Minimally Invasive Therapy for Urinary Incontinence and Pelvic Organ Prolapse (Current Clinical Urology) 2014th

5. Female SUI: Single-Incision Slings

Michael J. Kennelly  and John P. Selph2

(1)

McKay Department of Urology, Women’s Center for Pelvic Health, Charlotte Continence Center, Carolinas Medical Center, 2001 Vail Avenue, Suite 360, Charlotte, NC 28207, USA

(2)

Department of Urology, UNC School of Medicine, Chapel Hill, NC, USA

Michael J. Kennelly

Email: mkennelly@carolinas.org

Abstract

Single-incision slings (SIS) are the third generation of midurethral slings dedicated to the treatment of female stress urinary incontinence. SIS seek to mimic the efficacy of the traditional retropubic and transobturator slings, yet lower the risk of major organ and vessel injury by avoiding the passage of trocars through the retropubic or transobturator space. Placed via a single vaginal incision, SIS also aim to limit morbidity by avoiding external incisions, reducing postoperative pain, and affording the opportunity for placement under local anesthesia. Studies of currently available SIS show mixed results with regard to efficacy, and further study of this new generation of slings is warranted. This chapter highlights the important differences in design and surgical placement of the most popular SIS on the market, as well as reviews available outcomes data for each sling.

Stress urinary incontinence (SUI) as defined by the standardization subcommittee of the International Continence Society is the complaint of involuntary leakage of urine on effort or exertion, or on sneezing or coughing [1]. SUI has been estimated to affect up to 50 % of women [25], with an estimated annual direct cost of 12 billion dollars for the treatment of female incontinence [6]. While various nonsurgical options exist to treat symptomatic patients, surgical options for women who fail conservative measures include retropubic colposuspension, needle suspension, periurethral injection therapy, fascial pubovaginal slings, and synthetic midurethral slings. As studies showing favorable outcomes and long-term results have emerged over the last 2 decades, the synthetic midurethral sling has become the most commonly performed and gold standard treatment of female SUI [7].

The pubovaginal sling, with autologous fascia placed at the bladder neck, was the initial sling procedure of choice, seeking to correct urethral hypermobility and modify pressure transmission caused by intra-abdominal straining. After studies in the early 1990s by UImsten and Petros described the integral theory, elucidating the importance of the midurethra in maintaining continence during stress, the first midurethral tension-free vaginal tape (TVT) was developed. The midurethral placement of the polypropylene synthetic sling reinforced the pubourethral ligament retropubically and provided sub-urethral support, and initial reports showed satisfactory continence results with decreased morbidity compared to traditional procedures [89].

As evidence accumulated showing retropubic polypropylene tape (RPT) had cure rates similar to colposuspension, it became clear that RPT slings introduced a new set of potential complications. A review by Atherton et al. showed that RPT procedures are associated with a 0.2–1 % postoperative urinary retention rate, a 3–4 % risk of bladder, urethral, or intestinal perforation, and a 1–2.5 % risk of major vessel and nerve injury and hematoma in the retropubic space [10]. These complications, although infrequent, lead to further modifications and improvements in minimally invasive urinary incontinence surgery.

The next generation of sling procedures evolved from a retropubic to transobturator location, with the goal of maintaining success rates but avoiding complications (e.g., bladder, bowel, and vessel injury) associated with trocar passage through the retropubic space. Placement of transobturator tape (TOT) involved passing a trocar around the ischiopubic ramus and through the obturator membrane, thus avoiding the retropubic vessels and viscera but still providing midurethral support. Passage of the trocar from an “inside-out” and “outside-in” approach was developed [1012]. Multiple studies showed the new TOT technique to be not only comparable in efficacy to RPT slings [1317], but also successful in reducing bowel and bladder complications. Despite these successes, reports of subjective groin pain, presumably from obturator nerve compression or muscle irritation, emerged [17].

While midurethral slings have been shown to have acceptable cure rates and low morbidity rates [9101723], the blind passage of a trocar through the transobturator or retropubic space affords the potential for bladder or bowel injury, groin or thigh muscle pain, injuries to nerves and blood vessels, and ureteral injury. Building on the success of RPT and TOT slings, the latest innovation in sling procedures, the single-incision sling (SIS), or mini-sling, seeks to reduce morbidity even further.

Single-Incision Slings

Single-incision slings (SIS) seek to build on the efficacy and safety of retropubic tape (RPT) and TOT procedures, yet reduce patient morbidity. SIS are designed to provide midurethral support through a single vaginal incision with a shorter sling that avoids the blind passage of a trocar through the transobturator or retropubic space, thereby reducing the potential complication rate and providing the patient with added benefits: limiting postoperative pain, no external incisions, local anesthesia only, and office-based procedures. Multiple companies have introduced SIS to the market. Each product is made of type 1 uncoated polypropylene mesh, but, importantly, they differ in their sling length, trajectory pathway, delivery device, fixation method, and fixation location, and thus they should not be considered interchangeable products (Table 5.1). Five products currently on the market are discussed below, including procedural steps, postoperative considerations, and results.

Table 5.1

Single-incision slings

 

TVT Secur™ System

MiniArc™

MiniArc Precise™

Solyx™ SIS System

Ajust™

Manufacturer

Ethicon

AMS

AMS

Boston Scientific

Bard

Needle

Two needles and driver

One needle with driver

One needle with driver

One needle with driver

One needle with driver

Needle diameter (mm)

8.1

2.3

2.3

3.81

5

Size (cm)

1.1 × 8

1.1 × 8.5

1.1 × 8.5

9

 

Fixation

Absorbable tips coated with PDS™ and Vicryl™

Permanent self-fixating tips

Permanent self-fixating tips that are tapered and reinforced

Permanent polypropylene mesh carriers

Permanent self-fixating polypropylene anchors

Fixation location

Obturator internus muscle (“hammock”) or urogenital diaphragm (“U”)

Obturator internus muscle

Obturator internus muscle

Obturator internus muscle

Obturator membrane

Trajectory pathway

Transobturator or Retropubic

Transobturator

Transobturator

Transobturator

Transobturator

Tensioning method

By advancing only, prior to device release

Optional redocking feature

By advancing only, prior to device release

By advancing only, prior to device release

Bidirectional movement of adjustment mesh portion

Midline mark

No

Yes

Yes

No

Yes

Needle disengagement

Two-step process

One step

One step

One step

One step

Pull out force (lbs)

1.9

5.5

5.75

4.64

6.56

Appropriate patient selection is paramount to achieving satisfactory results with SIS. SIS are typically reserved for patients without prior anti-incontinence surgery, though experience with this method has led some surgeons to offer this technique to patients with previous anti-incontinence surgery. Renal insufficiency, coagulopathy, a compromised immune system, pregnancy or future planned pregnancy, and urinary tract obstruction or infection should be considered contraindications to SIS. As with all surgical procedures, informed consent should be obtained from patients before proceeding with intervention.

TVT-Secur System

Introduced in 2006, the first SIS was the Tension-Free Vaginal Tape-Secur™ System (TVT-S) (Ethicon Women’s Health and Urology, Somerville, NJ, USA). The TVT-S is an 8 × 1.1 cm laser-cut macroporous polypropylene mesh with absorbable fixation tips that can be fixed to the urogenital diaphragm in a retropubic-like “U” position, or to the obturator internus muscle in a transobturator-like “hammock” or “H” position [2425] (Fig. 5.1). The “U” configuration replicates the RPT trajectory by anchoring the fixation tips against the periosteum of the pubis through the connective tissue of the urogenital diaphragm. The “hammock” configuration mimics the transobturator approach, securing the tips of the mesh to the obturator internus muscle along the posterior inferior ischiopubic ramus. Regardless of the technique chosen, early studies revealed the importance of anchoring the fixation tips in contact with the nearby bony structures, rather than the mobile muscular tissue, in order to provide long-term stability [25].

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Fig. 5.1

TVT-Secur. The TVT-Secur’s 8.0 × 1.1-cm polypropylene mesh with 2-cm absorbable fixation tips can be placed in either the “U” retropubic trajectory position or the “hammock” transobturator trajectory position (© Ethicon, Inc. Reproduced with permission)

This product uniquely features 2-cm absorbable fixation tips that consist of a fleece layer composed of synthetic absorbable polyglactin 910 (Vicryl) and poly-p-dioxanone (PDS) yarn, which are sandwiched to the mesh using violet-dyed PDS in a thermal process. Once placed, these fixation tips provide immediate mechanical fixation similar to the standard TVT system and are absorbed over a period of approximately 90 days [26]. During this time, the polypropylene mesh is encased by a thin fibrous layer of tissue that secures it to the surrounding tissue. Furthermore, as opposed to tanged mesh edges, the laser cut mesh edges impart the mesh with less stretch and a consistent width to facilitate proper placement.

Procedure

Placement of the TVT-Secur mesh can be performed under general, regional, or local anesthesia. The patient is positioned in the dorsal lithotomy position, taking care to pad all pressure points. After local infiltration, a 1.0–1.5 cm incision in the anterior vaginal wall is made along the midurethra, about 1 cm proximal to the urethral meatus. Because of the larger trocar size for the TVT-S compared to conventional slings, the incision is slightly larger to avoid gathering of vaginal tissue. Bluntly dissect with scissors in the paraurethral tissue on each side, taking care to maintain the original width of the incision as one dissects proximally so as to avoid dragging paravaginal tissue during insertion. The direction of the paraurethral dissection can be guided at a 45° angle from the sagittal midline if one desires a “U” placement or at the 3 and 9 o’clock positions if the “hammock” method is to be used.

“U” Position

Dissection is performed to the inferior edge of the pubic bone, ensuring that the scissors do not pierce the urogenital diaphragm and weaken the tissue to which the fixation tips will be anchored. A urethral catheter is placed with a rigid catheter guide to reduce risk of injury to the lower urinary tract. With a needle driver providing stabilization, the TVT-S inserter is then passed until the pubic bone is contacted. The surgeon’s hand is then dropped until the inserter is parallel to the floor, and while aiming for the ipsilateral shoulder, the inserter is passed through the dense connective tissue of the urogenital diaphragm. Maintaining contact with the posterior pubic bone is critical to ensure appropriate anchoring. Once the mesh is firmly in the connective tissue, the procedure is repeated on the contralateral side. Adjustments to maintain tension-free placement of the mesh can be made by advancing or retracting the inserter for either the left or right side, ensuring that adequate contact with the pubic bone is maintained. A dynamic cough or crede stress test can be used to assist with tensioning. Unlike traditional midurethral slings, there should be no tissue left between the urethra and mesh, and because the sling is pushed rather than pulled through tissue, tension does not increase postoperatively with the TVT-Secur [25]. Careful separation of the inserters from the mesh is necessary to prevent unwanted withdrawal of the mesh. Once the release wires are pulled, the inserters cannot be reconnected to make adjustments. Cystoscopy is left at the surgeon’s discretion, and once positioning is confirmed, the inserters are removed and the incision closed.

“Hammock” Position

Similar to TOT placement, dissection is performed laterally at the 3 and 9 o’clock positions to the lower edge of the ischiopubic ramus, avoiding penetration of the obturator internus muscle by the scissors. The TVT-S is placed flat to and in contact with the lower edge of the ischiopubic ramus while being pushed into the obturator internus muscle. Maintaining contact with the bony surface allows for adequate long-term fixation as well as limits risk of damage to other organs. The procedure is repeated on the contralateral side. As with the “U” positioning, tension-free placement is ensured with bilateral incremental advancement of the device, leaving no tissue between the mesh and urethra. Twisting of the mesh or rotating movements, multiple passes through or tearing of the obturator muscle, and placement away from the bony pelvis yield suboptimal results. Cystoscopy is left at the discretion of the surgeon.

Results

Studies regarding outcomes and complications from TVT-S are limited to short- and medium-term follow-up, with most studies having 1-year data. Initial studies suggested low complication rates but short-term cure rates of 69–88 %, which is lower than traditional cure rates for RPT and TOT slings [2734]. These poor success rates were felt to be technical in nature as there was a significant learning curve associated with the procedure. Neuman noted a 20 % failure rate and 64 % complication rate in his first 50 patients compared to an 8 % failure rate and 26 % complication rate in the second fifty [25]. Modifications that generated better results included leaving no tissue between the urethra and sling, developing wider 12 mm tunnels due to the larger trocar, tunneling no further than the bone edge, and gently separating the locking mechanism to avoid unwanted tape removal when disconnecting the inserter. Another group noted improved results after the first 25 patients with modifications included tightening the sling such that no leakage of urine is noted during an intraoperative cough stress test and using a gentle rocking motion to release the inserter from the mesh [35].

Most initial reports have suggested a comparable success rate between the “U” and “hammock” type placement methods. Liapis et al. prospectively followed 82 patients who were alternately assigned to either the “U” or “hammock” technique. Objective cure rates based on cough test at 1 year were 62.8 and 71.8 % for the hammock and U technique, respectively, with an overall cure rate of 67.1 % for the TVT-Secur, which was notably less than success rates for traditional TVT procedures [36]. Kim et al. followed 115 women in a randomized comparative trial and reported no statistical difference in cure rate at 12 months based upon the Sandvik questionnaire (88.7 % cure for U-type and 87.1 % cure for hammock-type approach, p = 0.796) [37]. Unlike Liapis’s group’s findings, cure rates in this trial were similar to 1-year cure rates in studies of traditional TVT procedures [38]. Another group found that the U-type technique (100 %, 22/22) had better cure rates at 6 months compared to the hammock technique (69 %, 11/16) [39]. Long-term results showing a significant difference between the two methods need to be further studied.

As more groups have published their experiences with TVT-Secur with longer follow-up, several systematic reviews of outcomes have been undertaken. Walsh reviewed the literature on outcomes at 1 year for the TVT-Secur and identified ten studies involving 1,178 patients [40]. Subjective and objective cure rate at 12 months was 76 %, with the U-type method showing a statistically significant higher objective cure rate at 12 months when compared to the “hammock” technique (OR 2.2, p = 0.0005). Dmochowski et al. reported the outcomes at 12 months on 642 women undergoing the TVT-Secur procedure at 29 sites in eight countries—the objective cure rate at 1 year was 87.5 % [41]. A recent meta-analysis of nine randomized control trials (six TVT-Secur, two MiniArc, and one Ophira) involving SIS vs. standard midurethral slings found inferior objective and patient-reported cure rates in the SIS group [42]. Of the six trials involving TVT-Secur, subgroup analysis revealed a trend toward lower patient-reported and objective cure rates, though statistical significance was not reached. The authors concluded that the available literature on these SIS did not support their use in clinical practice. Two groups have published their experience with 3-year outcomes. Cornu’s group showed a cure rate that fell to 40 % at a mean follow-up of 30 months for the TVT-Secur, compared to a 93.5 % success rate at 1 year [43]. In contrast to this dramatic fall in cure rate, Neuman noted a 90.9 % cure rate for the TVT-Secur at 36 months of follow-up in his series [44].

Recently, Hinoul and colleagues published a prospective, randomized, controlled trial of the TVT-Secur vs. TVT-Obturator (TVT-O) system [45]. From 2007 to 2009, 96 patients underwent TVT-Secur and 98 had a TVT-O, with 75 and 85 patients of each group having follow-up at 1 year, respectively. Using a standing cough stress test with 300 cc in the bladder or filled to at least 70 % of capacity based on voiding diary, SUI was present in 16.4 % vs. 2.4 % (p < 0.05) of the TVT-Secur and TVT-O patients, respectively. Patients in the TVT-Secur experienced less postoperative pain and returned to work sooner, but the odds ratio for re-intervention for SUI 1 year after TVT-Secur vs. TVT-O was 2.3 (95 % CI 1.9–2.7).

Overall, efficacy rates of the TVT-S are mixed but tend to show lower efficacy rates than RPT and TOT slings in comparative trials. Clearly, surgical technique and surgeon skill play a key role in the providing patient success. Long-term data and advances in alternative SIS technologies have tempered the original enthusiasm for the TVT-S sling.

MiniArc

In August of 2007 the MiniArc™ (American Medical Systems, Minnetonka, MN, USA) became the second SIS released in the United States and Europe. It comprises an 8.5 × 1.1 cm type 1 polypropylene mesh with integrated self-fixation tips that anchor into the obturator internus muscle via a single 1.5 cm vaginal incision (Fig. 5.2). Unique design features include a narrower inserter, optional redocking feature, tanged mesh edges, a midline mesh mark, and the self-fixating tips.

A321341_1_En_5_Fig2_HTML.jpg

Fig. 5.2

MiniArc Precise. The MiniArc Precise’s 1.1 × 8.5-cm macroporous polypropylene mesh fused to self-fixating tips is placed with a 2.3 mm needle (Courtesy of American Medical Systems, Inc., Minnetonka, MN)

An early criticism of the TVT-Secur was the difficulty in removing the inserter from the mesh, and the MiniArc was designed to allow a smoother engagement and disengagement of the needle and mesh, thereby reducing the risk of unwanted loosening of the mesh during inserter removal. This feature was achieved by not only utilizing a single 2.3 mm diameter needle that minimizes tissue trauma during placement, but also by creating permanent self-fixating tips that, based on cadaveric testing, require a pull-out force four times (5.5 lbs) higher than normal pelvic floor pressures (1.3 lbs) [4647]. The surgeon is also permitted to redock the needle and mesh, thus allowing for further tensioning after the sling is placed. In 2010, modifications to the MiniArc were made based on surgeon feedback, and AMS released the new and improved MiniArc Precise Sling. Changes included: (1) a snap fit needle-to-tip connection that prevents rotation of the mesh on the needle and secures the sling to the inserter; (2) a needle that retracts into the body of the inserter to help prevent displacement of the sling tip during inserter removal; and (3) tapered and reinforced mesh ends that minimize the potential for mesh twisting and ensure a flat placement on the urethra.

Procedure

The sling is placed through a single 1.5 cm vaginal incision at the midurethra. Periurethral dissection is carried out with Metzenbaum scissors toward the interior portion of the inferior pubic ramus. The sling/needle assembly is advanced behind the ischiopubic ramus in a transobturator trajectory toward the obturator space bilaterally. The obturator internus fascia is pierced with the needle, and once the integrated self-fixating tip is fixed in the obturator internus muscle, the needle is removed. This step is repeated on the contralateral side. Should further tensioning be desired, redocking can be achieved by accessing the implanted tip on the initial side. The mesh should lie flat against the urethra with no mesh distortion or space left between the urethra and sling. Cough or Valsalva stress-testing or visual inspection of the tape assists with proper sling tensioning. Cystoscopy is left at the discretion of the surgeon, and the incision is irrigated and then closed.

Results

Initial studies showed promising results for the MiniArc, though other studies have shown mixed results at 1 year of follow-up. Moore and colleagues retrospectively reviewed 61 patients who had a MiniArc sling placed and found a 91.4 % cure rate with no intraoperative complications, pain, dyspareunia, or sling erosion [48]. In a multicenter prospective trial, Kennelly et al. assessed 157 of 188 women available for follow-up at 1 year and found 90.6 % of patients had a negative cough stress test [49]. There were no intraoperative complications, and 20 % of the cases were performed in the office setting. Pickens et al. noted a cure rate of 93.5 % (101/108) at 12 months in a prospective cohort of 108 patients who had follow-up, as well as significant improvement in quality of life based on the UDI-6 (65 of 100 vs. 13.32 of 100, P < 0.001) and IIQ-7 (89.91 of 100 vs. 12.5 of 100, P < 0.001) questionnaires [50]. In a retrospective cohort study at two centers comparing 75 patients undergoing the MiniArc and 56 patients undergoing the Monarc sling, 85 % of the MiniArc group vs. 89 % of the Monarc group had a negative cough stress test at 12 months [51]. Both groups saw significant improvement in subjective cure rates based on the IIQ-7 and UDI-6 questionnaires, and the authors concluded the MiniArc provides objective cure rates comparable to other slings, though longer follow-up is needed. In contrast to these findings, Hogewoning and colleagues noted a 56 % failure rate (not completely dry) and 68 % subjective cure rate (improvement in symptoms based on PGI-I questionnaire) at 1 year [52]. Others have noted lower efficacy rates of 77.8 % at 12 months and 75.7 % at 2 months [5354].

Overall, efficacy rates on the MiniArc are mixed but tend to show promising early results. Clearly, longer follow-up studies and ideally a long-term, prospective, randomized clinical trial are needed to help further elucidate the place of the MiniArc in the urologic armamentarium.

Solyx

The Solyx™ SIS system (Boston Scientific Corporation, Natick, MA, USA) was introduced in North America in 2009. The 9-cm polypropylene mesh is placed via a delivery device into the obturator internus muscle, where carrier barbs at each end of the mesh serve to anchor the sling in place while tissue ingrowth occurs over time (Fig. 5.3). The carriers snap on to the delivery device, and once passed into the obturator internus, minute adjustments to the sling can be made to gain appropriate tension. The lateral edges of the mesh are tanged in order to reduce loosening of the mesh as the delivery device is disconnected, and similar to the TVT-Secur, the delivery device cannot be reconnected to the carrier once they are detached. Additionally, the 4-cm central portion of the mesh is detanged and heat sealed to prevent irritation to the urethra and limit deformation.

A321341_1_En_5_Fig3_HTML.jpg

Fig. 5.3

Solyx Single Incision System. The 9.0 cm polypropylene sling fused to carrier barbs is placed in the obturator internus muscle with a snap-fit delivery device (Courtesy of Boston Scientific Corporation. Opinions expressed are those of the author alone and not of Boston Scientific)

Procedure

Anesthesia can be general, spinal, or local and is left to the surgeon’s discretion. The patient is placed in the dorsal lithotomy position and prepped and draped in a sterile fashion. After local infiltration, a 1–1.5 cm vaginal incision is made at the level of the midurethra. Periurethral dissection with Metzenbaum scissors is directed at a 45° angle toward the inferior pubic ramus. Once an appropriate tunnel has been created, the mesh is attached flush to the delivery device tip, which is confirmed by hearing an audible “click.” The device is inserted into the dissection tunnel and advanced toward the obturator foramen until it pierces the obturator internus muscle just lateral to the inferior pubic ramus. The midline mark on the mesh should be approximately at the midurethra. The carrier is released into the tissue by simultaneously holding the deployment mechanism and pulling the delivery device handle back. A similar procedure is repeated on the contralateral side. Appropriate tension is confirmed via cough stress test or visual assessment, ensuring the sling is placed against the urethra and leaving a space small enough to pass a small instrument in between or identifying “pillowing” of periurethral tissue through the mesh pores [55]. Slight adjustments to tension can be made prior to disconnecting the delivery device. Cystoscopy is left to the surgeon’s discretion, the wound is irrigated, and the incision is closed in the usual fashion.

Results

There are limited data describing results regarding the Solyx SIS. Serels et al. published a retrospective review of 63 patients undergoing Solyx implantation at three US medical centers [55]. Patients had not undergone previous incontinence surgery, all had urethral hypermobility >30° with a Q-tip test, and stress incontinence was the predominant symptom (29 % had urge incontinence). Fifty-nine percentage of patients underwent concomitant procedures. At a mean follow-up of 6.5 months (range 5–8 months), 95 % of patients (60/63) were subjectively dry and had a negative cough stress test. Other than two patients experiencing transient urinary retention, no postoperative complications were noted. Like its predecessors, further study is needed to determine long-term efficacy.

Ajust

The AJUST™ Adjustable Single-Incision Sling system (CR Bard, Inc., Covington, GA, USA) entered the marketplace in 2008 in Europe and 2009 in North America. It too was designed to provide the benefits of TOT placement through a single vaginal incision. Design features include self-fixating polypropylene anchors, a midline mesh mark, a flexible stylet used to lock the sling after adjustment, and an introducer to insert the sling through the obturator membrane. The sling is unique in that it has a sub-urethral mesh section and an adjustment mesh portion that allows for post-insertion tightening or loosening without further insertion of the anchors (Fig. 5.4). This feature is achieved by having one fixed anchor and a second adjustable anchor through which the tubular adjustable mesh portion can be bidirectionally shifted. This setup gives the surgeon full view of the sling mesh during tensioning without any visual obstruction from the introducer. Once the appropriate tension is achieved, the flexible stylet is used to lock the sling in place.

A321341_1_En_5_Fig4_HTML.jpg

Fig. 5.4

AJUST adjustable single-incision sling. The AJUST is placed through the obturator membrane with self-fixating anchors. Post-insertion adjustments can be made by loosening or tightening the mesh relative to the fixed anchors (© 2013 C. R. Bard, Inc. Used with permission. Ajust is a registered trademark of C. R. Bard, Inc.)

Procedure

The patient is placed in the dorsal lithotomy position, and after local infiltration, a 1.5 cm incision is made in the midurethra. Dissection is carried out horizontally toward the ischiopubic ramus. Starting with the fixed anchor side, the introducer is then passed toward the cephalad margin of the ischiopubic ramus. Once the fixed anchor passes the ischiopubic ramus, the surgeon halts the push maneuver and pivots the introducer handle past the midline and toward the obturator internus muscle. The fixed anchor is then pushed through the obturator internus muscle and membrane, ensuring the midline mark is at or slightly beyond midline on the side of insertion. The anchor is then released, the introducer is removed, and appropriate fixation is confirmed with a gentle tug on the mesh. The adjustable anchor is then loaded and placed on the contralateral side using the same technique. Once placed, the adjustment tab and tubular mesh are pulled until proper tensioning is achieved. If desired, gentle counter-traction on the sub-urethral sling will loosen the mesh. After proper tensioning, the flexible stylet is inserted in the adjustment tab opening and a sling lock is advanced up to the adjustable anchor to lock it in place. Excess adjustment mesh is then trimmed, the incision is irrigated, and the vaginal incision is closed. Cystoscopy is left to the discretion of the surgeon.

Results

Peer-reviewed literature describing results from the Ajust SIS is limited. One group recently published its 1-year outcomes of a multicenter, prospective cohort of 90 women undergoing Ajust-SIS placement [56]. Patients had SUI or mixed incontinence with predominant SUI symptoms, were not undergoing concomitant repairs, and did not have pelvic organ prolapse. At 12 months after surgery, 72/90 (80 %) patients reported being either “much improved” or “very much improved.” One patient had sling placement converted to a standard midurethral sling for unclear reasons. Thirteen patients (14 %) were considered failures, that is, their symptoms were the same or worse or they had repeat incontinence surgery (five patients). Two patients had erosion of mesh into the vagina but were managed with local excision of eroded mesh. Of the 85 patients not requiring reoperation, 17 % (14/85) had a positive cough stress test at 1 year, while 82 % (70/85) had a negative stress test. Thirty-one patients underwent sling placement under local anesthesia: 97 % were completed, with 1 patient asking to be converted to general anesthesia due to pain. No patients had groin pain postoperatively. Meschia et al. published their data on 102 women undergoing Ajust sling placement, with an 85.7 and 91.4 % patient-reported and objective cure rates, respectively [57].

Conclusion

SUI is a common yet surgically correctable problem in many adult women. Traditional retropubic and transobturator slings have high success rates that have years of data to support their use. Nonetheless, blind passage of trocars during these procedures affords the opportunity for serious injury to visceral and vascular structures. SIS seek to provide the same benefit with lower morbidity. While the procedures are similar to traditional midurethral slings, SIS are not interchangeable and require attention to detail as each sling has unique characteristics and operative steps. Rather than replace RPT and TOT slings, SIS seek to provide patients with an option for treatment that has decreased complications, high continence rates, and the potential for placement under local anesthesia in the office setting. To date, literature reviewing the efficacy of these slings is mixed, and further long-term and randomized controlled trials are needed to delineate the role of SIS in the treatment of SUI. An FDA panel convened in September of 2011 agreed with the need for further study. The group recommended that premarket evaluation of mini-slings should include clinical studies involving a control arm of women using a transobturator or retropubic sling. Furthermore, postmarket studies are necessary to study the efficacy and safety of currently available SIS. These studies should be randomized or have a rigorous cohort design, compare women with SIS to women with transobturator or retropubic slings, and have 3–5 years of follow-up [58].

References

1.

Abrams P, Cardozo L, Fall M, et al. The standardization of terminology in lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Urology. 2003;61(1):37–49.CrossRef

2.

Hannestad YS, Rortveit G, Sandvik H, et al. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPICONT Study. J Clin Epidemiol. 2000;53:1150–7.CrossRef

3.

Lara C, Nacey J. Ethnic differences between Maori, Pacific Island and European New Zealand women in prevalence and attitudes to urinary incontinence. N Z Med J. 1994;107:374–6.

4.

Minassian V, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008;111:324–31.CrossRef

5.

Peyrat L, Haillot O, Bruyere F, et al. Prevalence and risk factors of urinary incontinence in young and middle-aged women. BJU Int. 2002;89:61–6.CrossRef

6.

Chong EC, Khan AA, Anger JT. The financial burden of stress urinary incontinence among women in the united States. Curr Urol Rep. 2011;12(5):358–62.CrossRef

7.

Anger JT, Weinberg AE, et al. Trends in surgical management of stress urinary incontinence among female Medicare beneficiaries. Urology. 2009;74(2):283–7.PubMedCentralCrossRef

8.

Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand Suppl. 1990;153:7–31.CrossRef

9.

Ulmsten U, Johnson P, Reqapour M. A three-year follow up of tension-free vaginal tape for surgical treatment of female stress incontinence. Br J Obstet Gynaecol. 1999;106:345–50.CrossRef

10.

Atherton M, Stanton S. The tension-free vaginal tape reviewed: an evidence-based review from inception to current status. Int J Obstet Gynaecol. 2005;112:534–46.CrossRef

11.

de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003;44:724–30.CrossRef

12.

Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;6:1306–13.

13.

Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010;362(22):2066–76.PubMedCentralCrossRef

14.

Laurikainen E, Valpas A, Kivela A, et al. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007;109:4–11.CrossRef

15.

Barber M, Kleeman S, Karram M, et al. Transoburator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence. Obstet Gynecol. 2008;111:611–21.CrossRef

16.

Barry C, Lim Y, Muller R, et al. A multicentre randomized clinical controlled trial comparing the retropubic (RP) approach vs the transobturator approach (TO) for tension-free suburethral sling treatment of urodynamic stress incontinence: the TORP study. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:171–8.CrossRef

17.

Ogah J, Cody DJ, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn. 2011;30(3):284–91.CrossRef

18.

Nilsson C, Palva K, Rezapour M, et al. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:1043–7.CrossRef

19.

Ward K, Hilton P, UK and Ireland TVT Trial Group. Prospective multicentre randomized trial of tension-free vaginal tape and colposuspensions as primary treatment for stress incontinence. BMJ. 2002;325:67.PubMedCentralCrossRef

20.

Grise P, Droupy S, Saussine C, et al. Transobturator sling for female stress incontinence with polypropylene tape and outside in procedure: prospective study with 1 year follow up and review of transobturator tape sling. Urology. 2006;68:759–63.CrossRef

21.

De Leval J, Waltregny D. New surgical technique for treatment of stress urinary incontinence TVT-Obturator: new developments and results. Surg Technol Int. 2005;14:212–21.

22.

Davila G, Johnson J, Serels D. Multicenter experience with the Monarc transobturator sling system to treat stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:460–5.CrossRef

23.

Barry C, Lim Y, Muller R, et al. A multicentre randomized clinical controlled trial comparing the retropubic (RP) approach vs the transobturator approach (TO) for tension-free suburethral sling treatment of urodynamic stress incontinence: the TORP study. Int Urogynecol J Pelvic Floor Dysfunc. 2008;19:171–8.CrossRef

24.

Meschia M, Barbacini P, Ambrogi V, et al. TVT-Secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multicentre prospective trial. Int Urogynecol J Pelvic Floor Dysfunc. 2009;20:313–7.CrossRef

25.

Neuman M. Perioperative complications and early follow up with 100 TVT-Secur procedures. J Minim Invasive Gynecol. 2008;15:480–4.CrossRef

26.

Rezapour M, Novara G, Meier PA, et al. 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model. Int Urogynecol J. 2007;18:183–7.CrossRef

27.

Baracat F, Iglesias R, Pessoa R, et al. Unfavorable immediate outcome with the TVT Secure sling in twenty consecutive women with stress urinary incontinence. J Urol. 2008;179(4):535–6.CrossRef

28.

Karram M, Lucente V, Khandwala S, et al. An evaluation of the Gynecare TVT Secur System (tension-free support for incontinence) for the treatment of stress urinary incontinence [abstract]. Int Urogynecol J. 2007;18 Suppl 1:004.

29.

Neuman M, Shaare-Zedek MC. Training TVT Secur: the first 150 teaching operations [abstract]. Int Urogyn J. 2007;18 Suppl 1:045.

30.

Martan A, Masata J, Svabik K. Initial experience with TVT-Secur System procedure and the reason for persistent stress urinary incontinence [abstract]. Int Urogyn J. 2007;18 Suppl 1:044.

31.

Marsh FA, Assassa P. An audit of the introduction of TVT Secur in clinical practice [abstract]. Int Urogyn J. 2007;18 Suppl 1:043.

32.

Albrich S, Naumann G, Skala C, et al. TVT Secur® First experiences after a follow-up of 17 months [abstract]. Neurourol Urodyn 2008;27

33.

Saltz SM, Haff RE, Lucente VR. Short-term assessment of patients undergoing the new tension free vaginal tape Secur procedure for treatment of stress urinary incontinence [abstract]. Int Urogyn J. 2007;18 Suppl 1:046.

34.

Debodinance P, Lagrange E, et al. TVT-Secur: more and more minimal invasive—preliminary prospective study on 40 cases [abstract]. Int Urogyn J. 2007;8 Suppl 1:239.

35.

Molden S, Lucente V. New Minimally Invasive Slings: TVT Secur. Curr Urol Rep. 2008;9:358–61.CrossRef

36.

Liapas A, et al. Comparison of the TVT SECUR System “hammock” and “U” tape positions for management of stress urinary incontinence. Int J Gynaecol Obstet. 2010;111(3):233–6. Epub 2010 Sep 6.CrossRef

37.

Kim JJ, Lee YS, Lee KS. Randomized comparative study of the U- and H-type approaches of the TVT-Secur procedure for the treatment of female stress urinary incontinence: one-year follow-up. Korean J Urol. 2010;51(4):250–6.PubMedCentralCrossRef

38.

Lee KS, Choo MS, Doo CK, Han DH, Lee YS, Kim JY, et al. The long term (5-years) objective TVT success rate does not depend on predictive factors at multivariate analysis: a multicentre retrospective study. Eur Urol. 2008;53:176–82.CrossRef

39.

Gagnon LO, le Tu M. Better short-term outcomes with the U-method compared with the Hammock technique for the implantation of the TVT-SECUR under local anesthesia. Urology. 2010;75(5):1060–4.CrossRef

40.

Walsh CA. TVT-Secur mini-sling for stress urinary incontinence: a review of outcomes at 12 months. BJU Int. 2011;108(5):652–7.

41.

Dmochowski RR, Grier D, Franco N, et al. One year results from a World-Wide Registry of TVT-SECUR™ in women with stress urinary incontinence. J Urol. 2009;181:544.CrossRef

42.

Abdel-Fattah M, Ford JA, Lim CP, Madhuvrata P. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications. Eur Urol. 2011;60(3):468–80.CrossRef

43.

Cornu JN, Sebe P, Peyrat L, et al. Midterm prospective evaluation of TVT-Secur reveals high failure rate. Eur Urol. 2010;58:157–61.CrossRef

44.

Neuman M, Sosnovski V, Kais M, et al. Transobturator vs single-incision suburethral mini-slings for treatment of female stress urinary incontinence: early postoperative pain and 3-year follow-up. J Minim Invasive Gynecol. 2011;18(6):769–73.CrossRef

45.

Hinoul P, Vervest HA, den Boon J, et al. A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence. J Urol. 2011;185(4):1356–62.CrossRef

46.

Moore RD, Serels DR, Davila GW, et al. Minimally invasive treatment for female stress urinary incontinence (SUI): a review including TVT, TOT, and mini-sling. Surg Technol Int. 2009;18:157–73.

47.

Howard D, Miller JM, Delancey JL, et al. Differential effects of cough, valsalva, and continence status on vesical neck movement. Obstet Gynecol. 2000;95:535–40.PubMedCentralCrossRef

48.

Moore RD, Mitchell GK, Miklos JR. Single-center retrospective study of the technique, safety, and 12-month efficacy of the miniarc single-incision sling: a new minimally invasive procedure for treatment of female SUI. Surg Technol Int. 2009;18:175–81.

49.

Kennelly MJ, Moore RD, Nguyen JN, et al. Prospective evaluation of a single incision sling for stress urinary incontinence. J Urol. 2010;184(2):604–9.CrossRef

50.

Pickens RB, Klein FA, Mobley III JD, White WM. Single incision mid-urethral sling for treatment of female stress urinary incontinence. Urology. 2010;77:321–4.CrossRef

51.

De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J Pelvic Floor Dysfunct. 2010;21(7):773–8.CrossRef

52.

Hogewoning CR, Ruhe IM, Bekker MD. The MiniArc sling for female stress urinary incontinence: clinical results after 1-year follow-up. Int Urogynecol J. 2012;23(5):589–95.PubMedCentralCrossRef

53.

Gauruder-Burmester A, Popken G. The MiniArc sling system in the treatment of female stress urinary incontinence. Int Braz J Urol. 2009;35:334–41.CrossRef

54.

Debodinance P, Delporte P. MiniArc: preliminary prospective study on 72 cases. J Gynecol Obstet Biol Reprod. 2009;38:144–8.CrossRef

55.

Serels S, Douso M, Short G. Preliminary findings with the Solyx single-incision sling system in female stress urinary incontinence. Int Urogynecol J. 2010;21(5):557–61.CrossRef

56.

Abdel-Fattah M, Agur W, Abdel-All M, et al. Prospective multi-centre study of adjustable single-incision mini-sling (Ajust(®)) in the management of stress urinary incontinence in women: 1-year follow-up study. BJU Int. 2012;109(6):880–6.CrossRef

57.

Meschia M, Barbacini P, Baccichet R, et al. Short-term outcomes with the AjustTM system: a new single incision sling for the treatment of stress urinary incontinence. Int Urogynecol J. 2011;22(2):177–82.CrossRef