Review

Continuing Medical EducationNature Clinical Practice Urology (2008) 5, 194-201
doi:10.1038/ncpuro1052  
Received 16 October 2007 | Accepted 22 January 2008 | Published online: 4 March 2008

The evolution of midurethral slings

David E Rapp* and Kathleen C Kobashi  About the authors

Correspondence *Virginia Mason Medical Center, C-7 URO, 1100 Ninth Avenue, Seattle, WA 98111, USA

Email
 derapp@yahoo.com

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Medscape Continuing Medical Education online
Medscape, LLC is pleased to provide online continuing medical education (CME) for this journal article, allowing clinicians the opportunity to earn CME credit. Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide CME for physicians. Medscape, LLC designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. All other clinicians completing this activity will be issued a certificate of participation. To receive credit, please complete the post-test.

Learning objectives

Upon completion of this activity, participants should be able to:

  1. Identify the principles of early urethral slings used to address female incontinence.
  2. List the sources of material used for urethral slings.
  3. Describe principles of maintenance of urinary continence in females.
  4. Describe the cure rates associated with midurethral sling placement for stress urinary incontinence.
  5. List the most common complications associated with midurethral slings.

Competing interests

DE Rapp declared no competing interests. KC Kobashi has declared associations with the following companies: Astellas, Coloplast, and Novartis. Désirée Lie, the CME questions author, declared no relevant financial relationships.

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Summary

Use of urethral slings in the treatment of incontinence started in the early 20th century. An evolution in understanding the pathogenesis of urinary incontinence led to development of the midurethral sling, which was designed to replace the natural suburethral vectors of support, as described in the integral theory. Since the introduction of tension-free vaginal tape in 1995, multiple other commercially available types of midurethral sling have been introduced. In general, these sling types share the common characteristics of using a thin, type I synthetic mesh inserted at a midurethral level and applied without tension. The midurethral sling procedure has subsequently undergone multiple technical modifications, predominantly alterations to the technique and route used for sling insertion. Despite the variety in techniques, available evidence suggests that all sling types provide efficacious and durable outcomes. Several adverse effects have been reported that are specific to certain techniques, and include the risk of vascular, enteric or nerve injury, lower urinary tract injury, urinary retention or voiding dysfunction, and vaginal erosion. Nonetheless, the midurethral sling provides a safe surgical option overall, and represents a notable advance in the treatment of stress urinary incontinence.

Review criteria

A search for all original published articles that focused on urethral sling placement was performed in MEDLINE and PubMed databases. The search terms used were "incontinence", "urethral sling", "outcomes", and "complications". All articles identified were English-language, full-text papers. We also searched the reference lists of identified articles for further papers.

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Introduction

At the beginning of the 20th century, VonGiordano described the first urethral sling, which used gracilis muscle.1 Modifications to the technique were subsequently described that predominantly used other muscle bodies, such as a pyramidalis muscle flap and plication of the perivesical muscular structures.2, 3, 4 Common to these techniques was the belief that muscle placed around the bladder neck would provide a sphincteric function.

As sling techniques evolved, a variety of materials came into use. Price5 described the first fascia lata sling in 1933. The origin of the contemporary pubovaginal sling may be found in the classic technique described by Aldridge in 1942,6 in which a strip of rectus fascia was secured beneath the urethra to provide increased resistance at times of heightened abdominal pressures. This technique was later modified to leave the external oblique aponeurosis attached to the pubic tubercle and suture the fascial ends beneath the proximal urethra.7

This era of sling development was also notable for the popularity of abdominal retropubic and transvaginal suspension procedures, characterized by techniques to suspend the bladder neck by fixation of surrounding tissues. Accordingly, in 1949, Marshall et al.8 pioneered a technique for bladder-neck suspension through the fixation of perivesical bladder-neck tissue to the pubic symphysis. Rare but severe bony complications were attributed to pubic symphyseal fixation, however, and consequently Burch9 described a modified retropubic suspension in which the fixation point was positioned laterally along Cooper's ligament.

Although satisfactory continence rates were achieved by retropubic procedures, the invasive nature of the abdominal approach and consequently long durations of hospital stay and postoperative convalescence rendered them less ideal than the vaginal approach. Additionally, perioperative morbidity was notable. Despite the reduced morbidity associated with the transvaginal needle suspensions, however, the effects of these procedures on stress urinary incontinence (SUI) were not durable.

In an effort to improve the efficacy of surgical treatment of SUI, McGuire and Lytton10 revived, in 1978, the use of the pubovaginal sling. They described a combined abdominovaginal approach with complete detachment of the rectus fascia, which was repositioned suburethrally as a sling. The morbidity associated with autologous graft harvesting led, eventually, to exploration of the use of allografts and xenografts, for example, the use of cadaveric fascia lata anchored over the rectus fascia or via transvaginal bone anchors. Irrespective of allograft type or fixation method, however, early reports of isolated failure were attributed to weak tensile strength and suture pull-out.11 Continued refinements in materials were sought to identify an ideal compound for use in transvaginal slings that would be inert, sterile, noncarcinogenic, and mechanically durable. In this Review we provide an overview of the pathogenesis of SUI and of the evolution of the midurethral sling, with a focus on the types of slings currently available and the outcomes of this therapy.

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Theories of continence and the pathogenesis of incontinence

Mechanisms of continence

Concurrently, with the development of anti-incontinence surgery, there has been an evolution in understanding of the physiology of the continence mechanism and pathogenesis of SUI. Continence is thought to be maintained through a combination of intrinsic and extrinsic factors. These factors include the intrinsic coaptation of the urethra, combined with mechanical support of the bladder neck by pelvic-floor musculature, which maintains the bladder neck within an intrapelvic position. Additionally, a healthy submucosal vascular plexus, local hormonal balance, and an adequate neurologic reflex are all components thought to contribute to a normal, intact continence mechanism.

Indeed, the importance of correct positioning of the bladder neck and proximal urethra was thought to lie in the concept that pressure transmission to these structures (when in their proper anatomical positions) was equal even in periods of increased intra-abdominal pressure. Conversely, inappropriate descent of these structures would result in a pressure gradient between urinary-tract structures within and outside the abdomen, and thereby lead to incontinence. This theory was supported by anatomical studies that identified the bladder neck as an integral determinant of continence and showed that support for the bladder neck was provided through the lateral attachments of the endopelvic fascia.12 This understanding provided the basis for a variety of retropubic and transvaginal suspension procedures, described previously.

The integral theory

In 1990, Petros and Ulmsten13 described the integral theory of female urinary continence, a concept that would largely define the modern approach to anti-incontinence surgery and usher in the era of the midurethral sling. The theory proposes that a physiologic 'backboard' is created through fixation of the middle region of the urethra to the pubic bone, via the pubourethral ligaments, and that this factor is critical to the continence mechanism. Loss of this backboard inhibits normal urethral coaptation during times of increased intra-abdominal pressure, and results in urinary incontinence. The clinical application of this concept was seen in the subsequent repositioning of the sling to a more distal location beneath the urethra than had previously been used, which was appropriately described as the midurethral sling.

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Development of midurethral sling types and insertion procedures

Expanding on the integral theory, Ulmsten and Petros14 first described outcomes of 50 patients after intravaginal sling placement performed via a minimally invasive technique in 1995. In addition to its midurethral anatomic location, their procedure had a further novel modification, a tensionless sling placement that minimized direct urethral pressure. The resultant effect was an emulation of the backboard feature of the integral theory. The original midurethral sling model of Ulmsten and Petros led to the development of tension-free vaginal tape (TVT), which was introduced as a commercially available kit by Gynecare® Inc., Menlo Park, CA.15

As introduced, the TVT sling comprised a narrow polypropylene strip, housed within a plastic sheath to aid in retropubic sling passage. The sling was placed by specially designed trocars that were passed retropubically from a small vaginal incision to a suprapubic exit site at the skin surface. Importantly, passage in this fashion was described as a bottom-to-top technique.

Several modifications have been applied to the initial technique for TVT insertion. To overcome complications associated with the blind passage of the TVT through the retropubic space, the SPARC® or suprapubic arc system (American Medical Systems Inc., Minnetonka, MN) was developed. This system comprises a polypropylene sling of similar characteristics to the TVT, but which is inserted via a top-to-bottom approach. In theory, the greatest control of the trocar occurs at the beginning of the passage arc. Accordingly, a top-to-bottom insertion approach theoretically allows the greatest control to occur during passage through the retropubic space, while the device is in proximity to the vascular and enteric structures of the pelvis.

A transobturator approach was described by Delorme.16 This approach was introduced in the US for use with the commercially available ObTape® (Mentor Corporation, Santa Barbara, CA) transobturator sling. The transobturator approach, initially described as 'outside-in', preserved the principles of previous midurethral sling procedures but altered the route of needle passage. Trocar placement was initiated via an incision lateral to the labium majus and continued though the obturator foramen to a vaginal exit site at the midurethral position. While the transobturator technique theoretically minimizes the risk of complications involving enteric and vascular structures of the pelvis, this approach involves navigation of the obturator foramen, through which passes the obturator artery, vein and nerve. Nonetheless, because of the lateral position of these structures within the foramen, trocar passage should theoretically occur well medial to these structures. The sling trajectory specific to this approach does, however, raise the risk of groin or adductor tendon pain.

Similarly to the evolution of the technique described with the retropubic midurethral sling, subsequent modifications to the transobturator approach were described. De Leval17 reported an 'inside-out' transobturator technique, and commercially available kits using this design were subsequently introduced (Table 1). Assuming that maximum control of the needle path occurs at the point of entry, the outside-in approach theoretically affords greatest control in the proximity of the obturator structures, while the inside-out route would be most precise in the vicinity of the urethra. Importantly, the available data do not generally suggest significant differences in outcomes between these midurethral sling types. Moreover, the wide variety in sling procedures will probably continue, because it is driven by the large number of commercial manufacturers that participate in this market and, subsequently, by surgeons' preferences for the available products.

Table 1 Commercial kits available for midurethral sling placement.
Table 1 - Commercial kits available for midurethral sling placement.
Full tableFigures & Tables indexDownload PowerPoint slide (264K)

Finally, two further midurethral sling types have been introduced, but limited data are so far available on their safety and efficacy. The first type is a shortened sling placed via a vaginal incision. The design allows for sling fixation to the pubic ramus. Sling deployment may be achieved in either a U-shaped or hammock-shaped fashion, and separate incisions are not, therefore, needed for trocar exit sites. In addition, complications associated with trocar passage through either retropubic or obturator sites are avoided. This sling type is now commercially marketed by two different manufacturers: MiniArc® by American Medical Systems Inc., Minnetonka, MN, and Secur® by Gynecare® Inc.

The second type of sling was described by Daher et al.18 in 2003 and involves a prepubic approach. Again, this approach was designed to minimize the complications associated with retropubic or transobturator passage. Accordingly, trocar passage is directed from a vaginal incision to an exit site anterior to the pubic bone. Theoretically, this approach allows for avoidance of not only vascular and enteric structures, but the bladder as well. However, there is an added risk of injury to the neurovascular supply of the clitoris. This sling type is now commercially marketed as the Prefyx PPS® system (Boston Scientific Scimed Inc., Maple Grove, MN).

Many descriptions of polypropylene mesh slings placed without the use of the popular proprietary midurethral sling kits exist in the literature. Despite the variety of sling placement techniques, it must be emphasized that the concept of the midurethral sling has undergone minimal changes since its description by Ulmsten and Petros in 1995.14

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Outcomes after midurethral sling placement

A complete review of published outcomes is beyond the scope of this article. We attempt, therefore, to provide representative data on outcomes, with a focus on the series that have reported the longest follow-up. Comparison of outcomes data remains extremely difficult, however, owing to the variation in outcome measures and definitions of success that have been used by different reporting centers.

The greatest body of outcomes data is available for TVT. Combined, these data demonstrate this sling type to be highly efficacious. In general, cure rates of 80–89% are reported.16, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33 Outcomes seem to remain stable over the observed follow-up periods, and several centers have reported updated outcomes.15, 19, 20, 21, 22 Cure rates of 91%, 84% and 86% have been reported at minimum follow-up periods of 1, 2 and 3 years, respectively.15, 19, 20 The effects seem to be durable: reports with 6–8 years of follow-up demonstrate persistent cure rates of 80–81%.22, 25 Finally, successful outcomes have been achieved by use of TVT to treat recurrent SUI after failure of a previous midurethral sling placement.34

Similar data are available for the SPARC® sling, albeit from studies with limited follow-up.26, 27, 28, 29 One study with follow-up of longer than 1 year demonstrated subjective and objective cure rates of 75–95% (Table 2). Again, outcomes seem to remain stable over this period.

Table 2 Clinical outcomes in patients undergoing midurethral sling placement.
Table 2 - Clinical outcomes in patients undergoing midurethral sling placement.
Full tableFigures & Tables indexDownload PowerPoint slide (267K)

For the transobturator technique, outcome data are mainly available only for short-term and intermediate-term experiences. Given the smaller quantity of data, we present combined outcomes for both transobturator techniques here. In general, objective and subjective cure rates range from 80% to 92% and seem to be similar for both techniques. Outcomes with a minimum of 3 years' follow-up were reported by Waltregny and colleagues33 following transobturator TVT placement in 91 patients with SUI. In this patient cohort, 88% of patients were cured, and a further 9% improved. Again, these outcomes remained stable, with no significant differences in the cure rate being observed when compared with outcomes seen at 1 year follow-up.

Numerous sling techniques have been described in the literature, and the focus of research has accordingly turned to elucidating which of these give the best results. Included in this body of literature are large numbers of not only retrospective comparisons, but also prospective, randomized, controlled clinical trials. In a comparison of the retropubic techniques, several series demonstrated no difference in cure rates between TVT and SPARC® procedures.27, 35 A comparison of outside-in with inside-out transobturator techniques also demonstrated similar success rates at 1 year.36 Furthermore, comparisons of retropubic versus transobturator approaches reveal similar improvements in the severity of incontinence.37, 38 Finally, Ward and Hilton39 reported comparable efficacies for TVT versus Burch colposuspension in a prospective, randomized trial.

Novara et al.40 performed a meta-analysis to evaluate retropubic and transobturator sling procedures, as well as retropubic colposuspension. Their findings suggested similar efficacies for retropubic and transobturator approaches. Interestingly, TVT was more efficacious than use of the SPARC® system with Burch colposuspension. However, the authors note that caution should be exercised in extrapolating these data, given the poor methods of most of the studies used in their analysis. Despite these conclusions, analyses of comparable studies suggest that there is little difference in clinical outcomes between techniques.

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Complications associated with midurethral slings

Voiding dysfunction is a common concern after sling surgery. In contrast to the often prolonged period of incomplete bladder emptying observed after retropubic colposuspensions, spontaneous voiding is generally achieved rapidly with midurethral sling placement.41 Urinary retention requiring catheterization occurs in 2–20% of patients, although its duration is generally limited.41 Levin et al.42 reported a 2.5% rate of urinary retention requiring catheterization for a period of longer than 7 days; only one patient failed to void spontaneously by 1 month after surgery. Apart from the risk of overt urinary retention, the development of either objective changes to voiding patterns or debilitating obstructive symptoms is possible after sling placement.43, 44, 45 Klutke et al.46 noted a 2.8% rate of obstructive symptoms that ultimately required transvaginal sling release in a series of 600 patients who underwent TVT.

The development of de novo urgency following midurethral sling placement is a concern. This symptom is reported in 0–26% of patients, and is attributed to obstructive or locally irritative causes.41 Midurethral sling placement is, however, more likely than traditional sling procedures to alleviate preoperative urgency and irritative symptoms. For example, in one review, nearly 9% of patients required anticholinergic therapy for de novo urgency, whereas 58% of the patients (in the same cohort) who required anticholinergic drugs before surgery were able to stop this therapy after sling placement.47 When de novo urgency does occur, it is typically treated with dietary and behavioral modification and anticholinergic therapy.

Bladder perforation is a relatively common occurrence during sling placement, seen in 1–10% of cases.21, 48 A combined experience of 92 surgeons indicated a 7% bladder perforation rate in a study population of over 12,000 patients.49 Despite the theoretically improved control obtained through top-to-bottom passage during placement, no difference in bladder perforation rates has been noted between the use of SPARC® and TVT.26 Unsurprisingly, however, bladder perforation rates are substantially lower with the transobturator approach, although urethral perforation has been reported.50 Given these data, we believe that cystourethroscopy should be performed intraoperatively following sling placement, irrespective of technique.

Vascular injury and hemorrhage are arguably the most feared complications of any sling placement, despite their rarity; hemorrhagic complications have occasionally resulted in death.51 Abouassaly et al.52 report blood loss of greater than 250 ml in 5% and 500 ml in 3% of patients undergoing TVT, with only 2% of patients developing retropubic hematoma.52 Few data exist on the relative frequencies of hemorrhagic complications after retropubic versus transobturator sling insertion, although reported trends seem to favor the transobturator approach. Anatomical studies in cadavers have suggested a worse vascular safety margin with an inside-out approach than with outside-in transobturator techniques.

Similarly, bowel perforation is a rare but potentially devastating complication.53 In contrast to other types of complication, there is a definite advantage to the transobturator approach with respect to the avoidance of bowel injury.

Finally, mesh erosion and vaginal extrusion exist as notable concerns related to the use of synthetic slings. Use of polypropylene mesh has become standard, because of the increased erosion rates associated with other synthetic fibres, such as polyester.54, 55 Erosion and vaginal extrusion are seen not only with midurethral sling techniques, but also with most types of anti-incontinence and vaginal reconstructive surgeries that employ synthetic materials in general. Despite the common use of polypropylene, differences in sling characteristics, such as pore size and weave characteristics, could theoretically yield differences in erosion or extrusion rates. For example, our experience suggests an unacceptably high incidence of vaginal extrusion associated with use of ObTape®, despite its polypropylene makeup, which might be attributable to the small pore size of its mesh.56

Vaginal extrusion rates of 0–6% are reported.24, 26, 30, 50 A trend towards increased extrusion rates might be associated with the transobturator approach, although further data are needed to confirm this finding. Of importance, while erosion and extrusion can present with bleeding, pain, or recurrent incontinence, these complications may also be asymptomatic. Accordingly, a thorough postoperative examination and high index of suspicion for these sequelae is necessary following sling placement.

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Conclusions

Advances in the treatment of female SUI have been seen over recent decades. The emergence of the integral theory and the midurethral sling has resulted in an evolution of the theory and treatment of this disorder. Multiple midurethral sling types exist and seem to provide safe, efficacious, and durable treatment options. Further investigation is necessary to confirm long-term outcomes and to determine whether sling-specific outcomes vary over time.

Key points

  • The urethral sling has undergone a considerable evolution since its introduction in the early 20th century
  • Introduction of the integral theory advanced our understanding of incontinence, and led to the era of the midurethral sling
  • Multiple midurethral sling types are available, which share the common characteristics of a monofilament mesh placed in a tensionless fashion at a midurethral level
  • Significant data suggest excellent outcomes after sling placement, irrespective of midurethral sling type chosen
  • Specific adverse events are reported, including vascular and enteric injury, urinary voiding dysfunction, and vaginal erosion
  • The midurethral sling represents a notable advance in the treatment of stress urinary incontinence

Acknowledgments

Désirée Lie, University of California, Irvine, CA, is the author of and is solely responsible for the content of the learning objectives, questions and answers of the Medscape-accredited continuing medical education activity associated with this article.

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Competing interests

DE Rapp declared no competing interests.
KC Kobashi is a member of the speaker's bureaus and receives honoraria from Astellas and Novartis. She also works as a consultant for Coloplast.

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Subject areas under which this article appears: Urinary incontinence, urodynamics and lower urinary tract dysfunction

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