Introduction
Synthetic midurethral slings (MUSs) have become the most popular surgical procedures performed for the treatment of stress urinary incontinence (SUI) in the twenty-first century. Few operations in gynecology or urology have been as well studied, or have gained such wide acceptance. These procedures generally have been shown to be minimally invasive with a high efficacy, low morbidity, and a relatively quick recovery. This chapter discusses the currently available synthetic MUS kits on the market. Because the efficacy data are few, we do not discuss variations that use biologic materials for the slings. A complete discussion of autologous fascia bladder neck slings is found in Chapter 19 .
Synthetic Retropubic MUSs
Retropubic MUSs were developed in the mid-1990s in an attempt to create a minimally invasive surgical treatment for SUI. Until this time incontinence procedures aimed at suspending or supporting the proximal urethra and bladder neck. described a rationale for a more distally placed suburethral sling based on concepts they termed the “integral theory.” This theory was based on the presumption that the pubourethral ligaments support the midurethra and attach to the pubic bones, acting as a backboard for the midurethra. This backboard allows for compression of the midurethra against it when intra-abdominal pressure increases and thus maintains continence. The concept states that the absence of the backboard support causes a loss of this watertight seal, and SUI develops. By passing a strip of supportive material (loosely woven polypropylene) under the midurethra in women with SUI, this “backboard” action could theoretically be replicated. The strip of polypropylene is to be left loose or “tensionless,” and direct compression of the urethra is avoided. In its earliest configuration, placement of the MUS was achieved through an anterior vaginal wall dissection at the level of the midurethra. Placement of the sling material was accomplished by passing the arms of the tape in a retropubic fashion through the anterior abdominal wall with the aid of specially designed trocars.
The first commercially available retropubic MUS was the tension-free vaginal tape, or TVT (Gynecare, Somerville, NJ) ( Fig. 20.1 ), which consisted of a narrow polypropylene mesh strip with two specially designed trocars. The trocars were inserted through a small vaginal incision and passed on each side of the urethra through the retropubic space to two exit locations in the suprapubic area of the anterior abdominal wall. Passage of the trocars from the vaginal incision to the anterior abdominal wall has been described as the “bottom-up” approach. Several other retropubic sling “kits” ( Box 20.1 ) with minor modifications also are available, including a “top-down” approach whereby the trocars are passed retropubically from the anterior abdominal wall to the vaginal incision, and the tape is attached to the vaginal end of the trocar and then pulled back up through the retropubic space to the abdominal wall.
Sling | Manufacturer | Trocar Passage |
---|---|---|
TVT, TVT Exact | Ethicon, Sommerville, NJ | Bottom-up |
SPARC | American Medical Systems, Minnetonka, MN | Top-down |
RetroArc | American Medical Systems | Bottom-up |
Lynx suprapubic | Boston Scientific, Natick, MA | Top-down |
Advantage | Boston Scientific | Bottom-up |
Align retropubic | Bard Medical, Covington, GA | Bottom-up and top-down |
Indications, Patient Selection, and Types of Slings
The indications for retropubic MUS placement include symptomatic SUI or occult stress incontinence significantly affecting the patient’s quality of life. Patients should have failed all conservative treatments for SUI. Initial studies assessing functionality of the retropubic MUS mostly included “ideal” women—those who were not obese (body mass index >35 kg/m 2 ), who had stress-predominant incontinence with a mobile urethra, and who had no prolapse. In time, studies also documented excellent outcomes in women who were overweight, had recurrent or mixed urinary incontinence, had intrinsic sphincter deficiency (ISD) with a lack of urethral hypermobility, and in whom the procedure could be performed in conjunction with a vaginal prolapse repair. Retropubic anatomy, prior surgery, body habitus, and surgeon experience are important variables to consider in surgical planning.
Absolute contraindications to the procedure include any important structure potentially in the path of the trocars or sling, such as a pelvic kidney or vascular graft, low ventral hernias, pregnancy, and active oral anticoagulation. Relative contraindications include any previous condition that would put the patient at a high risk for significant pelvic adhesions, creating the risk for small bowel to be firmly adhered to the back of the pubic bone, such as a history of a ruptured appendix with peritonitis or stage 4 endometriosis. In such circumstances, a transobturator sling would be a preferred procedure because the retropubic space would be completely avoided.
Other patients in whom a synthetic sling is probably inappropriate include those who are undergoing concurrent or have undergone prior urethral reconstruction. Examples of such clinical situations include urethral diverticulectomy, urethrovaginal fistula repair, or urethral injury secondary to prior sling placement or pelvic fracture. Although there are no reports of MUSs being used in this setting, experience with synthetic material in the setting of urethral reconstruction has demonstrated a high rate of erosion ( ). In contrast, excellent outcomes have been reported with the use of a biologic pubovaginal sling (see Chapter 19 ) in the setting of reconstruction, with an 88% cure rate after diverticulectomy in 16 patients and an 86% cure rate after genitourinary fistula repair in seven patients, with no reported erosions ( ). Also, a synthetic MUS is not the preferred procedure in the case of neurogenic incontinence, such as in a patient with spina bifida. Because patients with neurogenic incontinence are already dependent on clean intermittent self-catheterization, a tension-free MUS may not provide the necessary compression to achieve continence in between catheterizations. Biologic pubovaginal slings have been used successfully in patients with neurogenic causes of SUI, successfully providing occlusion at the bladder neck, with continence rates of 95% in one study ( ).
As previously mentioned, the initial TVT system was classified as a bottom-up technique. An alternative system called SPARC (American Medical Systems, Minnetonka, MN) was developed a few years later; in SPARC, the trocar passes from the suprapubic region down into the vagina (top-down technique). A meta-analysis by comparing five randomized controlled trials of TVT versus SPARC systems showed that the TVT had higher subjective and objective cure rates of 85% and 92%, respectively, compared with 77% and 87% for SPARC. The same study showed significantly lower complication rates in the patients receiving TVT (fewer bladder perforations and mesh erosions and less voiding dysfunction). However, these findings have not been consistently shown in other single-arm series, which have demonstrated comparable efficacy and low complication rates with the top-down technique compared to TVT.
Surgical Technique
Bottom-to-Top
- 1.
Preoperative considerations. Single-dose intravenous perioperative antibiotics are given for skin and vaginal flora coverage. The antibiotic classes commonly used include intravenous cephalosporins and fluoroquinolones. Antiembolic prophylaxis is given as indicated. Sterile urine should be confirmed before the procedure; some physicians postpone surgery if an active urinary tract infection is documented.
- 2.
Patient positioning and preparation. The patient is positioned in the dorsal lithotomy position, with legs supported in Allen or candy cane stirrups and all pressure points padded appropriately. The perineum and vagina are prepared, and surgical draping is placed to allow access to the vagina and suprapubic area.
- 3.
Anesthesia. We prefer to use general anesthesia; however, some surgeons prefer intravenous sedation with local anesthesia to allow the cough stress test to be performed to facilitate appropriate tensioning of the sling. Because approximately 50% of cases are done in conjunction with a prolapse repair, all surgeons need to be well versed in tensioning techniques under general anesthesia (see step 8).
- 4.
Vaginal dissection. The anterior vaginal wall is hydrodissected with a combination of lidocaine and epinephrine, with the goal of completely blanching the anterior vaginal wall at the level of the mid- to distal urethra. A scalpel blade is used to make an incision from just below the external urethral meatus to the level of the midurethra. The vaginal wall is sharply dissected with Metzenbaum scissors off the posterior urethra, creating small tunnels to the inferior pubic ramus ( Fig. 20.2 ). Sharp dissection is required because the distal anterior vaginal wall and posturethra are fused at this level. Some physicians prefer to hydrodissect along the trocar trajectory bilaterally before passing the trocars.
- 5.
Trocar passage. A catheter guide is placed in the indwelling Foley catheter so that the urethra and bladder neck can be displaced away from where the trocar is inserted. The trocar tip is inserted into the previously dissected tunnel on each side, lateral to the urethra, and advanced to the undersurface of the pubic bone. The tip of the trocar should be sandwiched between the index finger of the surgeon’s nondominant hand placed in the anterior vaginal fornix and the undersurface of the interior pubic ramus. Care is taken not to “button-hole” into the vaginal lumen at the fornix. The tip of the needle is carefully advanced through the endopelvic fascia into the retropubic space ( Fig. 20.3 ). When the resistance of the endopelvic fascia is overcome and the tip of the needle is in the retropubic space, the handle of the trocar is dropped, and the needle is advanced through the retropubic space as it hugs the back of the pubic bone ( Fig. 20.4 ). The next resistance felt is the rectus muscle and anterior abdominal fascia. The needle is advanced through these structures to exit through the previously made suprapubic stab wound (see Fig. 20.4 ). Figure 20.5 illustrates the appropriate passage of the needle through the retropubic space when viewed from above, as well as examples of incorrect passage of the trocar.
- 6.
Cystoscopy. Careful cystoscopy is performed with a 30- and 70-degree scope to evaluate the bladder for inadvertent trocar injury with the trocar in place. If such an injury were to occur, it would generally be visualized in the anterolateral aspect of the bladder (usually the area between 1 o’clock and 3 o’clock on the left side and 9 o’clock and 11 o’clock on the right side). If the trocar is seen or there is any creasing of the bladder mucosa that does not disappear with bladder distention, the trocar should be withdrawn and repassed. When the bladder is perforated (which occurs in approximately 3-5% of cases), it is most often because the surgeon has allowed the trocar to migrate too medially, or away from the back of the pubic bone in a cephalad direction (see Fig. 20.4 A and C ). During repassing of the trocar, great care should be taken to hug the back of the pubic bone. In such cases, the patient may still proceed with the postoperative voiding trial without the need for discharge with an indwelling catheter because the bladder perforation is very small and usually in a high, nondependent portion of the bladder. If excessive hematuria is present or if the base or trigone of the bladder is perforated, postoperative bladder drainage should be continued for at least a few days.
- 7.
For passage of the sling, the trocar tips are disconnected from the handle, and the mesh and its plastic sheath are pulled up through the suprapubic stab wound along the trocar trajectory.
- 8.
Tensioning. Sling tensioning is very subjective. It may be done using a No. 8 Hagar dilator or surgical clamp, such as a right-angled clamp inserted between the posterior urethra and the suburethral portion of the sling if the patient is receiving general anesthesia ( Fig. 20.6 ). Some surgeons prefer to perform the procedure using a local anesthetic and use a cough stress test. Regardless of tensioning technique, the ultimate end point is to create a laxity in the mesh manifested by a ricochet of the mesh back toward the urethra if it is pulled on vaginally using a right-angled clamp as well as avoiding direct contact of the mesh with the underside of the urethra. Then the plastic sheaths covering the mesh matrix are removed, and tension of the mesh is rechecked. The mesh is suprapubically resected flush with the skin, making sure the skin is mobilized away from the mesh ends before skin closure (see Fig. 20.6 ).
- 9.
The vaginal wound is copiously irrigated and closed with a running 3-0 polyglycolic acid suture. The suprapubic stab wounds are closed with an absorbable suture or liquid tissue adhesive. Vaginal packing may be inserted temporarily at the completion of the surgery if the patient is bleeding or if concurrent prolapse procedures have been performed.
- 10.
The catheter may be removed, along with the vaginal packing, in the recovery room, and the patient is discharged after confirming voiding efficiency.
Top-to-Bottom
- 1.
Vaginal dissection. The vaginal incision should be larger than that described for the bottom-to-top technique because the dissection should allow the index finger of the surgeon’s nondominant hand to be placed into the incision to pick up the tip of the needle as it passes into the vaginal incision ( Fig. 20.7 ).
- 2.
Top-to-bottom trocar passage. Before passage of the trocars, complete drainage of the bladder is ensured. At the previously marked puncture sites in the suprapubic region, a stab incision is made on each side. The incisions should be well within the pubic tubercles bilaterally. A trocar is inserted into the first of the suprapubic incisions aligned with the sagittal axis of the body and then carefully punctures through the anterior rectus sheath. By angling caudally and “walking off” the superior posterior edge of the pubic bone, the trocar is advanced into the retropubic space, maintaining close contact with the posterior surface of the pubic bone. Concurrently, the surgeon’s finger is inserted into the previously dissected periurethral space on the ipsilateral side to control the distal tip of the trocar. In a controlled manner, the trocar is progressively advanced until the tip is visible in the vaginal incision. Cystoscopy, as previously described, is performed to confirm that the needle did not penetrate the bladder. The same maneuver is performed on the contralateral side ( Figs 20.8 and 20.9 ).
- 3.
Loading the mesh. The mesh is attached to the trocars, and the trocars are withdrawn through the suprapubic stab wounds. The sling is tensioned and tension is tested as previously described for the bottom-to-top technique ( Fig. 20.6 ).
Outcomes
The Cochrane Library published in 2009 a meta-analysis of minimally invasive suburethral sling operations for SUI ( ); overall 62 randomized studies involving 7101 women were included. Short-term cure rates for retropubic MUS were between 73% and 82%, and the quality of evidence was moderate for most trials. A number of important conclusions came from this Cochrane review.
- •
Minimally invasive synthetic suburethral sling operations seemed to be as effective as traditional suburethral fascial slings (8 trials, n = 599, risk ratio (RR) 1.03, 95% confidence interval (CI) 0.94-1.13) but had shorter operating times and less postoperative voiding dysfunction and de novo symptoms of urgency.
- •
Minimally invasive synthetic suburethral sling operations seemed to be as effective as open retropubic colposuspension (subjective cure rate at 12 months: RR 0.96, 95% CI 0.90-1.03; at 5 years: RR 0.91, 95% CI 0.74-1.12), with fewer perioperative complications, less postoperative voiding dysfunction, shorter operative time, and shorter hospital stay but significantly more bladder perforations (6% versus 1%; RR 4.24, 95% CI 1.71-10.52).
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There was conflicting evidence about the effectiveness of minimally invasive synthetic suburethral sling operations compared to laparoscopic colposuspension in the short term (objective cure: RR 1.15, 95% CI 1.06-1.24; subjective cure: RR 1.11, 95% CI 0.99-1.24). Minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence and shorter operating time, hospital stay, and time to return to daily activities.
- •
A retropubic bottom-to-top route was more effective than top-to-bottom route (RR 1.10, 95% CI 1.01-1.20) and incurred significantly less voiding dysfunction and fewer bladder perforations and tape erosions.
- •
Monofilament tapes had significantly higher objective cure rates (RR 1.15, 95% CI 1.02-1.30) compared with multifilament tapes and fewer tape erosions (1.3% versus 6%; RR 0.25, 95% CI 0.06-1.00).
- •
The objective cure of the obturator route was less favorable than that of the retropubic route (84% versus 88%; RR 0.96, 95% CI 0.93-0.99; 17 trials, n = 2434), although there was no difference in subjective cure rates. However, there was less voiding dysfunction, blood loss, and bladder perforation (0.3% versus 5.5%; RR 0.14, 95% CI 0.07-0.26) and shorter operating time with the obturator route.
Many studies have shown consistent and reliably good effectiveness of retropubic MUS for treating SUI. The largest randomized controlled study comparing retropubic and transobturator slings (Trial of Mid-Urethral Slings) with a strict definition of cure showed retropubic sling subjective and objective cure rates of 62% and 81%, respectively ( ). Objective cure of the retropubic MUS sling was about 3% better than that of transobturator MUS, a nonsignificant difference. Treatment success also seems to persist for many years. A prospective cohort study reported 11-year follow-up after TVT slings and showed a subjective cure rate of 77% ( ).
Earlier studies comparing retropubic MUS with open colposuspension procedures (a 2012 Cochrane review and the trial with 5-year follow-up) showed similar cure rates with open Burch colposuspension and TVT.
ISD and Recurrent Incontinence
Although there is no standardized definition, ISD has been defined in the literature based on the urodynamics findings of Valsalva leak point pressure of less than 60 cmH 2 O or maximum urethral closure pressure of less than 20 cmH 2 O. Women with ISD usually have more severe incontinence with higher risk of treatment failure, and before the development of synthetic sling kits, biologic bladder neck slings had been recommended in such cases, with cure rates of 80% to 85%. Numerous studies to date have reported good success with retropubic TVT in women with ISD. first reported their favorable and durable results using TVT in 49 women with ISD (defined maximum urethral closure pressure <20 cmH 2 O, not Valsalva leak point pressure), with a cure rate of 74% and significant improvement in 12% of cases. Only eight patients did not have urethral hypermobility (as defined by Q-tip test >30°), and of the seven failures, five had fixed urethras. Although the numbers were small, the authors suggested that lack of hypermobility may be a risk factor for failure.
Numerous subsequent studies compared retropubic with transobturator approaches in patients with ISD using the previously mentioned urodynamics criteria. retrospectively compared TVT, transobturator tape (TOT), and pubovaginal sling in women with ISD followed for 2 years. Patients with TVT had a cure rate of 86.9%, which was similar to the cure rate of 87.3% seen with the pubovaginal sling; in contrast, the TOT group had a cure rate of only 34.9% ( P < 0.0001). At 31 months, found cure rates of 78.3% using TVT versus 52.5% using TOT and reported that TOT was five times more likely than TVT to fail in women with ISD. In a prospective, randomized study addressing this issue, randomly assigned 164 women with ISD to TVT or TOT, with the primary outcome of urodynamic SUI at 6 months. After urodynamic testing, 21% of the TVT group versus 45% of the TOT group had SUI ( P = 0.004). At 3 years, 20% of women in the TOT group underwent repeat surgery to correct SUI compared with only 1.4% in the TVT group ( ). showed that lower Valsalva leak point pressure or maximum urethral closure pressure resulted in a nearly twofold increased risk of SUI 1 year after both retropubic or transobturator MUS.
Regarding the effectiveness of MUSs in recurrent SUI, reviewed the literature and found that the overall subjective cure rate following midurethral sling for recurrent SUI after any previous surgery was 78.5% after about a 30-month follow-up. There seems to be a lower cure rate with TOT compared to retropubic sling for recurrent SUI ( ).
Urethral Mobility
The studies noted earlier suggest that retropubic slings work relatively well for patients with ISD, whereas transobturator slings may not work as well. In contrast, a retrospective study by found no difference between retropubic and transobturator slings in women with ISD, with success rates of 76% and 77%, respectively. also reported no difference between TVT and TOT in women with ISD; they used a subset analysis of their randomized controlled trial—all of their patients had urethral hypermobility ranging from 43° to 90° as measured by the Q-tip test. They found no difference in outcomes between 45 patients with TVT and 50 patients with TOT at 35 months (68% versus 76%, respectively). Although this was a post hoc analysis that was underpowered to detect a difference, it does suggest that patients with ISD who have concurrent hypermobility may show similar outcomes with both TVT and TOT slings.
A study by examined the effect of ISD and urethral hypermobility in 65 patients with TOT by dividing them into 3 groups: ISD with hypermobility ( n = 18), ISD with fixed urethra ( n = 16), and hypermobility without ISD ( n = 31). At 24 months, the 2 groups with hypermobility with and without ISD had similar cure rates (87.5% and 96.4%, respectively). However, patients with no hypermobility had a significantly lower cure rate (66.7%).
Hypermobility was also a predictive factor of treatment failure in patients undergoing TVT in studies by (success rates of 92% with Q-tip test >30° versus 70% for Q-tip test <30°) and (Q-tip <30° had an odds ratio of 1.89 for treatment failure). ISD, which was defined in this study as maximum urethral closure pressure less than 20 cmH 2 O, had no effect on success rate. The literature seems to indicate retropubic and transobturator MUS procedures are effective in treating patients with ISD and hypermobility; however, the less mobile urethra is a risk factor for transobturator sling failure, and a retropubic approach may be favored in these cases.
Mixed Stress and Urge Incontinence
In a systematic review of the effectiveness of MUS in mixed urinary incontinence, found that there was a persistent and good cure of the stress component (85-97%) but a variable and lower cure of the urgency and urge incontinence component (30-85%). Retropubic and transobturator MUS had similar subjective cure of mixed incontinence.
Obesity
Both safety and effectiveness are important when assessing surgical procedures. Multiple studies reported no significant difference in outcomes in obese patients undergoing long-term follow-up. However, a meta-analysis in 2008 showed a statistically significant difference in SUI cure rates: 81% in obese patients versus 85% in nonobese patients. De novo urge incontinence did not vary between the two groups, but the rate of persistent urge incontinence was significantly higher in obese patients. When comparing safety, the same meta-analysis showed that obese patients had a statistically significant lower rate of bladder perforation.
Avoiding and Managing Complications
Complications of retropubic MUS procedures include bladder perforation, pelvic visceral injuries, vascular injuries and hemorrhage, mesh erosion and exposure, de novo development of urgency and urge incontinence, bladder outlet obstruction, pelvic pain, and urinary tract infection. Retropubic MUS have a higher frequency of bladder perforation, postoperative voiding dysfunction requiring surgical intervention, and urinary tract infections than transobturator MUS ( ).
Bladder perforation occurs in 3% to 5% of cases and is simply managed by removing and carefully reinserting the trocar. However, if a large injury has been encountered in a dependent portion of the bladder (trigone or bladder base), prolonged drainage or, rarely, aborting the procedure is recommended. Mesh immediately adjacent to a bladder injury can result in erosion into the urinary tract. If urethral injury is noted, the procedure is preferably abandoned until complete healing has occurred to reduce the likelihood of erosions of mesh into the urethra.
Depending on the amount, bleeding may indicate trocar-induced injury to pelvic vessels including paravesical veins, accessory obturator vessels, obturator vessels, superficial or inferior epigastric vessels, and in rare situations external iliac or femoral vessels. Cadaver studies have shown that major vascular structures are as close as 3.2 cm cephalad and lateral to the retropubic MUS trocar ( ; Fig. 20.10 ). Sometimes this bleeding may be concealed and result in a large hematoma with the only indications being a subjective feeling of discomfort, pressure, frequent urination, or orthostatic changes from the anemia. Objective indicators include patient vital signs, oliguria, a palpable suprapubic mass and/or ecchymosis, and loss of consciousness in extreme cases. One study showed a correlation between hematoma size and symptoms; patients were in severe discomfort if the collection was larger than 300 mL compared with minimal to absent symptoms at volumes less than 100 mL. Persistent bleeding refractory to passive actions such as compression and fluid resuscitation may require angiographic management with vascular surgical consultation or surgical exploration.
Retropubic MUS also may induce pain, which may be experienced in the suprapubic or vaginal areas. Although often transient, persistent pain after mesh implantation rarely results in significant morbidity and disturbances in the patient’s quality of life. Sling tensioning may play a role in the de novo development of pain. First-line therapy is based on optimization of analgesia and use of anti-inflammatory medications. Local anesthetic “trigger” injections and more advanced pain management may be necessary. Cystourethroscopy may be necessary to make sure that sling mesh is not in the lumen of the bladder or urethra. A final intervention is surgical excision of the sling, which results in resolved or improved pain in 50% to 68% of patients. If the suburethral portion of the sling is excised, recurrent SUI can develop in 30% of cases.
Sexual function usually improves after both retropubic and transobturator MUS, mainly because of resolution of SUI ( ). However, dyspareunia can occur and often is related to superficial mesh location or mesh exposure in the vagina. Although application of topical vaginal estrogen and observation have been advocated for this problem, many patients require mesh removal for symptom resolution.
Mesh erosion and extrusion is a known complication of all synthetic mesh systems. In a series of 241 women, reported a 1% vaginal erosion rate after TVT. In the Trial of Mid-Urethral Slings, with 24-month follow-up, 3.3% of women had mesh erosion or exposure after TVT ( ). Initial treatment after diagnosis is typically conservative: using vaginal estrogen cream; avoiding vaginal insertions or trauma, including pelvic rest; and avoiding tampon use. If conservative treatment is unsuccessful, applicable surgical options include mobilization and reapproximation of vaginal epithelium, excision of the exposed mesh, or extensive or complete removal of the suburethral portion of the mesh with vaginal closure. The mesh should be removed only after adequate patient counseling regarding the likelihood of recurrence of SUI.