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

3. Retropubic Midurethral Synthetic Slings for Female Stress Urinary Incontinence

Oussama El Yazami Adli¹ and Jacques Corcos¹

(1)

Department of Urology, McGill University, Jewish General Hospital, 3755 Côte Sainte-Catherine Road, Montreal, QC, Canada, H3T 1E2

Jacques Corcos

Email: jcorcos@uro.jgh.mcgill.ca

Abstract

Female stress urinary incontinence (SUI), defined as involuntary leakage on effort, exertion, sneezing, or coughing (Urology, 61(1):37–49, 2003), is a prevalent condition with significant impact on patient quality of life (QoL). About 18.3 million American women suffered from urinary incontinence in 2010, and almost 50 % of them reported SUI as the primary or sole symptom, with a financial burden of over US $12 billion a year (Curr Urol Rep, 12(5):370–6, 2011; Obstet Gynecol, 114(6):1278–83, 2009). This number is expected to increase substantially as the population ages. Worldwide, the prevalence of female SUI ranges from 5 to 61 %, and its incidence is estimated to be 4–11 % per year (Int Urogynecol J, 22(2):127–35, 2011; Incontinence: Fourth International Consultation on Incontinence, Paris, France, Health Publications Ltd., 2009, 35–112). Tension-free vaginal tape (TVT^®; Gynecare, Ethicon, Somerville, NJ, USA) was the first retropubic midurethral synthetic sling (Int Urogynecol J, 7(2):81–6, 1996) proposed to address defective suburethral support, hypothesized to be responsible for the development of stress incontinence. Since then, the procedure has changed the perspective of SUI treatment and has become standard of care. It has several advantages, including a mini-invasive vaginal approach, short operation time, and hospital stay, combined with excellent short- and long-term results.

Female stress urinary incontinence (SUI), defined as involuntary leakage on effort, exertion, sneezing, or coughing [1], is a prevalent condition with significant impact on patient quality of life (QoL). About 18.3 million American women suffered from urinary incontinence in 2010, and almost 50 % of them reported SUI as the primary or sole symptom, with a financial burden of over US $12 billion a year [2, 3]. This number is expected to increase substantially as the population ages. Worldwide, the prevalence of female SUI ranges from 5 to 61 %, and its incidence is estimated to be 4–11 % per year [4, 5].

Tension-free vaginal tape (TVT^®; Gynecare, Ethicon, Somerville, NJ, USA) was the first retropubic midurethral synthetic sling (MUSS) [6] proposed to address defective suburethral support, hypothesized to be responsible for the development of stress incontinence. Since then, the procedure has changed the perspective of SUI treatment and has become standard of care. It has several advantages, including a mini-invasive vaginal approach, short operation time, and hospital stay, combined with excellent short- and long-term results.

Development of the TVT Procedure

The retropubic MUSS procedure was first based on the work of Petros and Ulmsten [7] describing the “integral theory” as the basis of female urinary continence during sudden increases in intra-abdominal pressure through the vaginal connective tissue and/or pelvic ligamentous support. In 1994, the “hammock theory” of DeLancey postulated the role of two elements, the sphincter and urethral support [8]. The supportive hammock under the urethra provides a firm backstop against which it is compressed during heightened abdominal pressure, preventing urine leakage.

Retropubic MUSSs (Fig. 3.1) reinforce urethral support at the level of the pubourethral ligaments. Sling placement at the midurethra enables dynamic urethral kinking when abdominal pressure is amplified and provides continence without affecting the bladder neck. This has been well-demonstrated in sonographic and dynamic magnetic resonance imaging studies [9, 10].

Fig. 3.1

Position of the retropubic tension-free vaginal tape

In its original description, the procedure involved sling positioning in a retrograde manner (bottom-to-top). Since then, several modifications have been made regarding trocar passage and sling composition.

Based on animal and clinical studies [11–14], most commercially available MUSSs nowadays are made from type I, macroporous, monofilament, uncoated mesh that is believed to be resistant to infection and inflammation (Table 3.1). Interestingly, in a randomized controlled trial (RCT) on 100 female SUI patients, Rechberger et al. [15] reported similar cure and complication rates with both monofilament and multifilament meshes up to 18 months, but published no long-term data.

Table 3.1

Commercially available retropubic slings

Brand	Approach	Material
TVT® (Gynecare, Ethicon, Somerville, NJ, USA)	Retrograde	Monofilament
Advantage® (Boston Scientific Corporation, Natick, MA, USA)	Retrograde	Monofilament
SPARC® (American Medical Systems, Minnetonka, MN, USA)	Antegrade	Monofilament
Lynx® (Boston Scientific)	Antegrade	Monofilament
Anterior intravaginal slingplasty (Tyco Healthcare LP, Norwalk, CT, USA)	Retrograde	Multifilament

Surgical Procedure

We first describe a surgical technique inspired by the original bottom-to-top procedure, with some minor changes. The top-to-bottom approach is addressed thereafter.

The TVT^® kit consists of two curved needles attached to a 1.1 × 40 cm polypropylene mesh sling sheathed in plastic, with a detachable handle to facilitate retropubic passage of the needles and a guide to rigidify the Foley catheter.

Although the original method emphasized the use of local anesthesia, most procedures are now performed under spinal or general anesthesia. Patients are placed in the dorsal supine lithotomy position, prepped and draped in a sterile manner. Perioperative broad spectrum antibiotics are administered, and appropriate anti-embolism precautions are taken, depending on hospital policy. An 18-Fr Foley catheter is placed in the urethra.

Local anesthetics are infiltrated vaginally (10 cc on the side of the urethra up to the urogenital diaphragm and 5 cc under the vaginal mucosa) prior to incision if the procedure is to be performed under local anesthesia. Anesthetics (20 cc) are injected in the suprapubic area as well as on each side of the planned skin incision site.

A 1.5-cm midline vaginal incision is made, starting 0.5 cm from the external meatus of the urethra. Blunt dissection with Metzembaum scissors is undertaken in the paraurethral area between the vaginal mucosa and the pubocervical, orienting towards the symphysis pubis. Special care must be taken to coagulate or compress any bleeding. Dissection is advanced as far as the subsymphysial space with scissors or finger through the incision.

The guide is placed in the Foley catheter which is tented towards the ipsilateral side of trocar passage to mobilize the bladder neck and proximal urethra away from the trocar path. The needle is secured to the handle, then placed within the paraurethral tunnel with the needle tip between the surgeon’s index finger in the vagina and the lower rim of the pubic ramus. Slow, controlled pressure is needed to bring the needle, oriented along the previously dissected path, through the urogenital diaphragm, the space of retzius and the rectus abdominal fascia, in close contact with the pubic bone, targeting the skin mark about 1 cm from midline above the pubis (Fig. 3.2a, b). The skin is then breached with a scalpel, and the needle is externalized. The same procedure is followed on the other side. At this point, cystoscopy is undertaken to ensure bladder integrity.

Fig. 3.2

Passage of the trocar in bottom-to-top fashion. (a) Schematic view of the path of passage from the vaginal incision through the urogenital diaphragm, the space of retzius, and the rectus abdominal fascia in close contact with the pubic bone and (b) perioperative view

The sling is positioned suburethrally by pulling on the threads and adjusted. The bladder is filled with 250–300 cc of saline, and a cough test is performed. The tape is tightened accordingly, until only a drop of saline is at the meatus. The Metzembaum scissors are then placed between the urethra and the tape to avoid over-adjustment, and the plastic sheet is removed. The tips of the sling are sectioned at the level of the skin and retracted from the cutaneous plane. Hemostasis is verified, and the vaginal incision is sutured. A vaginal gauze pad is left in the vagina for 24 h.

In the top-to-bottom approach, the suprapubic arc sling kit (SPARC^® American Medical Systems, Minnetonka, MN, USA) contains two needles that are smaller than TVT^® trocars. Prepubic incisions are first made 1 cm from midline on each side above the pubis, and the needles are passed from there onto the surgeon’s finger placed within the periurethral dissection. The mesh is attached to the needles by sliding dilating connectors and withdrawn from the prepubic incisions. It is tensioned similar to the bottom-to-top approach.

Results

Efficacy

TVT is the best studied and documented procedure among MUSSs. Table 3.2 summarizes the long-term outcome data. Cure rates up to 11.5 years are reported to be up to 90 % and are in the same order as those reported in initial, early trials [6], indicating effective maintenance over the years.

Table 3.2

Results of retropubic midurethral slings in the literature

Authors	Number of patients	Mean age at surgery	Recruitment criteria	Length of follow-up	Testing	Results	Notes
Nilsson et al. [16]	85	57	Primary SUI	5 years	Urodynamics	84.7 % cured
					QoL evaluation	10.6 % improved
						4.7 % failed
Rezapour and Ulmsten [17]	49	66	Stress incontinence and ISD	4 years	Urodynamics QoL evaluation	74 % cured	Failing patients were over 70 years old with severe ISD
						12 % improved
						14 % failed
Reich et al. [18]	108	63	Unselected group	7 years	Urodynamics	Objective cure rate: 89.8 %	Urge incontinence is the main reason for dissatisfaction after surgery
					QoL evaluation	Subjective cure rate: 82 %
						13 % improved
						4.6 % failed
Liapis et al. [19]	65	58.1	SUI with stage 1 cystocele	7 years	Urodynamics	Cure rate: 80 %
						Failure rate: 13.5 %
Song et al. [20]	306	50.7	SUI	7 years	Urodynamics QoL evaluation	Cure rate: 84.6 %	23.2 % had complications at 1-month follow-up after surgery
Groutz et al. [21]	52	62.4	Urodynamically confirmed SUI	10 years	Questionnaire	Subjective cure rate: 65 %	54 % of patients had concomitant UUI
						Improvement: 12 %
						Failure rate: 23 %
Serati et al. [22]	58	58	SUI without ISD or POP	10 years	Urodynamics	Objective cure rate: 93.1 %
						Subjective cure rate: 89.7 %
Abdul-Rahman et al. [23]	12	53.3	Neuropathic bladder dysfunction and SUI	10 years	Urodynamics (incontinence impact questionnaire)	7 patients cured	2 patients lost to follow-up at 10 years were continent at 5 years
						2 patients improved
						1 failed
Olsson et al. [24]	128	54.4	SUI	11.5 years	Stress test, 23-h pad test, questionnaire	Objective cure rate: 84 %
						Subjective cure rate: 77 %
						18 % improved
Nilsson et al. [25]	–	69	SUI	11 years	Urodynamics QoL evaluation	Objective cure rate: 90 %
						Subjective cure rate: 77 %

Comparison Between Retropubic MUSSs According to the Tape Placement Approach

Few RCTs comparing TVT^® with other retropubic MUSSs have been published. Comparison of different bottom-to-top slings has revealed no significant differences [26]. Andonian et al. [27] randomized 41 patients with SUI to either SPARC^® or TVT^® but did not find statistically significant differences in terms of cure rates and complications at 1-year follow-up. Lord et al. [28] and Tseng et al. [29] reported a higher cure rate and fewer short-term complications with the bottom-to-top compared to the top-to-bottom approach. Meta-analysis by Novara et al. [30] led to the conclusion that the bottom-to-top procedure was more efficacious than the top-to-bottom mode, and similar results were published recently by Ogah et al. [31]. The long-term follow-up data of Heidler et al. [32] seem to endorse this conclusion.

TVT Versus Other Procedures for the Treatment of Incontinence

Meta-analyses of available RCTs suggest that retropubic MUSSs outperform Bursh colposuspension in terms of postoperative cure rates, but colposuspension is associated with fewer perioperative complications, shorter indwelling catheter duration and less long-term voiding dysfunction [30, 33, 34]. Similar success rates have been reported for both TVT^® and fascial pubovaginal slings.

Comparison of retropubic and transobturator approaches reveals that both have globally similar postoperative outcomes. Sung et al. [35] and Long et al. [36] did not discern statistically significant differences in subjective cure or improvement rates, but the objective cure rate seemed to favor retropubic MUSS (88 % vs. 84 % for the transobturator approach) [31]. On the other hand, the transobturator route is linked with lower peri- and postoperative complication rates as well as shorter surgery time but with more frequent postoperative groin pain.

Minimally invasive, synthetic suburethral slings appear to be as effective as retropubic MUSSs in the short-term but with fewer postoperative complications (shorter operation time, less postoperative voiding dysfunction, and de novo urgency). However, quality of the evidence is insufficient because available trials and long-term data are lacking [31].

Complications

Perioperative and postoperative complications after retropubic MUSSs are rare. Table 3.3 summarizes the complication rate with the TVT^® procedure. The risk of intraoperative complications is not related to patient age, body mass index (BMI), or parity, but may be due to surgeon experience and previous prolapse or incontinence surgery [39, 40]. Long-term follow-up data do not disclose any signs of rejection or adverse tissue reactions to the polypropylene tape.

Table 3.3

Complication rates with the TVT procedure

Authors	Number of patients	Bladder injury	Bleeding	Voiding difficulties	De novo urgency	Hematoma	Urinary tract infections	Sling erosion/extrusion	Notes
Tamussino et al. [37]	2,795	2.70 %	2.30 %	Not reported	Not reported	0.67 %	17.0 %	Not reported	41 % of patients had concomitant surgery
Kuuva and Nilsson [38]	1,455	3.80 %	1.90 %	7.60 %	0.20 %	1.90 %	4.1 %	Not reported
Olsson et al. [24]	124	2.7	2.7	12.1 %	21.2	–	7.2 %	0
Kristensen et al. [39]	788	6.6 %	0.6 %	56 %	Not reported	0.8 %	3.1 %	Not reported
Pushkar et al. [40]	207	5.4 %	Not reported	5.9 %	8 %	9.1 %	Not reported	0.5 %
Tincello et al. [41]	437	2.1 %	1 %	2.1 %	3 %	2 %	1.9 %	1.5 %	1-year data
Lleberia-Juanos et al. [42]	243	6.2 %	1.6 %	13.2 %	24.7 %	Not reported	4.5 %	4.1 %
Serati et al. [22]	63	2 cases	0	0	18.9 %	Not reported	Not reported	Not reported	10-year data

Perioperative Complications

The bladder injury rate seems to be consistent in different series. Insufficient surgeon experience, previous incontinence, and pelvic surgery are independent risk factors for trocar injury [39], which should be promptly recognized on perioperative cystoscopy for correct application needle reinsertion. There is no need for primary closure or longer than usual bladder drainage, so that healing can take place without sequelae. Urethral injury is rare (less than 1 %) and should be repaired immediately [43].

Bowel injury is a rare complication that may occur during trocar passage in patients with a previous history of abdominal or pelvic surgery [44].

The incidence of vascular injury, estimated to be 2.7–6 % with the TVT^® procedure, is due to lack of direct pelvic vascular structure visualization during trocar passage. The risk can be minimized (but not entirely eliminated) by a good operating technique. Bleeding can be managed by vaginal packing or compression of the anterior vaginal wall directly against the symphysis pubis. Persistent bleeding indicates major vessel injury and warrants retropubic exploration.

Postoperative Complications

Voiding dysfunction may present as complete urinary retention, persistently elevated post-void residual (PVR) or bothersome and poorly characterized lower urinary tract symptoms with variable incidence, depending on its definition [45]. It may occur despite standard perioperative use of scissors contact to provide a space between the tape and the urethra. Preoperative voiding difficulties and concomitant prolapse surgery are independent risk factors for postoperative voiding problems [46]. In case of complete, immediate postoperative urinary retention, re-intervention within 48 h is strongly advocated to release tension. This procedure is easily performed under local anesthesia compared to delayed sling mobilization (after 3–4 days) which can prove to be extremely difficult. The options for patients with initially high PVR include long-term clean intermittent catheterization, suprapubic catheterization, and alpha-blocker pharmacotherapy. Insufficient improvement after 1 month should prompt transvaginal sling excision or urethrolysis, acknowledging the significant risk of recurrent SUI symptoms [45].

De novo urgency, with or without incontinence episodes, is a significant problem after all types of incontinence surgery. The incidence rate after retropubic MUSSs ranges from 4 to 33 % [34, 47–49], and the symptoms are reported to be as bothersome as preoperative SUI [50]. The origin of de novo urgency and its mechanism are unclear. Risk factors include old age, parity, history of cesarean section and recurrent urinary tract infections (UTI), elevated detrusor pressure over 15 cmH₂O during the filling phase, and maximal detrusor pressure (P_detmax) of less than 28 cmH₂O during the voiding phase on preoperative cystometry [51]. Antimuscarinics in this particular type of symptomatic DO seem to be less efficient in this than in idiopathic overactive bladder syndrome [34]. Urethrolysis with sling resection remains an option in the presence of obstruction.

The incidence of vaginal extrusion and urinary tract erosion is reported to be around 2 %. Interestingly, Nilsson et al. [25] did not encounter any cases of tape extrusion/erosion on 11-year patient follow-up. Extrusion may be related to poor surgical technique, infection, or physical properties of the implanted material [45]. Large extrusions should be managed by excision and removal of the extruded sling segment, but simple observation could be an option for nonsexually active patients with small extrusions. On the other hand, urinary tract erosion is confirmed by endoscopy and must be managed operatively by scissors or laser transection of the intraluminal portion of the sling or by an open technique.

The incidence of other complications, such as dyspareunia, is poorly documented, but must warn of possible sling extrusion. Surgical site infections are rare and occur mostly with multifilament meshes.

Special Considerations

Mixed Urinary Incontinence

Mixed urinary incontinence is defined as the involuntary loss of urine associated with the sensation of urgency and also with exertion, sneezing, or coughing [1]. Up to 80 % of patients diagnosed with SUI report mixed symptoms [49], and these women may be difficult to manage with conservative measures alone.

Several studies have described retropubic MUSS outcomes in patients, showing overall improvement of both stress and urge components [52–54]. Paick et al. [55] reported an overall cure rate of 81.9 % at mean follow-up of 10.9 months, and multivariate analysis disclosed that failure to cure urgency urinary incontinence was related to low maximum urethral closure pressure (MUCP) and the presence of uninhibited DO. Resolution of urodynamic DO after the retropubic MUSS procedure has been noted in 23–40 % of patients [56, 57]. Objective and subjective cure rates are encouraging in women with a predominant stress component and in those with equal urgency and stress incontinence than in subjects with predominant urgency [58]. In a systemic review of the published data, Jain et al. [59] found good cure rates of the stress component (85–97 %) and lower (30–85 %) and declining cure rates of urgency incontinence over time.

Intrinsic Sphincter Deficiency

Intrinsic sphincter deficiency (ISD), defined by objective urodynamic measurements of urethral function as MUCP of 20 cmH₂O or less, or Valsalva leak point pressure (VLPP) lower than 60 cmH₂O [60, 61], is associated with poor surgical outcome after urethral suspension procedures [62]. We strongly support the statement that, to a certain degree, ISD is always coupled with SUI.

Most studies of retropubic MUSSs excluded or contained small numbers of patients with ISD. Thus, fewer series are available for analysis. Overall, the retropubic approach is effective in treating SUI and ISD, although the cure rates are slightly lower than those of SUI without ISD. Rodriguez et al. [63] did not detect a significant impact of various VLPP values on TVT outcomes. Rezapour et al. [64], who reported 4-year follow-up of TVT in ISD patients, obtained objective and subjective cure rates of 74 % and improvement in 12 % of patients, which are lower than the cure rates of SUI without ISD. Multivariate analysis of several observational studies failed to demonstrate ISD as an independent risk factor for surgical failure. Some authors suggested that the coexistence of poor urethral mobility and ISD may be associated with a higher surgical failure rate [65]. The failure rate with retropubic MUSSs remains lower than with transobturator slings, as seen in two large, comparative, retrospective, and randomized controlled studies [66, 67]. Proper explanations remain unclear.

Recurrent SUI

Recurrent SUI may be related to the underlying mechanism in SUI (ISD) or inappropriate intraoperative tape adjustment. Management of these situations can be difficult. Clinical guidelines from the Society of Obstetricians and Gynaecologists of Canada call for conservative measures as the first-line modality in recurrent SUI [68]. However, such conclusions are mainly extrapolated from studies of primary SUI. Surgical options include bulking agents, abdominal urethropexy, artificial urinary sphincter (AUS), and repeat MUSSs. The success rate with bulking agents tends to decrease over time. The failure rate of Bursh colposuspension is 55 % in patients with recurrent ISD without urethral hypermobility. The cure rates of AUS in properly selected patients are reported to be 76–89 % [69–72].

Secondary retropubic MUSSs are associated with significant cure rates after retropubic or transobturator synthetic sling placement. Objective and subjective cure rates in retrospective and prospective studies varied between 77.4 % and 62 % after median follow-up of 19 and 40 months, respectively [73–75]. It is noteworthy that all these studies exclusively or predominantly recruited patients with ISD. The repeat retropubic approach is significantly more successful than the repeat transobturator procedure (71 % vs. 48 %) with no increase in the incidence of complications compared to primary surgery, except for de novo urgency (30 % vs. 14 %, p < 0.001).

Concomitant Pelvic Organ Orolapse Surgery

The TVT procedure is more easily undertaken with a vaginal Pelvic Organ Orolapse (POP) approach than with abdominal surgery. The sequence of MUSS placement depends on POP procedure, but the tape should be adjusted after its completion [76].

Despite limited follow-up in most published studies, the objective cure rate of urinary incontinence is between 84 and 94 % [77–80]. The question of whether or not to perform a TVT procedure for occult SUI at the time of prolapse surgery was addressed by Liang et al. [81] who reported a significantly higher rate of postoperative stress incontinence in women who did not undergo TVT^® vs. those who did (64 % vs. 10 %). In a Cochrane database review, Maher et al. [82] concluded that the addition of TVT to prolapse repair may reduce the incidence of postoperative urinary incontinence (relative risk 5.5, 95 % confidence interval 1.32–22.32), but needs to be balanced against possible differences in adverse effects.

Retropubic MUSS in Obese (BMI >30) and Elderly (>65-Year-Old) Women

Several small studies have evaluated the outcomes of retropubic MUSS procedures in overweight and obese patients. Killingsworth et al. [83] reported no differences in improvement or complication rates between normal, overweight (BMI 25–29.9), and obese patients at 12-month follow-up. In another retrospective investigation, obesity did not appear to influence the rate of bladder injury or urinary retention after TVT^® procedure [84]. On the other hand, in a study with median 5.7-year follow-up, Hellberg et al. [85] noted a decrease in the subjective cure rate between women with BMI less than 25 and those above 35 (81.2 % vs. 52.1 %). However, these obese patients were significantly older and more often suffered from diabetes mellitus and chronic bronchitis. There was no increase in the complication rate between patient groups, depending on the BMI.

As for age, older women are more prone to ISD and mixed urinary incontinence than younger women [86]. The retropubic MUSS procedure is associated with decreased cure rates in elderly patients. Jun et al. [87] observed a decline of cure and improvement rates in elderly patients (over 65 years old) vs. younger patients at median 48.8-month follow-up (66.7 % vs. 80.2 % and 3.3 % vs. 4.7 %). Hellberg et al. [85] compared patients older than 75 years with younger subjects. Older women more frequently had mixed urinary incontinence with inferior subjective cure rates than their younger counterparts (55.7 % vs. 79.7 %), and a higher failure rate for the stress component over urgency symptoms. Adjustment for previous vaginal repair, incontinence surgery, and history of recurrent UTI did not alter the lower odds ratios for cure in these women.

Conclusion

Retropubic MUSSs represent standard care in female SUI. The procedure has the advantage of minimally invasive surgery (short operation time, ambulatory surgery) with excellent objective and subjective cure rates in all groups of patients on long-term follow-up. The complication rate is low, provided the procedure is performed in a standardized manner.

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