Kai-Wen Chuang1 and Farzeen Firoozi2
Department of Urology, North Shore—Long Island Jewish Health System, New Hyde Park, NY, USA
Hofstra North Shore—LIJ School of Medicine, The Smith Institute for Urology, Lake Success, NY, USA
Farzeen Firoozi (Corresponding author)
Stress urinary incontinence (SUI) has a reported prevalence between 12.8 and 46 % . There is no doubt that SUI has been clearly shown to negatively impact the everyday quality of life (QOL) of the women who suffer from this dysfunction . The economic burden for the treatment of urinary incontinence have been estimated to be approximately 19 billion annually in the United States . Risk factors for the development of UI include age, obesity, previous pelvic surgery, and childbirth .
Surgical management of SUI is the standard of care once conservative options, such as behavioral modification, pelvic floor exercises, fluid modification, and scheduled voiding, have been exhausted . The surgical options have evolved over the last few decades to include the Burch colposuspension, periurethral bulking agents, pubovaginal slings, and the newest multitude of approaches for midurethral synthetic slings . The synthetic slings include retropubic, transobturator, and the newest additions which include the so-called single-incision slings. The aims of this chapter include the evaluation and management of SUI and review each of the surgical techniques currently available to pelvic floor surgeons.
In 1961, Burch reported his series of retropubic uretropexies for the management of SUI . The surgery today can be performed via laparotomy, laparoscopy, or Robotic assistance. Although the approaches have become more minimally invasive, the basic surgical tenets remain unchanged.
The surgical selection for the Burch colposuspension includes patients with genuine UI and hypermobility of the urethra. This specifically includes patients who have low leak point pressures with urethral hypermobility as well as those with low urethral closure pressures. Patients with intrinsic sphincteric deficiency (ISD)—defined as SUI despite complete support of the urethra—are not good candidates for the Burch colposuspension. Nowadays, most pelvic surgeons would agree that the Burch colposuspension is a safe and effective surgical option for SUI, largely considered for women undergoing a concomitant open or laparoscopic procedure such as pelvic organ prolapse repair.
There have been some modifications to the techniques of the Burch colposupension described in the literature since its inception in 1961. The majority of open Burch colposuspensions performed today are closest in technique described by Tanagho . The laparosopic/robotic Burch colposupensions adopt essentially all the same surgical steps but differ in that these are minimally invasive options with equivalent outcomes.
The patient is placed in a dorsal lithomtomy position with legs in stirrups. A 16 Fr. Foley catheter is placed at the beginning of the procedure. A 5 cm transverse suprapubic incision is made to expose the rectus facsia. The rectus fascia is then opened with a similar length incision. The fascia is then mobilized from underlying rectus muscle with electrocautery. The space of Retzius is then entered bluntly and dissected laterally in both directions. A self-retaining retractor (e.g., mini-Bookwalter or Balfour retractor) is placed followed by entry into the dome of the bladder. The surgeon’s nondominant hand is placed into the vagina. Two No. 1 nonabsorbable sutures are placed on each side of the urethra. The sutures are thrown with double bites, almost including full thickness of the vaginal wall. The initial suture is at the urethrovesical junction and the second suture is approximately 1 cm caudal. Care is taken to place these sutures at least 4 mm lateral to the urethra. The sutures are then placed through Cooper’s ligament (Fig. 3.1). The interior of the bladder is then examined to rule out injury and bilateral efflux from the ureteral orifices is noted. A cotton swab test is performed, after the Foley catheter is removed, demonstrating a 0–10° angle to the horizon by loosening or elevating the sutures. Once this is established, the sutures are tied down. The bladder is then closed with 2-0 absorbable suture in standard 2-layer fashion. A Foley catheter is left indwelling at the end of the procedure.
Burch colposuspension: The initial suture is at the urethrovesical junction and the second suture is approximately 1 cm caudal. Care is taken to place these sutures at least 4 mm lateral to the urethra. The sutures are then placed through Cooper’s ligament
The patient is placed in a dorsal lithomtomy position with legs in stirrups. A 16 Fr. Foley catheter is placed at the beginning of the procedure. Monitors, typically two for the surgeon and assistant surgeon, are placed at the patient’s feet. The two midline trocars are for both introduction and extraction of curved needles and passage of the laparoscope. The 5 mm trocars are placed laterally at the border of the rectus muscles, at the level of the suprapubic 12 mm trocar (the distance between the pubic symphysis and 5 mm trocars would be no less than 4 fingerbreadths). This distance allows for adequate access to the space of Retzius.
Once any concomitant procedures are completed (e.g., hysterectomy, prolapse repair) the space of Retzius is entered. Blunt and sharp dissection is used to expose the pubic symphysis and Cooper’s ligament. Also dissected out and exposed are the lateral pelvic sidewall, obturator neurovascular canal, ischial spine and arcus tendinius, arcus of the levator ani, and the paravaginal fascia. If indicated, a paravaginal repair can be performed if there is a lateral cystocele defect.
At this point, Ethibond No. 0 sutures are placed in the same fashion as described for the open approach. After the sutures are tied down, cystoscopy is performed after indigo carmine is injected intravenously to check for ureteral efflux, ruling out any obstruction. The 12 mm trocras are closed in standard fashion with 2-0 absorbable suture. The 5 mm trocar facsia does not need to be closed. The patient may undergo a voiding trial in the recovery room according to individual surgeon preference.
The Burch colposuspension has been shown to outperform pharmacotherapy, conservative management, needle suspensions, Marhsall–Marchetti–Krantz procedure, and anterior colporraphy . A recent Cochrane review of open Burch colposuspensions reported an overall success rate of 69–88 %. This same meta-analysis had separately reviewed 12 trials comparing open approach versus laparoscopic approach and found no statistically significant difference in patient-reported incontinence and the 1-year and 5-year follow-up periods.
There have been studies that have evaluated the long-term success rates of the open Burch colposuspension. Sivaslioglu et al. reported an 84 % success rate at 7 years in their series of 262 patients . The Burch colposuspension is a safe and effective surgical option for SUI, largely considered for women undergoing a concomitant open or laparoscopic procedure such as pelvic organ prolapse repair .
As any open or laparoscopic abdominal procedure, there are common risks including bleeding, infection, erosion of materials involving the bladder, injury to abdominal organs, and hernias . The main long-term issues at hand center around voiding dysfunction and pelvic organ prolapse postoperatively. These pelvic floor issues include detrusor overactivity, urinary retention, and formation of enterocele/rectocle.
Many studies have reported differing rates of de novo detrusor overactivity. The mechanism of the dysfunction is widely thought to be secondary to increased elevation of the vagina, and ostensibly the bladder trigone at urethropexy. This therapy further emphasizes the importance of stabilization versus elevation as an important factor in the success of the Burch colposuspension. One of the earlier reports that came from Stanton et al., whose group reported postoperative urodynamic-proven de novo detrusor overactivity, demonstrated a rate of de novo detrusor overactivity at 18.5 % . In Langer et al.’s 10-year follow-up study, the incidence of de novo detrusor overactivity was 16.6 %. Voiding dysfunction appeared within the first year in 70.5 % of the patients ultimately diagnosed with de novo detrusor overactivity .
In reviewing the literature the on incidence of long-term urinary retention, the authors acknowledge that there is not a great deal reported. Alcalay et al. reported four of the 366 patients who underwent the Burch colposuspension required urethrolysis postoperatively . Although Feyeriesl reported a 16 % rate of residual >60 ml in their patient population at 5- to10-year follow-up, the authors do not report on any patients with residuals greater than 150 ml. Suffice it to say, there is a risk of urinary retention in the Burch colposuspension technique, albeit most likely a low risk.
As discussed in the technique section, the goal of Burch colposuspension is stabilization, not elevation. In early series, the risk of enterocele or rectocele formation is widely thought to be secondary to over-elevation of the vaginal wall . Keeping this in mind, more recent series have lower rates of this anatomic sequelae by avoiding excessive elevation.
Periurethral Bulking Agent
The first description of the injection of a periurethral agent for the management of stress urinary incontinence came from Murless in 1938. The substance used was sodium morrhuate. Following that, may others published experiences with a wide variety of injectables, including paraffin wax, sclerosing agents, polytetrafluoroethylene, collagen, autologous fat, silicone, and stem cells. Despite the significant presence of injectable agents in urologic practice, there have been very few well-designed published studies evaluating the efficacy of this therapy.
The patient selection for this procedure consists of patients with ISD and normal detrusor function. The urodynamic cutoff for Leak Point Pressure (LPP) is typically 60 cm H2O . The success in ISD patients is thought to be secondary to the mechanism of action which is thought to be a result of increased area and pressure transmission ratio. This would ostensibly prevent the bladder neck or proximal urethra from opening under stress. Patients may also have hypermobility of the urethra, and still have their ISD component addressed with an injectable agent . In this section, we will review the technique and outcomes of this therapeutic modality. In addition to these indications, urethral bulking agents are also indicated in patients who are young and desire more children, poor surgical candidates, persistent SUI after anti-incontinence procedure, and SUI with poor bladder emptying.
The most common environment for this procedure is under local anesthesia in an outpatient basis. There are two main approaches—transurethral and periurethral. The agent is typically placed submucousally or into the lamina propria. The injectable can be placed at the bladder neck or the proximal urethra. The typical sites of implant are the 3 and 9 o’clock positions. The size of the needle is dependent on the injectable agent. The propose mechanism of action is to achieve coaptation of the urethra during the storage phase, with maintenance of this coaptation when there is an increase in abdominal pressure transmitted to the bladder with a valsalva maneuver.
The patient is placed in dorsal lithotomy position. Local anesthesia is injected in the 3 and 9 o’clock positions 3 mm lateral to the urethral meatus. A 30° cystoscope is introduced after local anesthesia is injected. The periurethral needle is then placed lateral to the urethral meatus (same site as local injection) and advanced to the bladder neck/proximal urethra. The agent is injected in the 3 o’clock position on the right, followed by 9 o’clock position on the left. The goal is to create blebs that meet in the midline, akin to prostatic lateral lobes (Fig. 3.2). If there is any mucosal leakage of the injectable agent from a rent in the mucosa, which can be seen with a transurethral technique, the needle can be repositioned and agent reinjected. At this point, the patient is asked to valsalva to evaluate for SUI. If there is still SUI, more of the injectable agent may be injected. Once completed, the patient is asked to void and residual is checked. If in urinary retention, a small caliber catheter, 8 or 10 Fr., is inserted. A theoretical benefit of the periurethral technique is the avoidance of mucosal leakage and local bleeding that may occur with transurethral needle injection.
Bulking agent injection for SUI: The agent is injected in the 3 o’clock position on the right, followed by 9 o’clock position on the left. The goal is to create blebs that meet in the midline, akin to prostatic lateral lobes
The set up is quite similar to the periurethral approach. Local anesthesia may be instilled via the urethra. Needles specific to the injectable agent or generic needles may be used to inject transurethrally in the same locations described in the above section. A proposed advantage of this technique is better visualization of the injected material compared to the periurethral technique.
There have been many agents that have been used over the years as periurethral bulking materials. For the purposes of remaining current, the authors will review outcomes of bulking agents that are available at the time of publication of this text.
Macroplastique® (Uroplasty Inc, Minneapolis, MN) is a nonbiodegradable hydrogel composed of vulcanized polydimethylsiloxane elastomer suspended in a water-soluble carrier gel (polyvinylpyrrolidone). The agent does not require preadministration testing. The bulking agent can be administered with a 18 gauge endoscopic needle or a proprietary nonendoscopic transurethral injection device called the MIS (Macroplastique® Implantation System, Uroplasty Inc, Minneapolis, MN). The device is a mutichanneled needle positioning tool angled needle entry point with 6, 2, and 10 o’clock position. The typical volumes of injection are 2.5 ml, 1.5 ml, and 1.5 ml, respectively. There have been many studies reporting the success rates of Macroplastique. Most recently, there was a multicenter trial of 247 patients randomized to Macroplastique or Contigen® (collagen) (Bard Medical, Murray Hill, NJ). At 12 months follow-up, improved and dry/cure rates were 61.5 % and 36.9 % in patients injected with Macroplastique versus 48 % and 24.8 % in patients injected with Contigen.
Durasphere® (Boston Scientific, Natick, MA) is made of pyrolytic carbon-coated zirconium beads suspended in a water-based carrier gel composed of 2.8 % glucan. Due to concern for the potential of migration, Durasphere was designed with large-caliber particles (>80 m) in order to obviate this issue. There are 1 ml and 3 ml formulation. That having been said, there have been reports published on local periurethral and local lymphatic migration . The first generation of Durasphere was plagued by issues of difficulty with injection using a proprietary 18 gauge needle with standard endoscopic instruments. Dusrasphere EXP was developed, which included a reformulated carbon bead size and carrier gel to be injected with a customized, side-firing 18-gauge or 20-gauge needle. One of the larger randomized trials of 355 women compared Durasphere to bovine collagen. The study showed no significant difference in outcomes: 80.3 % treated with Durasphere and 69 % treated with collagen were improved by one or more continence grade at 12 months .
Coaptite® (Boston Scientific, Natick, MA) is composed of particles of calcium hydroxylapatite ranging in diameter from 75 to 125 μ suspended in an aqueous gel carrier composed of sodium carboxymethylcellulose and glycerin. There is a 1 ml formulation. The injection can be performed with standard endoscopic instruments with a supplied 21-gauge rigid injection needle, available in end-firing and side-firing capability. One of the largest multicenter randomized trials compared Coaptite to cross-linked collagen in 296 women. Patients treated with Coaptite had 63.4 %, versus 57 % of those treated with collagen, rate of improvement of 1 Stamey incontinence grade or more; this was statistically significant. The study also demonstrated that fewer patients treated with Coaptite required repeat injections compared to collagen patients, 62 % versus 74 % .
Complications have been reported in all injection agents currently available in the US market. Macroplastique adverse events have included dysuria (short-lived, self-limited), frequency, and hematuria in many patients. Urinary retention has been reported in 6–10 % of patients injected with Macroplastique . In addition to the common adverse events listed above for Macroplatique, Dursaphsere has been shown to result in noninfectious periuerthral abscess formation and urethral prolapsed . There have also been case reports of urethral prolapsed after Coaptite injection .
First introduced at the beginning of the twentieth century, the pubovaginal sling procedure has remained an excellent, viable option for the management of SUI. The materials used include both synthetic and biologic options. A common synthetic described in the literature is polypropylene. Biologic have included autografts (rectus fascia, fascia lata, and vaginal wall), allografts (fascia, dermis, and dura mater), and xeongrafts (procine or bovine). Although there are many published studies evaluating all of these options, autologous rectus fascia is the most commonly used approach and represents the greatest body of literature (this will be the focus of this section). Before the widespread application of the synthetic midurethral sling, pubovaginal slings were largely considered the gold standard of care for the management of SUI.
The patient is placed in a dorsal lithotomy position and the abdomen and vagina are prepped and draped in standard fashion. A transverse lower abdominal incision is made 2 cm above the pubic symphysis approximately 7 cm in length. Dissection is carried down to the rectus fascia, which is cleared of overlying fat. A 2 × 8 cm portion of the fascia is marked. The fascia is then harvested with either sharp or electrocautery dissection (Fig. 3.3a, b). Once the fascia is harvested, the defect is closed with 0 delayed absorbable suture. With a Foley catheter in place, the bladder neck is identified. A midline, vertical incision is made after the anterior vaginal wall is hydrodissected with a mixture of 1 % lidocaine with 1:200,000 epinephrine solution. A tunnel is then created to the retropubic space using sharp and blunt dissection. The dissection is carried to the level of the posterior rectus abdominis facsia. Pereyra needles are then passed suprapubically 2 cm on either side of the midline into the vaginal incision. A cystoscopy is performed with both 30 and 70° lenses to rule out injury to the urethra or bladder.
Pubovaginal sling: A 2 × 8 cm portion of the fascia is marked (a). The fascia is then harvested with either sharp or electrocautery dissection (b)
The harvested fascia is then prepared for implantation. 0 prolene sutures are placed on either side. The sutures are then placed through the eyelet of the Pereyra needles and brought through the abdominal wall bilaterally (Fig. 3.4a, b, c). The sutures are then tied over the abdominal wall (on top of one finger to avoid overtensioning). The anterior abdominal subcutaneous layer is closed with 2-0 absorbable suture and skin with 4-0 absorbable suture. The vaginal wall is closed with 2-0 absorbable suture. A vaginal packing is placed along with a 16 Fr. Foley catheter. The patient will have a voiding trial in 5–7 days. If there are elevated residuals (>150 ml), the patient will perform intermittent straight catheterization until her residuals return to normal.
Pubovaginal sling: the anterior vaginal wall dissection is performed (a). 0 prolene sutures are placed on either side (b). The sutures are then placed through the eylelet of the Pereyra needles and brought through the abdominal wall bilaterally (c)
The SISTeR trial was the largest randomized control trial reported in the literature evaluating the efficacy of autologous rectus fascia pubovaginal sling. The Urinary Incontinence Treatment Network (UITN) designed and executed this multicenter trial. The study, which consisted of 655 women, compared outcomes of patients randomized to autologous rectus fascial pubovaginal sling and Burch colposuspension. The success rates, defined as no self-reported symptoms of SUI, was higher in the pubovaginal sling group than the Burch colposuspension group, 66 % and 49 % respectively. This reached statistical significance with a P < 000.1. The same group went on to publish their 5-year follow-up data on 482 patients. The authors found that there were significant declines in continence in both groups.However, there were higher continence rates in the pubovaginal sling group compared to the Burch colposuspension group, 30.8 % and 24 % respectively (P = 0.002). Although patient satisfaction decreased for both groups, rates of patient satisfaction were still higher in the pubovaginal sling group compared to the Burch colposuspension group after 5 years, 83 % and 73 % respectively (P = 0.03) .
There are 14 other published RCTs looking at pubovaginal slings, a majority utilizing autologous rectus fascia. All consistently demonstrated the efficacy of the pubovaginal sling in the management of SUI. The pubovaginal sling has also seen another indication in light of recent complications noted with midurethral synthetic slings, namely lower urinary tract erosion . In addition, pubovaginal slings have become the transvaginal anti-incontinence procedure of choice for concomitant repairs of urethral diverticula and urethrovaginal fistulas .
There are known complications related to pubovaginal slings. Some common adverse events include urinary tract infections (UTI) (48 %), voiding dysfunction (14 %), and postoperative urge incontinence requiring treatment (27 %) . Of note, adverse events were more common in studies which used synthetic material for pubovaginal slings.
Midurethral Synthetic Slings
In 1995, Ulmsten first introduced the synthetic midurethral sling procedure . In the last 3 decades, this procedure has become the most commonly employed for the treatment of SUI . Proponents of this surgical option would argue the reason for this overwhelming popularity is due to short learning curve, brevity of the procedure, and low morbidity. In addition, there have been many studies that have demonstrated the excellent long-term durability and success rate of the procedure.
The first iteration of the technique was retropubic placement. This approach was based on the integral theory proposed by Ulmsten and Petros . The theory postulates that there are three structures (the pubourethral ligament, the suburethral vaginal hammock, and the pubococcygeus muscles) that, as a group, control the opening and closing of the bladder neck and urethra (Fig. 3.5). The goal of the was to retropubic placement of a synthetic sling was to reconstitute the suburethral vaginal support and the pubourethral ligament. A top-down and bottom-up approach has been described, which will be discussed in the next section.
The transobturator approach was introduced in 2001 in an attempt to reduce the risk of bladder, bowel, and vascular injury experienced with the retropubic approach. The mechanism of action of the procedure is based on Delancy’s “hammock theory” of SUI. The hammock theory postulates that a combination of urethral support and constriction are necessary for continence. It is the layers of facsia, muscles and vaginal wall that comprise this support and construction, according to the theory (Fig. 3.6). The transobturator synthetic sling placed in a horizontal plane provides the same support for the urethra during moments of increased abdominal pressure, thereby preventing incontinence. An out-in and in-out technique has been designed and utilized for the transobturator synthetic sling, also described in the following section.
Some examples of the top-down retropubic slings available in the United States include the Lynx® (Boston Scientific, Natick, MA) and SPARC® (American Medical Systems, Minnetonka, MN). The technique below applies for all top-down approaches, regardless of specific brand.
The patient is placed in a dorsal lithotomy position with legs in stirrups. The abdomen and vagina are prepped and draped in standard fashion. A 16 Fr. Foley catheter is placed and the bladder is drained. The anterior vaginal wall over the midurethral complex is hydrodissected using 1 % lidocaine diluted with 1:200,000 epinephrine. A 2 cm vertical midline incision is made in the anterior vaginal wall, approximately 1 cm from the urethral meatus. Suburethral pockets are created with sharp and blunt dissection, carried to the retropubic space. The trocars are placed bilaterally through stab incisions directly above the pubic symphysis, each one fingerbreadth lateral to the midline. The trocars are advanced into the vaginal incision (Fig. 3.7). The vaginal wall is evaluated for any perforation by the trocar. The Foley catheter is removed and a rigid cystoscopy is performed with 30 and 70° lenses. Once injury is ruled out, the 16 Fr. Foley catheter is replaced. The mesh is then attached to the trocars and the mesh is placed under the midurethral complex which is covered by a Kelly clamp. This prevents any tension while placing the mesh. Excess mesh is then excised. The stab incisions may be closed with a skin adhesive or 4-0 absorbable suture. The vaginal wall is then closed using 2-0 absorbable suture. A vaginal packing is placed. The patient can undergo a voiding trial in the recovery room.
Retropubic sling: top-down
Some examples of the bottom-up retropubic slings available in the US market include the TVT and TVT Advantage (Boston Scientific, Natick, MA). The technique below applies for all bottom-up approaches, regardless of specific brand.
The patient is placed in a dorsal lithotomy position with legs in stirrups. The abdomen and vagina are prepped and draped in standard fashion. A 16 Fr. Foley catheter is placed and the bladder is drained. The anterior vaginal wall over the midurethral complex is hydrodissected using 1 % lidocaine diluted with 1:200,000 epinephrine. A 1 cm vertical midline incision is made in the anterior vaginal wall, approximately 1 cm from the urethral meatus. Metzenbaum scissors are used to sharply dissect a tract in the direction of the retropubic space. Stab incisions are made 2.5 cm on either side of the midline at the level of the pubic symphysis (some surgeons will choose to hydrodissect through these incisions to aide with trocar placement). The Foley catheter is replaced with the catheter guide in the direction of the contraletral side to where the trocar will be placed. The trocars are placed one at a time through the vaginal incision into the suprapubic stab incision. The trocar is aimed towards the patient’s ipsilateral shoulder (Fig. 3.8). The vaginal wall is evaluated for any perforation by the trocar. The Foley catheter is removed and a rigid cystoscopy is performed with 30 and 70° lenses. Once injury is ruled out, the 16 Fr. Foley catheter is replaced. The mesh is then placed under the midurethral complex which is covered by a Kelly clamp. This prevents any tension while placing the mesh. Excess mesh is then excised. The stab incisions may be closed with a skin adhesive or 4-0 absorbable suture. The vaginal wall is then closed using 2-0 absorbable suture. A vaginal packing is placed. The patient can undergo a voiding trial in the recovery room.
Retropubic sling: bottom-up
Some examples of the out-in transobturator slings available in the US market include the Monarc® (American Medical Systems, Minnetonka, MN) and Aris® (Coloplast, Humblebaek, Denmark). The technique below applies for all out-in approaches, regardless of specific brand.
The patient is placed in a dorsal lithotomy position, legs in stirrups. The lower abdomen and vagina are prepped and draped in standard fashion. The anterior vaginal wall over the midurethral complex is hydrodissected with 1 % lidocaine diluted with 1:200,000 epinephrine. A vertical midline incision is made 1 cm from the urethral meatus 2 cm in length. Suburethral pockets are created with sharp and blunt dissection carried to the level of the obturator internus. Stab incisions are made in the inguinal groin crease at the level of the clitoral hood (two fingerbreadths inferior to the adductor longus tendon). The helical trocars are placed through the stab incision and advanced to the vaginal incision on both sides (Fig. 3.9). The vagina is inspected for any sign of perforation. The Foley catheter is removed and a rigid cystoscopy is performed with 30 and 70° lenses to rule out any injuries. The Foley catheter is then replaced, and the mesh is then attached and placed under the midurethra. A Kelly clamp is placed between the urethra and mesh to prevent tension. Excess mesh is excised. The stab incisions are closed with a skin adhesive or 4-0 absorbable suture. The vaginal wall is closed with 2-0 absorbable suture. A vaginal packing is placed. The patient undergoes a voiding trial in the recovery room.
Transobturator sling: out-in (Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography © 2005–2014. All Rights Reserved)
Some examples of the in-out transobturator slings available in the US market include the TVT-O and Abbrevo® (Ethicon, Blue Ash, OH). The technique below applies for all in-out approaches, regardless of specific brand.
The patient is placed in a dorsal lithotomy position, legs in stirrups. The lower abdomen and vagina are prepped and draped in standard fashion. The anterior vaginal wall over the midurethral complex is hydrodissected with 1 % lidocaine diluted with 1:200,000 epinephrine. A vertical midline incision is made 1 cm from the urethral meatus 1 cm in length. Stab incisions are made 2 cm lateral to the inguinal groin crease and 2 cm superior to the level of the clitoral hood. The helical trocars with mesh attached are placed with a guide and advanced to the groin incisions on both sides (Fig. 3.10). The vagina is inspected for any sign of perforation. The Foley catheter is removed and a rigid cystoscopy is performed with 30 and 70° lenses to rule out any injuries. The Foley catheter is then replaced, and the mesh positioned under the midurethra. A Kelly clamp is placed between the urethra and mesh to prevent tension. Excess mesh is excised. The stab incisions are closed with a skin adhesive or 4-0 absorbable suture. The vaginal wall is closed with 2-0 absorbable suture. A vaginal packing is placed. The patient undergoes a voiding trial in the recovery room.
Transobturator sling: in-out (Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography © 2005–2014. All Rights Reserved)
There have been many meta-analyses and systematic reviews reported in the literature evaluating outcomes of the different synthetic midurethral slings. In 2010, Novara et al. performed a systematic review and meta-analysis of the comparative data on Burch colpopsuspensions, pubovaginal slings, and midurethral synthetic slings. They found that patients with retropubic slings had higher continence rates compared to those treated with Burch colposuspensions. Retropubic slings and pubovaginal slings were similarly effective. Although objective cure rates were higher in retropubic slings compared to transobturator slings, there was no difference in subjective cure rates between the two .
Another meta-analysis conducted by Ogah et al. in 2009 reviewed 62 trials involving 7,101 patients who underwent synthetic midurethral sling for SUI. A subanalysis of eight RCTs comparing pubovaginal slings to synthetic midurethral slings demonstrated an equivalent subjective cure rate at 12 months follow-up (RR 1.03, 095 % CI 0.94–1.13). Six trials evaluated in this meta-analysis compared laparoscopic Burch colposuspensions to synthetic midurethral slings and found no difference in subjective cure rates at 12 months follow-up (80 % vs. 74 %) .
In terms of comparing retropubic versus transobturator, there have also been meta-analyses describing the outcomes based on these two different approaches. Novara et al. discovered that retropubic synthetic slings were associated with a higher objective cure rate when compared to transobturator synthetic slings (OR 0.8, 95 % CI 0.65–0.99) . Although, the same analysis found that the subjective cure rates were equivalent in both approaches. Ogah et al. also compared retropubic and transobturator slings and reported that subjective cure rates in both approaches were 83 %. In addition, even though the objective cure rates were statistically significantly greater in the retropubic versus transobturator groups, 88 % and 84 % respectively, the clinical significance could be argued .
There have also been RCTs comparing retropubic synthetic slings and transobturator slings. Richter et al. published their RCT of 587 women randomized to retropubic or transobturator synthetic sling for SUI. The retropubic group did demonstrate higher subjective performance compared to the transobturator group at 12 months follow-up. In addition, the objective success rate for the retropubic group was 80.8 % compared to 77.7 % in the transobturator group (3 % difference, 95 % CI 3.6–9.6).
The author continued this study with a 5-year Longitudinal follow up and found that long-term treatment success and satisfaction with retopublic and transobturator midurethral slings declined over time. They also reported that complications continued to rise. They demonstrated that women who underwent transobturator midurethral slings had more sustained improvement in urinary symptoms, quality of life and sexual function despite lower treatment success rates .
Taken in aggregate, the data suggest that retropubic synthetic slings have a slight edge on transobturator synthetic slings in terms of success rates. Of course, the complications do differ as will be discussed in the next section.
Complications stemming from placement of synthetic midurethral slings range from minor to major. Similar to vaginal mesh for prolapsed complications, these issues are typically codified to timing of complication: intraopertaive, early postoperative, or delayed postoperative.
Intraoperative complications include injury to the urethra, bladder, bowel, vascular structures, or vagina. Urethral injuries have been shown to be equivalent in retropubic and transobturator synthetic slings, 0.88 % and 1.09 % respectively . Bladder injuries have been reported as more common in retropubic synthetic slings compared to transobturator synthetic slings. In terms of bowel and vascular injury, no differences have been reported between retropubic and transobturator slings .
Early postoperative complications include voiding dysfunction, UTI, groin pain, and urinary retention. Retropubic synthetic slings have been shown to have higher rates of voding dysfunction and urinary retention compared to transobturator synthetic slings. Voiding dysfunction requiring surgical intervention has also been reported greater in retropubic versus transobturator synthetic slings, 2.7 % and 0 %, respectively. Groin pain is a complication more common in transobturator synthetic slings, reported as high as 8.2 % in some studies. Although suprapubic pain is more common in retropubic synthetic slings, the rates are low (1.7 %) .
Late postoperative complications include de novo voiding dysfunction and mesh extrusion/erosion. Similar to early voiding dysfunction, late de novo voiding dysfunction has also been reported to be more common in retropubic synthetic slings. Mesh extrusion/erosion rates have been equivalent for retropubic and synthetic slings .
Single-incision slings, or sometimes referred to as mini-slings, were introduced into the market with the purpose of minimizing morbidity and anesthetic requirements. There has been a paucity of literature on outcomes of this procedure. Some of the initial publications reported on devices that are no longer available in the market . The basic tenet of the procedure involves use of no external trocar, with the sling deployed with transvaginal trocar (Fig. 3.11). This section will discuss the current available devices and outcomes published on these currently practiced procedures.
Single-incision sling: Trocar with sling (MiniArc™ ; Used with permission of American Medical Systems, Minnetonka, MN, USA)
Some examples of the SISs available in the US market include the MiniArc™ (American Medical Systems, Minnetonka, MN), Altis® (Coloplast, Humlebaek, Denmark), and Ajust® (Bard Medical, Covington, GA). The technique below applies for all SIS approaches, regardless of specific brand.
The patient is placed in a dorsal lithotomy position, legs in stirrups. The lower abdomen and vagina are prepped and draped in standard fashion. The anterior vaginal wall over the midurethral complex is hydrodissected with 1 % lidocaine diluted with 1:200,000 epinephrine. A vertical midline incision is made 1 cm from the urethral meatus 1.5 cm in length. Suburethral pockets are created with sharp dissection carried to the level of the obturator internus. Push the first slip tip onto the curved needle. Advance the needle at a 45° angle on one side. Advance the needle into the obturator internus until the midline of the sling is over the midline of the urethra. Release the sling tip and remove the needle. Perform the same maneuver to place the other end of the sling into the contralateral obturator internus. Tension appropriately. (Some devices do differ with respect to method and device-specific aspects for this portion of the procedure.) Check both vaginal sulci to rule out mesh perforation. The Foley catheter is removed and a rigid cystoscopy is performed with 30 and 70° lenses to rule out any injuries. The vaginal wall is then closed with 2-0 absorbable suture.
There have been varying results reported for single-incision slings. Although the TVT-Secure (Gynecare) were among the first published, due to the fact that it is no longer available in the market, we will not discuss outcomes. The MiniArc™ (American Medical Systems, Minnetonka, MN) has had success rates reported between 77.8 % and 94 % at 12 months follow-up. A recent meta-analysis published by Abdel-Fattah in 2011 compared SIS to standard synthetic slings. A total of nine RCTs with 758 women were reviewed. In this review, although operative times and pain scores were significantly lower in the SIS group, the subjective and objective success rates were significantly lower when compared to standard synthetic slings (RR 0.83, 95 % CI 0.70–0.99 and RR 0.85, 95 % CI 0.74–0.97, respectively). There were also significantly higher rate of repeat continence surgery in the SIS group (RR 6.72, 95 % CI 2.39–18.89). Even though the SIS were found safe and somewhat efficacious, the conclusion was that they were inferior to standard synthetic slings.
The same approach to evaluation of complications that applies to standard slings applies to SIS. Adverse events include UTI (4.3 %), urinary retention (3.2 %), dyspareunia (2.1 %), and vaginal extrusion (1.6 %) . Despite the fact that complication rates for SIS have been comparable to standard slings, the FDA has requested postmarketing surveillance data from manufacturers of these devises to ensure safety and efficacy.
The surgical management of SUI options has evolved over the past few decades. The modern era of SUI management started with Burch colposuspensions and have slowly followed a path of less invasive options including periurethral bulking agents, pubovaginal slings, and the newest multitude of approaches for midurethral synthetic slings. The synthetic slings include retropubic, transobturator, and the newest additions which include so-called single-incision slings. As a result of this evolution, there are now many surgical procedures in the armamentarium of pelvic floor surgeons for treating SUI.
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