New Procedures for Pelvic Floor Repair: Progress or ...

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Ziegler + Müller Herst. Baurenschmidt Datum 13.06.2008

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New Procedures for Pelvic Floor Repair: Progress or Propaganda? n please add headline in German

Authors

J. B. Gebhart, E. C. Trabuco

Affiliation

Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA

Schlüsselwörter " n l

Abstract

Zusammenfassung

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New procedures and new materials are introduced annually to the gynecologic surgeon, with the implication that new is better. Although often this implication may be the case, most new products and procedures lack clinical outcome and safety data over a clinically relevant period. In addition, products may have substantial differences in their makeup – synthetic, biologic, or other characteristics – that make direct comparisons inaccurate or impossible. We review why pelvic organ prolapse occurs and why procedures fail, and we summarize available data on restorative and compensatory surgical procedures, in attempting to determine whether new procedures for pelvic floor repair represent progress or propaganda.

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Introduction

The estimated annual societal cost of prolapse repair in the United States exceeded 1 $ billion (USD) in 1997 [7]. Projections by the US Census Bureau show that the number of US women older than 65 years will double in the next 25 years [8, 9], and further estimates suggest that health care services for pelvic floor disorders will increase at twice the rate of the population [10].

Key words " biomaterials l " gynecologic surgical l procedures " pelvic floor l " prolapse l " surgical mesh l

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received accepted

9. 5. 2008 20. 5. 2008

Bibliography DOI 10.1055/s-2008-1038708 Geburtsh Frauenheilk 2008; 68: 1 – 9 © Georg Thieme Verlag KG Stuttgart • New York • ISSN 0016-5751 Correspondence John B. Gebhart, MD, MS Department of Obstetrics and Gynecology Mayo Clinic 200 First Street SW Rochester, MN 55905 USA [email protected]

“If a study of the history of medicine reveals anything, it reveals that clinical judgment without the check of scientific controls is a highly fallible compass.” (Arthur Schafer [1]) Pelvic organ prolapse is a common disorder of parous women and can greatly affect their quality of life. Data show that nearly half of all women older than 50 years in Sweden and nearly twothirds of older women in Iowa (USA) are affected [2, 3] and an estimated 11.1% of women will undergo a pelvic reconstructive operation during their lifetime [4]. An estimated 200 000 surgical procedures are performed annuallyn? in the United States alone because of symptomatic prolapse [5]. Yet, 6 to 29% of women who undergo pelvic floor repair will require an additional surgical procedure because of recurrence of the prolapse, and the time interval between repeat procedures will decrease with each successive repair [4, 6].

Overview !

“One of the chief defects in our plan of education in this country is that we give too much attention to developing the memory and too little to developing the mind; we lay too much stress on acquiring knowledge and too little on the wise application of knowledge.” (Dr. William J. Mayo) Who is most at risk of pelvic organ prolapse? Bump and Norton [11] proposed that risk factors for prolapse can be viewed as those factors that predispose, incite, promote, or cause pelvic floor

Gebhart JB and Trabuco EC. New Procedures for … Geburtsh Frauenheilk 2008; 68: 1 – 9

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decompensation. Factors that predispose decompensation include race (white more than African American), sex (female more than male), and genetics (e.g., hereditary connective tissue disorders). Factors that incite decompensation include vaginal parity, prior pelvic surgery, myopathy, and neuropathy. Those that promote decompensation include smoking, obesity, and medical conditions (e.g., constipation, chronic cough), as well as occupational status (e.g., work that involves heavy lifting). Finally, factors that cause decompensation over time are menopause, aging, myopathy, neuropathy, and debilitation [9,11 – 13]. What constitutes pelvic organ prolapse? Physicians all know that the prolapse represents a “falling”, or descent, of the uterus (or the vaginal vault after the uterus has been removed), anterior vaginal wall (bladder), or posterior vaginal wall (rectum). Although physicians may observe the prolapse on physical examination, the patient may be asymptomatic, and, thus, symptoms are not well correlated with physical findings [3]. Various grading and staging systems have been used to more objectively quantify or quantitate the degree of prolapse. The 2 systems most commonly used in the United States are the Baden-Walker and the Pelvic Organ Prolapse Quantification systems [14,15]. It is generally accepted that most anatomical failures after surgical intervention are typically defined as stage 2 (between 1 cm above and 1 cm below the hymen) or greater.


gen I/(III + V). This decrease in collagen may both compromise tensile strength and increase susceptibility to prolapse [20]. Zong et al. [21] also found that only the combination of 17b-estradiol and progesterone decreased the active form of matrix metalloproteinase-1, which suggests that both hormones are necessary to maintain the integrity of the female pelvic floor. In cases of younger patients with advanced-stage prolapse, physicians should keep in mind the less common causes, such as inherited connective tissue disorders.

Trauma It is generally well accepted that factors such as vaginal birth (parity), obesity, increased intra-abdominal pressure (e.g., coughing, straining, lifting), and chronic constipation contribute to repetitive force injury of the pelvic floor over time, with parity showing the strongest relationship [13]. For a large percentage of women, symptoms may not manifest acutely at the time of injury. Whether the pelvic floor is able to compensate for a period of time after an acute injury or tear or whether the patient makes physical or lifestyle changes to adapt to the injury is not clear. It is apparent, however, that tissue trauma combined with changes in the architectural structure of myofascial support brought on by aging, hormonal changes, and various disease states ultimately lead to support failure.

Technique Why Procedures Fail – the 3 Ts !

“We all hope our results are better than they are.” (Dr. Richard W. TeLinde [personal communication]) When evaluating patients in the office, whether preoperatively or postoperatively, physicians need to consider why the patients have prolapse or why their surgical procedures sometimes fail. We have concluded that most prolapse (or recurrence of prolapse) probably occurs because of one or more of the 3 Ts – tissue, trauma, and technique – and, possibly, stage.

Tissue What happens to tissues as they age? The nature of connective tissue and extracellular matrix changes over time. Matrix metalloproteinases are normally expressed throughout the body and cleave various extracellular matrix components, including collagen and other noncollagenous glycoproteins. Data suggest that tissue from patients with pelvic organ prolapse shows a substantially greater amount of protease activity than tissue from controls without prolapse [16]. This molecular alteration may have a role in pelvic organ prolapse by contributing to degradation of the extracellular matrix. Moalli et al. [17] found an increase in both collagen III and active matrix metalloproteinase-9 expression in the vaginal tissues of patients with prolapse, suggesting that vaginal tissue is actively remodeled under the biomechanical stresses associated with prolapse. Other investigators have also found that genitourinary prolapse is associated with a reduction in total collagen content and a decrease in collagen solubility [18]. What changes are induced by the onset of menopause? We have previously shown that substantial differences exist between premenopausal women and postmenopausal women in the presence and expression of estrogen receptor a and estrogen receptor b in vaginal tissue [19]. Menopause in the absence of hormone replacement therapy is associated with a decrease in quantity of collagen I, resulting in a decrease in the ratio of colla-

A seldom discussed topic, but one that contributes a far greater role in the etiology of recurrent prolapse than physicians like to admit, is whether surgeons are failing in the execution of their surgical procedures for prolapse repair [22]. Reconstructive surgeons must understand the nature of this condition and how to address it effectively, using various surgical approaches while simultaneously maintaining function and support. Extirpative surgery has well-defined approaches. Reconstructive surgical technique for the pelvic floor, however, has a less welldefined dogma. Great debate continues over such issues as where the defect is – midline, lateral, or transverse – for both anterior and posterior compartments and what is the best surgical approach for apical, anterior, and posterior compartment defects. If this confusion is combined with residency training requirements in the United States that deemphasize surgical experience and repetition, then one must acknowledge that poor training results in poor surgical technique and execution and is a noteworthy factor in why procedures fail.

Stage Is there an optimal stage of prolapse at which to operate? Do patients with repair of stage 2 prolapse have less recurrence than patients with repair of stage 3 or stage 4 prolapse, when matched for age, parity, surgical procedure, and other characteristics? Is stage 4 prolapse beyond repair, or at least beyond functional repair? Does stage 4 prolapse represent less healthy tissue or simply end-stage disease? Little evidence guides us about the optimal time to intervene. It has been our experience that most patients with stage 4 prolapse are elderly and have avoided surgical or medical intervention because, as they report, the prolapse did not cause many symptoms until they had bleeding. Certainly, in addition to having substantial myofascial defects and myopathy, these patients also have neuropathy. Ultimately, what initiates and promotes pelvic organ prolapse is multifactorial – the 3 Ts.



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New Procedures vs. Old Procedures !

In the study of some apparently new problems we often make progress by reading the work of the great men of the past…” (Dr. Charles H. Mayo) Weber and Richter [9] described surgical procedures for treating pelvic organ prolapse as 1) restorative (using the patient’s own tissues), 2) compensatory (using some type of graft to replace deficient support), and 3) obliterative (involving closure of the vagina). Because obliterative procedures constitute a small percentage of cases in a select group of patients, we focus on a review of data on restorative and compensatory procedures. First, though, we discuss the role of hysterectomy in treatment of prolapse. Hysterectomy is considered a risk factor for subsequent pelvic organ prolapse [13, 23]. This concept is controversial, however. Data from Blandon et al [6] showed that the indication for the hysterectomy (a nonprolapse indication vs. a prolapse indication) correlates with the risk of a future operation for prolapse recurrence. Patients who have a hysterectomy because of symptomatic prolapse are more likely than patients who have a hysterectomy without prolapse to require a subsequent surgical procedure for prolapse [6], especially if other areas of prolapse are not addressed at the time of hysterectomy. Furthermore, longitudinal data in consideration of a 30-year follow-up showed that, when a prophylactic culdoplasty is combined with hysterectomy, risk of future reconstructive surgery is less [6]. Thus, we recommend that a culdoplasty be performed at hysterectomy, to reduce the rate of future intervention for prolapse.

Restorative Procedures !

Anterior Compartment The success rate of anterior colporrhaphy for the management of anterior compartment prolapse ranges from 80 to 100% in retrospective series [24]. However, 2 randomized trials conducted with various techniques reported far less success: 42 and 57%, respectively [25, 26]. Weber et al. [26] did not find significant differences in cure rates for cystocele when comparing standard midline repair, ultralateral repair, and standard midline repair with a polyglactin mesh inlay at a mean follow-up of 24 months. Abdominal paravaginal defect repair was popularized by Richardson et al. [27], who described a 97% success rate in their case series. Other series report a success rate of 76 to 97% [28 – 30]. Laparoscopic techniques for performance of this procedure are well described, but little data exist about their outcomes. No trials have compared anterior repairs with abdominal paravaginal repair in the management of anterior compartment prolapse. The vaginal approach to paravaginal defect repair has also been advocated; yet, concerns about the morbidity of this approach have been noted. Success rates of 67 to 99 % have been reported in some studies, all of which had a follow-up of 3 years or less [30 – 32]. Bleeding complications resulting in transfusion have been noteworthy in 2 series, with Young et al. [32] reporting a 16% transfusion rate in their series of 100 patients [31]. No case-control trials or randomized trials exist about paravaginal defects that were treated surgically. Evaluation of much of the data on anterior colporrhaphy is difficult because various procedures (i.e., midline plication; vaginal paravaginal, abdominal paravaginal, and laparoscopic paravaginal repair; retropubic urethropexy; and a combination thereof)

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were performed, and outcome measures and follow-up differ. As previously mentioned, great debate continues about the site of the defect and, therefore, about the best surgical approach to address it.

Posterior Compartment Many of the difficulties in the evaluation of outcomes from treatment of anterior compartment prolapse also apply to the evaluation of outcomes from treatment of posterior compartment prolapse. Various approaches are advocated (e.g., midline plication, site-specific defect repair, transanal repair). In 2 small series, traditional midline plication was reported to have excellent anatomical outcomes and to improve obstructive defecation symptoms in more than 80 % of patients with follow-up of at least 12 months [33, 34]. Transanal repair (typically advocated by colorectal surgeons) has been compared with transvaginal repair in 2 randomized trials [35, 36]. Both trials showed that the transvaginal approach was more effective in symptom relief and recurrence. Levator ani plication, in which the medial portion of the puborectalis muscle is plicated, can result in excellent anatomical outcomes but is associated with a high rate of dyspareunia. Thus, it has been largely abandoned, unless it is used in an obliterative procedure. Richardson [37] also popularized the concept of isolated breaks in the rectovaginal fascia, termed site-specific defects, and recommended repair of only these isolated defects. Several studies have reported excellent anatomical outcomes, combined with improvement in sexual function, after site-specific defect repair [38 – 40]. However, these same studies reported that the procedures improved symptoms of obstructed defecation by only 35 to 50 %. In 1 nonrandomized retrospective trial comparing midline plication with site-specific defect repair, recurrent prolapse was more common in the site-specific repair group (33%) than in the midline plication group (14%) at 1 year [41]. No randomized trials compare midline plication with site-specific defect repairs [42].

Apical Compartment For the purposes of this review, we focus on the treatment of posthysterectomy apical prolapse (enterocele). A number of vaginal procedures have been described to address the apex, among them sacrospinous ligament fixation, uterosacral ligament suspension, and iliococcygeal suspension. Sacrospinous ligament fixation has been reported to have high success rates [43]. Both unilateral and bilateral techniques have been described. Subsequent reports, however, have described high rates of anterior vaginal prolapse, thought to result from the posterior angulation of the vaginal apex with this technique [42]. Buttock pain may occur (thought to arise from pudendal nerve irritation or entrapment) and may require reoperation. Hemorrhage also may result from injury to the pudendal or inferior gluteal vessels and may be difficult to control, given the limited access. Uterosacral ligament suspension has also been reported to be highly successful, with recurrence rates of 4 to 18% in several case series [43 – 46]. This procedure has been the preferred treatment for vaginal vault prolapse at Mayo Clinic for several decades, and several case series from our institution have been published [45 – 49]. Our approach combines techniques described by Moschcowitz [50], Torpin [51], Waters [52], and McCall [53] and has been previously described [47, 49 – 51]. It is


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unknown whether this procedure is superior to sacrospinous ligament fixation, because the 2 procedures have never been compared in a randomized trial. Cystoscopy should be performed intraoperatively, because ureteral obstruction has been reported to be as frequent as 11% with uterosacral ligament suspension [43]. Iliococcygeal suspension involves attachment of the apex bilaterally to the iliococcygeal muscle and fascia, and good success has been reported [54]. This procedure is less commonly performed than the previously mentioned procedures, and no randomized or controlled trials of iliococcygeal suspension have been done. Abdominal sacrocolpopexy is discussed in the following section. Three randomized trials were analyzed in a 2007 Cochrane review (55) of surgical management of pelvic organ prolapse [33, 56, 57]. The abdominal approach had less failure at the apex and less dyspareunia but was associated with more complications, more operative time, and longer patient recovery [55].

Compensatory Procedures !

When a surgeon is considering compensatory procedures for prolapse treatment, it is incumbent on the surgeon to 1) have knowledge about the options available (to know the pros and cons of each), 2) have the technical expertise to use the materials, and 3) have the ability to recognize and deal with complications associated with placement. We first discuss the grouping of available materials. Synthetic meshes are available as both resorbable materials (e.g., polyglactin 910 [Vicryl; Ethicon Inc, Somerville, New Jersey]) and nonresorbable materials (e.g., polypropylene [Marlex; C. R. Bard Inc, Murray Hill, New Jersey]) and polytetrafluoroethylene PTFE (Gore-Tex; W. L. Gore, Flagstaff, Arizona). This class of material has been used extensively in ventral hernia repair, but complications of infection and mesh erosion, especially with the transvaginal route of implantation, have prompted a search for alternative materials. Autografts are autologous materials harvested from the patient for use during the procedure. The materials typically used include fascia lata and rectus fascia. They have been used since the 20th century and yield excellent results. However, morbidity associated with harvest of the materials (pain, bleeding, theoretical risk of infection, and hernia formation) has limited their use. Allografts are processed cadaveric fascia lata or acellular extracts of collagen harvested from the dermis of human donors. Although tissue banks in North America are accredited through the National Association of Tissue Banks, the harvesting, processing, and preservation of these materials are varied and are proprietary, making rigorous comparisons a challenge. The human donors are screened, and those donors with a high-risk history or who test positive for human immunodeficiency virus, syphilis, human T-lymphotropic virus, hepatitis B, or hepatitis C are excluded. Proprietary processes are used to render the allograft nonimmunogenic. Although no infection associated with the use of this class of grafts has been reported, the theoretical risk of transmission exists. Furthermore, limited donor availability and increased demand can lead to supply shortages of allografts. Xenografts are acellular extracts of collagen, with or without additional extracellular matrix components, that are harvested from nonhuman sources. They differ in the species used (bovine


origin or porcine origin), the site of harvest (pericardium, dermis, or small intestine submucosa), and whether chemical cross-linking is used in processing the material [58, 59]. It is not clear whether the inherent architectural difference among harvest sites (e.g., dermis with high-elastin content compared with intestinal submucosa with no elastin content) affects in vivo response. Similar to allografts, bovine-derived xenografts pose a theoretical risk of infection (e.g., bovine spongiform encephalopathy). Trabuco et al. [58, 59] have published a comprehensive review of xenografts and reconstructive materials in surgical procedures for pelvic organ prolapse and urinary incontinence in women. The review details the histologic behavior of each of these classes of graft materials.

Clinical Considerations !

Numerous synthetic, autologous, allograft, and xenograft materials are on the market today; however, there is a paucity of data justifying their use over suture plication repairs. Placement of these materials can be accomplished via vaginal or abdominal approaches. With the vaginal approach, the graft can be used to augment a suture plication repair (i.e., mesh overlay), or it can directly bridge the fascial gap. Furthermore, the graft can be secured to fascial structures (i.e., pubocervical fascia or the arcus tendineus fasciae pelvis) or placed tension-free with or without the use of commercially available “kits” that use blind trocar passage to assist in graft placement. The use of grafts in reconstructive pelvic surgical procedures seems to center primarily on correction of anterior and posterior compartment defects. None of the commercially available kits are designed specifically for apical support. Correction of the apical compartment can be addressed in various ways, including transvaginal suspension of the apex to the uterosacral ligaments or to the sacrospinous ligament(s) and abdominal sacrocolpopexy. It is technically challenging to place the kit trocars into these ligaments. The use of overlay grafts that are secured to these structures by sutures placed under direct visualization represents a theoretical advantage to the later approach. Both the optimal approach and material to use and whether graft use decreases prolapse recurrence after vaginal repair are unknown. More importantly, limited information is available to guide clinical decision making and patient counseling about the function of the pelvic floor and vagina (i.e., sexual, urinary, and bowel function) after graft augmentation.

Compensatory Vaginal Approaches !

Synthetic Results are conflicting about the use of absorbable mesh in vaginal surgery. Sand et al. [25] randomly assigned 161 women to anterior repair or anterior repair augmented with polyglactin 910 (Vicryl) mesh. At 1-year follow-up, the within-protocol analysis showed no difference in prolapse to the midvaginal plane between the groups (p = 0.20). However, more women with recurrent stage 2 or stage 3 prolapse were in the no-mesh group compared with the women in the mesh group (p = 0.02 and 0.04, respectively). No mesh-related complications were reported.



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By comparison, Weber et al [26] randomly assigned to standard anterior colporrhaphy women who had symptoms and anterior compartment prolapse of stage 2 or greater and did not require a concomitant urinary incontinence operation (n = 37), ultralateral anterior colporrhaphy (n = 39), or standard anterior colporrhaphy with polyglactin 910 (Vicryl) mesh overlay (n = 38). At 1-year follow-up, there was no difference between anterior compartment cure rates (defined as optimal [Aa or Ba at – 3 cm {stage 0}] or satisfactory [Aa or Ba < – 2 cm {stage 1}] anterior compartment prolapse) between groups with an intention-totreat analysis. The within-protocol analysis found no difference in cure rate at a median follow-up of 23.3 months. However, differential and noteworthy loss to follow-up (5.4 % for standard anterior colporrhaphy, 38.5 %, ultralateral anterior colporrhaphy, and 23.7 %, standard anterior colporrhaphy with mesh overlay) led to underpowering of the within-protocol analysis. One woman required mesh removal during follow-up. Differences in cohort makeup (Sand et al. [25] allowed concomitant incontinence repairs whereas Weber et al. [26] did not) and surgical methodology (Sand et al. [25] placed mesh beneath the pubocervical fascia compared with Weber et al. [26], who used a fascia overlay) make it difficult to compare the 2 studies. Ever since Julian [60] introduced synthetic, nonabsorbable grafts (e.g., polypropylene [Marlex]) to repair recurrent, anterior compartment defects in 1996, gynecologic surgeons have been experimenting with this class of material in the hope of lowering recurrence rates of prolapse. Unfortunately, there is still no consensus about the type of material to use (heavy, medium, or lightweight polypropylene), the approach to placing the graft (e.g., a graft overlay with or without midline plication, use of kits, a hand-fashioned graft specific to the patient, a transobturator or vaginal paravaginal approach), which patients should receive grafts (e.g., patients with recurrent versus primary prolapse, patients with or without concomitant hysterectomy), who should perform the procedure (general obstetrician gynecologist or urogynecologist), and whether synthetic graft–reinforced repairs improve outcomes compared with traditional approaches (and, if the reinforced repair improves anatomical outcomes, the morbidity associated with its use). de Tayrac et al. [61] reported a low rate of failure (defined as a prolapse of stage 2 or greater) of anterior (6.8% [9/132]) and posterior (2.6% [2/76]) compartment prolapses at 10 months in 143 patients who had a tension-free repair with low-weight (38 g/ m2), microporous polypropylene mesh (Pelvitex; C. R. Bard Inc, Covington, Georgia) (the material is coated with a hydrophilic film of atelocollagen, glycol, and glycerol). No midline plication was used, and the mesh was placed tension-free through either a retropubic or a transobturator approach. There were 9 mesh erosions, and, of the 69 female patients who were sexually active, 10 (14.5%) had de novo dyspareunia. Sivaslioglu et al. [62] randomly assigned patients with isolated anterior compartment prolapse (with no enterocele, rectocele, or stress urinary incontinence) (n = 90) to site-specific (n = 45) anterior repair or tension-free, transobturator mesh repair without midline pubocervical fascia plication (using a lightweight [38 g/m2], macroporous [0.4 mm] polypropylene mesh [Parietene; Sofradim Co, Trevoux, France]). The within-protocol analysis found higher rates of recurrence (defined as prolapse of stage 2 or greater determined by a nonmasked observer) in the sitespecific repair (12/32) than in the mesh repair (4/43) (p = 0.004). Three (7 %) patients among 43 patients had mesh erosion.

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Hiltunen et al. [63] randomly assigned 202 female patients with symptomatic anterior wall prolapse (without concomitant stress urinary incontinence or apical defect requiring surgical repair) or for whom the main prolapse characteristic was restricted to the posterior compartment to either anterior colporrhaphy (n = 97) or mesh-reinforced repair (n = 104). The polypropylene (Parietene) graft was hand-tailored in the shape of a central trapezoid with 4 arms of approximately 3 cm each in length and used to reinforce the anterior repair after midline pubocervical connective tissue plication. The arms were secured in place via 4 tunnels (2 superior tunnels extending toward, but not penetrating, the obturator membrane and 2 inferior tunnels extending toward the ischial spines). In 60 % of the patients, the mesh was not secured in place (other than with eventual scarring of the arms in the tunnels); in the other patients, the mesh was fixed with 1 to 3 absorbable sutures. At 1-year follow-up, the within-protocol analysis showed a higher rate of recurrent prolapse (defined as anterior compartment prolapse of stage 2 or greater) in the anterior colporrhaphy group than in the mesh-reinforced anterior repair group (38.5 [37/96] vs. 6.5% [7/104]; p = 0.002). However, patients in the mesh group had longer operative times than the no-mesh group (58 ± 26 min vs. 73 ± 26 min; p = 0.001), and there was an increased tendency for blood loss of greater than 400 mL in the mesh group than in the no-mesh group (10 vs. 3%, respectively; p = 0.07). Of 104 patients who received the mesh, 18 (18.6 %) patients had mesh erosion during follow-up. Interestingly, 12 of the 18 mesh erosions occurred in patients with concomitant hysterectomy. de Tayrac et al. [61] also observed an increased risk of mesh erosion (which approached statistical significance [p < 0.09]) after tension-free mesh anterior repair with concomitant hysterectomy versus without concomitant hysterectomy (10.5 vs. 3.5 %). Although the emerging data on synthetic augmented repair appears promising, caution is advised against widespread use of this material because long-term safety and efficacy data are lacking. Both the Hiltunen et al. trial [63] and the Sivaslioglu et al. trial [62] showed statistically significant improvement in anatomical outcome. However, the lack of outcome assessment by a masked observer may have introduced ascertainment bias that led to the observed differences. Furthermore, the trials were performed in a subset of patients without concomitant apical prolapse [63] or stress urinary incontinence [62, 63], limiting the generalizability (i.e., the external validity) of the findings. More importantly, although patients had to have either no stress urinary incontinence or mild stress incontinence that did not require surgical intervention for inclusion in the Hiltunen et al. trial [63], 26 % of patients had persistent stress incontinence at 1year follow-up. Among patients with mild stress urinary incontinence symptoms at presentation, only 1 (10 %) of 10 patients had persistent urinary incontinence at 1 year in the no-mesh group compared with 8 (42 %) of 19 patients in the mesh group (p = 0.04). Finally, data are insufficient on the morbidity associated with the use of transvaginal mesh. Whereas these studies quote relatively low rates (< 10 %) of erosion, which is reported as mild and easily remedied, a growing body of evidence reports severe mesh-related complications. Blandon et al. (unpublished data) have reported a series of patients referred to Mayo Clinic with mesh-related complications. These complications include dyspareunia precluding intercourse and refractory response to estrogen treatment, chronic pain requiring narcotic therapy, fistula, chronic erosion, and multiple reoperations. Because the patients were referred, it was not pos-


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sible to ascertain how common these complications are. Nevertheless, given the highly morbid nature of the complications, it is important to conduct longer trials and postimplantation monitoring to evaluate their incidence. The importance of postimplantation tracking is highlighted by the fact that only 9% of the women referred for severe mesh-related complications were referred by the surgeon who performed the original mesh implantation.


anatomical failure (defined as point Ba > – 1 cm) than participants who had anterior repair with the porcine dermis augmentation (7/98 [7 %]). One patient required graft removal at 1 month in the porcine dermis augmentation group. No xenograft comparative trials have been published. It is yet to be determined whether, and how, xenograft augmentation impacts anatomical outcomes after reconstructive surgery. More importantly, little is known about how these materials ultimately affect vaginal function.

Allograft Although allografts have been used successfully in orthopedic, oral, and plastic surgery, few data are available on the use of this class of material in vaginal reconstruction. Gandhi et al. [64] randomly assigned 100 patients to either traditional anterior colporrhaphy or anterior colporrhaphy with human tissue graft overlay (Tutoplast; Tutogen Medical Inc, Alachua, Florida) (attached to the lateral-most aspect of the pubocervical fascia). The 2 groups did not differ in survival free of recurrent prolapse, which suggests that allograft augmentation after anterior repair had no effect on the rate of recurrence. Clemons et al. [65] had a 41% (13/33) rate of anatomical recurrence (defined as prolapse of stage 2 or greater) at a median follow-up of 18 months after using an overlay of acellular dermal matrix (AlloDerm; LifeCell Corp, Branchburg, New Jersey) (attached to arcus tendineus fascia pelvis) to repair recurrent stage 2 or primary stage 3 or stage 4 anterior wall prolapse. These data suggest that allograft-reinforced repairs did not improve surgical outcomes after vaginal reconstruction. Further well-designed, large clinical trials are needed to assess this class of materials in vaginal reconstructive surgery.

Autograft There are no reported uses of fascia lata or rectus fascia autografts in vaginal reconstructive surgery.

Xenograft Trabuco et al. [59] reviewed the medical literature on xenograft use in reconstructive surgery. Unfortunately, most published literature consisted of small case series with noncomparative arms and short-term follow-up. Recently, 2 randomized trials with conflicting results have been published. Paraiso et al. [66] randomly assigned patients with symptomatic posterior vaginal wall prolapse of stage 2 or greater to 3 arms: traditional posterior colporrhaphy (n = 37), site-specific repair (n = 37), and sitespecific repair with augmentation of chemically cross-linked porcine small intestine graft (FortaGen; Organogenesis, Inc, Canton, Massachusetts) (n = 32). Anatomical failure was defined as posterior wall descensus of stage 2 or greater (as determined by a masked research nurse). Anatomical failure occurred more often and sooner in the site-specific arm augmented with the porcine small intestine graft than in the traditional posterior repair group – an occurrence of 22.2 % (6/27) versus 14.3% (4/28) and a 48% recurrence by 15 months versus a 15% recurrence by 30 months, respectively. Conversely, in a multicenter trial, Meschia et al. [67] randomly assigned female patients with symptomatic anterior wall prolapse of stage 2 or greater to anterior colporrhaphy with (n = 106) or without (n = 100) augmentation with a chemically cross-linked porcine dermis (Pelvicol; C. R. Bard Inc, Covington, Georgia). The graft was attached to the lateral pubocervical fascia after midline plication. At 1-year follow-up, a greater proportion of patients in the anterior-repair arm (20/103 [19%]) had

Compensatory Abdominal Approaches !

Synthetic Although mesh sacral colpopexy is regarded as the gold-standard operation for apical prolapse, the reported success rates vary from a range of 78 to 100 % (when success is defined as no apical prolapse) to a range of 58 to 100% (when success is defined as prolapse of any compartment [anterior or posterior]) [68]. There are no data on the ideal synthetic mesh material that should be used. Polypropylene, polyethylene terephthalate (Mersiline; Ethicon Inc, Somerville, New Jersey), polytetrafluoroethylene PTFE (Gore-Tex), and fluoropolymer (Teflon; E. I. du Pont de Nemours and Co, Wilmington, Delaware) have been successfully used with varying rates of erosion – from 0.5 % (1/ 211) for 1 polypropylene mesh (Prolene; Ethicon Inc, Somerville, New Jersey) to 5.0 % (20/402) for a different polypropylene mesh (Marlex), 3.4% (25/811) for polyethylene terephthalate (Mersiline), 3.1% (12/350) for polytetrafluoroethylene PTFE (Gore-Tex), and 5.5% (6/119) for fluoropolymer (Teflon) [68]. There are contradictory data on the safety of implanting mesh in a patient who has concomitant hysterectomy, with associated mesh erosion occurring at a rate as high as 27% (3/11) [69]. Interestingly, increased erosion risk was observed only in studies where polytetrafluoroethylene or fluoropolymer was used (Amid Type II mesh and Amid Type III mesh, respectively) [68, 69]. On the other hand, Brizzolara and Pillai-Allen [70] found no increased risk of mesh erosion after concomitant hysterectomy and polypropylene (Amid Type I material) colpopexy compared with colpopexy alone (0/60 vs. 1/64). When compared with colpopexy that involves autograft, allograft, and xenografts, mesh sacral colpopexy has consistently outperformed the biologic material but at the expense of increased rates of erosion (see below). If lightweight polypropylene mesh further lowers the risk of erosion, the need for alternative materials for sacral colpopexy (i.e., to reduce erosion rate) will be decreased.

Allograft The rates of reported failures associated with human tissue graft overlay (Tutoplast) (Suspend [Mentor, Santa Barbara, California] and Tutoplast are the same material) have increased consistently, warranting the restriction of this material to clinical trials [64, 71 – 75]. FitzGerald et al. [75] reported a high reoperation rate in a large series of patients who had a lyophilized, gamma-irradiated fascia lata sacral colpopexy. In their study, 21 of 102 patients required reoperation at a median follow-up of 17 months. Surprisingly, at reoperation, residual graft material was identified in only 3 of 21 patients. When a composite failure was calculated (reoperation, anterior compartment prolapse of stage 2 or greater, and point C descensus greater then half of the total vaginal length), the failure rate rose to 81%! Even if all nonrespondents



Satz n.a. n.a.


are considered as cured, the failure rate remained unacceptably high at 66% [75]. Culligan et al. [72] randomly assigned 100 female patients with symptomatic prolapse to either sacral colpopexy with human tissue graft overlay or polypropylene mesh. At 1-year follow-up, more patients in the human tissue graft overlay group had higher anatomical failure rates (anterior and apical compartments; p = 0.007 and p £ 0.001, respectively) compared with the patients who had a mesh sacral colpopexy. Conversely, Flynn et al. [76] reported good anterior (11 and 16% anatomical failures of points Aa and Ba, respectively) and apical support (5% anatomical failure of point C) in a small (n = 24) series of patients at 1 year after sacral colpopexy repair with a lyophilized, gamma-irradiated fascia lata graft (LifeNet Health, Virginia Beach, Virginia). Flynn et al. concluded that this material may be a safe and effective substitute for synthetic mesh. However, a historical cohort study comparing sacral colpopexy of the same allograft used by Flynn et al with mesh sacral colpopexy showed that the proportion of patients with “optimal” surgical outcome was significantly less in the allograft group than in the mesh group (61 vs. 89 %; p = 0.06) [77]. It is difficult to ascertain without further comparative trials how other allografts compare with mesh sacral colpopexy. Nevertheless, the currently available data do not support allograft use for sacral colpopexy, because it has been consistently shown to have inferior outcomes compared with synthetic mesh sacral colpopexy.

Autograft Data of only 2 small (fewer than 20 patients) case series are available on autologous graft use for sacral colpopexy [78, 79]. Larger, comparative trials are needed to ascertain the role, if any, for this class of material in abdominal approaches to reconstruction.

Xenograft Altman et al. [80] retrospectively compared female patients who had sacral colpopexy with polypropylene (n = 12) or fluoropolymer (Teflon) (n = 13) with patients who had sacral colpopexy with a cross-linked porcine dermis (Pelvicol) xenograft (n = 27). Although there was no difference in the proportion of patients with apical prolapse of stage 2 or greater (8/27 [30 %] in the xenograft group vs. 6/25 [24%] in the mesh group; p = 0.40), the xenograft group were observed for an average of 1.8 years less than the synthetic mesh group. Larger, comparative trials are needed to ascertain the role, if any, for this class of material in apical reconstruction via an abdominal route.

Conclusion !

“There is no condition or disease that cannot be made worse by surgery.” (Dr. Ulf Ulmsten [personal communication]) Pelvic organ prolapse is a common condition that affects women and has a negative impact on their quality of life. The degree of observed prolapse does not correlate well with patient symptomatology. The potential risk factors are well described; however, future research is needed to further delineate these factors and examine ways to prevent their occurrence. Although surgical intervention is common, the desired anatomical support and function are not always achieved. The 3 Ts – tissue, trauma, and technique – and, possibly, stage may influence successful outcomes.

Übersicht

Up to one-third of women who undergo surgical intervention for pelvic organ prolapse require subsequent surgical intervention for recurrent prolapse. This failure rate, combined with the success of mesh used by general surgeons to treat hernias, have led gynecologic surgeons to investigate an array of surgical approaches and reconstructive materials. In vaginal reconstructive surgery, no material has been shown to unequivocally improve anatomical outcomes compared with traditional suture plication repairs. Although preliminary studies have shown a modest advantage in anatomical outcomes with vaginal mesh repairs, there continues to be considerable controversy about the safety and long-term efficacy of transvaginal synthetic mesh use. Data are insufficient to advocate the use of grafts in primary prolapse repair. Use should be restricted to randomized clinical trials or to centers with mechanisms in place to track mesh-associated morbidity. Detailed informed consent that outlines the risks associated with vaginal graft use is of paramount importance for the establishment of patient expectations and for protection from litigation. It is not clear whether theoretical advantages of a given material translate into clinically meaningful differences or benefits. For example, light-weight polypropylene, which is less dense and stiff than heavy, older polypropylene prosthesis (i.e., Marlex), has been associated with mesh erosion and dyspareunia. The US Food and Drug Administration’s approval process of new materials used in reconstructive pelvic surgery requires only that the material be substantially “equivalent” to an existing material in use (510K process). However, equivalence is a subjective process, and no equivalence or superiority trial comparing the new material with the old material is required before the new material is marketed. Surgeons are advised to make informed decisions about which approach and material offer the greatest benefit with the least amount of harm. What surgical procedure is best to treat prolapse in the apical, anterior, or posterior compartment? This question continues to be difficult to answer. Until researchers know more, surgeons are encouraged to individualize treatment, know the pelvic floor anatomy, execute a technically sound surgical procedure, be selfcritical about skill level and outcomes, and critically appraise the medical literature when evaluating new devices and technologies.

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Übersicht

70 Brizzolara S, Pillai-Allen A. Risk of mesh erosion with sacral colpopexy and concurrent hysterectomy. Obstet Gynecol 2003; 102: 306 – 310 71 Carbone JM, Kavaler E, Hu JC, Raz S. Pubovaginal sling using cadaveric fascia and bone anchors: disappointing early results. J Urol 2001; 165: 1605 – 1611 72 Culligan PJ, Blackwell L, Goldsmith LJ, Graham CA, Rogers A, Heit MH. A randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy. Obstet Gynecol 2005; 106: 29 – 37 73 Howden NS, Zyczynski HM, Moalli PA, Sagan ER, Meyn LA, Weber AM. Comparison of autologous rectus fascia and cadaveric fascia in pubovaginal sling continence outcomes. Am J Obstet Gynecol 2006; 194: 1444 – 1449 74 Huang YH, Lin AT, Chen KK, Pan CC, Chang LS. High failure rate using allograft fascia lata in pubovaginal sling surgery for female stress urinary incontinence. Urology 2001; 58: 943 – 946 75 FitzGerald MP, Edwards SR, Fenner D. Medium-term follow-up on use of freeze-dried, irradiated donor fascia for sacrocolpopexy and sling procedures. Int Urogynecol J Pelvic Floor Dysfunct 2004; 15: 238 – 242 76 Flynn MK, Webster GD, Amundsen CL. Abdominal sacral colpopexy with allograft fascia lata: one-year outcomes. Am J Obstet Gynecol 2005; 192: 1496 – 1500 77 Gregory WT, Otto LN, Bergstrom JO, Clark AL. Surgical outcome of abdominal sacrocolpopexy with synthetic mesh versus abdominal sacrocolpopexy with cadaveric fascia lata. Int Urogynecol J Pelvic Floor Dysfunct 2005; 16: 369 – 374 78 Latini JM, Brown JA, Kreder KJ. Abdominal sacral colpopexy using autologous fascia lata. J Urol 2004; 171: 1176 – 1179 79 Traiman P, De Luca LA, Silva AA, Antonini R, Dias R, Rodrigues JR. Abdominal colpopexy for complete prolapse of the vagina. Int Surg 1992; 77: 91 – 95 80 Altman D, Anzen B, Brismar S, Lopez A, Zetterstrom J. Long-term outcome of abdominal sacrocolpopexy using xenograft compared with synthetic mesh. Urology 2006; 67: 719 – 724


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