This chapter should be cited as follows:
Mahoney, C, Smith, A, Glob. libr. women's med.,
(ISSN: 1756-2228) 2014; DOI 10.3843/GLOWM.10482
This chapter was last updated:
September 2014

Surgery for Stress Urinary Incontinence in Women

Charlotte Mahoney, MBChB MRCOG
Royal Lancaster Infirmary, University Hospitals Morecambe Bay Trust, Lancaster, UK
Anthony Smith, MBChB MD FRCOG
St Mary’s Hospital, Central Manchester Foundation Trust, Manchester, UK

INTRODUCTION

Stress urinary incontinence (SUI) is defined as the involuntary leakage of urine during any activity which increases intra-abdominal pressure, such as laughing, coughing, running, and for some women even walking.1 It is a common condition, affecting 1–3% of women under 60 and 5–11% of those over 60.2

SUI occurs as a result of anatomical defects in the structures supporting the urethra and bladder, or damage to nerves or muscles controlling urethral closure. The urethra is supported by the endopelvic fascia, which functions as a sling, compressing the urethra during episodes of increased intra-abdominal pressure. This endopelvic fascia is dependent on lateral support from the vaginal wall, arcus tendineus fasciae pelvis and levator ani muscles.3 When there is a defect in these supporting structures the endopelvic fascia fails and the compressive forces will be weakened. This leaves the urethra incompletely sealed during abdominal pressure rises and there is involuntary leakage of urine. SUI can therefore be caused by any condition which can weaken this supporting system, including childbirth, chronic cough, and connective tissue disease. The relative importance of the urethral support and the urethral muscles will vary from one woman to another.

During bladder filling and storage spinal sympathetic reflexes stimulate detrusor muscle relaxation and concomitant urethral muscle closure to maintain continence. This is assisted by the pudendal nerve control of the urethral sphincter. Nerve injury from pregnancy, childbirth, spinal trauma, or neuropathy from diabetes mellitus or multiple sclerosis to any of these neural pathways can result in SUI. Symptoms of SUI are often due to a combination of anatomic and neuromuscular defects. Surgical treatment can only improve the support of the urethra since it does not improve muscle or nerve function.

Surgical procedures to treat SUI were first described in the literature in the early 1900s, and have undergone significant change since then; some procedures have been simply modified, others abandoned entirely. Given the speed with which new procedures to treat SUI are developed and introduced into clinical practice, it is even more important that the modern Urogynecologist keeps abreast of the latest recommendations, emerging long-term complications and maintains a healthy level of caution for introducing new procedures without a robust evidence base.

 

Fig. 1 Graph to show change in surgical procedures over time4







 

 

This chapter discusses the different surgical treatment options in context of the evidence and national guidelines, the indications for each and relevant complication rates.

 

INITIAL ASSESSMENT

Prior to performing any surgical procedure, patients should be seen in the outpatient setting to take a detailed urogynecological history, including symptoms of urgency and stress incontinence, as well as pelvic organ prolapse (POP). It is also helpful to explore the presence of chronic conditions such as asthma, chronic obstructive airways disease or constipation which could exacerbate SUI. Patients should undergo an abdominal and pelvic examination to exclude a mass, assessment for POP using the pelvic organ prolapse quantification system (POP-Q).

Baseline investigations include urinalysis, post-void residual and a frequency-volume bladder diary. A symptom specific validated questionnaire such as the king’s health questionnaire (KHQ), Bristol female lower urinary tract symptoms questionnaire (BFLUTS), stress and urge incontinence quality of life questionnaire (SUIQQ) can be helpful to aid objective assessment of treatment success at a later date.5

The use of preoperative urodynamics studies (UDS) is currently a contentious issue due to a lack of large randomized controlled trials to establish their value. UDS are time-consuming, embarrassing for the patient and expensive. A Cochrane systematic review6 found that 17% of women undergoing UDS versus 3% of women with clinical assessment alone had their management plan changed (95% CI, 1.87–13.74). This did not lead to improved patient outcomes, with 37% of women with UDS versus 36% of women with clinical assessment alone reporting incontinence at 12 months (95% CI, 0.86–1.21). The review concluded that larger definitive trials were needed to determine the role of urodynamics.6 In a large adequately powered study Nager et al. showed that pr-operative UDS does not improve long-term outcomes in women with demonstrable SUI. Women were randomly assigned to office evaluation or office evaluation with UDS. Follow-up at one year by questionnaire showed 77% of patients in both groups were successfully treated (n=630), with no difference in adverse outcomes.7 NICE guidelines recommend that UDS is not required in women with SUI with no symptoms of overactive bladder or voiding dysfunction. Preoperative UDS are of value in the patient with mixed symptoms, POP or after failure of primary surgery.5

INDICATIONS FOR SURGERY

If conservative treatments fail then surgery may be appropriate. There are a variety of surgical treatments for SUI, and the surgeon and patient must choose which procedure suits the patient best. In order to do this, there are a number of factors to consider. The choice of approach may be influenced by the need for concomitant surgery, the skill and familiarity of the surgeon with a particular approach, whether this is a secondary procedure or there has been other previous vaginal or abdominal surgery. The patients background health will guide whether they will tolerate the type of anaesthetic required for the procedure.

Timing of surgery in women of childbearing age is difficult. There are no randomized controlled trials or large observational cohort studies following women who conceive after surgery for SUI, so there is limited evidence to recommend vaginal delivery or caesarean section after SUI surgery. One systematic review reported the incidence of postpartum SUI between 20 and 30% for vaginal delivery and 5 and 18% for cesarean section, with two women developing urinary retention antenatally.8 Overall, most surgeons would recommend postponing surgery until she has completed her family.

SLING PROCEDURES

Slings have been described in a variety of procedures since the 1900s. In essence, the sling operation aims to support the urethra and urethro-vesical junction, providing mechanical support and a higher urethral closure pressure, thereby reducing SUI.

A wide range of procedures have been reported, with each generation of procedure changing the type of approach as well as the sling material itself. Sling material has ranged from: autologous (fascia, dermis, and tendon), allograft (fascia, dermis, and dura), xenograft (porcine dermis, bovine pericardium and dura) and synthetic (macroporous, microporous, mono and multifilament). Furthermore, sling length has varied between studies from 20 to 3 cm.9

The changes in approach have often followed the availability of different sling materials, and some operations were adapted to incorporate the harvesting of autologous sling material through the primary skin incision. Over the years, the approach has included abdominal, abdominovaginal, laparoscopic and vaginal.

HISTORY OF SLINGS

Sling procedures were first described in 1907 by Giordiano, who used the gracilis to support the bladder neck. In 1910 Goebell used the pyramidalis muscles transposed through the retropubic space. By 1914 there was a further modification made by Frangenheim who incorporated the anterior abdominal fascia with the pyramidalis as the sling material, and modified yet further by Stoekel in 1917.10

Price described a sling made of fascia lata in 1933, which was passed beneath the urethra and attached to the anterior rectus fascia via the retropubic space. This procedure has had many minor modifications and is referred to as the Goebell-Stoekel-Frangenheim procedure. However, muscle grafts were abandoned due to difficulties with maintaining the blood and nerve supply, and thus viability of the graft.

The Aldridge procedure, first described in 1942, overcame this difficulty by utilising the rectus abdominis fascia as the sling material. This is harvested through an abdominal incision, with two lateral strips of fascia passed through the retropubic space and secured beneath the urethra. As such, the intrinsic blood and nerve supply to the graft remains intact, improving its viability.11 It did not become popular until 40 years later, after McGuire and Blaivas independently confirmed its efficacy.12, 13

The Aldridge procedure did not overcome all the difficulties encountered with autologous graft material (inadequate length, inherent poor quality of the material, and complications at the harvesting site), and so surgeons began using synthetic sling materials. This was first reported by Bracht in 1956, who used a Nylon sling.14 Other materials included Goretex, Mersilene and Silicone sheets. In a series of 12 cases reported in 1962, the use of Mersilene was associated with abscess formation, sinus tract formation and urethral trauma – however, the authors did not attribute this to the material itself but rather to the vaginal route.15

In 1985, Stanton described 30 cases where silastic sheets (silicone) were used as the sling material, cure rate was 83% objective and subjective.16 Horeback in 1988 used Goretex and reported similar cure rates of 85% objective and subjective.17

Ulmsten et al., introduced the tension free vaginal tape (TVT) in 1996.18 This has been followed by many commercial modifications of the original concept including a change in approach employing the transobturator route in addition to the retropubic approach.19

FASCIAL SLINGS

Both rectus fascia and fascia lata appear to have common properties. They are available in nearly all patients although the quality may vary and since they are autologous they are not rejected. There has been no scientific study of the biological processes which occur when these materials are used; some women replace the fascia with dense fibrosis whilst others produce minimal fibrosis. Harvest of either material requires additional tissue dissection or a second incision.

A randomized controlled trial in 2010 by Guerrero et al. compared the current gold standard of transvaginal tape (TVT) with porcine dermis (Pelvicol) and autologous rectal fascial sling (AFS) (n = 201). At 12 month follow-up subjective cure was 61% for porcine slings, 93% TVT’s and 90% for AFS (p <0.001 for porcine sling vs. TVT and porcine sling vs. AFS, p = 0.789 for TVT vs AFS, 95% CI). There was no significant difference between the three groups in terms of bladder injury (porcine sling 2%, TVT 5.5%, AFS 2.5%, p = 0.6386, 95% CI), blood transfusion (0% for all groups), intermittent self-catheterisation at six months (porcine sling and TVT 0%, AFS 1.4%, p = 0.450, 95% CI). The porcine sling demonstrated a statistically significant re-operation rate (porcine sling 19.5%, TVT and AFS 0%, p <0.0001, 95% CI). The authors found that operation time and length of hospital stay is longer with AFS than for the TVT; however in all other aspects they found the two to be equivalent.20

Two further small underpowered RCT’s are reported in the literature. Bai et al. compared TVT, open colposuspension, and AFS (n=145), with cure rates of 87%, 88% and 93% respectively at 12 months.21 The second study (n=53) reported cure rates of 92% for TVT and AFS at 6 months. Complication rates for TVT vs AFS were de novo detrusor overactivity (0% vs 0–4%), wound pain (7% vs. 28%) and urinary retention (13% vs. 7%).22

Both rectus fascia and fascia lata slings result in a similar incidence of de novo voiding symptoms postoperatively (0–27%). Other rare complications have resulted almost exclusively from excessive sling tension. Two cases of urethral erosion have been reported with rectus fascia and one case with fascia lata.23, 24, 25 Three cases of urethro-vaginal fistula were reported in early experience with fascia lata.26

Both rectus sheath fascia and fascia lata vary in quality on harvesting; it is not known how much this influences outcome. While harvesting fascia lata avoids a larger suprapubic incision, a change in patient position and an additional incision is necessary. Additionally, incisional leg pain and seroma formation are complications unique to fascia lata harvest. There is little documentation about the incidence of problems associated with harvesting autologous fascia.

In summary, rectus fascia and fascia lata slings are safe, associated with few complications and result in long term cure. On the available evidence they should be considered the “gold standard” of materials available for sling surgery. It should be noted, however, that this statement is made from level one/two evidence.

 

MID-URETHRAL SYNTHETIC SLINGS

Suburethral slings were first described in 199618 and have become the procedure of choice for SUI. The aim is to provide mechanical support in place of the deficient endopelvic fasica, which then closes the urethra during exertion and prevents involuntary leakage of urine.

There are three main types in use at this time, named according to the route of approach: the retropubic transvaginal tape (TVT), the transvaginal tape obturator (TVT-O), and the transobturator tape (TOT). Newer procedures have been described such as the single incision mini-sling, however, large randomized controlled trial data on long-term outcomes and complications are lacking and so for the time being these procedures should only be used in a research context or through submission of data to a national register.27 Over 40 variations of sub-urethral slings have been marketed often with little data to support their safety or efficacy. Clinicians should only use devices with robust evidence in routine clinical practice. The devices will often have different insertion mechanisms and different mesh material.

 

Retropubic approach

The retropubic approach involves blind insertion of two trochars into the retropubic space from the vagina to abdomen (bottom to top), or abdomen to vagina (top to bottom).

Fig. 2 Retropubic approach for mid-urethral sling (courtesy of Ethicon).

 

 

 

 

 

The most popular retropubic device is the original TVT which uses a bottom to top approach. It is a type one macroporous polypropylene mesh inserted via a small suburethral incision, blindly guided into the retropubic space using two trochars, and exits through two small skin incisions above the pubic rami. The most important part of the procedure is that the tape is left tension free underneath the urethra. It is advisable to perform a cystoscopy to exclude bladder perforation. It can be performed as a day case procedure under local, regional or general anaesthetic depending on the preference of the surgeon and patient.

There have been a number of randomized controlled trials comparing the TVT with no treatment, the TVT-O, TOT, and open and laparoscopic colposuspension. The UK and Ireland TVT group which compared TVT with a colposuspension,28 found the objective cure rate to be 66%, with 63% at 2 years (n = 344).28, 29 At 5-year follow-up subjective cure rates were 81% and 90% for TVT and colposuspension respectively (p = 0.21, Fisher's exact test, 95% CI).30 Reported complications included bladder injury 9%, wound infection 2%, UTI 22%, retropubic haematoma 2%, vascular injury 1% and tape erosion 1%.[27]

A Cochrane Systemic Review of suburethral slings reported at 12 months for the TVT a cure rate of 85% subjective, and 92% objective.31 Complications included infection, bleeding, pain, bladder perforation 4.7%, tape erosion 0.7%, voiding dysfunction 2.2%, and de novo urgency symptoms 10.3%.31

The top to bottom approach, e.g. SPARC is no longer recommended by NICE.5 This is supported by the Cochrane review on suburethral slings which evaluated both approaches and found the bottom to top approach to be superior. They reported a lower cure rate at 12 months for SPARC when compared to the TVT of 77% for subjective cure (RR 1.10, 95% CI 1.01–1.20), and 87% objective cure (RR 1.06, 95% CI 1.01 to 1.11), as well as significantly higher rates of bladder perforation 8.5% (RR 0.55, 95% CI 0.31–0.98), tape erosion 3.5% (RR 0.27, 95% CI 0.08–0.95), and voiding dysfunction (RR 0.40, 95% CI 0.18–0.90).31 It is now difficult to justify performing such a procedure in light of this evidence, particularly when the safer and more effective TVT is equally available and simple to perform.

 

Obturator approach

The obturator approach involves inserting the tape horizontally underneath the middle of the urethra between the two obturator foramulin, and through the obturator muscle. It can be from outside to inside (TOT) exiting through a midurethral vaginal incision, or from inside out (TVT-O) exiting through bilateral groin incisions. It is also performed as a day case procedure under local, regional or general anesthesia.

Fig. 3 Obturator approach for mid-urethral slings (courtesy of Ethicon).

 

 

 

 

 

The Cochrane review of suburethral slings (Ogah, 2009) performed a meta-analysis of four small studies evaluating the TOT versus TVT-O. The review found no difference between the TOT and the TVT-O in terms of subjective cure rate reported at 83% (RR 1.00, 95% CI 0.86–1.16), and objective cure rate reported as 84% (RR 0.95, 95% CI 0.86–1.04).31 The review also reported no difference between the TOT and TVT-O in complication rates. The obturator procedures do not enter the retropubic space, so the risk of bladder perforation is significantly lower at 0.3%, thus many surgeons do not routinely perform cystoscopy. Groin pain is a specific complication of the obturator approach, and estimates vary from 9% to 12%. Other complications include infection, bleeding, pain, tape erosion 1.3–6%, voiding dysfunction 4%, and de novo urgency symptoms 7%.31 Although none of the studies in the meta-analysis were adequately powered.

The evaluation of transobturator tapes (E-TOT) study was an adequately powered single blind randomized trial comparing the TOT and TVT-O (n = 341).32 This study found no difference in subjective cure rate for the TOT at 77.6% versus TVT-O at 81.2% (OR 1.25, 95% CI 0.71–2.20). Neither was there any difference in objective cure rate, TOT 88% and TVT-O 94% (OR 2.21, 95% CI 0.85–5.75). No major complications occurred with either arm. Apart from a higher rate of vaginal perforations with the TOT (p <0.001), there was no difference in complication rates between the two procedures.

 

Retropubic versus obturator

The retropubic route is associated with a marginally higher objective cure rate than the obturator route, 88% versus 84% (RR 0.96, 95% CI 0.93–0.99), but there is no significant difference in subjective cure between either approach, 83% (RR 1.00, 95% CI 0.96 –1.05). However, patients undergoing a TOT or TVT-O have less voiding dysfunction, blood loss, and shorter operating time, but higher levels of post-operative groin pain.31 Bladder perforation is also higher with the TVT, although this is clinically less significant, as it adds little to patient recovery time or duration of inpatient stay, and has no serious sequelae.

This is further supported by a prospective observational cohort study from the Norwegian National Incontinence Registry of 6232 women from 27 hospitals, who also reported a higher objective cure rate (TVT 89.5% vs TVT-O 83.6%, p<0.001; TVT vs. TOT 85.1%, p<0.011) but also a higher complication rate with the TVT procedure. However, contrary to previously published studies they found that subjective cure was also higher in the TVT group (TVT 83.4%, TVT-O 75.2%, p<0.001, TVT vs TOT 77.0%, p<0.002).33

 

Synthetic mesh

There has been some controversy regarding the use of mesh in surgery for SUI and POP in recent years, and it has been the subject of a large Federal Drugs Agency review. The FDA reported that serious complications such as erosion and shrinkage are not rare.34 Synthetic mesh is made of polypropylene or polyester and is classified as follows:

·         Type 1   Macroporous, pore size greater than 75 µm

·         Type 2   Microporous, pore size less than 10 µm

·         Type 3   Macroporous, with multifilamentous or microporous components

·         Type 4   Super microporous, pore size less than 1 µm35

In order to reduce mesh related complications, the current recommendation is to use a low weight, macroporous, inert, monofilament mesh with elasticity between 20 and 35%.36 All tapes for synthetic suburethral sling procedures should therefore be made of a type 1 mesh.

BIOLOGICAL SLINGS

Biological slings, also referred to as traditional slings have been mainly superceeded by the synthetic suburethral sling procedures in recent years. Sling material can originate from a number of areas: rectus fascia, fascia lata, dura or very rarely porcine skin. Due to harvesting of the sling tissue from another location, a general or regional anaesthetic is required. A suburethral incision is made and a plane dissected from either side along the retropubic space to the pubic crest. If the tissue comes from the rectus sheath (the Aldridge procedure), a curved clamp is passed along the now dissected retropubic space, the sheath grasped abdominally and pulled down underneath the urethra. The rectus sheath sling from either side is then sutured together underneath the urethra and the incisions closed.37

Continence rates vary from 73–77% for autologous and 71–74% for allograft material.38 Reported complications include sling failure, haemorrhage, infection 6%, persistent thigh pain 11%, POP 1%, voiding dysfunction 4–7%, UTI 27%, and lower extremity neuropathy.5

 

Biological slings versus synthetic suburethral tapes

Biological slings are equal to synthetic slings in terms of efficacy in the short term (RR 0.97, 95% CI 0.78–1.20), and medium to long-term (RR 1.23, 95% CI 0.91–1.66). However minimally invasive synthetic slings have a shorter operating time, fewer perioperative complications apart from bladder perforation, less voiding dysfunction and de novo detrusor overactivity.39

 

COLPOSUSPENSION

The Burch colposuspension was first described in 1961.40 It involves suturing the retropubic paravesical tissues to the ileopectineal ligament of the pelvic sidewall and is usually performed through a low Pfannenstiel incision.37

 

Fig. 4 Pelvic anatomy as it relates to colposuspension41

               

 

 

 

 

 

A Cochrane review of open colposuspension (Lapitan, 2012) evaluated 53 trials involving 5244 women. Overall cure rates ranged from 85% to 90% within the first 12 months, falling to 70% at five years. Complications include wound infection 7%, UTI 32%, bleeding, pain, bladder injury 2%, DVT 2%, de novo detrusor overactivity 13%, voiding difficulties, incisional hernia 2%, and injury to abdominal structures.28, 31 The rate of developing post-operative POP in the longer-term is significantly higher at 9%, compared to 0.5% for the TVT (RR 8.18; 95% CI 1.96–34.19).42 It has been reported in up to 25% women.

Other colposuspension procedures such as the Marshall-Marchetti-Kranz and the paravaginal defect repair are no longer recommended in the surgical treatment of SUI (discussed further below).5, 9

 

Colposuspension versus synthetic midurethral tapes

A Cochrane meta-analysis of five trials comparing the TVT and open colposuspension found no difference in subjective cure at 12 months (RR 0.88; 95% CI 0.67–1.16). Two trials performed follow-up at 2 years, again these did not show any significant difference between the TVT and open colposuspension groups (RR 1.11, 95% CI 0.91–1.34), neither did follow-up of the same cohort at 5 years (RR 0.91, 95% CI 0.74–1.12).29, 30, 31 Further meta-analysis for objective cure also found no difference within 1 year (RR 1.21; 95% CI 0.84–1.75), 1–5 years (RR 1.12; 95% CI 0.82–1.54) and more than 5 years (RR 0.70; 95% CI 0.30–1.64).42

 

Laparoscopic colposuspension

The laparoscopic procedure also inserts sutures from the retropubic paravesical tissues into the ileopectineal ligaments. It allows the option to perform the procedure by the transperitoneal or extraperitoneal route, using mesh, staples or a variety of sutures and to vary the site of the anchor. Depending on the skill and experience of the surgeon, operating time for the laparoscopic approach is typically longer than for the open procedure. However, duration of hospital stay is shorter, with less perioperative complications 12%, and postoperative pain.43 As with open colposuspension, other complications include de novo detrusor overactivity 11%, voiding difficulties 9%, and new or recurrent POP 11%.

Studies have shown that at least two paravaginal sutures each side is required, with an 89% subjective cure in the two suture group, compared to 65% for one suture (RR 1.37, 95% CI 1.14–1.64); and an 85% objective cure compared to 58% (RR 1.42, 95% CI 1.14–1.77). Sutures are also better than mesh and staples for subjective (RR 1.28, 95% CI 1.11–1.47) and objective cure (RR 1.20, 95% CI 1.07–1.35).43

 

Laparoscopic versus open

To date, the majority of randomized trials comparing laparoscopic colposuspension with suburethral sling procedures and open colposuspension have been underpowered. Subsequent metanalysis of subjective cure found there to be no significant difference between laparoscopic and open colposuspension at 12 months (RR 0.97; 95% CI 0.79–1.18). At 1–5 years there was a trend towards favoring open colposuspension, but this was not statistically significant (RR 0.88; 95% CI 0.75–1.03).43

One longitudinal cohort study has reported on the 10 year outcomes of laparoscopic versus open colposuspension and found no difference in subjective cure rates at 6 months (laparoscopic 71%, open 67%, p = 0.669), 2 years (laparoscopic 58%, open 50%, p = 0.364), and 10 years (laparoscopic 48%, open 32%, p = 0.307).44

 

Laparoscopic versus synthetic suburethral tapes

The Cochrane review also evaluated laparoscopic colposuspension against the TVT. They found no significant difference in subjective cure (RR 0.91, 95% CI 0.80–1.02) at 18 months or at long-term follow-up of 4–8 years (RR 1.18, 95% CI 0.36–3.81).

Further analysis showed there to be no difference in perioperative complications, de novo detrusor overactivity or voiding dysfunction. The procedural costs appeared to be similar, but laparoscopy had a longer operating time, duration of hospital stay, and recovery time. As such current recommendation is that laparoscopic colposuspension is not performed as a first line procedure where suburethral tapes are available. This may change in the future with the advent of expected as well as unforeseen mesh complications on long-term follow-up.

 

INTRAMURAL BULKING AGENTS

Intramural bulking agents work by increasing the volume of the urethral wall, thus increasing the force with which the urethra closes. Typically, the fluid is injected directly into the submucosa of the proximal or mid-urethra. The procedure is usually performed under local anaesthesia. The agent can be made of silicone, carbon-coated zirconium beads or hyaluronic acid/dextran copolymer. Bulking with collagen is no longer available. It is common to require repeat injections as efficacy deteriorates over time.

Objective cure ranges from 48 to 59%. Complications are usually transient and include dysuria 90%, hematuria 58%, frequency 74%, acute retention 11% and UTI 6%.5 Abscess formation has been reported. Whilst bulking agents may be put forward as a treatment with low risk it cannot be said that there is no risk with this form of treatment and alternative treatments may be compromised if they are required.

 

Bulking agents versus synthetic tapes

The cure rate from bulking agents is inferior to suburethral synthetic tape procedures.5 Bulking agents are usually selected by patients who have other co-morbidities or who wish to have a less invasive treatment with the understanding that the chance of cure is lower than with slings or colposuspension. The role of bulking agents in patients who have had a sling and have a well supported urethra is not well defined but theoretically it is logical to employ a bulking agent in this situation.

 

ARTIFICIAL URINARY SPHINCTER

The artificial sphincter is a device which is placed circumferentially around the bladder neck and this is linked to a pressure balloon implanted in the labia. When inflated the sphincter maintains a constant pressure around the urethra, preventing the involuntary leakage of urine. If the woman wishes to pass urine she deflates the cuff manually by pressing on the balloon pump, once she has finished, the cuff reinflates automatically via the pump.

This procedure is typically performed in specialist centers, usually after conservative and routine first-line surgery has failed. It is particularly useful for patients with neuropathic SUI.5 Cure rates between 84% and 100% have been reported, although there is a high rate of device failure and revision procedures. There is little robust data to support the high success rate reported by a few protagonist centers.

OPERATIONS THAT SHOULD NOT BE CONSIDERED A TREATMENT FOR SUI – ALL NICE AND ICS

Certain operations are no longer recommended by NICE or the International Continence Society, either because they have been shown to be ineffective or simply become outmoded by newer less dangerous and simpler procedures.

Anterior colporrhaphy

This falls under the ineffective category The procedure is described in different ways but essentially involves plicating the fascia under the urethra (and possibly bladder base too) to stabilize the support of the urethra. Whilst the procedure may be effective in the short term, the long term results are poor.

Paravaginal repair

There has been only one inadequately powered study evaluating the paravaginal repair with Burch colposuspension. At 2 year follow-up the objective cure (100% colposuspension versus 61% paravaginal repair, p <0.004) and subjective cure (100% colposuspension versus 72% paravaginal repair, p <0.004) were significantly higher in the colposuspension group. The ICS group also compared this study with the limited case series available and concluded that paravaginal repair is less effective than colposuspension.9

Transvaginal needle suspension

Bladder neck needle suspension procedures were initially created for those women who were unsuitable to undergo an abdominal colposuspension, typically in frail or elderly women, with previous surgery or radiotherapy. They are less effective that the Burch colposuspension, which in turn is as effective as the TVT. It is now difficult to justify performing this procedure when the same patient would be suitable for a less invasive and more successful TVT.9

Marshall Marchetti Kranz

Another earlier version of retropubic colopsuspension, this operation attaches the vesico-urethral junction to the periosteum of the symphysis pubis. Longer-term outcomes suggest it is less effective than the Burch colposuspension and should not be performed in preference to the Burch procedure.9 It has been associated with the development of osteitis pubis.

 

SECONDARY PROCEDURES

A woman attending with symptoms following a primary procedure, either from failed primary surgery or recurrence of symptoms, should be seen by a urogynecology sub-specialist or urologist with a sub-specialty interest. In order to ensure she receives the best care, it is appropriate that the surgeon manages over 20 of these cases annually.

A detailed assessment is required, including urodynamic studies and imaging of the urethrovesical anatomy. The aim of the investigations is to ascertain whether the support provided by the original surgery has failed or whether there is another cause of the incontinence such as severe urethral sphincter weakness or detrusor overactivity.5

Management includes a review of conservative treatments, including weight loss and smoking cessation. Surgical options depend on patient and surgeon preference and skill but can include a repeat tape procedure, fascial sling or colposuspension. Continence rates for secondary procedures are difficult to quantify accurately as there are no comparative studies at present, therefore all data that follows are from case series.

Repeat tape procedures provide a continence rate ranging from 54% to 84%,45, 46, 47, 48, 49, 50 laparoscopic colposuspension 55%,51 open colposuspension 77%,52 bulking agents 35%,53 and tape shortening 47% to 71%.46, 54

 

 

 

CONCLUSION

Stress incontinence is a common condition affecting one in ten women over the age of 60 years. A wide range of surgical procedures have been described for the treatment of stress incontinence, including sling procedures with fascia or mesh, laparoscopic and open suspension of the bladder neck, bulking agents and specialist artificial urinary sphincters. The choice of operation is dependent on surgical skill and training, resources and patient preference. Historically, new surgical procedures for the treatment of stress incontinence have been quickly adopted into clinical practice, often without a robust evidence base. Given the emerging mesh complications of recent years, caution is advised when considering changing practice outside of a research context without long-term follow up data.

REFERENCES

1

Haylen B, de Ridder D, Freeman D, et al. An International Urogynaecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. International Urogynaecological Journal. 2010; 21: p. 5-26.

 

2

Milsom I, Altman D, Lapitan M, et al. Epidemiology of Urinary (UI) and Faecal (FI) Incontinence and Pelvic Organ Prolapse (POP). In Abrams P, Cardozo L, Khoury S, et al , editors. Incontinence: 4th International Consultation on Incontience. Paris: Health Publication Ltd; 2009. p. 35-112.

 

3

DeLancey J. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Americal Journal of Obstetrics and Gynecology. 1994; 170(6): p. 1713.

 

4

Hilton P. Commentary: Long-term follow-up studies in pelvic floor dysfunction: the Holy Grail or realistic aim? BJOG. 2008; 115(2): p. 135-142.

 

5

National Institute for Clinical Excellence. Urinary Incontinence in Women. Clinical Guideline (CG 171). London: National Institute for Clinical Excellence; 2013.

 

6

Clement K, Lapitan M, Omar M, et al. Urodynamic studies for management of urinary incontinence in children and adults. Cochrane Database of Systematic Reviews. 2013;(10).

 

7

Nager C, Brubaker L, Litman H, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. New England Journal of Medicine. 2012; 366(21): p. 1987-97.

 

8

Pollard M, Morrisroe S, Anger J. Outcomes of pregnancy following surgery for stress urinary incontinence: a systematic review. Journal of Urology. 2012 June; 187(6): p. 1966-70.

 

9

Smith A, Dmochowski R, Hilton P, et al. Surgery for urinary incontience in women. In Abrams P, Cardozo L, Khoury S, et al , editors. Incontience: 4th International Consultation on Incontinence. Paris: Health Publication Ltd; 2009. p. 1191-1272.

 

10

Bent A. Sling and Bulking Agent Placement Procedures. Reviews in Urology. 2004; 6(5): p. 26-46.

 

11

Aldridge A. Transplatation of fascia for relief of urinary stress incontinence. American Journal Obstetrics and Gynaecology. 1942; 44: p. 398-411.

 

12

McGuire E, Lytton B. Pubovaginal sling procedure for stress incontinence. Journal of Urology. 1978; 119(1): p. 82-84.

 

13

Blaivas J, Jacobs B. Pubovaginal fascial sling for the treatment of complicated stress urinary incontinence. Journal of Urology. 1991; 145(6): p. 1214-8.

 

14

Kohli N, Karram M. Surgery for genuine stress incontinence. In Urogynaecology and Reconstructive Pelvic Surgery. 2nd ed. St Louis: Mosby; 1999. p. 178.

 

15

Williams T, TeLinde R. The sling operation for urinary incontinence using Mersilene ribbon. Obstetrics and Gynecology. 1962; 19: p. 241.

 

16

Stanton S, Brindley G, Holmes D. Silastic sling for urethral sphincter incompetence in women. British Journal of Obsetrics and Gynaecology. 1985; 92: p. 747

 

17

Horback N, Blanco J, Ostergard D. A suburethral sling with polytetrafluoroethylene for the treatment of genuine stress incontinence in patients with low closure pressure. Obstetrics and Gynecology. 1988; 71: p. 648.

 

18

Ulmsten U, Henriksson L, Johnson P, et al. An Ambulatory Surgical Procedure Under Local Anesthesia for Treatment of Female Urinary Incontinence. International Journal Urogynecology. 1996; 7(2): p. 81-86

 

19

Ulmsten U, Falconer C, Johnson P, et al. A multicentre study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. International Urogynecology Journal Pelvic Floor Dysfunction. 1998; 9(4): p. 210-213.

 

20

Guerrero K, Emery S, Wareham K, et al. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence. BJOG. 2010; 117: p. 1493-1503.

 

21

Bai S, Sohn W, Chung D, et al. Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary incontinence. International Journal of Gynaecology and Obstetrics. 2005; 91(3): p. 246-51.

 

22

Wadie B, Edwan A, Nabeeh A. Autologous fascial sling vs polypropylene tape at short-term follow up: a prospective randomized study. Journal of Urology. 2005; 174(3): p. 990-3.

 

23

Wright E, et al. Pubovaginal sling using cadaveric allograft fascia for the treatment of intrinsic sphincter deficiency. Journal Urology. 1998; 160(3): p. 759-62.

 

24

Wall L, Copas P, Galloway N. Use of pedicled rectus abdmoninis muscle flap sling in the treatment of complicated stress urinary incontinence. American Journal Obsetetrics and Gynaecology. 1996; 175(6): p. 1460-6.

 

25

Neal D, Foster L, Foster J. Southern Illinois University sling-bone anchored semitendinosus. Tech Urology. 2001; 7(1): p. 62-3.

 

26

Berman C, Kreder K. Comparative cost analysis of collagen injection and fascia lata sling cystourethropexy for the treatment of type III incontinence in women. Journal Urology. 1997; 157(1): p. 122-4.

 

27

Single incision sub-urethral short tape incision for stress urinary incontinence in women. Interventional Procedure Guidline (IPG 262). London: National Institute for Clinical Excellence; 2008. Report No.: ISBN 1-84629-710-9.

 

28

Ward K, Hilton P. Prospective Multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002; 325(7355): p. 67-73

 

29

Ward K, Hilton P. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamics stress incontinence: two year follow up. American Journal of Obsetrics and Gynecology. 2004; 190(2): p. 324-31.

 

30

Ward K, Hilton P, UK and Ireland TVT Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG. 2008; 115: p. 226-233.

 

31

Ogah J, Cody J, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Systematic Reviews. 2009 October;(4).

 

32

Abdel-Fattah M, Ramsay I, Pringle S, et al. Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. British Journal of Obstetrics and Gynaecology. 2010; 117: p. 870-878.

 

33

Dyrkom O, Kulseng-Hanssen S, Sandvik L. TVT compared with TVT-O and TOT: results from the Norwegian National Incontience Registry. International Urogynaecology Journal. 2010; 21: p. 1321-1326.

 

34

US Food and Drug Administration. [Online].; 2011 [cited 2014 04 12. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.

 

35

Amid P. Classification of biomaterials and their related complications in abdominal wall surgery. Hernia. 1997 May; 1(1): p. 15-21.

 

36

Haylen B, Freeman R, Swift S, et al. An International Urogynaecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prosthesis (meshes, implants and tapes) and grafts. International Urogynecology Journal. 2011 January; 22: p. 3-15.

 

37

Lopes T, Spirtos N, Naik R, et al. Bonney's Gynaecological Surgery. 11th ed. London: Wiley-Blackwell; 2010.

 

38

Insertion of biological slings for stress urinary incontinence in women. Interventional Procedure Guideline (IPG 154). London: National Institute for Clinical Excellence; 2006.

 

39

Rehman H, Bezerra C, Bruschini H, Cody J. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database of Systematic Reviews. 2011;(1).

 

40

Burch J. Urethrovaginal fixation to Cooper's ligament for correction of stress incontience, cystocele and prolapse. American Journal of Obstetrics and Gynecology. 1961 Feb; 81: p. 281-90.

 

41

Baggish M, Karram M, editors. Atlas of Pelvic Anatomy and Gynecologic Surgery New York: Harcourt; 2001.

 

42

Lapitan M, Cody J. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database of Systematic Reviews. 2012;(6).

 

43

Dean N, Ellis G, Herbison G, et al. Laparoscopic colposuspension for urinary incontinence in women. Cochrane Database of Systematic Reviews. 2006;(3).

 

44

Barr S, Reid F, North C, Hosker G, Smith A. The long-term outcome of laparoscopic colposuspension: a 10-year cohort study. International Urogynecology Journal. 2009; 20: p. 443-445.

 

45

Eandi J, Tanaka S, Hellenthal N, et al. Self-reported urinary continence outcomes for repeat midurethral sling placement. International Brazilian Journal of Urology. 2008; 34: p. 336-342.

 

46

Han J, Moon K, Park C, et al. Management of recurrent stress urinary incontinence after failed midurethral sling: tape tightening or repeat sling? International Urogynaecology Journal. 2012; 23: p. 1279-1284.

 

47

Liapis A, Bakas P, Creatsas G. Tension--free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape. European Urology. 2009; 55: p. 1450-1455.

 

48

Palva K, Nilsson C. Effectiveness of the TVT procedure as a repeat mid-urethra operation for treatment of stress incontinence. International Urogynaecology Journal. 2009; 20(7): p. 769-774.

 

49

Sabadell J, Poza J, Esgueva A, et al. Usefullness of retropubic tape for recurrent stress incontinence after transobturator tape failure. International Urogynaecology Journal. 2011; 22(12): p. 1543-1547.

 

50

Van Baelen A, Delaere K. Repeat transobturator tape after failed mid-urethral sling procedure: follow-up with questionnaire-based assessment. Urologia Internationalis. 2009; 83: p. 399-403.

 

51

de Cuyper E, Ismail R, Maher C. Laparoscopic Burch colposuspension after failed sub-urethral tape procedures: a retrospective audit. International Urogynaecology Journal. 2008; 19(5): p. 681-685.

 

52

Giarenis I, Mastoroudes H, Cardozo L. What do we do when a midurethral tape fails? Rediscovery of open colposuspension as a salvage operation. International Urogynaecology Journal. 2012; 23(8): p. 1117-1122.

 

53

Lee H, Lee Y, Han J, et al. Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures. International Urogynecology Journal. 2010; 21(12): p. 1479-1483.

 

54

Lo T, Wang A, Liang C, et al. Treatment for unsuccessful tension-free vaginal tape operation by shortening pre-implanted tape. Journal of Urology. 2006; 175(6): p. 2196-2199.