Surgical treatment for stress urinary incontinence

Transcription

1 International Journal of Urology (2008) 15, doi: /j x, Review Article Surgical treatment for stress urinary incontinence Chris K Harding and Andrew C Thorpe Department of Urology, Freeman Hospital, Newcastle-Upon-Tyne, UK Abstract: The prevalence of stress urinary incontinence is quite significant with large numbers of women affected. Many of these women will not seek medical help in the belief that they will not be cured or improved. With the increasing numbers of procedures now available we present a review of both established and novel surgical techniques that is intended to help both urologists and primary care physicians in the counselling of patients complaining of stress incontinence. We compare the gold standards of surgical treatment for all types of stress incontinence with the newer techniques that have recently become popular among urologists and gynaecologists. Key words: stress urinary incontinence, surgery. Introduction Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as involuntary leakage of urine on exertion, effort, coughing or sneezing. 1 This bothersome symptom is experienced by a significant number of women and has a dramatic effect on quality of life. The reported prevalence of SUI is variable but several studies suggest that it may be as high as one in four adult women. In 1993 Brocklehurst published data from a MORI poll, which surveyed over 4000 adults in the United Kingdom. 2 Fourteen percent of women interviewed admitted that they had been incontinent at some point with over half of these recalling an incontinent episode within the previous 2 months. More recent publications have suggested that the prevalence of incontinence is higher than this. A large study from Norway involving over women reported that 25% had experienced urinary leakage. 3 A postal survey in 2004, conducted in four European countries (UK, France, Germany and Spain) involving over participants found that 35% of women questioned admitted urinary incontinence. 4 In a review of all relevant studies published in English on Medline, Minassian et al reported a median (range) prevalence of urinary incontinence of 27.6% ( ). 5 Data from all of the above studies confirm that SUI is the most common type of urinary incontinence. Around one half of women reporting urine leakage are diagnosed with pure SUI and approximately 30% exhibit mixed urinary incontinence. Despite this a recent report using data from the four-country European study suggests that less than one-third of women with incontinence will seek medical help. 6 Possible reasons influencing whether or not women discuss urinary incontinence with their doctors include beliefs that treatment will have no effect on their symptoms and the perceived unacceptability of surgery, which was recorded in almost 50% of the women questioned. 6 Matsuyama et al. reported long-term results on a group of 90 women undergoing surgery for pelvic floor disorders and concluded that in the majority, long-term efficacy is sustained at a median follow up of 65.5 months, but also pointed out that results were better in women undergoing surgery before the age of 70 years. 7 It is absolutely essential therefore that physicians are well informed to counsel women regarding the wide Correspondence: Chris K Harding, MA MB BChir (Cantab) MRCSEd MD, Freeman Hospital, Urology, c/o MR Thorpes Secretary, Department of Urology, Newcastle, Newcastle-Upon-Tyne, NE7 7DN, UK. chris@ harding73.fsworld.co.uk Received 13 May 2007; accepted 4 September Online publication 19 October 2007 range of possible treatment options for SUI if we are to encourage help-seeking behavior in this large group of affected women. We review the commonly practised surgical treatments for SUI and compare well-established surgical treatments with newly developed techniques. Making the diagnosis of SUI SUI may present as a symptom or sign 8 and the diagnosis of urodynamic stress incontinence may be made by several urodynamic observations, which may include videourodynamics and leak point pressure measurement. Videourodynamic observations Urodynamic stress incontinence, as observed during a videourodynamic study, is noted during filling cystometry, and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction. The type of urodynamic stress incontinence can be subclassified according to the scheme originally described by Green 9 and modified by Blaivas, 10 these are: Type 0 A good history of stress incontinence is obtained. During videourodynamic study the vesical neck and proximal urethra are closed at rest, being situated at or above the superior margin of the pubic symphysis. During stress (cough or strain) although the vesical neck and proximal urethra open, no leakage is observed. Type 1 The vesical neck is closed at rest, and is situated at or above the inferior margin of the pubic symphysis. During stress maneuver with increased abdominal pressure, the vesical neck and proximal urethra open and descend <2 cm, with urinary incontinence being demonstrated. Type 2a The vesical neck is closed at rest and above the inferior margin of the pubic symphysis. During stress the vesical neck and proximal urethra descend >2 cm and urinary incontinence is demonstrated. A cystocoele is also present The Japanese Urological Association 27

2 CK HARDING AND AC THORPE Type 2b At rest the vesical neck is closed but is situated below the inferior margin of the pubic symphysis. During stress there is further descent, the proximal urethra opens and urinary incontinence is demonstrated. Type 3 At rest the vesical neck and proximal urethra are open, despite the absence of a detrusor contraction, there is obvious leakage of urine, which is either gravitational or associated with a minimal increase in intravesical pressure. Leak point pressure The diagnosis of urodynamic stress incontinence may also be made using the abdominal leak point pressure measurement, which is defined as the intravesical pressure at which urinary leakage occurs due to increased abdominal pressure in the absence of a detrusor contraction. This investigation was devised by McGuire, 11 and helps to define the overall urethral function, in terms of the intravesical pressure, at which there is the start of leakage of urine from the urethra. This investigation has been used to define those women who have intrinsic sphincter deficiency from those with urethral hyper mobility (i.e. Type 3 incontinence vs Type 1 2b on the Blaivas classification). Generally, those women with an abdominal leak point pressure of less than 90 cmh 2O are diagnosed as having intrinsic sphincter deficiency. Currently controversy remains as to whether this should be measured by cough or Valsalva maneuvers (VLPP). Thus, both the Blaivas classification and the abdominal leak point pressure are identifying urodynamic stress incontinence, secondary to either urethral hyper mobility or intrinsic sphincter deficiency. Once the type of SUI has been identified an appropriate curative surgical procedure can then be selected. More recently Abrams et al. 12 have suggested a new classification for the operative procedures involved in the treatment of stress urinary incontinence. Essentially this classification seeks to simplify, clarify and sub classify the huge armamentarium of operations that are available in the treatment of this condition. The classification suggests two main groups of urethral/bladder neck-stabilizing procedures and urethral sphincter augmentation. These two groups are then further sub classified. This sub classification, for the first time allows both new and established procedures to be viewed according to their theoretical mode of action, and as new procedures emerge they should easily fit into one of the sub classifications. Likewise, if a new technology or mode of action is developed this should bolt on easily to one of the main groups. Gold standards Several well-established treatments for SUI are in existence and many have long-term data to support their use. Within this group are included colposuspension for type 2a and 2b SUI, pubovaginal slings (Type 1 and 3 SUI) and the artificial urinary sphincter for type 3 SUI. It is to these gold standards that newer techniques need to be compared. Colposuspension Bladder neck suspension is traditionally carried out for SUI secondary to urethral hyper mobility and several procedures have been described. The most extensively studied include the Marshall-Marchetti-Krantz (MMK) procedure and Burch colposuspension. The principle of open retro pubic colposuspension is fixation of the bladder neck and proximal urethra to a retro pubic position in order to reduce urethral hyper mobility. The MMK procedure was initially described in the late 1940s and many studies have identified excellent short-term success rates. In a literature review published by Jarvis in 1994 the subjective continence rate following the MMK procedure in over 6800 patients was 92.7%. 13 Within this report an attempt was made at standardization of follow-up times and figures reflect success rates at around one year. Despite this a report by Czaplicki in 1998 identified a sharp decrease in continence rates with time following the MMK procedure. 14 Sixty cases with a mean postoperative time of 9.9 years were evaluated and, although short-term (6 months) results revealed a success rate of 81%, this fell to 57% at 5 years, and 28% at 10 years. However 69% of those women who were incontinent when reviewed indicated that they would be willing to undergo repeat surgery. Another study by Clemens et al. also examined the long-term success of the MMK procedure in 36 women. 15 With a median follow-up time of 16.8 years only 33% remained dry. It is apparent from these two studies that the success rate of the MMK procedure decreases with time. Complications of the MMK procedure include wound infection, urinary tract infection (UTI), injury to the urinary tract, postoperative voiding problems, pelvic organ prolapse and detrusor overactivity. In the MMK procedure, sutures are placed through the pubic symphysis and this carries the risk of osteitis pubis. A report by Colombo 1994 concluded that the MMK procedure was associated with a higher rate of complications than the Burch colposuspension and recommended that the Burch procedure is the operation of choice for SUI. 16 The Burch colposuspension was introduced in the early 1960s and has been described as the most effective surgical procedure for stress incontinence in a recent set of guidelines from the Royal College of Obstetricians and Gynecologists (RCOG). 17 In the meta analysis by Jarvis the subjective and objective early continence rates following the Burch procedure are described as 89.6% and 84.3%, respectively. 8 Many reports exist regarding long-term outcome from this procedure and most describe a durable outcome superior to that of the MMK procedure. Kinn 1995 reports results from 153 women undergoing Burch colposuspension with a 2-month self-reported failure rate of only 7%. 18 The failure rate at 5 years follow up was an impressive 11%. Kjolhede and Ryden 1994 published a retrospective study with quite different results. 19 They evaluated 232 women following Burch colposuspension using postal questionnaires and reported a 55% continence rate at 10 years. A further publication from Kjolhede 2005 reports longer-term results. 20 With a median follow-up time of 14-years only 19% of the 190 women reported no incontinence with significant incontinence reported by 56%. Contrary to these reports Bergman and Elia 1995 prospectively evaluated women 5 years following Burch colposuspension and found 91% had a negative cotton swab test. 21 In addition Alcalay 1995 reported a 69% cure rate from SUI at 12 years and suggested that a plateau is reached at that time without further decline in continence rates. 22 Complications from Burch colposuspension are similar to those of the MMK procedure and in the prospective study published by Colombo 1994, Burch colposuspension was associated with a shorter hospital stay, earlier resumption of spontaneous voiding and a lower overall complication rate when compared to the MMK procedure. 16 The RCOG guidelines on the surgical treatment of SUI quotes complication rates of 10% voiding difficulties, 17% de novo detrusor overactivity and 14% pelvic organ prolapse at 5 years. 17 Furthermore, a recent Cochrane review of surgery for SUI concludes that Burch colposuspension should be regarded as the standard The Japanese Urological Association

3 Surgery for SUI procedure for open retro pubic colposuspension due to its improved and more durable cure rates. 23 Recently laparoscopic colposuspension procedures have been developed and investigated. These use similar techniques to open colposuspension and carry all of the advantages of laparoscopic surgery. A Cochrane review published by Moehrer 2002 concluded that the longterm performance of laparoscopic colposuspension is uncertain. 24 Trials had shown a trend towards higher complication rates, longer operating time, less intraoperative blood loss, less postoperative pain, shorter hospital stay, quicker return to normal activities, and shorter duration of catheterization for laparoscopy compared with open colposuspension. Direct comparisons of open and laparoscopic techniques are scarce to date there have been six published randomized trials, comparing the two techniques, and there has been no perceived advantage in the laparoscopic technique. Three randomized trials found laparoscopic colposuspension to be equivalent to open colposuspension in terms of objective cure rates, but three found laparoscopic colposuspension to be inferior Multiple bladder neck needle suspension procedures have been described dating back to the 1950s and include Raz, Stamey and Peyrera techniques. The long-term results of this type of surgery are poor with a failure rate of over 80% reported by Tebyani et al. ata median follow-up of 29 months. 31 Furthermore in a randomized controlled trial comparing needle suspension with open colposuspension a significantly higher continence rate at one year was found in the group undergoing open surgery. 32 Needle suspension procedures are no longer recommended for the treatment of SUI. 17 However urologists may encounter patients who have undergone these procedures, many years after their initial surgery. Such patients may represent with delayed complications such as vaginal discharge and irritative voiding symptoms, which may indicate migration or erosion of Dacron bolsters. In any patient with even a remote history of a needle bladder neck suspension, thorough vaginal and cystoscopic evaluation is recommended. 33 Pubovaginal slings These procedures date back to the late 19th century and have been refined over the years. The sling procedures may be used for Types 1 and 3 incontinences when carried out alone or for type 2a if combined with an anterior repair. Perhaps the predominant use of slings in the modern era has been in women who have failed previous surgical treatments for SUI. Despite this, many authorities advocate the use of sling procedures as a primary procedure. The material used for pubovaginal slings ranges from autologous fascia (most commonly rectus or fascia lata), to allograft fascia and a wide range of biological (porcine small intestine submucosa and porcine xenograft acellular matrix), and synthetic materials (Marlex, Mersilene, Goretex). In the literature review published by Jarvis in 1994, subjective and objective cure rates were 82.4% and 85.3%, respectively. 13 These data were taken from over 1700 women and indicate success at around 12 months but the material used is not specified. Although the three main subcategories of pubovaginal sling endofascial, biological and synthetic, involve the use of quite diverse materials, they now all work on the same principle of providing support to the mid-urethra. The original pubovaginal slings were bladder neck slings, and could cause a significant degree of bladder outflow obstruction. More recently however, the comprehensive anatomical studies of Petros and Ulmstein 34 have moved the region of interest from the bladder neck and proximal urethra and retro pubic fixation. Petros advanced integral theory in 1990 before DeLancey s hammock hypothesis, 35 both pointed to the pubourethral ligaments, and reinforcement of support at this level. Petros and Ulmstein have argued that in females, continence is maintained by three mechanisms, the muscular activity of levator ani and pubococcygeus, the tension of the pubourethral ligaments, and the quality of the sub urethral vaginal hammock. This has lead to the genesis of the tension free vaginal tapes (see below). Endofascial slings In a review by Bidmead and Cardozo 2000 it was noted that as a general rule autologous slings were associated with a greater cure rate and fewer complications than either cadaveric or synthetic materials. 36 This review recognized the main disadvantage of sling procedures is the relatively high complication rate. Cadaveric materials may be associated with a high rate of long-term failure according to a report by Fitzgerald A failure rate of at least 20% was suggested in this paper and degeneration of the grafts was noted on histology. Further supporting evidence is reported by Carbone et al. who describe persistent moderate to severe stress incontinence in around 40% at a mean follow-up of just 10 months. 38 They found all allogenic cadaveric fascia used for sling material to be fragmented, attenuated or simply absent at re-operation. Contrary to this in a larger series reported by Morgan 2000 using autologous rectus fascia over 200 cases were reviewed and a long-term success rate of 88% reported. 39 Sling on a string This variant of the endofascial pubovaginal sling has been widely reported by a number of authors including Webster from the USA, and Lucas from the UK. 40,41 Essentially, instead of constructing a full-length pubovaginal sling from either rectus fascia or fascia lata of 20 cm or so, a much shorter length of either fascia is taken of 8 10 cm. The two ends are then over sewn with an over and over Prolene suture, which is then passed upwards and through the anterior abdominal wall to a point just above the pubic symphysis. The two sutures are then tied with no tension. This procedure is much less invasive and hence has the advantage of a much smaller incision, less wound pain, but equal continence rates to the full-length pubovaginal sling. Artificial urinary sphincter The procedure of implanting an artificial urinary sphincter (AUS) dates back to the 1970s. The principle of this procedure involves increasing outlet resistance using an inflatable cuff around the proximal urethra. A prerequisite is that the patient must be able to manipulate the pump to allow for intermittent deflation and bladder emptying. AUS insertion is often carried out when other surgical treatments have failed but good results have been reported when the AUS is inserted primarily for women with SUI secondary to intrinsic sphincter deficiency. Webster et al reported over 90% continence at 2.5 years following AUS insertion in women without previous surgery for SUI. 42 Longer-term results are however, less encouraging. A single-center review of AUS insertion by Thomas et al examined 68 cases and found at a median follow up of 7 years only 37% retained the original sphincter. 43 The reason for removal was infection or erosion in almost half. Only one third remained dry after sphincter removal with 39% undergoing subsequent urinary diversion. In this study a sphincter replacement rate of 16% at 5.5 years for mechanical failure was quoted. It would appear therefore, that the use of the AUS for SUI as a primary operation remains controversial due to the risk of complications and possible need for revision surgery The Japanese Urological Association 29

4 CK HARDING AND AC THORPE Newer surgical techniques for SUI The techniques described above exhibit very acceptable success rates but the potential morbidity arising from these procedures has been the driving force for introduction of less invasive surgical procedures. These include injectable urethral bulking agents, biological and synthetic slings, trans-vaginal and trans-obturator tapes and a new design of AUS. The evidence for these new techniques will be reviewed. Injection of peri-urethral bulking agents The principle underlying the technique of peri-urethral bulking injections is to create sub mucosal cushions ensuring apposition of the urethral wall, which aids continence. The advantages of this technique include the low associated morbidity. This technique may be indicated in Type I or Type III SUI. It can be carried out under local anesthesia and does not necessitate an inpatient stay. There is a range of injectable materials from autologous fat, through collagen to manufactured polymers (Teflon, Durasphere, Macroplastique). Autologous fat and PTFE (Teflon) are no longer used due to concerns about their safety profiles. The injection of collagen as a bulking agent was compared with three types of open surgery for SUI (Burch colposuspension, Sling procedure and Bladder neck suspension procedure) in a study by Corcos in The subjective outcomes at 12 months were not significantly different (53% cured in injection group compared with 72% in the open surgery group), but objective pad weight testing revealed more people were cured after open surgery. However complication rates were significantly higher for those undergoing open surgery and the nature of those complications more severe. Of the newer injectable preparations, Durasphere (Carbon Medical Technologies Inc., St.Paul Minnesota) seems to have been the most promising. In a long-term multicentre randomized controlled trial, 45 comparing Durasphere with bovine collagen in women with Type III SUI, involving 355 patients, the continence rates were 80% vs 69%, although only 129 of the original patients were available for follow up, and the last follow up was only 1 year following their treatment. In a long-term comparison study 46 of Durasphere vs Bovine collagen, Durasphere gave a 40% continence rate at 2.6 years compared to a 14% continence rate for collagen at 2.8 years. Thus although Durasphere seems to be superior to bovine collagen, its longer-term success rates do not seem to be particularly impressive. Reported complications following Durasphere injection have included urethral prolaspse 47 and particle migration. 48 Zuidex, a compound consisting of dextranomer micro spheres in a cross-linked hyaluronic acid vehicle, has also been trailed recently in the treatment of stress urinary incontinence. It has been shown to be safe in children, with a substantial improvement in incontinence at 12 months, 49 but long-term data in adults are still deficient. A Cochrane review published in 2003 by Pickard examining the evidence behind peri-urethral bulking injections concluded that the use of established manufactured bulking agents results in both subjective and objective short-term improvement in women with symptoms of SUI. 50 Further to this Chapple et al state that in short-term studies peri-urethral injection therapy cures or improves three in every four women. 51 They add that it should be considered a first-line treatment for those who have failed conservative measures. The lower complication rate is pointed out along with the apparent absence of postoperative de novo detrusor instability. The Cochrane group however, found no evidence to recommend injection therapy over open surgery in women fit for surgery. The recommendation was to use this therapy in patients unfit for general anesthesia where short-term outcome was favored. It was also recognized that two or more treatments may be necessary for the majority of patients. 50 It would appear from the published reports that longer term follow up and increased numbers of randomized controlled trials are necessary before injection therapy can be considered as an alternative to open surgery. Despite this many patients may prefer the low risk of complications and the minimally invasive nature of this procedure as an initial treatment for SUI prior to considering more invasive open surgery. Following a review into the available urethral bulking agents, Lightner 45 comments that the price of minimal invasiveness may well be lower efficacy, a comment recently supported by Appell et al. 52 Sling operations Biological slings The use of biological sling materials is also well described. One such material is porcine small intestinal submucosa (SIS) and this has been the subject of a histological study by Wiedemann et al examining 15 patients following SIS sling procedures. 53 Biopsies of the SIS implantation site were taken and these revealed no evidence of foreign body or inflammatory reaction indicating excellent biocompatibility. Furthermore 12 of the 15 patients were dry at follow-up in this study a similar success rate to autologous rectus fascia. Another biological material extensively studied is porcine xenograft acellular matrix (Pelvicol). Abdel-Fattah et al. published a randomized controlled trial of Pelvicol slings vs TVT and found similar success rates at 3 years follow-up without significantly different complication rates. 54 This study examined 142 women with SUI and demonstrates both efficacy and safety when using Pelvicol. A further prospective comparative study by Giri-Subhasis et al. 55 of rectus fascia pubovaginal sling vs acellular cross linked porcine dermis slings in the treatment of urodynamic stress incontinence in 101 consecutive patients, found at 36 months follow up cure rates of 80% vs 54%, respectively (complete data were available in 94 patients). The rectus fascia slings tended to fail early (mean time to failure 9 months) whilst the porcine dermis slings failed at a slightly later stage (mean time to failure 24 months). The authors concluded that porcine dermis slings showed a significantly inferior long-term cure rate when compared to rectus fascia slings and should not therefore be used as a substitute for rectus fascia slings. This is further borne out by Guerrero and Lucas 56 who point out the high recurrent stress incontinence rates and risks of complete failures with some biological slings, questioning the future role, in general, of nonautologous biological slings. Synthetic slings Synthetic sling materials are wide ranging but one specific complication of these procedures is erosion into vagina or urethra. Chin reported on 88 women with SUI undergoing sling procedures and published an erosion rate of 11%. 57 In addition to this other complications include wound infection, UTI, injury to the urinary tract, postoperative voiding problems, pelvic organ prolapse and detrusor over activity and the incidences appear to be slightly higher than the figures quoted for colposuspension above. In the review by Bidmead the incidence of sling procedures complicated by detrusor over activity ranges from 0 to 36%, voiding difficulties 0 63% and other sling complications 0 29%. 35 In a paper by Ku et al. the issue of postoperative complications following sling procedures was examined; 58 no significant difference was found in postoperative urinary retention, persistent urgency The Japanese Urological Association

5 Surgery for SUI and most importantly surgical outcome across a range of women classified according to body mass index indicating widespread feasibility of the sling procedure. One problem when evaluating the use of pubovaginal slings in the treatment of SUI is the lack of comparable data. In a review published in 2005 Bezerra comments that the data on sub urethral sling operations remains too few to address the effects of this type of surgical treatment and reliable evidence on which to judge whether or not sub urethral slings are better or worse than other surgical or conservative management is currently not available. 59 However, in one randomized trial of pubovaginal sling vs Burch colposuspension vs tension free vaginal tape for stress urinary incontinence, 60 involving 92 women with 12 month follow up, the cure rate for pubovaginal sling was found to be significantly higher. The efficacy of the other two procedures showed no difference. Tension free vaginal tape Development of the tension free vaginal tape (TVT) has occurred in the last 10 years and works on a similar principle to sling procedures. A manufactured tape is placed sub urethrally at the mid urethral point, to create a pubo urethral neoligament that is anchored suprapubically. The tape tightens around the urethra on increased abdominal pressure. 34 The procedure can be carried out as a day case and without general anesthesia. Early reports suggested excellent rates of improvement from the symptoms of SUI with a low rate of complications. This led to a multicentre randomized controlled trial comparing TVT insertion with a gold standard treatment, colposuspension. Three hundred and forty-four women were studied and Ward 2002 reported on success both subjectively and objectively at 6 months. 61 Using a validated set of questionnaires the subjective cure rate was 66% for TVT compared to 57% of those randomized to colposuspension. Objectively, 73% of patients in the TVT group had a negative 1-h pad test compared to 64% in the colposuspension group. TVT was associated with decreased operative time, analgesia requirement and hospital stay. There was however, a higher rate of intraoperative complications, most often bladder perforation with no long-term effects. Petros has developed a new technique 62 from integral theory against all complications of TVT; the tissue fixation system (TFS) uses two small plastic anchors to fix an (adjustable) midurethral polypropylene mesh sling into the soft tissues below the pubic bone. The authors claim this variation on TVT is a promising new method with similar efficacy but greater safety than conventional TVT. Overall the above work appears to confirm TVT as an equivalent to open colposuspension in the short term as a treatment for SUI. Ohkawa has reported on 151 women with SUI treated by TVT insertion and found a similar level of success; interestingly the results from this study suggest that outcome is significantly better in women with types I or II SUI. 63 In a recent review by Atherton and Stanton studies with longer term follow up after TVT are examined. The technique has been shown to provide 7-year cure rates of over 80% with minimal long-term complications. 64 Potential complications from this technique include injury to blood vessels, abdominal viscera and urethra but to date there has been a low number reported. Although voiding disorder after TVT insertion is not negligible, it appears less than with other incontinence procedures. 36 It is pointed out that the results following TVT insertion should be interpreted with caution as many studies are published in abstract form only, and the 5-year results from the Colposuspension vs TVT randomized study 61 are necessary before TVT can be confirmed as equally efficacious in the longer term. A further consideration with the TVT (and also the trans obturator tape [TOT], see below), are the vast numbers of different tapes now being marketed by numerous companies. 65,66 Although all claim to be the same, tapes vary in whether they are knitted or are a weave, and also in the pore size of the individual tapes, an important factor when considering tape infection and hence erosion. Trans obturator tape insertion Trans Obturator Tape (TOT) insertion is newer even than TVT and is a slight modification on that technique. It dates back to the early 2000s and again involves the placement of a manufactured tape sub urethrally but in TOT the tape is anchored through the obturator foramen. Due to the recent nature of this technique less data currently exists. Some short-term studies have been carried out on relatively large numbers and show encouraging results. Roumeguere et al reported on 120 consecutive patients undergoing TOT insertion for SUI and quoted 93% cure at 1 month with 80% dry at 1 year as assessed using a validated questionnaire. 67 A low rate of complications was noted with 2.5% reporting de novo urgency and 4% persistent voiding dysfunction. This study examined patients with two of the more common manufactured tapes inserted (Obtape and Uratape) and found no difference between them. In a prospective randomized trial of TVT vs TOT, involving 88 women followed up for 12 months, Darai et al., 68 reported similar high cure rates (89% vs 88%) within the two groups. The improvement in quality of life was also similar between the two groups. Ignjatovic et al. reported promising results from 40 women with 1 year follow up and demonstrated a favorable outcome at 1 year with post operative urodynamic studies showing unobstructed voiding in the majority. 69 Two methods of inserting a trans obturator tape are in existence and both involve the passage of a curved needle through the obturator foramen. The difference is in the direction of penetration. Using the inside out technique the needle passes from the sub urethral position in the midline, while for the outside in method the needle is passed from a lateral position to sit sub urethrally. A recent review by Costa 2004 identified no major differences in efficacy or morbidity between the two techniques of TOT insertion. 70 However, one theoretical morbidity, pudendal nerve damage does need to be taken into consideration. When using the outside in technique the introducer will glance safely over the inferior pubic symphysis as in goes through the obturator foramen, avoiding all contact with Alcock s canal and its contents (the pudendal nerve and vessels). If the introducer is placed from inside to out, however, there is the theoretical possibility of the introducer damaging Alcock s canal and its contents as it traverses the space toward the inferior pubic symphysis. There is no doubt that TOT insertion is a promising technique but more work is needed specifically to compare this technique to other surgical options for SUI. Furthermore longerterm follow-up is needed before a clear safety profile of this novel technique can be built up. Supporters of this technique over TVT insertion claim that it avoids the potential complications of blind needle passage through the retro pubic space. A new artificial urinary sphincter In 2005 Hussain et al. published details of a patented new design of AUS. 71 The periurethral cuff was molded on a curved rather than flat template producing a single curved compression cushion when activated. The authors argued that cracking and perforation was less likely using this new design. The other modification was the addition of a second pressure balloon to accommodate rapid changes in intraabdominal pressure. The design allows for lower pressures to be exerted on the urethra with the theoretical advantage of lower urethral erosion The Japanese Urological Association 31

6 CK HARDING AND AC THORPE Despite the perceived theoretical advantages the technique is currently in the early stages but initial reports are encouraging. 71 Cost effectiveness/health economics Since the TVT was introduced in 1996, approximately 1 million surgical interventions have been carried out using this procedure, worldwide. 72 Approximately $11.2 billion dollars are spent yearly in the USA, as direct costs for the treatment of USI. 73 It is vitally important therefore that the financial impact and cost effectiveness of new surgical treatments for SUI are fully evaluated. In the UK this is more an exercise in increased bed use and throughput (i.e. efficiency) rather than true cost savings. Cody et al., 74 however, have reported via a systematic review, on the clinical and cost effectiveness of TVT, using a literature search extending from 1966 to Procedures included in the review were retro pubic suspensions (open and laparoscopic), traditional sub urethral sling procedures, injectable peri-urethral bulking agents, and TVT. The authors found that, despite few robust comparative data, TVT appeared in the short and medium term to be equally clinically effective to retro pubic suspensions and traditional slings. Injectables had a much lower cure rate. TVT was the more cost effective procedure. The authors pointed out that with the advent of the new minimally invasive tape operations, women who might otherwise have opted for conservative management of their urinary incontinence, could start to opt for these minimally invasive procedures. This obviously has implications in terms of the total cost burden to the system. Likewise, Kondo et al., 75 in a prospective comparative study of TVT vs Pubovaginal sling in 60 women, when reviewed at 2 years found that TVT was significantly superior to Pubovaginal sling in terms of operative time, postoperative pain and hospital charges, although cure rates between the two groups were broadly similar. Conclusions Historically, the gold standard for surgical treatment of SUI in the United Kingdom has been the colposuspension. This technique has good short-term improvement rates, which appear to be durable in the majority of patients. The amount of published evidence on this technique reflects the length of time that it has remained popular. Women could expect a good chance of full long-term cure following colposuspension but complication rates are not negligible. This has been the catalyst for the development of newer techniques associated with lower morbidity. Injectable peri-urethral bulking agents appear to provide a short-term option for symptom control but several treatments may be required. The TVT represents a technique that shows good short-term symptom improvement with a low rate of complications. Even though, at present, there is a lack of high quality long-term data on this technique, and the long-term results from prospective randomized controlled trials are still awaited comparing this technique with the historical gold standard, in terms of long-term safety and efficacy, it would appear that, clinically, the TVT has superseded the colposuspension and has become the new gold standard. To date this technique has stood up well against the traditional surgical procedures 61 and does show promise for the future. In a recent survey of 530 members of the International Urogynecology Association, the preferred primary incontinence procedure in 68% of respondents was TVT indicating that newer techniques are being embraced. 76 Furthermore, we would feel that when assessing outcomes of the next generation of surgical procedures such as the TOT, in terms of morbidity and success rates that randomized trials should be carried out using the TVT as the gold standard. It is only by carrying out these trials that we can be reassured that in the pursuit of low morbidity we are not compromising our patients in terms of long-term success rates. References 1 Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function. Neurourol. Urodyn. 2002; 21: Brocklehurst JC. Urinary incontinence in the community analysis of a MORI poll. BMJ 1993; 306: Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. J. Clin. Epidemiol. 2000; 53: Hunskaar S, Lose G, Sykes D, Voss S. The prevalence of urinary incontinence in women in four European countries. BJU Int. 2004; 93: Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int. J. Gynaecol. Obstet. 2003; 82: O Donnell M, Lose G, Sykes D, Voss S, Hunskaar S. Help-seeking behaviour and associated factors among women with urinary incontinence in France, Germany, Spain and the United Kingdom. Eur. Urol. 2005; 47: Matsuyama M, Hirata H, Tomimatsu T, Yamakawa GI, Tatsumura M, Naito K. Follow-up of surgical repair of female pelvic floor disorders by a mailed questionnaire. Int. J. Urol. 2006; 13: Schafer W, Abrams P, Liao L et al. Good urodynamic practices: uroflowmetry, filling cystometry and pressure flow studies. Neurourol. Urodyn. 2002; 21: Green TH, Thomas H Jr. The problem of urinary stress incontinence. Obstet. Gynaecol. Surv. 1968; 23: Blaivas JG. Classification of stress urinary incontinence. Neurourol. Urodyn. 1984; 2: McGuire EJ, Fitzpatrick CC, Wan J et al. Clinical assessment of urethral function. J. Urol. 1993; 150: Abrams P, Hilton P, Lucas M, Smith T. A proposal for a new classification for operative procedures for stress urinary incontinence. BJUI 2005; 96: Jarvis GJ. Surgery for genuine stress incontinence. BJOG 1994; 101: Czaplicki M, Dobronski P, Torz C, Borkowski A. Long-term subjective results of Marshall-Marchetti-Krantz procedure. Eur. Urol. 1998; 34: Clemens JQ, Stern JA, Bushman WA, Schaeffer AJ. Long term results of the Stamey bladder neck suspension: direct comparison with the Marshall-Marchetti-Krantz procedure. J. Urol. 1998; 160: Colombo M, Scalambrino S, Maggioni A, Milani R. Burch colposuspension versus modified Marshall-Marchetti-Krantz urethropexy for primary genuine stress urinary incontinence: a prospective, randomised clinical trial. Am. J. Obstet. Gynecol. 1994; 171: Adams EJ, Barrington JW, Brown K, Smith ARB. Surgical treatment of urodynamic stress incontinence. Royal College of Obstetricians and Gynaecologists Guideline no. 35; October [Cited October 2003.] Available from URL: 18 Kinn AC. Burch colposuspension for stress urinary incontinence. 5 year results in 153 women. Scand. J. Urol. Nephrol. 1995; 29: Kjolhede P, Ryden G. Prognostic factors and long-term results of the Burch colposuspension. A retrospective study. Acta Obstet. Gynecol. Scand. 1994; 73: Kjolhede P. Long-term efficacy of Burch colposuspension: a 14 year follow-up study. Acta Obstet. Gynecol. Scand. 2005; 84: Bergman A, Elia G. Three surgical procedures for genuine stress incontinence: five-year follow-up of a prospective randomised study. Am. J. Obstet. Gynecol. 1995; 173: Alcalay M, Monga A, Stanton SL. Burch colposuspension: a years follow up. Br. J. Obstet. Gynaecol. 1995; 103: Lapitan MC, Cody DJ, Grant AM. Open retro pubic colposuspension for urinary incontinence in women. Cochrane Database Syst. Rev. 2005; 20: CD The Japanese Urological Association

7 Surgery for SUI 24 Moehrer B, Ellis G, Carey M, Wilson PD. Laparascopic colposuspension for urinary incontinence in women. Cochrane Database Syst. Rev. 2002; 1: CD Carey MP, Goh JT, Rosamilla A. Laparoscopic versus open Burch colposuspension: a randomised controlled trial. BJOG 2006; 113: Kitchener HC, Dunn G, Lawton V et al. Laparoscopic versus open colposuspension results of a prospective randomised controlled trial. BJOG 2006; 113: Cheon WC, Mak JHL, Lui JYS. Prospective randomised controlled trial comparing laparoscopic and open colposuspension. Hong Kong Med. J. 2003; 9: Ankardal M, Ekerydh A, Crafoord K et al. A randomised trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. BJOG 2004; 111: Su TH, Wang KG, Hsu Cy et al. Prospective comparison of laparoscopic and traditional colposuspension in the treatment of genuine stress incontinence. Acta Obstet. Gynaecol. Scand. 1997; 76: El Toukhy TA, Davies AE. The efficacy of laparoscopic mesh colposuspension: results of a prospective controlled study. BJUI 2001; 88: Tebyani N, Patel H, Yamaguchi R, Aboseif SR. Percutaneous needle bladder neck suspension for the treatment of stress urinary incontinence in women: long-term results. J. Urol. 2000; 163: Karram MM, Angel O, Koonings P, Tabor B, Bergman A, Bhatia N. The modified Peyrera procedure; a clinical and urodynamic review. Br. J. Obstet. Gynaecol. 1992; 99: Smith A, Rovner E. Long term chronic complications from Stamey Endoscopic bladder neck suspension: a case series. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2006; 17: Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet. Gynecol. Scand. (Suppl.). 1990; 153: DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am. J. Obstet. Gynecol. 1994; 170: Bidmead J, Cardozo L. Sling techniques in the treatment of genuine stress incontinence. BJOG 2000; 107: Fitzgerald MP, Mollenhauer J, Brubaker L. Failure of allograft suburethral slings. BJU Int. 1999; 84: Carbone JM, Kavaler E, Hu JC, Raz S. Pubovaginal sling using cadaveric fascia and bone anchors: disappointing early results. J. Urol. 2001; 165: Morgan TO Jr, Westney OL, McGuire EJ. Pubovaginal sling: 4 years outcome analysis and quality of life assessment. J. Urol. 2000; 163: Lucas M, Emery S, Carr N. Specialist treatment. Drugs and Surgery. In: Lucas M, Emery S, Benyon J (eds). Incontinence, 1st edn, Chapter 6. Blackwell Science, Oxford, 1999; Chopra A, Raz S, Stothers L. Technique of rectangular fascial sling. In: Raz SMD (ed.). Female Urology, 2nd edn. Springer Verlag, New York, 1995; Webster GD, Perez LM, Khoury JM, Timmons SL. Management of Type III stress urinary incontinence using artificial urinary sphincter. Urology 1992; 39: Thomas K, Venn SN, Mundy AR. Outcome of the artificial urinary sphincter in female patients. J. Urol. 2002; 167: Corcos J, Collet JP, Shapiro S et al. Surgery vs collagen for the treatment of female stress urinary incontinence (SUI): results of a multicentric randomized trial (Abstract). J. Urol. 2001; 165: Lightner D, Calvosa C, Anderson R et al. A new bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomised, controlled, double-blind study of Durasphere. Urology 2001; 58: Anderson RC. Long-term follow up comparison of durasphere and contigen in the treatment of stress urinary incontinence. J. Low. Genit. Tract. Dis. 2002; 6: Ghoniem GM, Khater U. Urethral prolapse after durasphere injection. Int. Urogynecol. J. Pelvic Floor Dysfunct. 2006; 17: Pannek J, Brands FH, Senge T. Particle migration after transurethral injection of carbon coated beads for stress urinary incontinence. J. Urol. 2001; 166: Caione P, Capozza N. Endoscopic treatment of urinary incontinence in paediatric patients: 2 years experience with dextranomer/hyaluronic acid. J. Urol. 2002; 168: Pickard R, Reaper J, Wyness L, Cody DJ, McClinton S, N Dow J. Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst. Rev. 2003; 2: CD Chapple CR, Wein AJ, Brubaker L et al. Stress incontinence injection therapy what is best for our patients? Eur. Urol. 2005; 48: Appell RA, Dmochowski RR, Herschorn S. Urethral injections for female stress incontinence. BJUI 2006; 98 (Suppl 1): Wiedemann A, Otto M. Small intestinal submucosa for pubourethral sling suspension for the treatment of stress incontinence: first histopathological results in humans. J. Urol. 2004; 172: Abdel-Fattah M, Barrington JW, Arunkalaivanan AS. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence: a prospective randomized three-year follow-up study. Eur. Urol. 2004; 46: Giri-Subhasis K, Hickey JP, Sil D et al. The long term results of pubovaginal sling surgery using acellular cross linked porcine dermis in the treatment of urodynamic stress incontinence. J. Urol. 2006; 175: Guerrero KL, Lucas MG. Do nonautologous biological slings have a future? Curr. Opin. Urol. 2006; 16: Chin YK, Stanton SL. A follow-up of Silastic sling for genuine stress incontinence. Br. J. Obstet. Gynecol. 1995; 102: Ku JH, Oh JG, Shin JW, Kim SW, Paick JS. Outcome of mid urethral sling procedures in Korean women with SUI according to BMI. Int. J. Urol. 2006; 13: Bezerra CA, Bruschini H, Cody DJ. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst. Rev. 2001; 3: CD Bai SW, Sohn WH, Chung DJ et al. Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension free vaginal tape for stress urinary incontinence. Int. J. Gyneacol. Obstet. 2005; 91: Ward K, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002; 325: Petros PE, Richardson PA. Midurethral Tissue Fixation System sling a micromethod for cure of stress incontinence preliminary report. Aust. N. Z. J. Obstet. Gynaecol. 2005; 45: Ohkawa A, Kondo A, Takei M et al. Tension free vaginal tape surgery for SUI: a prospective multi-centred study in Japan. Int. J. Urol. 2006; 13: Atherton MJ, Stanton SL. The tension-free vaginal tape reviewed: an evidence based review from inception to current status. BJOG 2005; 112: de-tayrac R, Haab F, Madelenat P, Boccon-Gibod L. Distribution of surgical operations for female stress urinary incontinence in Parisian public hospital in Prog. Urol. 2004; 14: Bats A, Thoury A, Dhainaut C, Madelenat P. Evolution of surgical operations for stress urinary incontinence in Gynaecology departments of Parisian public hospitals between 2002 and Gynaecol Obstet. Fertil. 2006; 34: Roumeguere T, Quackels T, Bollens R et al. Trans obturator vaginal tape (TOT) for female incontinence: one year follow up in 120 patients. Eur. Urol. 2005; 48: The Japanese Urological Association 33

8 CK HARDING AND AC THORPE 68 Darai E, Frobert JL, Grisard AM et al. Functional results after the suburethral sling procedure for urinary stress incontinence: a prospective randomised Multicentre study comparing the Retropubic and Transobturator routes. Eur. Urol. 2007; 51: Ignjatovic I, Vuckovic M, Srzentic Z. Transobturator tension free composite sling for urethral support in patients with SUI: favourable experience after 1 year follow-up. Int. J. Urol. 2006; 13: Costa P, Delmas V. Trans-obturator-tape procedure inside out or outside in : current concepts and evidence base. Curr. Opin. Urol. 2004; 14: Hussain M, Greenwell TJ, Venn SN, Mundy AR. The current role of the artificial urinary sphincter for the treatment of urinary incontinence. J. Urol. 2005; 174: Deng D, Rutman M, Raz S, Rodriguez L. Presentation and management of major complications of midurethral slings: are complications under reported? Neurourol. Urodyn. 2007; 26: Bullock T, Ghoniem G, Klutke C, Staskin D. Advances in female stress urinary incontinence: mid-urethral slings. BJUI 2006; 98 (Suppl 1): Cody J, Wyness L, Wallace S et al. Systematic review of the clinical effectiveness and cost effectiveness of tension free vaginal tape for treatment of urinary stress incontinence. Health Technol. Assess. 2003; 7: Kondo A, Isobe Y, Kimura K et al. Efficacy safety and hospital costs of tension free vaginal tape and pubovaginal sling in the surgical treatment of stress incontinence. J. Obstet. Gynaecol. Res. 2006; 32: Jha S, Arunkalaivanan AS, Davis J. Surgical management of SUI: a questionnaire based survey. Eur. Urol. 2005; 47: The Japanese Urological Association