverse events that nel members. The TMUS data were not analysed in the included groin pain and potential neurovascular injury in Guideline as there were few long-term data in 2005 when the obturator region. the literature search was completed. In 2003 Rodriguez and Raz [11] described the distal The Guidelines refer to the index patient; cure rates urethral polypropylene sling (DUPS). This MUS is and improvement outcomes were calculated for all anti- placed retropubically distal to the pubourethral liga- incontinence procedures at 12 and 48 months with and ments, under finger guidance, with the use of reusable without concomitant prolapse repair. RMUS placed via Raz or Stamey needles. According to the limited reports, a transvaginal approach had a cure rate of 81–84% (at the DUPS has proven to be effective and safe, at a re- 12–48 months) with no concomitant prolapse repair, duced cost. and 76–87% when placed during prolapse surgery [8]. A single-incision sling (SIS) was developed as a less The consensus of the Guideline was that although the invasive procedure with fewer adverse events. The first five major types of procedures, including injectables, SIS (TVT-Secur, Gynecare, Ethicon, Somerville, NJ, laparoscopic suspensions, MUS, PVS and retropubic USA) was approved by the FDA in 2006. Subsequently suspensions, were not equivalent, all should be offered other SISs were produced and by 2009 short-term data to the index patient. The AUA Guideline also reported were published showing equally effective objective and on urgency, retention and complications. In the RMUS subjective cure rates (Table 1) [12–14]. The TVT-Secur group with no prolapse surgery, the de novo urge incon- can be placed in one of two ways. The U-shaped tech- tinence rate was estimated to be 6%, and the rate for nique consists of introducing the sling into the para-ure- unspecified urgency was 22%. In patients treated with concomitant prolapse surgery the rates were 11% and 9%, respectively. Retention was defined as that for Table 1 Synthetic slings. >1 month or requiring intervention, and the rate was Name Manufacturer Technique/approach 3% for RMUS with or with no simultaneous prolapse TVT Ethicon RMUS bottom to top repair. Complication rates for RMUS were ‘generally SPARC AMS RMUS top to bottom higher than recently reported data’ and included bladder Advantage Boston Scientific RMUS bottom to top injury in 6%, UTI in 11% and mesh extrusion in 8%, Lynx Boston Scientific RMUS top to bottom reported as vaginal in 7% and not defined in 1% [8]. TVT-O Ethicon TMUS inside to out Monarc AMS TMUS outside to in ObTryx Boston Scientific TMUS outside to in The FDA notification on vaginal mesh Aris Coloplast TMUS outside to in TVT-Secur Ethicon Single incision In October 2008 the FDA issued a public health state- MiniArc AMS Single incision Solyx Boston Scientific Single incision ment announcing that although transvaginal surgical Ajust Bard Single incision (adjustable sling) mesh complications are rare, these can have serious con- 120 Barboglio, Ann Gormley sequences when used to repair pelvic organ prolapse symptoms are and how the patient’s quality of life is af- (POP) and/or SUI [15]. Later the FDA released an up- fected. The AUA SUI Guideline recommends a focused date (July 2011) stating that these complications are history that should include the characterisation of the not rare and included mesh erosion (also called expo- incontinence, the frequency, bother and severity of the sure, extrusion, or protrusion) and contraction. More- incontinence episodes, the effect of symptoms on life- over, the FDA noted that complications with the style, and the patient’s expectations of treatment [8]. vaginal mesh might lead to severe pelvic pain, dyspareu- Also, the patient’s medical, surgical and gynaecological nia or inability to engage in sexual intercourse, and dis- history, and her social history, might be important in comfort in the male sexual partner during sexual counselling the patient about surgical therapy. intercourse when there is exposed mesh [16]. The remainder of the evaluation should be a focused The safety and efficacy were evaluated by reviewing physical examination, including an objective demonstra- reports from 1996 to 2011. This systematic review tion of SUI and additional tests such as a urine analysis showed that transvaginal POP repair with mesh neither and an assessment of the postvoid residual urine vol- improved the symptomatic results nor the quality of life ume. In most patients this will constitute an adequate over a traditional mesh-less repair. The complications evaluation. The use of validated questionnaires and sur- associated with the use of surgical mesh for POP repair veys is recommended to assess the patient’s symptoms have not been linked to one brand of mesh. The FDA in and bother. Voiding diaries, urodynamics, cystoscopy their notification discussed training for mesh insertion, and other diagnostic imaging studies should be ordered and the consent procedure for the use of synthetic mesh. if it is not possible to make a definitive diagnosis with Although much of the FDA notification dealt with mesh the initial evaluation, or there is evidence of voiding dys- used for transvaginal POP, mesh used for SUI was function, POP, a history of previous incontinence sur- implicated by association. The FDA noted that they gery, excess postvoid residual volume, unexplained continue to evaluate reports for SUI surgery using sur- haematuria, pyuria, concomitant overactive bladder gical mesh, and that at a later date they would release symptoms, or known or suspected neurogenic bladder additional information, but to date no additional infor- [8]. mation has been released [16]. The selection of the type of surgical management for SUI will rely not only on the diagnosis and characterisa- The AUA Position Statement tion of SUI, but also on the patient’s treatment expecta- tions. Women desiring a surgical correction of SUI should be advised about the outcomes and advantages The AUA released a Position Statement in November and possible complications for all treatments for SUI, 2011 on the use of vaginal mesh for the surgical treat- including the MUS. ment of SUI [17]. The statement noted that the efficacy of synthetic polypropylene mesh slings is equivalent or Outcomes with the MUS superior to other surgical techniques, based on Level 1 evidence, with a follow-up to 10 years, and these are not associated with a significant increase in adverse A review of reports identified using the word ‘subure- events. The AUA agreed with the FDA recommenda- thral sling’ in PubMed resulted in 1694 articles. When tion of including a comprehensive informed consent be- these were limited to humans (1637), the English lan- fore synthetic sling surgery, disclosing all possible risks guage (1419), clinical trials (235) and meta-analyses and adverse events. Additional recommendations in- (24), there was a total of 259 studies. RCTs already in- cluded not only rigorous urological training in pelvic cluded in most recent meta-analyses were then excluded. anatomy and pelvic surgery, and intraoperative cystos- In all, 16 articles were included in the present review of copy to exclude urinary tract injury, but specific surgical the outcomes of the MUS. The meta-analysis for the expertise on ‘specific sling techniques’ as well as the Update of the AUA Guideline on the surgical manage- diagnosis and treatment of related complications. The ment of SUI [8] and two landmark meta-analyses by statement concluded that ‘synthetic slings are an appro- Novara et al. [18] and the Cochrane review by Ogah priate treatment choice of women with stress inconti- et al. [19] provide Level 1 evidence from the comparison nence, with similar efficacy but less morbidity than of the outcomes of the MUS with those from colposus- conventional nonmesh techniques’ [17]. pension, PVS and when comparing the RMUS to the TMUS. Subsequently, five RCTs comparing the RMUS and TMUS, with longer term outcomes, were published Patient evaluation [20–24]. A meta-analysis reviewing different TMUS ap- proaches (inside-out vs. outside-in) was also included The purpose of the patient’s evaluation is to diagnose [25]. A data analysis of the SIS was obtained from one and characterise the SUI, and to assess for other con- meta-analysis [26] and three recent RCTs [27–29]. Other comitant urinary issues, as well as other possible comor- selected articles were identified to briefly address non- bidities. It is important to understand what the patient’s The fate of synthetic mid-urethral slings in 2013: A turning point 121 index cases, included women who had a concomitant quicker operation [19], less postoperative voiding dys- prolapse repair [30], those undergoing second anti- function [18,19] and a lower reoperation rate [19]. This incontinence surgery for recurrent SUI [31], those with is explained by the PVS historically having been a tigh- intrinsic sphincteric deficiency (ISD) [24], and those with ter sling, with the potential need to cut the sling if the mixed UI [32]. Two authors independently reviewed and patient is unable to void after surgery or if the patient assessed these papers for eligibility. develops symptoms of voiding dysfunction. MUS vs. colposuspension RMUS ‘bottom-to-top’ vs. ‘top-to-bottom’ MUS have equivalent patient-reported outcomes to col- The largest available body of literature on the RMUS posuspension (Level 1 evidence) as supported by three placed via the bottom-to-top approach is that for the meta-analyses [8,18,19]. The landmark study on colpo- classic TVT. Most of the data from RCTs on the top- suspension vs. TVT is the RCT reported by Ward and to-bottom approach are with the SPARC. The Cochra- Hilton [33]. This trial showed similar objective cure ne review from Ogah et al. [19] described five studies rates, at 63% for TVT and 51% for colposuspension, comparing the TVT and SPARC. Although both with a follow-up of 2 years. Although other RCTs MUS approaches showed very high success rates, the showed analogous results, Novara et al. [18] reported bottom-to-top approach TVT had better subjective a meta- analysis which included 11 RCTs assessing the (RR 1.10; 95% CI 1.01–1.2) and objective (RR 1.06; overall cure rate, and confirmed the superiority of 95% CI 1.01–1.11) outcomes at 12 months of follow- MUS (odds ratio, OR, 0.61, 95% CI 0.46–0.82) over up, as well as fewer vaginal erosions (RR 0.27; 95% open colposuspension. Objective data also favoured CI 0.08–0.95), fewer bladder perforations (RR 0.55; the MUS when evaluating specifically a negative stress 95% CI 0.31–0.98) and a lower voiding dysfunction rate test (OR 0.38, 95% CI 0.25–0.57), which was available (RR 0.40; 95% CI 0.18–0.90) than the SPARC top-to- in three studies. bottom approach [19]. A Cochrane review by Ogah et al. [19] specifically examined the comparison of MUS with laparoscopic RMUS vs. TMUS colposuspension, and also showed favourable results for MUS when assessing objective data (relative risk, Since the introduction of the TMUS by Delorme in 2001 RR, 1.15, 95% CI 1.0–1.24). However, there was no sta- there has been controversy about its efficacy compared tistically significant difference when assessing specifically to the retropubic approach. Studies have shown similar, a negative pad test and subjective data [18,19]. More- superior and inferior outcomes when compared to the over, the Cochrane review showed that the MUS was RMUS. There is no question that both techniques have associated with fewer perioperative complications, a very high cure rates in the index patient. In the Cochra- shorter perioperative time and hospital stay, but a high- ne review the RMUS was judged to be better than er rate of bladder perforations (RR 4.24, 95% CI 1.71– TMUS (RR 0.96, 95% CI 0.93–0.99) [19]. However, gi- 10.52) when compared to open colposuspension [19]. ven the narrow CI the difference between the groups Similarly, and not unexpectedly, the risk of bladder per- might not represent a clinically significant difference, foration reported by Novara et al. was five times higher as indicated by the authors. Moreover, when assessing for those women who had a MUS than in those with a objective data, the analysis showed a moderate degree Burch colposuspension [18]. of heterogeneity (I = 47%), which weakens the result, due to inconsistency across the included studies. How- MUS vs. PVS ever, the meta-analysis of Novara et al. [18], published at almost the same time, confirmed this finding. The There is also Level 1 evidence from meta-analyses that a RMUS was better than the TMUS when assessing MUS is as effective as an autologous PVS for treating objective data (OR 0.80; 95% CI 0.65–0.99) with a fol- the index patient with SUI [8,18,19]. This finding has low-up of 12 months. Interestingly, in a subanalysis spe- significantly reduced the use of the PVS. Nonetheless, cifically comparing the (inside-out) TMUS to the TVT, an autologous fascia PVS is sometimes advocated in pa- the efficacy was no longer higher in the RMUS group tients in whom a MUS has already failed, and they re- (OR 0.9; 95% CI 0.66–1.22). Furthermore, there was main an option for the patient who does not want a no difference on the efficacy outcomes when reviewing synthetic mesh sling. In some practices this has become subjective data. important after the FDA warning about mesh. If a pa- When assessing surgical outcomes and adverse tient prefers not to have a synthetic sling, the best alter- events, the TMUS was associated with a higher risk of native might be a PVS instead of a colposuspension, as groin pain (RR 5.95; 95% CI 3.22–11.02). The RMUS the latter has been shown to be inferior to a PVS [34].In was associated with twice the risk of bladder perforation comparison to a PVS, the MUS is associated with a (OR 2.39; 95% CI 1.32–4.32), almost three times the risk 122 Barboglio, Ann Gormley of pelvic haematoma (OR 2.62; 95% CI 1.35–5.08) and However, neurological symptoms like groin pain, or 1.35 times the risk of voiding dysfunction (95% CI 1.05– thigh numbness, were more common in the TMUS group 1.72) [18]. There is no difference in these complications (10% vs. 5%; P = 0.045), whereas symptoms of voiding when only the TMUS placed using the outside-in ap- dysfunction requiring surgery (3% vs. 0%; P = 0.002), proach is compared to the RMUS. The risk of erosion and UTI (17.1% vs. 10.7%; P = 0.025) were more com- was lower for the RMUS than the TMUS, and this dif- mon in the RMUS group [21]. ference remained significant when only the TMUS Angioli et al. [22] reported on an RCT with a 5-year placed via an outside-in approach was subanalysed follow-up that included 72 patients, 35 in the RMUS [18]. The operative duration appeared to be shorter, group and 37 in the TMUS group, with a 72% complete but the heterogeneity was very high in this analysis follow-up. This study showed no significant difference in (I = 94%). Data suggest that the estimated blood loss the objective cure rates between the RMUS (71%) and was lower in the TMUS group and there was no statis- the TMUS (73%) group. There were also no differences tically significant difference between the RMUS and in adverse events, but unlike many of the other studies, TMUS when assessing UTI or reoperation rates [19]. fewer patients (only 61%) were satisfied. The authors Two large multi-institutional trials recently reported commented that dissatisfaction could be influenced by their 24-month treatment results of the RMUS com- sexual dysfunction, which was found in six of 16 dissat- pared to the TMUS. A French study included 149 pa- isfied patients. tients with an 88% follow-up at 2 years. The classic Two other trials reported on the 36-month follow-up TVT (bottom-up) was compared to TVT-O (inside-out) outcomes. A Finnish multicentre RCT of 267 women by and there was no difference on objective and subjective Palva et al. [23] reported no difference in efficacy be- outcome data when assessing success. Similarly, there tween the RMUS vs. TMUS in objective and subjective was no difference (P = 0.68) when assessing bladder in- outcomes, of 91% and 85%, respectively. Objective out- jury; the RMUS group had four of 75 and the TMUS comes were measured by a negative stress test and pad group two of 74, and all were diagnosed intraoperatively. weight, and subjective outcomes relied on patient satis- There was only one urethral injury and this occurred in faction. These results confirmed previous reported out- the RMUS group, and one mesh extrusion that occurred comes at 12 months. An Australian RCT of 164 at 2 months in the TMUS group. There was no difference women by Schierlitz et al. [24] also confirmed their pre- in voiding dysfunction or repeat surgery, and although vious reported outcomes at 3 years. The authors re- women had more pain after the TMUS, this was no long- ported a significant difference in objective outcomes er statistically significant at 24 months [20]. favouring the RMUS over TMUS, but no difference The Urinary Incontinence Treatment Network in subjective outcomes. Objective failure was defined (UITN) trial was a randomised equivalence trial that as the patient having repeat surgery for SUI and 20% compared the TMUS and RMUS at 12 and 24 months. of women (15 of 75) in the TMUS group required a sec- At 24 months they had a complete follow-up on 86.4% ond anti-incontinence operation, vs. only one in the of 597 patients. Their study showed a trend of greater RMUS group. Further analysis showed that repeat sur- benefit with the RMUS approach, with the objective suc- gery could have been avoided in one of six women cess rates not meeting the pre-specified criteria for (P < 0.001) if the RMUS was used for all patients. It equivalence. Clinical significance was based on a deter- is important to recognise that women in this trial had mination of equivalence, with the entire 95% CI for ISD and the authors used one of the worst measures the difference between the two surgical groups required to assess the objective outcomes. Alternatively, women to be within the equivalence margin. Objective data with poor outcomes who did not proceed to a second showed equivalence at 1 year and this decreased at anti-incontinence procedure might have been lost to fol- 24 months, from 81% to 77% in the RMUS group and low-up. 78% to 72% in the TMUS group. With this decrease in objective success rates at 2 years there was no longer TVT-O vs. ‘outside-in’ approach equivalence between the groups (95% CI for the differ- ence of 5.1% was –2.0 to 12.1), favouring the superiority A recent meta-analysis published by Madhuvrata et al. to the RMUS approach. Subjective data were not equiv- [25] included five full articles and one abstract in their alent at 12 or at 24 months, and also favoured the comparison analysis, as well as three cohort studies for RMUS. Although equivalence was not met for the objec- a subsensitivity analysis. One type of sling (TVT-O) tive and subjective outcomes, the CIs suggested no statis- was used for the inside-out approach and different slings tical difference, as zero was included in the range. In this (Aris; Monarc; TOT from Korea, Dow, Medics) large multi-trial study the participants in both groups were used in the trials for the outside-in approach. Both had a high level of satisfaction, despite a decrease in TMUS techniques were shown to be equally effective at objective success rates, and there was no difference in the 12-month follow-up, as previously reported in the urinary symptom severity or quality of life at 24 months. Cochrane review by Ogah et al. [19]. When assessing The fate of synthetic mid-urethral slings in 2013: A turning point 123 surgical outcomes and adverse events, intraoperative Although this new generation of slings was developed vaginal-angle injuries were more common in the out- to have lower complication rates, a systematic review of side-in approach (RR 0.33; 95% CI 0.01–8.21). How- 10 observational studies on the TVT-S reported a vagi- ever, bladder or urethral perforations, voiding nal perforation rate of 1.5%, mesh exposure of 2.4%, dysfunction, mesh erosion, groin or thigh pain and void- urinary retention of 2.3%, UTI of 4.4%, dyspareunia ing dysfunction were not different [25]. of 1% and a 10% incidence of de novo overactive blad- der symptoms [38]. The SIS The right sling for the right patient There are reports supporting the safety and efficacy of these products, with shorter operating times and an ear- The index patient, as defined above, is likely to fare well lier return to work and other activities than with the regardless of what procedure she undergoes for SUI. standard MUS [35]. However, there is still controversy These women should be offered an explanation of the as to whether SIS achieve long-term outcomes similar risks and benefits of all the previously mentioned anti- to the other MUS [36,37]. incontinence procedures, and allowed to make an in- There is Level 1 evidence from a recent meta-analysis formed choice as to which procedure they want. Based that included nine RCTs showing inferior subjective on the available reports, both the RMUS and TMUS (RR 0.83; 95% CI 0.70–0.99) and objective (RR 0.85; should be offered as first-line procedures. When assess- 95% CI 0.74–0.97) short-term outcomes, as well as high- ing RMUS approaches, the data suggest that the bot- er reoperation rates for SUI (RR 6.72; 95% CI 2.39– tom-to-top is better than top-to-bottom approach, 18.89) than for MUS. Most of the trials included in based on a lower rate of genitourinary injuries [19]. the meta-analysis used the TVT-S, which has recently However, further larger-sample trials are needed to as- been removed from the market [26]. sess this difference. Proponents of the DUPS procedure, The largest and longest RCT comparing a SIS to a which uses a re-useable needle passed from top to bot- TMUS is that published by Sivaslioglu et al. [27], tom, note that passage of the needle on the tip of the comparing the tissue-fixation mini-sling (TFS, Surgi- surgeon’s finger might help to avoid bladder injuries cal, Adelaide, South Australia, Australia) with an out- [11]. The patient who does not want a synthetic sling side-in TMUS. The authors reported more favourable should be offered a PVS. outcomes with the TFS at 5 years, of 85% vs. 75% The use of the SIS should only be offered in the set- for the objective cure rate. Although they presented ting of full disclosure. Although the data remain contro- the 5-year follow-up with only a 10% loss in each versial, and even suggest inferior results for these types group, their power was limited, with only 36 patients of slings, the level of uncertainty is even higher when in each group. assessing the long-term outcomes of these procedures It is also still not clear whether there is a significant [26]. We recommend that only those surgeons who are difference between the two SIS insertion techniques. A experienced with the SIS and who produce favourable recent RCT by Lee et al. [28] reported comparable cure long-term outcomes should offer a SIS. rates but a lower quality of life/satisfaction rate for the Women with other signs and symptoms of lower uri- H-type method. Unfortunately, in this study there were nary dysfunction should be properly evaluated, so they significant differences in the patient characteristics be- can be offered the most efficient therapy or surgical pro- tween the groups, with patients in the U-shaped sling cedure available. Unfortunately there are few prospective group being older, having more urgency and twice the RCTs that address these particular non-index patients. rate of detrusor overactivity. These differences might have influenced the quality-of-life results. Mixed UI A more recent RCT by Barber et al. [29], that com- pared TVT-S placed in the U-position to the TVT In the patient with mixed UI the goal of any inconti- showed similar subjective cure rates, but the efficacy of nence surgery is to treat the SUI component and to the SIS was inferior to the RMUS, as defined by a dif- not exacerbate the patient’s urge component. As with ference in the CI of 12%, based on a subjective outcome. other incontinence procedures, the urge component, The incontinence severity at 1 year was worse in those particularly idiopathic detrusor overactivity, might im- women who had the SIS. Another important finding prove after correcting the stress component with a was the high rate (8.8%) of device malfunction or tech- MUS [39,40]. A recent meta-analysis by Jain et al. [32] nical difficulties encountered at the time of surgical found six RCTs and seven cohort studies. The authors implantation with the SIS. The TVT group had a worse reported an overall cure rate of 56.4% (95% CI 45.7– bladder perforation rate, more pain in the first 3 days 69.6) at 34.9 ± 22.9 months of follow-up, based on se- after surgery, and they were more like to need a urethral ven cohort prospective studies, and commented on the catheter at discharge. heterogeneity of their outcome measures. Further 124 Barboglio, Ann Gormley subanalysis showed no difference in outcomes when they When to avoid MUS compared the RMUS and TMUS. The data remain scarce to define which MUS approach has better long- Following the FDA notification on synthetic mesh use term outcomes for mixed UI. and the subsequent legal actions against mesh manufac- turers, some patients are not interested in having a mesh Simultaneous prolapse repair sling. Since the warning was not directed at the use of synthetic slings, this needs to be explained to patients The most recent multicentre study by the Pelvic Floor as part of the informed-consent process. Patients need Disorder Network showed that in 337 women undergo- to be told that there are risks inherent to synthetic mesh, ing prolapse repair, occult SUI was prevented with the but that these risks are small. A woman who does not use of a prophylactic MUS. Patients who had a TVT want a synthetic sling should be offered other treatments placed had significantly less SUI than patients who for her SUI. Furthermore, women who have been trea- had a sham procedure, at the 1-year follow-up. This ted for a sling complication, particularly erosion into the study also confirmed a higher rate of adverse events urinary tract, and remain incontinent, are best re-treated and complications for those who had the TVT. It was without using more synthetic material. Patients who calculated by the authors that six women need to be have had other previous extensive or significant genito- treated with a TVT to prevent one case of SUI after pro- urinary reconstruction, urethral fistula repair, urethral lapse repair [30]. diverticulectomy, or a history of radiation, might be bet- ter treated with autologous tissue rather than a synthetic ISD and urethral hypermobility material. The MUS should also not be used when ten- sion is required. MUS are designed to be placed without The definition of ISD remains controversial. Histori- tension to avoid the risk of erosion. When more tension cally, ISD was defined in women with ‘pipe stem’ ure- is desired to intentionally occlude the urethra and cause thras that were fixed and rigid. These women were an emptying problem (urinary retention), as in some very incontinent. When ISD is defined using a strict uro- particular cases of neurogenic bladder, an autologous dynamic measure such as the Valsalva leak-point pres- fascia PVS is preferred. sure (VLPP) or maximum urethral closure pressure, it can be diagnosed in women who have bladder neck Summary mobility. Given that the mechanism of action of a MUS depends on bladder neck mobility, most clinicians The most recent update on the AUA guidelines recom- favour either an injectable agent or a PVS for those wo- mends the MUS for treating the index patient with men with no bladder neck mobility. There are data for SUI [46]. The European Association of Urology guide- MUS showing that in some women described as having line similarly recommends the MUS [47]. The FDA ISD, a RMUS or TMUS is comparable to a PVS warning needs to be considered when counselling pa- [41,42]. There is also Level 1 data suggesting that the tients, but it should not be used as a reason not to offer RMUS approach has more favourable outcomes than these procedures to patients. The FDA warning has also TMUS, based on a 3-year follow-up RCT [24] and espe- changed the way in which new slings will be released, cially in women with urethral hypermobility [43]. and might lead to some products being withdrawn from the market. Recurrent SUI In the present review we assess data which shows that for the index patient these are reasonable options. If cli- nicians choose not to use a synthetic sling they should at Recurrent SUI must be evaluated in an effort to under- least discuss with their patient that a MUS is a reason- stand why the patient leaks. If urethral mobility is lack- able option and offer a referral to a clinician who will ing and the patient has a low VLPP, a PVS or an do the procedure. The patient who chooses not to have injectable bulking agent can be used. However, there are few long-term results on either of these procedures a synthetic mesh implanted they should be offered other to treat patients with recurrent SUI. A recent Cochrane reasonable alternatives. We should not take a step back- review reported no RCT to date and the authors were wards by doing surgical procedures that have been unable to draw any conclusions [31]. In the age of shown to have inferior outcomes. Patients need to be MUS there are minimal data on the treatment of a failed educated that there remain good surgical treatments MUS with another MUS. Liapis et al. [44] reported for SUI. favourable results with TVT, and Stav et al. [45] sug- For the non-index patient, including those in whom a gested that a RMUS might be better than a TMUS. previous MUS has failed, data as to how to best treat Some surgeons have advocated using a different ap- this patient are lacking. Large prospective clinical trials proach for the patient’s second surgery, although there are needed to examine these issues. In these trials pa- are no data to support this. tients will need to be well characterised, and they will The fate of synthetic mid-urethral slings in 2013: A turning point 125 incontinence; 95% CI [annual meeting abstract]. J Urol need to be followed for sufficiently long periods. Until 2009;181:544. further data-driven recommendations are made as part [13] Neuman M. Perioperative complications and early follow-up with of a Guideline process, clinicians should use the MUS 100 TVT-SECUR procedures. J Minim Invasive Gynecol as part of their clinical options in the treatment of pa- 2008;15:480–4. tients with SUI. [14] Kennelly MJ, Moore R, Nguyen JN, Lukban JC, Siegel S. Prospective evaluation of a single incision sling for stress urinary At this point, the MUS remains the standard for the incontinence. J Urol 2010;184:604–9. surgical treatment of female SUI in the index patient, [15] FDA Public Health Notification. Serious complications associ- and has a place in the treatment of the non-index ated with transvaginal placement of surgical mesh in repair of patient. pelvic organ prolapse and stress urinary incontinence; 95% CI. Issued October 20, 2008. Available from: http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifica- Conflict of interest tions/UCM061976. [16] FDA Safety Communication. UPDATE on serious complications None. associated with transvaginal placement of surgical mesh for pelvic organ prolapse; 95% CI [Internet], July 13, 2011. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ Funding ucm262435.htm. [17] AUA Position Statement on the Use of Vaginal Mesh for the Repair of Pelvic Organ Prolapse; 95% CI [Internet], November None. 2011. Available from: http://www.auanet.org/content/aua-poli- cies/position-statements/pelvic-organ-prolapse.cfm. References [18] Novara G, Artibani W, Barber MD, Chapple CR, Costantini E, Ficarra V, et al. Updated systematic review and meta-analysis of [1] Ulmsten U, Petros P. Intravaginal slingplasty (IVS). An ambu- the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress latory surgical procedure for treatment of female urinary incon- urinary incontinence. Eur Urol 2010;58:218–38. tinence. Scand J Urol Nephrol 1995;29:75–82. [19] Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic [2] Petros PE, Ulmsten UI. An integral theory of female urinary suburethral sling operations for stress urinary incontinence in incontinence. experimental and clinical considerations. Acta women. Cochrane Database Syst Rev 2009(4);CD006375, October Obstet Gynecol Scand Suppl 1990;153:7–31. [3] Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson [20] Deffieux X, Daher N, Mansoor A, Debodinance P, Muhlstein J, CG, et al. A multicenter study of tension-free vaginal tape (TVT) Fernandez H. Transobturator TVT-O versus retropubic TVT for surgical treatment of stress urinary incontinence. Int Urogy- Results of a multicenter randomized controlled trial at 24 months necol J Pelvic Floor Dysfunct 1998;9:210–3. follow-up. Int Urogynecol J 2010;21:1337–45. [4] Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. [21] Albo ME, Litman HJ, Richter HE, Lemack GE, Sirls LT, Chai Long-term results of the tension-free vaginal tape (TVT) proce- TC, et al. Treatment success of retropubic and transobturator dure for surgical treatment of female stress urinary incontinence. mid urethral slings at 24 months. J Urol 2012;188:2281–7. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Suppl. 2), S5-8. [22] Angioli R, Plotti F, Muzii L, Montera R, Panici PB, Zullo MA. [5] Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years Tension-free vaginal tape versus transobturator suburethral tape. prospective follow-up of the tension-free vaginal tape procedure Five-year follow-up results of a prospective, randomised trial. Eur for treatment of stress urinary incontinence. Int Urogynecol J Urol 2010;58:671–7. Pelvic Floor Dysfunct 2008;19:1043–7. [23] Palva K, Rinne K, Aukee P, Kivela A, Laurikainen E, Takala T, [6] Andonian S, Chen T, St-Denis B, Corcos J. Randomized clinical trial comparing suprapubic arch sling (SPARC) and et al. A randomized trial comparing tension-free vaginal tape tension-free vaginal tape (TVT): one-year results. Eur Urol with tension-free vaginal tape-obturator: 36-month results. Int 2005;47:537–41. Urogynecol J 2010;21:1049–55. [7] Lord HE, Taylor JD, Finn JC, Tsokos N, Jeffery JT, Atherton [24] Schierlitz L, Dwyer PL, Rosamilia A, Murray C, Thomas E, De MJ, et al. A randomized controlled equivalence trial of short- Souza A, et al. Three-year follow-up of tension-free vaginal tape term complications and efficacy of tension-free vaginal tape and compared with transobturator tape in women with stress urinary suprapubic urethral support sling for treating stress incontinence. incontinence and intrinsic sphincter deficiency. Obstet Gynecol BJU Int 2006;98:367–76. 2012;119:321–7. [8] Dmochowski RR, Blaivas JM, Gormley EA, Juma S, Karram [25] Madhuvrata P, Riad M, Ammembal MK, Agur W, Abdel-Fattah M. Systematic review and meta-analysis of ‘inside-out’ versus DJ, Lightner DJ, et al. Update of AUA guideline on the surgical ‘outside-in’ transobturator tapes in management of stress urinary management of female stress urinary incontinence. J Urol incontinence in women. Eur J Obstet Gynecol Reprod Biol 2010;183:1906–14. 2012;162:1–10. [9] Delorme E. Transobturator urethral suspension. Mini-invasive [26] Abdel-Fattah M, Ford JA, Lim CP, Madhuvrata P. Single- procedure in the treatment of stress urinary incontinence in incision mini-slings versus standard midurethral slings in surgical women. Prog Urol 2001;11:1306–13. management of female stress urinary incontinence: a meta- [10] de Leval J. Novel surgical technique for the treatment of female analysis of effectiveness and complications. Eur Urol stress urinary incontinence: transobturator vaginal tape inside- 2011;60:468–80. out. Eur Urol 2003;44:724–30. [27] Sivaslioglu AA, Unlubilgin E, Aydogmus S, Keskin L, Dolen I. A [11] Rodriguez LV, Raz S. Prospective analysis of patients treated prospective randomized controlled trial of the transobturator tape with a distal urethral polypropylene sling for symptoms of stress and tissue fixation mini-sling in patients with stress urinary urinary incontinence: surgical outcome and satisfaction deter- incontinence: 5-year results. J Urol 2012;188:194–9. mined by patient driven questionnaires. J Urol 2003;170:63. [28] Lee KS, Lee YS, Seo JT, Na YG, Choo MS, Kim JC, et al. A [12] Dmochowski RR, Grier D, Franco N. One year results from a prospective multicenter randomized comparative study between world-wide registry of TVT-secur in women with stress urinary 126 Barboglio, Ann Gormley the U- and H-type methods of the TVT SECUR procedure for the operative procedures. Female Pelvic Med Reconstr Surg treatment of female stress urinary incontinence: 1-year follow-up. 2012;18:41–5. Eur Urol 2010;57:973–9. [38] Walsh CA. TVT-secur mini-sling for stress urinary incontinence. [29] Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, A review of outcomes at 12 months. BJU Int 2011;108:652–7. Karram MM, et al. Single-incision mini-sling compared with [39] Duckett JR, Tamilselvi A. Effect of tension-free vaginal tape in tension-free vaginal tape for the treatment of stress urinary women with a urodynamic diagnosis of idiopathic detrusor incontinence: a randomized controlled trial. Obstet Gynecol overactivity and stress incontinence. BJOG 2006;113:30–3. 2012;119:328–37. [40] Gamble TL, Botros SM, Beaumont JL, Goldberg RP, Miller JJ, [30] Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton Adeyanju O, et al. Predictors of persistent detrusor overactivity K, et al. A midurethral sling to reduce incontinence after vaginal after transvaginal sling procedures. Am J Obstet Gynecol prolapse repair. N Engl J Med 2012;366:2358–67. 2008;199(696):e1–7. [31] Bakali E, Buckley BS, Hilton P, Tincello DG. Treatment of [41] Rezapour M, Falconer C, Ulmsten U. Tension-free vaginal tape recurrent stress urinary incontinence after failed minimally (TVT) in stress incontinent women with intrinsic sphincter invasive synthetic suburethral tape surgery in women. Cochrane deficiency (ISD) – a long-term follow-up. Int Urogynecol J Pelvic Database Syst Rev 2013;2:CD009407. Floor Dysfunct 2001;12(Suppl. 2):S4–S12. [32] Jain P, Jirschele K, Botros SM, Latthe PM. Effectiveness of [42] Jeon MJ, Jung HJ, Chung SM, Kim SK, Bai SW. Comparison of midurethral slings in mixed urinary incontinence: a systematic the treatment outcome of pubovaginal sling, tension-free vaginal review and meta-analysis. Int Urogynecol J 2011;22:923–32. tape, and transobturator tape for stress urinary incontinence with [33] Ward KL, Hilton P. UK & Ireland TVT Trial Group. A intrinsic sphincter deficiency. Am J Obstet Gynecol 2008;199:76. prospective multicenter randomized trial of tension-free vaginal [43] Haliloglu B, Karateke A, Coksuer H, Peker H, Cam C. The role tape and colposuspension for primary urodynamic stress incon- of urethral hypermobility and intrinsic sphincteric deficiency on tinence: two-year follow-up. Am J Obstet Gynecol the outcome of transobturator tape procedure: a prospective 2004;190:324–31. study with 2-year follow-up. Int Urogynecol J 2010;21:173–8. [34] Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, [44] Liapis A, Bakas P, Creatsas G. Tension-free vaginal tape in the Zimmern PE, et al. Burch colposuspension versus fascial sling to management of recurrent urodynamic stress incontinence after reduce urinary stress incontinence. N Engl J Med previous failed midurethral tape. Eur Urol 2009;55:1450–5. 2007;356:2143–55. [45] Stav K, Dwyer PL, Rosamilia A, Lee J. Long-term outcomes of [35] Tincello DG, Botha T, Grier D, Jones P, Subramanian D, patients who failed to attend following midurethral sling surgery – Urquhart C, et al. A worldwide observational registry for long- a comparative study and analysis of risk factors for non- term data. Safety and efficacy of suburethral sling insertion attendance. Aust NZ J Obstet Gynaecol 2010;50:173–8. approaches for stress urinary incontinence in women. J Urol [46] Guideline for the surgical management of female stress urinary 2011;186:2310–5. incontinence. Update, 2009: 95% CI [Internet], 2012 [36] Hinoul P, Vervest HA, den Boon J, Venema PL, Lakeman MM, Available from: http://wwwauanetorg/content/media/stress2009 Milani AL, et al. A randomized, controlled trial comparing an – chapter1pdf. innovative single incision sling with an established transobturator [47] Guidelines On Urinary Incontinence; 95% CI [Internet], 2012. sling to treat female stress urinary incontinence. J Urol Available from: <http://www.uroweb.org/guidelines/online- 2011;185:1356–62. guidelines>. [37] Hota LS, Hanaway K, Hacker MR, Disciullo A, Elkadry E, Dramitinos P, et al. A randomized trial of suburethral sling
Journal
Arab Journal of Urology
– Taylor & Francis
Published: Jun 1, 2013
Keywords: Mid-urethral; Sling; Synthetic; Stress urinary incontinence; Retropubic; Transobturator tape; DUPS, distal urethral polypropylene sling; FDA, United States food and drug administration; ISD, intrinsic sphincteric deficiency; MUS, Mid-urethral sling; OR, odds ratio; POP, pelvic organ prolapse; PVS, pubovaginal sling; RCT, randomised controlled trial; RMUS, retropubic mid-urethral sling; RR, relative risk; SIS, single-incision sling; SUI, stress urinary incontinence; TMUS, transobturator mid-urethral sling; TOT, transobturator tape; TVT, tension-free vaginal tape; TVT-O, TVT-obturator; TVT-S, TVT-Secur; TFS, tissue-fixation mini-sling; UITN, urinary incontinence treatment network; VLPP, Valsalva leak-point pressure
