Sling procedures for urinary incontinence in women

Transcription

1 Update Article SLING PROCEDURES FOR URINARY INCONTINENCE IN WOMEN Z.G. KASSARDJIAN Sling procedures for urinary incontinence in women Z.G. KASSARDJIAN St.Elie Center, Antelias, Lebanon SUMMARY There are many different techniques of sling surgery for female incontinence and numerous materials are available for use as a suburethral sling. Autologous materials are associated with more success and fewer complications than cadaveric material. The objectives of this review are to identity the benefits and adverse effects of suburethral sling procedures. There is no evidence that suburethral slings are better or worse than other surgical or conservative management because no trials have addressed this comparison. INTRODUCTION Sling procedures for female incontinence have been used for over a century; suburethral procedures were developed initially in 1888, by Schultze [1], and the suburethral sling procedure was first reported by Von Giordono in 1907 [1]. Goebell [2] is credited with devising and describing the pubovaginal sling in 1910 and Price [3] described the first fascial sling in In the 1940s Millen, a urologist, and Aldridge, a gynaecologist, described the creation of slings using paired strips of rectus fascia [4]. Initially slings were made from muscle, including the pyramidalis, gracilis, levator ani, rectus and bulbocavernosus [5]. McGuire [6] has published most extensively on this procedure and deserves credit for popularizing the concept in urology. Since then many procedures using this principle have been described, using either autologous or alloplastic material. METHODS Study designs of evaluations included in this review were randomized controlled trials, unrandomized trials and prospective cohort studies. Retrospective cohort studies and case-control studies were included if they provided additional information. Medline was searched from January 1994 to February 2003, as was the Cochrane Library. The search term used was sling. Data were extracted by the author but a statistical meta-analysis was not used because of the variability among studies. The studies were grouped according to the surgical procedures and study designs. The objectives of this review are to identify the benefits and adverse effects of suburethral sling procedures for treating urinary incontinence in women. SLING MATERIALS Various materials have been used as slings, including muscular and fascial tissues, and synthetic materials (Table 1) [7 9]. Proponents of fascia may soon have the opportunity to use allograft collagen, which avoids the morbidity of harvesting autologous fascia, and the variability and infection risk of cadaveric fascia. Cell-free, cross-linked collagen isolated from human, bovine or porcine sources has been developed. Differences in processing account for differences in tensile strength, fibroblast ingrowth and susceptibility to collagenolysis. They have the advantages of being well tolerated, support fibroblast ingrowth and are biodegradable. The use of autologous fascia, rectus fascia, or fascia lata tissues has been shown to result in early high success rates of 92 95% in several studies [10]. The results are durable in some patients for >10 years. Complications have usually been minor, consisting of de novo instability and/or urinary retention. Urethral erosion has not been reported with autologous fascia. All of the autologous tissues currently used have certain limitations. Most importantly, autologous fascia needs to be harvested intraoperatively from either the patient s abdominal wall or the thigh. In addition to increasing the operative duration this results in a substantially larger incision for a rectus fascia sling or a second incision for harvesting a lata sling. This results in increased morbidity, including postoperative pain and wound complications, and a longer hospital stay [11]. Autologous fascia lata has been favoured by some as an alternative to rectus fascia [12]. The strength of the reconstruction will depend entirely upon the scar tissue left from the operation. It has been estimated that the risk of acquiring HIV infection from a properly screened donor is 1 in [13]. Mersilene (a polyester) was the first artificial material used as a sling to support vesicourethral function for continence [14]. Unfortunately Mersilene gauze was reported to erode [15]. The use of a synthetic sling avoids the morbidity of harvesting autologous fascia, and avoids the risk of infective disease transmission of cadaveric fascia. Furthermore, as it is not degraded, the tensile strength of the sling does not decrease with time. It may even increase, as scar tissue is formed by collagen deposition between the interstices of the graft [16]. As it avoids abdominal incision, the use of a synthetic sling allows surgery under spinal rather than general anaesthesia [17]. However, the reported rates of urethral and vaginal infection and erosion of these foreign bodies, at 2 23% [18], has been the primary deterrent to their universal acceptance. Vaginal erosions may present as early as 4 weeks after surgery, with no healing of the vaginal incision over the mesh [19] (Table 1), whereas urethral erosion may not occur until 8 months after surgery. Conservative excision of only the exposed part of the sling, with primary closure of the tissues and concurrent antibiotic therapy, has been successful in treating erosion without compromising the patient s continence. Thus, the complication of erosion may not be as fearsome as it was previously. One of the larger studies with polypropylene mesh was by Morgan et al. [20]. With a mean follow-up of 49.7 months and with 88 patients, they reported a cure rate of 85% with a 9% improvement rate. In an earlier series with up to 16 years of follow-up, with 290 Marlex slings with no fixation, they reported two patients with urethral erosion at 1 and 3 years after surgery. Thus long-term success is possible with a synthetic sling material, especially if adhering to the concepts of broad urethral support with no tension. Cure rates for cadaveric fascia are 60% or 71% [21] and 96% [22]. Long-term results with autologous fascia in one study [23] gave a 97% cure rate, while Amundsen et al. [24], using allograft fascia, reported a 63% cure rate. Comparative results between autologous and cadaveric fascia show similar postoperative symptom 2004 BJU INTERNATIONAL 93, doi: /j x x 665

2 Z.G. KASSARDJIAN scores and similar complication rates in two distinct studies [25,26]. Material costs are variable and there are no comparative studies on the cost effectiveness of different materials. SURGICAL PROCEDURES Various techniques have been described for sling surgery; the focus has been on decreasing the morbidity and improving durability and predictable success. Advances included using synthetic materials to decrease pain from harvest sites and to avoid biodegradation, limiting the dissection of the retropubic space, and avoiding an incision in the endopelvic fascia. What once required several days in hospital for convalescence can now typically be accomplished in <30 min under local anaesthesia and as an outpatient procedure. Pubovaginal slings restore urethral and bladder neck anatomy more to normality than any other procedure for stress urinary incontinence. Artificial graft materials which allow rapid tissue in-growth and revascularization appear to decrease the incidence of complications, and currently may still provide an excellent alternative. The surgical approach to stress incontinence requires a thorough knowledge of the anatomy of the pelvis. Deciding on the type of surgery to correct pelvic organ prolapse and/ or incontinence is one of the most difficult challenges facing the genitourinary surgeon. Obviously there is no single operative procedure, nor should there be, that will correct the types of disorders and associated pelvic pathology that the clinician may encounter during a lifetime of surgical experience. PATIENT SELECTION Proper patient selection should be based on a thorough history and physical examination, including a meticulous neurological assessment. Patients with significant anorectal symptoms and/or rectal prolapse need thorough investigations, which may include anorectal motility studies, before deciding for surgical correction. The principles of reconstructive pelvic surgery are based on a thorough understanding of the pelvic floor anatomy and physiology, and appreciation of the mechanisms involved in normal pelvic floor support, pelvic organ function and pelvic spaces [27]. Pelvic floor defects involve combinations of three compartments, i.e. the Natural Synthetic Rectus fascia (full length, patch) Gore-tex Fascia lata (autologous, allogenic) Nylon Dermis (porcine, human) Teflon Dura Prolene Other Mersilene Silastic Polyglactin mesh Marlex Complications, % Autologous grafts urethral erosions, 0 5 voiding dysfunction, 2 20 vaginal erosions, 0 16 long-term CIC, removal or revision, 1.8, 35 de novo detrusor instability, Allogenic cadaver grafts no higher erosion rates long-term material failure > 20 anterior, apical and posterior. Anterior compartment defects consist of urethrocele, cystocele (which may be lateral, central [posterior], or anterior) [28], and/or cystourethrocele. Apical vaginal prolapse (post-hysterectomy vault prolapse) and posterior vaginal prolapse (enterocele and/or rectocele) and their various approaches to pelvic floor reconstruction are outside the scope of this review. The treatment for all pelvic disorders rests on restoring functional anatomy, correcting site-specific defects and maintaining satisfactory continence and sexual function [29]. An established team approach with fully integrated services can be more effective and offers many advantages, including dynamic links between many disciplines [30]. Evidence-based treatment strategies are still lacking and there is little consensus on a standardized treatment approach in this area. The understanding of the pathophysiology of stress incontinence is still developing. For the present the focus has shifted towards the mid-urethral complex and on the intrinsic and extrinsic forces maintaining adequate closure pressures and urethral resistance. In the last few years there have been extraordinary modifications in the technique of sling surgery. Are all of these sling modifications comparable? The definitive answer is unknown but several important principles must be followed. First, the sling must be positioned in the retropubic space. This is done by perforating the endopelvic fascia and using a long enough graft to TABLE 1 Sling materials and the associated complications CIC, clean intermittent catheterization. Data compiled by [7 9]. extend into the retropubic space. If this material becomes scarred in the proper position in the retropubic space, the normal lattice-like anatomy of the endopelvic fascia will be restored. Slings that do not gain access to the retropubic space may be prone to failure if scarring does not restore posterolateral support. The minimum accepted period for assessing the results (success or failure) has generally been accepted to be a year, with 1 2 years representing the intermediate period and >2 years defining long-term results. Outcomes can be classified into those pertaining to voiding function/dysfunction and those which assess the correction of the anatomical prolapse. Stratification into cured, improved and failed is generally accepted, although criteria for assessing improvement may depend on some combination of factors assessed by the patient and investigator. Success also varies with the method of assessment, with many authors now stressing some combination of subjective and objective criteria to best define procedural success. A pubovaginal sling most precisely recovers the normal anatomy by restoring the posterior and lateral support of the urethra provided by the urethropelvic ligament and periurethral fascia. If a sling is created that enters the retropubic space the continuous hammock of support created by the sling most closely re-approximates the insertion of the periurethral fascia into the pelvic sidewall at the arcus (urethropelvic ligament). This BJU INTERNATIONAL

3 SLING PROCEDURES FOR URINARY INCONTINENCE IN WOMEN TABLE 2 Comparative outcome of synthetic slings and transvaginal tape procedures Variable Study [36] [20] [37] [38] [39] Material Mersilene Marlex Gortex TVT TVT No. of patients Mean follow-up, months % cure/improved / /9.6 % de novo urge symptoms NR % urinary retention %vaginal erosion 2 NR % urethral erosion NR, not reported. eliminates urethral hypermobility and augments proximal urethral resistance [31]. SUBURETHRAL SLING VS OPEN ABDOMINAL RETROPUBIC SUSPENSION The AUA stress urinary incontinence clinical guideline panel concluded that pubovaginal slings and retropubic suspensions are the most effective in managing stress urinary incontinence [8]. There are few data comparing slings directly with retropubic suspensions, but slings have given success rates similar (or better) than retropubic suspensions in more difficult groups of patients [32]. Fixing the suspending sutures using anchors has been reported to enhance the durability of the repair. However, there are no data showing improved outcomes using bone anchor fixation. Placing anchors facilitates a complete transvaginal approach to slings but there are concerns that the graft may not be long enough to form an eschar in the retropubic space. Carbone et al. [33] noted a high failure rate in >100 patients when using a transvaginal bone anchor-based system. The addition of anchors increases the costs of the procedure. The reported incidence of urinary retention for >4 weeks after surgery was 5% for retropubic and transvaginal suspensions, and 8% for sling procedures (no statistical difference) [34]. SUBURETHRAL SLING VS NEEDLE SUSPENSION One trial compared Stamey needle suspension with a porcine dermis sling [35] but it was small, with only 10 women in each arm. The women were unsuitable for open abdominal retropubic suspension (the author s preferred procedure) because they had vaginal narrowing secondary to either previous interventions or atrophic vaginitis. Although the trial was too small to address differences in cure rates, sling operations were associated with higher complication rates (nine vs two). ONE TYPE OF SUBURETHRAL SLING VS ANOTHER These are listed in Table 2 [20,36 39]. Both the tension-free vaginal tape (TVT) and the suprapubic arc (SPARC) procedures rely on nonabsorbable polypropylene mesh to support the mid-urethra. The techniques differ in the passage of the mesh sling. The TVT procedure requires the passage of needle passers from the vaginal incision up through the suprapubic skin, while the SPARC relies on innovative needle carriers that are passed from above through small suprapubic incisions down through the vaginal incision. By minimizing dissection they probably reduce the risk of nerve and tissue damage. Both procedures are same-day surgery and can be done under local anaesthesia to monitor the effects of the increased urethral support. Patients with intrinsic sphincteric deficiency frequently respond to pubovaginal slings and, most recently, to techniques such as TVT and SPARC, which are placed at the level of the mid-urethra. The origin of TVT studies is Europe (71%), USA (23%) and others (6%), as assessed using Medline; all TVT studies were of cohorts. Including both subjective and objective criteria for cure or significant improvement, the results varied from 82% to 96% in recent series [9,37 39]. In the same series, TVT complications include de novo detrusor instability (up to 26%), obstruction (2 8%), bladder perforation (7 19%) and urethral erosion. Haemorrhage usually did not require transfusion and pain occurred at the site of pelvic haemorrhage. The two-stage intravaginal slingplasty (IVS) [41] uses two longitudinal paraurethral incisions in the anterior vaginal wall and a small abdominal skin incision, just behind the pubic symphysis, which is then carried down to the rectus sheath. The suburethral vaginal hammock is tightened by suturing deep into the anterior portion of the pubococcygeus muscle on either side. A multicentre trial of IVS with a critical analysis of results, surgical methods and complications gave a cure rate of 81% (using Nylon tape) to 91% (using polypropylene tape). Tape rejection was 7% for Nylon and zero for polypropylene [42]. The transobturator tape has two original features; its unwoven polypropylene structure is coated with silicone on the urethral surface to limit retraction of polypropylene and to establish a barrier to extension of periurethral fibrosis; also the transmuscular insertion, through the obturator and puborectalis muscles, reproduces the natural suspension fascia of the urethra while preserving the retropubic space. A preliminary study [43] confirmed the feasibility of this surgery, the low morbidity and the encouraging results. The MONARC sling system relies on polypropylene mesh and is derived from the SPARC device. The primary change is the needle, which is spiral instead of curved. The sling mesh and absorbable suture remain the same. Further studies are awaited. DISCUSSION Numerous materials are available for use in a suburethral sling. The use of graft substitutes has flourished in recent years. Cadaveric fascia lata was initially used with success. As the advantages of decreased hospital stay and postoperative discomfort became obvious, the availability of cadaveric fascia became a problem, leading to the development of alternative biological sling material. Several large series documented equal efficacy of biological sling materials and autologous fascia. However, there are reports of increased failure rates using biological sling materials. Concerns over early failures of biological 2004 BJU INTERNATIONAL 667

4 Z.G. KASSARDJIAN materials led to a renaissance in the use of synthetic material. Emphasizing minimal tension, minimally invasive sling procedures using polypropylene mesh are yielding encouraging early results, but further longterm follow-up is needed. Major concerns about erosion into the urinary tract have diminished as a result of meticulous detail in placing the mesh through a small incision, and tying loosely below the urethra to avoid excessive tissue compression and ischaemia. There are reports of the failure of allograft material and a very small incidence of urinary tract erosion of the mesh slings. In general, autologous material is associated with a greater success and cure rate and fewer complications than cadaveric material [44]. The ideal synthetic material for pelvic surgery has yet to be developed, but new information from molecular biology will contribute to defining new materials and ameliorating the management of related dysfunctions. Many different techniques are described for sling surgery and differences can be classified by the surgical approach and the material used as the sling. Placing autologous, heterologous or synthetic material beneath the urethra increases urethral compression and provides a plate for receiving the transmitted intraabdominal pressure to the bladder neck and proximal urethra. Except for two studies [38,45] the included trials were small with a short follow-up. There are no trials comparing suburethral slings with conservative management, anterior repair, laparoscopic retropubic suspension, peri-urethral injections or artificial sphincters. Also, there are no trials with slings made of vaginal wall, fascia lata or cadaveric fascia. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population [46]. The inclusion of women whose symptoms have significantly improved with those who are cured is common. The broader effects of suburethral slings could not be established as trials did not include appropriate outcome measures, e.g. general health status, health economics, pad-testing, third-party analysis and time to return to normal activity level. The AUA guidelines panel and other reviews have found inconclusive data to recommend any one procedure [8]. The prototype IVS appears to be no longer used and has been superseded by the two-stage IVS and the TVT procedure [41]. The two-stage IVS has apparently been modified to incorporate a third component involving fixing the external urethral meatus to the pubic bone [41]. Preliminary results from a larger trial and the long-term results of the TVT provide reassuring evidence about the performance of the less invasive TVT sling procedure [45]. CONCLUSION Publications on sling procedures are extensive; there are many deficiencies in the studies which make it difficult to compare the relative merits of the numerous procedures described. Case selection is varied and often not well described. The assessment before and after surgery varies from full urodynamics, including pad-tests, to symptom review alone. The surgical technique and perioperative complications are often omitted. Cure is defined in many different ways, both subjectively and objectively. Preliminary results provide evidence about the performance of the TVT sling procedure; cure rates after TVT were similar to those after open abdominal retropubic suspension but long-term results are awaited. The data are too few to address whether other types of suburethral slings are as effective as open abdominal retropubic suspension. Data for comparison with needle suspension were inconclusive because they came from a small and atypical population. No studies were identified which compared sling procedures with anterior vaginal repair or laparoscopic retropubic suspensions, nor different techniques of sling procedures with each other. There is no evidence that suburethral slings may be better or worse than other surgical or conservative management because no trials have addressed these comparisons. There is limited evidence that slings made of Goretex have more complications than slings of rectus fascia. Long-term data suggest that sling procedures, using autologous or synthetic materials, produce a cure rate of ª80% and an improvement rate of 90%. There are more results which show that autologous material is associated with a higher cure rate and fewer complications than cadaveric material, but there is a need to scientifically study whether the choice of material influences outcome. The technical demands on the surgical approach are the accurate placement of the sling beneath the bladder neck and proximal urethra, with a broad base of compression and a simple and safe passage of the ends of the sling through the retropubic, extra-vesical space for attaching the rectus fascia or pubic bone with no excessive tension that could provoke permanent urinary retention or intractable detrusor instability by obstructing the outlet. The aim is coaptation of the urethra and not obstruction. The optimum surgical approach should minimize the risk of damage to the bladder neck, proximal urethra and vagina. The surgical treatment of stress incontinence must improve the quality of life, with minimal morbidity, a long-term effect and low cost. The ideal surgical procedure will augment urethral resistance during sudden increases in intra-abdominal pressure without preventing normal decreases in urethral pressure during voiding. There is an urgent need for further trials to assess the effectiveness of suburethral slings compared with other conservative management, surgical techniques and different types of slings, and in specific populations. Valid and reliable data on the frequency of complications after surgery are lacking. Second and subsequent operations to correct stress incontinence are less successful than initial procedures, but relevant studies have not taken confounding factors into account. In particular, trials should incorporate quality-of-life, psychological and economic outcomes. The ideal treatment for female stress urinary incontinence has yet to be determined. ACKNOWLEDGEMENTS I express my thanks to Ajami Imperia and Rady Dolly for editorial assistance. REFERENCES 1 Barrett D, Wein AJ. Voiding dysfunction. diagnosis, classification and management. In Gillenwater JY, Grayhack JT, Howards ST, Duckett JW eds Adult and Pediatric Urology. Chicago: Year Book Medical, 1987: Goebell R. 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6 Z.G. KASSARDJIAN 46 Glazener CMA, Cooper K. Anterior vaginal repair for urinary incontinence in women (Cochrane review). The Cochrane Library.; Issue 3. Oxford: Update Software, 2000 Correspondence: Z.G. Kassardjian, St.Elie Center Bloc A 5th floor, Antelias, Lebanon. zgk@dm.net.lb Abbreviations: TVT, tension-free vaginal tape; SPARC, suprapubic arc; IVS, intravaginal slingplasty BJU INTERNATIONAL