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Current Obstetrics and Gynecology Reports

, Volume 2, Issue 3, pp 147–158 | Cite as

Recent Developments in the Surgical Management of Urinary Stress Incontinence

Urinary Incontinence and Pelvic Organ Prolapse (KL Noblett, Section Editor)
First Online:

Abstract

Surgical management continues to be the mainstay of treatment for patients with moderate to severe stress urinary incontinence who are nonresponsive to conservative measurements. In the past, the Burch colposuspension was considered the first line of treatment; however, since the introduction of mid-urethral slings in the mid 1990s the retropubic sling has become the “gold standard.” Tension-free vaginal tape (TVT) is the original retropubic procedure with good long-term efficacy and safety data available. However, in an attempt to decrease the risk of retropubic complications, such as vascular, bowel, or bladder injury, the transobturator and single incision mini-slings have been described. In this review, we give an overview on the recent data available on conventional anti-incontinence procedures as well as other more recently developed procedures. Recent studies with more than 10 years of follow-up continue to confirm the effectiveness of the TVT sling in the long-term, which the other approaches need to match.

Keywords

Stress urinary incontinence Surgery Surgical management Urinary incontinence Tension-free vaginal tape Anti-incontinence procedures 

Introduction

Stress urinary incontinence (SUI) is a common indication for surgery in women [1, 2]. Since the first introduction of the Kelly plication as anti-incontinence procedure in 1913, the surgical procedures have evolved over the decades. Following Petros’ integral theory based on Zacharin’s description of midurethral support by the pubourethral ligaments, anti-incontinence surgery has evolved from abdominal retropubic urethropexies (Burch colposuspension and Marshall-Marchetti-Krantz procedures), through the use of the autologous fascial slings (Aldridge and M’Guire pubovaginal sling), and needle procedures, described in the 1960s and 1970s, to the mid-urethra synthetic slings based on Petros and Ulsmten work in the 1990s. The original tension-free vaginal tape (TVT) sling was placed with trocars via the retropubic space; however, in an attempt to minimize the blind passage of the retropubic space and the subsequent risk of major bleeding and bladder injury, DeLorme described a transobturator passage through the obturator foramen. More recently, single-incision slings or mini-slings have been developed to eliminate the use of blind passage of trocars all together and minimize the risk of complications further [3, 4, 5]. In this manuscript, we will review recently published studies on the surgical treatment of SUI, retropubic, and obturator slings and the more recently introduced mini-slings.

Traditional Surgeries

For several decades, the pubovaginal sling and Burch colposuspension have been proven to be efficacious for SUI. Randomized trials in a Cochrane review have shown that Burch colposuspension is effective even in the long-term, with overall cure rates from 68.9-88% [6]. Open Burch colposuspension appears to be superior to anterior vaginal repair, needle suspension, and Marshall-Marchetti-Krantz procedure and to have similar success rates as the suburethral sling [6]. There were no differences in efficacy between open and laparoscopic colposuspensions [7]. In another Cochrane review, the pubovaginal sling was found to be more successful than open colposuspension and transurethral injection of bulking agents in the treatment of SUI and similar compared with retropubic mid-urethral sling (MUS) [8]. In a review by Novara et al. [9] of 39 RCTs, patients with Burch colposuspension had lower overall (p = 0.00009) and objective (p < 0.0001) cure rates than those with midurethral tapes (including both retropubic and transobturator), although they had a lower risk of bladder perforations (p = 0.00003). Patients undergoing pubovaginal slings and midurethral tapes had similar cure rates, but the former had a lower storage urinary tract symptoms (p = 0.04) and reoperation rate (p = 0.02). In terms of biological suburethral slings, autologous rectus fascia was found to be more effective than other biological materials, such as porcine dermis, lyophilised dura mater, fascia lata, vaginal wall, and autologous dermis. However, the long-term efficacy still needs to be determined. In a recent prospective cohort study of 357 SUI women by Brubaker et al. [10], 174 patients underwent a Burch colposuspension and 183 a fascial sling. In this study, the overall continence rate at 5 years follow-up was quite low in both methods with continence rates in the Burch and fascial sling of 24.1% and 30.8%, respectively, although most patients were satisfied with the results (73% in the Burch versus 83% in the sling groups).

The rates of adverse effects have been reported to be similar between Burch colposuspension and pubovaginal slings: 10% and 9% respectively. Compared with open Burch colposuspension, the pubovaginal sling was associated with fewer bladder perforations but longer indwelling catheter duration, more long-term voiding dysfunction, and an increase in the incidence of urinary tract infections. Generally, traditional pubovaginal slings are associated with higher adverse effects, such as longer operation time, more postoperative voiding dysfunction, and overactive bladder symptoms, than minimally invasive slings, such as retropubic TVT or transobturator tape (TOT) [8]. In a recent analysis of pubovaginal autologous fascia sling in 264 women with SUI, the most common complication was postoperative urgency, which was 18.5% [11].

There have been concerns that pregnancy and childbirth will negatively affect the outcome of SUI surgeries, and many surgeons recommend delaying surgery until the completion of childbearing. In 2010, a retrospective study described the results of 341 women of childbearing age followed for 5 years after pubovaginal sling [12]. In this study, nine women (7 normal vaginal deliveries and 2 cesareans) had another child. Using the Incontinence Symptom Index, the authors reported that five remained dry, three had no change in incontinence, and one had an increase in her symptomatology. Based on that study, the pubovaginal sling seems to be a durable option in women of childbearing age; however, this conclusion still needs caution as the number of analyzed subjects was small and follow-up was short-term.

Retropubic Midurethral Slings

Since its introduction, the TVT (Gynecare Ethicon Inc., Somerville, NJ) has become the “gold standard” treatment for SUI. The success rates appear to be comparative or superior to fascial slings or the Burch colposuspension [9]. Overall complications and morbidity are low with midurethral slings (MUS), most studies report a bladder injury around 6% and mesh exposure less than 1% [13, 14].

In the past 3 years, one multicenter, randomized, controlled trial and seven prospective cohort studies have been published analyzing the outcome of the retropubic/TVT procedures [13, 15, 16, 17, 18, 19, 20]. These published prospective studies of the retropubic TVT are of 30 to 173 women with 5 to 10 years follow-up (REFS). The overall subjective and objective cure rates were 89.8-93.1% and 59–89.7%, respectively (Table 1). The most common complications were de novo urgency or urgency urinary incontinence (18.9-42%), recurrent urinary tract infection (15%), and repeat surgery for SUI (4%-7.8%). Postoperative impaired emptying was a risk factor for long-term failure (odds ratio, 6.4; 95% confidence interval (CI), 1.3-30.1).
Table 1

Recent data on retropubic tension-free vaginal tape (TVT) procedure for the treatment of stress urinary incontinence

Reference

Year

Design

No. of subjects

Follow-up period

Procedure

Outcome measure

Results

Complications

Tincello et al. [13]

2011

Worldwide multicenter, prospective

1334 (TVT 32.8%; TVT-O 17.8%; TVT-Secur 49.4%)

1 y

TVT, TVT-O, TVT-Secur

Objective cure: standing cough stress test Subjective cure: I-QOL

High effectiveness of all 3 operations. Single-incision sling appeared to have efficacy similar to that of retropubic sling.

Bladder perforation: TVT > TVT-O, TVT-secur (2.1% vs. 0.4% vs. 0.1%) Urinary retention: 2.1% vs. 0.8% vs. 0.3% De novo OAB: 3% vs. 0 vs. 2.2% Groin pain: 0.4% vs. 1.6% vs. 0

Positive cough stress test: TVT-O < TVT, TVT-Secur (3.6% vs. 12.8% vs. 15.8%) I-QOL: no difference among three (85.4% vs. 79.0% vs. 85.2%) TVT-Secur: shortest operation time, lowest overnight stay, and rapid return to normal life

Serati et al. [16]

2012

Prospective

63

10 y

TVT

Subjective satisfaction and objective cure rate

Highly effective with high cure rate and low complications

De novo overactive bladder symptoms: 18.9% Intraoperative bladder perforation: 2 cases No severe bleeding and other complications

Subjective cure: 89.7% Objective cure: 93.1% Urodynamic cure: 91.4%

Glavind et al. [17]

2012

Prospective

173

5 y

TVT

International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

Slight subjective SUI deterioration, but ICIQ was unchanged

No rise in urgency urinary incontinence

Groutz et al. [18]

2011

Prospective

60 (initial) 52 available for follow-up (28(54%) concomitant urgency urinary incontinence)

10 y

TVT

Subjective outcome

Ten-year subjective outcome of retropubic TVT are less favorable than previously reported.

Urgency urinary incontinence (de novo one in 9): 22 (42%) Recurrent urinary tract infection: 8 (15%) Repeat TVT: 2 (4%)

Cure 65%; improved 12%; fail 23%

Postoperative impaired emptying was a risk for long-term failure. (odds ratio 6.4, 1.3-30.1)

Aigmueller et al. [19]

2011

Prospective

210 (initial); finally 141 available for follow-up

10 y

TVT

History, clinical exam, cystoscopy, urodynamic study, cough stress test, and incontinence outcome questionnaire

Satisfactory cure rates

Reoperation: 11 (7.8%) De novo urgency: 20%

Negative clinical stress test 84%; Slightly positive 8.5%; and strongly positive 4.3% Subjective cure 57%; improved 23%; unchanged 6.4%; and worse 11%

Obesity seemed to be a risk for failure.

Reich et al. [20]

2011

Prospective

108

102 m (median)

TVT

Subjective and objective cure rates

Good results more than 7 y

No late-onset adverse effects

Objective cure rate: 89.8% Subjective cure rate: 82.4% (13% improved; 2.8% unchanged; 1.8% impaired stress incontinence)

Urge incontinence was main reason for dissatisfaction with surgery.

However, it will be in the long-term results that all stress incontinence procedures will be compared and judged. In a long-term observational study by Olsson et al. [21] with follow-up of 11 years (138 months), the objective and subjective cure rates of TVT were 84% and 77%, and 94% of the patients were satisfied with the surgery. There were no late adverse effects. In a study by Nilsson et al. [22] looking at 17-year follow-up, they report that 48 of 55 (87.2%) of the women regarded themselves cured or significantly better than before surgery. Objective cure, defined as a negative stress test, was seen in 42 of 46 women (91.3%). Only one woman had a further stress incontinence procedure.

There is still debate on whether a synthetic polypropylene is superior to autologous or xenograft slings for suburethral support. In a recent RCT by Guerrero et al. [15], a total of 201 women with urodynamically proven stress urinary incontinence (USI) were randomized to one of three groups: TVT (N = 72); Pelvicol (porcine acellular collagen matrix, C. R. Bard Inc., Murray Hill, NJ; N = 50); and 79 patients to autologous fascial slings. At 1-year follow-up, the TVT and autologous fascial slings groups had better patient-reported improvement rates than Pelvicol (93%, 90%, and 61%; p < 0.001). There was no difference in the success rates between TVT and autologous fascial sling. Pelvicol had poorer dry rates (22%) than TVT (55%) and autologous fascial slings (48%; p = 0.001) at 1 year. Moreover, one in five women in the Pelvicol arm had further surgery for SUI within the 12 months follow-up compared with none in the other arms. The authors concluded that Pelvicol should not be recommended for the management of SUI. Contrary to this, Paparella et al. [23] found no differences between biological and synthetic materials for sling regarding objective and subjective cure rates and quality of life. In a randomized study with 70 patients assigned to UretexTO (polypropylene, C. R. Bard Inc.) or Pelvic Lace TO (porcine acellular collagen matrix, C. R. Bard Inc.) at 3-year follow-up, objective cure rates were 88.2% and 88.8% in UretexTO and PelviLaceTO arms, respectively. However, the overall evidence is that biological slings for SUI are not as effective long-term as synthetic nonabsorbable polypropylene slings.

Recently, there have been a number of studies of other retropubic MUS. Lim et al. [14] compared the Advantage sling (Boston Scientific) with the conventional TVT procedure. In this 4-year observational study, subjective cure rates were similar 83.3% for Advantage and 85.3% for TVT. There were no differences in complications (bladder injury, de novo urgency, urge incontinence, and voiding difficulties) between the Advantage and TVT groups.

Most retropubic slings are bottom-up procedures, yet a top-down approach also has been analyzed. The Suprapubic Arch Sling Procedure (SPARC) in an observational study by Heidler with a mean follow-up of 5.2 years reported an objective cure rate of 76% and a subjective cure rate of 52% [24]. The complications reported with this procedure were mild de novo urgency (10.9%) and erosion (2.2%).

Another study on an adjustable retropubic sling (the Remeex by Giberti) presented a patient-reported improvement of 86% and a 7% failure rate at 5 years follow-up [25]. Postoperative sling tension readjustment was performed in 7% of the patients. Complications reported were persistent urinary retention 10%, seroma 3%, and de novo urgency 7%.

Comparative Studies of TVT with the Transobturator Tape

The transobturator tape (TOT) avoids the retropubic space and therefore theoretically has less bladder, bowel, and blood vessel injuries compared with retropubic slings. However, the transobturator route is associated with an increased risk of groin and leg pain and a lower success rate in patients with intrinsic sphincter deficiency (ISD) [26]. In randomized and prospective studies reviewed [23, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54], there have been no differences in objective and subjective cure rates between retropubic and transobturator slings. The cure rate has been reported as 69.5-91.4%, yet most studies are considered short-term. The presence of pelvic organ prolapse and its correction did not significantly affect the cure rates [42]. In fact, a number of studies have shown that concomitant prolapse surgery decreases the likelihood of surgical failure after MUSs [55].

The debate regarding the efficacy of retropubic TVT versus TOT for women who have USI associated with ISD continues. In a randomized, controlled study of 164 women with ISD, Schierlitz et al. [26] found that the long-term cure rates for retropubic sling were higher than TOT at 3 years follow-up, 15 of the 75 (20%) women in the TOT group underwent repeat surgery to correct recurrent or persistent SUI compared with 1 of the 72 (1.4%) in the TVT group; the median time to repeat surgery 15.6 and 43.7 months for TOT and TVT respectively.

Richter et al. [43] in a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator MUSs in 565 women with stress incontinence found objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% at 12 months. They found no correlation between failure and valsalva leak point pressure or urethral closure pressure but said that the number of women with ISD was small.

Zhu et al. [56] compared the retropubic and transobturator approach and found that the transobturator approach was relatively safe for bladder injury and pelvic hematoma but had more postoperative pain. Other complications, such as mesh erosion, urinary tract infections, lower urinary tract symptoms, and recatheterization were similar between both routes. Comparing both transobturator routes, inside-out versus outside-in slings, there were no differences in objective and subjective SUI cure rates. Abdel-Fattah et al. [57] studied 46 women with recurrent SUI randomly assigned to undergo "inside-out" TVT-O or "outside-in" TOT-ARIS. The patient-reported success rate and objective cure rate were 69.6% and 76.5%, respectively, with no significant differences between the direction of insertion. A maximal urethral closure pressure of <30 cmH2O was the only independent risk factor for failure. Bladder and vaginal sulcus injury may be lower and groin pain higher in inside-out route.

Brubaker et al. [45] found over a period of 24 months that 42% (253/597) of all study participants experienced at least 1 adverse events. Seventy-five adverse events (20%) were classified as serious (serious adverse events), occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs. 20 events, respectively). Twenty-three (4%) women experienced mesh complications in both groups. Bladder perforations in the TVT group were related to surgical experience and were always successfully treated by overnight bladder drainage, whereas other complications, such as pain proved to be more long-term and problematic.

In summary, the mid-term data on transobturator slings presented similar efficacies with retropubic ones except for in cases of ISD. The long-term results are excellent for the TVT. The TOT is a popular procedure but has increased leg and groin pain, and a possible lower success in ISD SI, so we await the long-term success rate with interest.

Overactive Bladder Symptoms and Sexual Function after MUS

Postoperative urgency and urge incontinence are a common cause of dissatisfaction and failure after all forms of SUI surgery. These symptoms may have been present preoperatively (mixed incontinence) or occur for the first time following the procedure (de novo). In a large number of women with mixed stress incontinence and overactive bladder (OAB) symptoms, Lee et al. [58] found that urinary urgency persisted in 40% and urge incontinence in 32%. Coexistent detrusor overactivity, baseline symptom severity and age increased the risk of persistent urgency, while transobturator sling surgery and concomitant prolapse surgery decreased the risk. For urge incontinence, detrusor overactivity, baseline symptom severity, previous incontinence surgery increased the risk of persistence, whereas apical prolapse surgery decreased the risk. Women were more likely not to recommend surgery when they experienced persistent urgency (15.8% vs. 2.7%) or urgency urinary incontinence (24.7% vs. 2.9%). In another study by the same authors [59], de novo urgency occurred in 27.7% and urge incontinence occurred in 13.7% of women at long-term follow-up after MUS. De novo OAB symptoms were more common in women with previous ISD, previous stress incontinence surgery, colposuspension, previous prolapse surgery, and preexisting detrusor overactivity.

Palva et al. [28] evaluated the effect of MUS for SUI on urgency symptoms preoperatively and during 3-year follow-up. In the randomized study with 267 women (TVT-O, 131; TVT, 136), both methods were beneficial for urgency symptoms based on Detrusor Instability Score and Urogenital Distress Inventory-6 questionnaires. They concluded that MUS, both TVT and TVT-O, could be recommended in mixed urinary incontinence.

It should be noted that recently a variety of surgical modifications to improve the efficacy of TOT have been tried. In a prospective, randomized study, 463 patients with SUI were randomly allocated to treatment with a standard TOT or to a TOT with additional 2-point tape fixation [51]. Clinical efficacy of the procedure with fixation had a higher clinical efficacy. As a tape fixation, two additional polyglactin No. 1 sutures were placed parallel to the urethra 0.5 cm laterally on each side of the mid urethra, and between 1.0 and 1.5 cm from the external urethral meatus. The cured or improved rates at 12 months were greater with the fixation than with the standard sling (95.1% vs. 88.7%, p = 0.0169). The benefit of fixation was much higher in ISD (95.1% in the fixation vs. 73.8% in the standard method). Their idea was that the introduction of simple surgical modification during MUS procedure ensures proper tape positioning and eliminates an important risk factor for failure. In a study, the modified inside-out TVT-O procedure using a shorter, 12-cm tape without any perforation of the obturator membrane had a similar effectiveness with the original TVT-O method and less immediate postoperative groin pain [35]. A limited paraurethral dissection and a more medial trocar trajectory were helpful to reduce groin pain 24 hours after transobturator sling procedure [37]. A multicenter, prospective study using Transobturator adjustable (TOA, Agency for Medical Innovations, AMI, Feldkirch, Austria) showed a good cure rate of 84.4% at 6-week follow-up [36]. The tension could be readjusted with the TOA even postoperatively.

In a prospective comparative study by De Souza et al. [27] looking at sexual function at 6 months following a TVT or a Monarc procedures, overall sexual function was improved and this benefit was maintained at 12 months. Coital incontinence and fear of leakage were reduced in both groups and it was the reason for the improvement in sexual function; there was no change in dyspareunia or orgasm intensity pre- and postoperatively in either group.

However, in another study comparing retropubic, transobturator outside-in, and inside-out tension-free vaginal tape procedures, the outside-in transobturator sling had an increased de novo rate of female sexual dysfunction than the retropubic or inside-out transobturator ones at 12 months [40].

In a 7-year follow-up study comparing complications between retropubic and transobturator slings, transobturator tapes were less obstructive but were associated with more persistent pain, dyspareunia, and tape-related infections [60].

Single-incision Sling or Mini-sling

Synthetic MUS, such as the retropubic and transobturator slings, are now considered first line of surgical treatment for female SUI. In an attempt to decrease morbidity, a third-generation sling known as single-incision or mini-slings have been introduced (Table 2).
Table 2

Recent data on single-incision slings for the treatment of stress urinary incontinence. TVT, tension-free vaginal tape

Reference

Year

Design

No. of subjects

Follow up period

Procedure

Outcome measure

Results

Complications

Barber et al. [62]

2012

Randomized controlled trial, noninferiority study design

263 (mini-sling 136; TVT 127)

1 y

Mini-sling or retropubic TVT

Primary: subjective cure rate (Incontinence Severity Index and Pelvic Floor Distress Inventory-20) Secondary: complications, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Prolapse/Urinary Incontinence Sexual Questionnaire-12, and Patient Global Index of Improvement

The mini-sling had similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is higher with the mini-sling than with TVT. Subjective cure: mini-sling 55.8% vs TVT 60.6%

Intraoperative bladder injury: mini-sling < TVT (0.8% vs 4.8%) Long-term complications: no differences

Cornu et al. [63]

2010

Prospective

45

30.2 m (mean)

TVT-Secur

Pad count, bladder diary, clinical examination with stress test, Patient Global Impression Improvement scale, and evaluation of side effects

TVT-Secur had a high recurrence rate of SUI. Cure: 18 (40%) Improvement: 8 (18%) Failure: 19 (42%)

5 cases of de novo overactive bladder symptoms and 3 cases of urinary tract infection

De Ridder et al. [65]

2010

Retrospective, dual-center, cohort study

131 (Mini-Arc 75; Monarc 56)

1 y

Mini-Arc or Monarc

Cough stress test, daily pad use, Incontinence Impact Questionnaire short form-7, Urogenital Distress Inventory short form-6, and a 0–5 visual analog scale

At 1 year, 85% of the Mini-Arc group and 89% of the Monarc group (p = 0.6) maintained a negative cough stress test.

Similar complications

Kennelly et al. [66]

2012

Multi-center, prospective, single-arm, industrysponsored study

188

2 y

Mini-Arc

Subjective and objective efficacies via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements

Negative cough stress test and pad weight test: 84.5% and 80.1%, respectively Subjective cure rate: 92.9%

Urinary tract infection (4.8%), constipation (3.7%), and temporary urinary retention (3.2%) throughout the 2-year follow-up period

Basu et al. [67]

2010

Randomized trial

71 (Mini-Arc 37; TVT 33)

6 m

Mini-sling or Advantage retropubic TVT

Patient Global Impression of Improvement, King’s Health Questionnaire, dual-channel subtraction cystometry and pressure-flow studies

Compared to TVT, significantly greater rate of persistent stress incontinence symptom at 6 weeks (odds ratio (OR 9.49, 95% confidence interval CI 2.8–32.6) and 6 months (OR 8.14, 95% CI 2.7–24.7), and of urodynamic incontinence at 6 months (OR 7.58, 95% CI 2.7–24.7).

Similar complications

CI, confidence interval; OR, odds ratio

The first mini-sling introduced into the market in 2006 was the TVT-Secure (TVT-S; Gynecare). The TVT-Secure is a polypropylene mesh 8 x 1 cm, which does not require the use of blindly passed trocars through the retropubic or transobturator space. Theoretically, it eliminates the risk of trocar-related injury, such as vessel injury or bladder perforation. This mini-sling, just like the others, is placed through a single incision underneath the urethra and fixed to the obturator internus muscle and its fascia. Since its introduction into the market, a review of outcomes at 12 months reported a subjective cure rate of 76% using questionnaires or patient-reported outcomes and an objective cure rate defined as a negative cough test of 76% at 12 months [61]. More recently, a prospective multicenter RCT of 263 patients comparing the mini-sling to TVT found a similar subjective cure rate 55.8% versus 60.6% (p = 0.43) at 12 months [62]. However, another study of TVT Secur had only a 40% cure rate at 3 years [63].

The second single-incision sling to be introduced in the market was the Mini-Arc™ (American Medical Systems, Minnetonka, MN) in 2007. The Mini-Arc is an 8.5 x 1 cm monofilament polypropylene mesh that is anchored to the obturator internus muscle or membrane through a hook anchored bilaterally. As with other single-incision slings, the Mini-Arc must be placed firmly against the urethra. Previous studies suggest a success rate of 80% at 12 months follow-up [64, 65]. More recently one published prospective study and two prospective RCTs comparing Mini-Arc to other classical MUS were presented at the International Urogynecology Association Meeting in Brisbane 2012 and have provided more light on the debate. Kennelly reported that 84.5% of 142 patients presented a negative cough stress test at 24 months follow-up [66]. Lee et al. reported similar subjective and objective success rates between Mini-Arc and Monarc (92% vs. 94%, p = 0.54; and 73% vs. 77%, p = 0.91, respectively) in a cohort of 224 patients followed for 6 months. Basu et al. [67] in a RCT study of 71 patients with the Advantage TVT (Boston Scientific, Natick, MA) or the Mini-Arc single incision sling (American Medical Systems) found that 50% of the Mini-Arc reported persistence of SUI symptoms versus 9% in the Advantage TVT arm at 3 years follow-up. In this same cohort, 9 of 37 patients underwent a second anti-incontinence procedure during the 3 years all in the Mini-Arc group.

Many other single-incision slings have been studied recently and one of them is the SIMS-Ajust® (C. R. Bard Inc.) This is considered an adjustable single-incision sling. One end is fixed into the obturator internus muscle and membrane through a trocar-deployed hook. The counterpart end of the sling has a “pulley” system that allows the hook to be anchored, and the sling can then be adjusted to the surgeon’s preference. A recent prospective study involving 90 patients published in 2012 showed a patient-reported success of 80% at 12 months follow-up with no urinary tract injury or major hemorrhage [68].

A recent meta-analysis by Abdel-Fattah et al. [69] with a total of 758 women in nine RCTs showed that single-incision slings had a lower patient-reported and objective cure rates and higher reoperation rates for SUI on the short-term follow-up compared with MUS. In their study, single-incision slings were associated with lower cure rates at 6–12 months but were associated with shorter operative time, lower day 1 pain scores, and less postoperative groin pain. Repeat continence surgery and de novo urgency incontinence were more prevalent in the single-incision slings group.

In summary, the results for single-incision slings to date are inferior to conventional MUSs for the management of SUI despite some favorable clinical advantages, such as short operation time and less pain. We need to wait for the results of post-market analyses as US-FDA recommendation for these recently introduced single-incision slings [70].

Bulking Agents

Traditionally, urethral bulking agents have been used to treat stress incontinence, in medically unfit or elderly women or in patients with a bleeding tendency [71]. The simplicity and efficiency of TVT and other MUS have decreased the usage of the bulking agents as a first-line treatment of SUI [71]. Currently bulking agents are reserved for patients with SUI and ISD without urethral hypermobility, yet there is no absolute contraindication for bulking therapy. The ideal bulking agent would be one that is easy to apply, nonreabsorbable, noncarcinogenic, and nonallergenic. However, the ideal periurethral injecting material has not yet been identified. In a 12-month follow-up study with 514 elderly women with SUI, including mixed urinary incontinence, collagen (Contigen, Bard), hyaluronic acid (Zuidex, Q-Med), ethylene vinyl alcohol (Tegress, Bard), or polyacrylamide hydrogel (Bulkamid, Gynecare) were compared as bulking injectables [72]. At 12 months, the rate of negative pad test was 73.2% in the overall group and the complication was low for all agents (collagen 3.2%, ethylene vinyl alcohol 5.7%, hyaluronic acid 5.6%, polyacrylamide hydrogel 0%).

In a study of Macroplastique injection in 35 patients with SUI with ISD, it was shown to be effective and safe for SUI with or without a history of an anti-incontinence surgery [73]. Quality of life and Incontinence scores were improved. Side effects were rare. A recent Cochrane review by Kirchin et al. [74] extensively analyzed what materials would be optimal for bulking injection and how efficacious the bulking agents are. In their review with 14 randomized or quasi-randomized, controlled trials, including 2,004 women, 8 trials compared different agents with collagen among silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol, carbon spheres, and dextranomer hyaluronic acid. The authors concluded that no one compound was better than any others, but dextranomer hyaluronic acid was significantly associated with higher rates of injection site complications (16% vs. none with collagen; relative risk 37.78, 95% confidence interval 2.34-610). With regard to the efficacy compared with surgical treatments, two randomized trials should be reviewed. A study by Maher et al. [75] compared Macroplastique™ (Uroplasty Inc., Minneapolis, MN) (n = 23) with open pubovaginal sling (n = 22) for women with SUI plus ISD at mean 62-month follow-up. They showed that the satisfaction rates were similar between two groups with the objective success rate being greater (p < 0.001) following the sling (81% vs. 9%). However, because Macroplastique had lower morbidity, the authors retained the transurethral Macroplastique injection as an option in selected cases of SUI and ISD. The other trial by Corcos et al. [76] randomized 66 patients to collagen injection and 67 to surgery (6 needle bladder neck suspensions, 19 Burch, and 29 slings). The success rate, defined as having dry 24-hour pad test and no additional interventions, 12 months after collagen injections (53.1%) was lower than that after surgery (72.2%; p = 0.01) with no differences in quality of life score and patients' satisfaction. With the comparable subjective outcome, they concluded that collagen injections might be an alternative to surgery.

Where and how should the bulking agents be injected? Only RCT on mid-urethral injections of Zuidex-Implacer (Q-Med AB, Uppsala, Sweden) versus proximal urethral cystoscopic injections of Contigen (CR Bard, Covington, GA) in 344 women with ISD failed to report the conclusion because of the flawed study design with confounding multiple variables (material, site of placement, and injection technique), although the successful treatment (50% reduction in urinary leakage on provocation testing) was achieved in 84% of Contigen-treated women versus 65% of Zuidex-treated women [77]. One published RCT of 40 women with genuine stress incontinence (n = 36) or mixed incontinence (n = 4) comparing periurethral versus transurethral injection approaches showed that the subjectively improved rates of patients in the periurethral group were 52% and 37% at 6 and 12 months, and in the transurethral group, 30% and 36%, respectively [78]. Both periurethral and transurethral methods had an equal efficacy, even though the clinical outcome was poor in both methods (periurethral injection, 17% dry at 6 months, and 6% at 1 year; transurethral group, 17% and 18%).

In conclusion, bulking agents certainly have a place in the treatment of female stress incontinence; a lower effectiveness is counterbalanced by a lower morbidity making them an option in the elderly and infirm. More research is needed into materials, and injection methodologies of bulking agents.

Cell-based Therapy

As the etiology of SUI is the aging of or injury to urethral and paraurethral connective tissue and muscle, autologous stem cells potentially could be ideal material to restore function. Stem cells have the characteristics of self-renewing and multi-potency with the potential to develop into a variety of cell types to regenerate/repair a damaged urethral sphincter. So far, the cells used for injection in human studies have been autologous myoblasts with or without fibroblasts, muscle-derived stem cells, muscle-derived cells, and umbilical cord blood stem cells [79]. The reported success rates are 50-100%, although follow-up is short-term and less than 1 year [80, 81, 82]. A recent study of 12 women with severe SUI with fixed urethra and previous failed surgery showed that intrasphincteric injections of autologous progenitor muscular cells isolated from a biopsy of the deltoid muscle are feasible and safe as a second-line treatment [81]. In this study, 3 of 12 patients were dry at 12 months, 7 other patients were improved on pad test but not on voiding diary, and 2 patients were slightly worsened by the procedure. There was no immediate local complication due to injection and pain was moderate during the injection, which spontaneously resolved. In a 6-week study using autologous myoblasts isolated from a biceps muscle sample and postinjection electrical stimulation, intrasphincteric injection was found to be feasible and safe with the rates of cure and improvement at 13.5% and 78.4% [82].

Major concerns of cell-based therapy to date are carcinogenesis of stem cells and their cost-effectiveness. Despite considerable in vitro and in vivo animal research data, large randomized, comparative, clinical studies comparing to placebo injections to remove placebo and bulking effect and to conventional treatments, such as MUS, should be performed to investigate the effectiveness and safety. Nevertheless, stem cells have the potential to be a major step forward in clinical efficacy with potentially minimal risks.

Management of Recurrent SUI

The success rate of primary surgery for SUI is far from 100% and varies considerably with criteria used for the definition of success, as well as time of follow-up, so recurrence of SUI is inevitable for some patients. Risk factors for failure have been analyzed and were reported to be similar in the retropubic and transobturator MUSs. Stav et al. [55] studied 1,225 women following MUS; multivariate analysis revealed that body mass index >25 (odds ratio (OR), 2.9), mixed incontinence (OR, 2.4), previous continence surgery (OR, 2.2), ISD (OR, 1.9), and diabetes mellitus (OR, 1.8) are significant independent predictors for MUS failure. Concomitant prolapse surgery decreased the likelihood of surgical failure after MUS (OR, 0.6). Patient's age and the type of MUS were not found to be risk factors for surgical failure. Richter et al. [83] found risk factors for overall failure were previous SUI operation, Q-tip test less than 30 degrees, severity of urge symptoms, and a high preoperative pad weight.

Recently many procedures have been analyzed for recurrent SUI. These procedures include repeat retropubic and transobturator slings, Burch colposuspension, and less frequent procedures, such as bulking agents and spiral sling.

The reported cure rates of MUS following previous anti-incontinence procedures is 47-100% based on objective measurements, such as cough stress test or pad test [84, 85]. Retropubic MUS however have been shown to be more effective than transobturator slings for recurrent SUI in patients who have failed a previous transobturator sling in recurrent SUI associated with ISD and following a Burch colposuspension [86, 87].

Prior bulking agent does not appear to affect negatively future anti-incontinence surgery success. In a study by Koski et al. [88], patients with persistent SUI after a bulking injection were treated with pubovaginal slings or MUSs. The subjective cure rate was 60.5%.

In a retrospective study of 1,225 women who underwent a MUS procedure with a mean follow-up of 5 years, Stav et al. [87] reported a subjective success rate of 86% for primary sling versus 62% in the repeat-sling group (p <0.001). The repeat retropubic approach was significantly more successful than the repeat transobturator approach (71% vs. 48%, p = 0.04). The rates of intraoperative and postoperative complications were similar between the primary and the repeat groups. However, de novo urgency (30% vs. 14%, p <0.001) and de novo urge urinary incontinence (22% vs. 5%, p < 0.001) were more frequent in the repeat or second-sling group.

Shortening of the tape surgically was found to have a lower success rate in recurrent SUI rather than placing a second MUS (46.7% vs. 72.2%, p = 0.034, respectively) [89]. The second tape can be placed without removal of the previous tape.

Several readjustable slings, such as Remeex, Adjustable Continence Tape, and AMI sling, for recurrent SUI have been reported [90, 91, 92]. The cure rates were 68-87%, and the complications were minimal.

Artificial urinary sphincters have been used for many years but have high complication and reoperation rates and has little place even in recurrent SUI in women today [93]. Repeat synthetic MUS are likely to form the mainstay of secondary continence procedures presently. Based on recent data, medium-term cure rates are 60–70%, which is lower than that achieved with primary surgery [87, 93]. Including short- and long-term results, the cure rate of repeat surgery varies: 47-100% up to 12 years [84, 85]. Secondary transobturator sling appears inferior to secondary retropubic in women with ISD [93].

Conclusions

The MUS have been a major advance for the treatment of women with SUI. The TVT and other retropubic slings have excellent long-term effectiveness and may be the first option in patients with SUI associated with ISD and in recurrent SUI patients. In patients without ISD, the transobturator approach seems to be a feasible alternative and many gynecologists feel that it is a safer procedure in their hands. As more long-term data become available, single-incision slings also may become a viable alternative. However clinicians need to be cautious about trying new procedures with little safety or efficacy data. Bulking agents may be considered for women in medically poor condition or with recurrent USI or ISD, and is a safe procedure but frequently needs repeating. The Burch colposuspension and the autologous pubovaginal fascial sling procedures continue to have a role when combined with other abdominal surgery or where there is infection or allergy of polypropylene mesh. Mini-sling or stem cell injection therapy is promising, but we need to wait for more long-term efficacy and safety results.

Notes

Compliance with Ethics Guidelines

ᅟ

Conflict of Interest

The Department of Urogynecology received research grants from American Medical Systems (AMS) and Boston Scientific. Ki Hoon Ahn declares that he has no conflict of interest.

Julio Alvarez declares that he has no conflict of interest.

Peter L. Dwyer declares that he has no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.Department of UrogynaecologyMercy Hospital for WomenMelbourneAustralia
  2. 2.University of MelbourneMelbourneAustralia

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