Int Urogynecol J DOI 10.1007/s00192-008-0660-5
ORIGINAL ARTICLE
The outcome of transobturator cystocele repair using biocompatible porcine dermis graft: our experience with 32 cases Ayman Mahdy & Mostafa Elmissiry & Gamal Ghoniem
Received: 27 February 2008 / Accepted: 11 May 2008 # The International Urogynecological Association 2008
Abstract This study aims to evaluate the outcome of cystocele repair using Perigee® with biocompatible matrix (InteXen®). After IRB approval, a retrospective chart review of patients who underwent Perigee®/InteXen® repair was done. Success was defined as a postoperative anatomical stage 0 or I using POP-Q system. Thirty two patients were included with 14 (43.75%) who had failed previous repair. Preoperatively, eight patients (25%) had stage II cystocele, 21 (65.6%) had stage III, and three (9.4%) had stage IV. Twenty six patients (81.25%) were available for a median follow up of 8.72 (6–31) months that showed success in 25 patients (96%) with 14 (54%) having stage 0 and 11 (42%) having stage I. Complications included bladder perforation (n=1), incidental cystotomy (n=1), mesh erosion (n=1), and wound dehiscence (n=1). This study suggests cystocele repair using Perigee® with InteXen® has a high short-term success with lower morbidity. Keywords Cystocele . Grafts . InteXen® . Porcine dermis Abbreviations IRB Institutional review Board POP Pelvic Organ Prolapse A. Mahdy : M. Elmissiry : G. Ghoniem Section of Female Urology, Voiding Dysfunction and Reconstructive Surgery, Cleveland Clinic Florida, Weston, FL 33331, USA G. Ghoniem (*) Urology Department, Cleveland Clinic, 2950 Cleveland Clinic Blvd, Weston, FL 33331, USA e-mail:
[email protected]
BMI POP-Q UDS SUI ISD UUI MUI DNA TOT
Body Mass Index Pelvic Organ Prolapse Quantification staging system Urodynamic Studies Stress urinary incontinence Intrinsic Sphincter Deficiency Urge Urinary Incontinence Mixed Urinary Incontinence Deoxy Ribonucleic Acid Transobturator Tape
Introduction Pelvic organ prolapse (POP) has a high risk of developing among women, in a study of 27,342 women; Hendrix SL et al reported a POP rate of 67.1% amongst the group who had their uterus and 51.2% amongst the group who had hysterectomies. Anterior vaginal wall prolapse was the most common type of POP in this study, with an incidence of 34.3% in the former group and 32.9% in the later one [1]. Unfortunately, traditional colporrhaphy has a recurrence rate of up to 40% [2] and, even among better reported outcomes, aggressive medial plication of the laterally placed pubocervical fascia has caused unacceptable vaginal shortening and narrowing [3]. Additionally, the sole plication of the pubocervical fascia is not a viable option for cystocele repair in cases of a concomitant lateral defect, which is found in 70 to 80% of cystocele cases [4]. Given these limitations for traditional surgery, various types of grafts have been developed for the purpose of providing more effective and durable anterior vaginal wall prolapse repair, with maintenance of sexual function and without negative impacts on vaginal length and/or caliber. The wide variety of grafts includes autologous grafts,
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allografts, xenografts, and synthetic grafts. A major drawback associated with non-absorbable synthetic grafts is the high incidence of erosion, which is reportedly as high as 25% using polypropylene mesh [5]. In order to be successful, xenografts should be biocompatible, strong, durable, infection-resistant, and facilitate host tissue in-growth [6]. InteXenLP is a noncrosslinked porcine dermis that is processed by radiation and effective viral and prion inactivation. Being noncrosslinked facilitates tissue in growth with subsequent endogenous host connective tissue replacement without encapsulation [7]. In an experimental study comparing porcine dermis with polypropylene grafts for repair of full thickness abdominal wall defects in rats, Zheng et al. [8] found decreased adhesion formation and milder inflammatory response associated with porcine dermis. The use of porcine dermis for cystocele repair has been recently reported with variable outcomes. In these reports, the graft was secured with laterally placed delayed absorbable sutures [3, 4, 9]. In this study, we present our experience with transobturator cystocele repair using Perigee® with the biocompatible porcine dermal graft (InteXen®) which can be fixed into the arcus tendinious fascia pelvis by self-fixating polypropylene tape mesh for tension-free adjustment.
Materials and methods After Institutional Review Board approval, a retrospective chart review was undertaken, which included all women who underwent cystocele repair using the Perigee® with the biocompatible porcine dermal graft (InteXen®). A total of 32 women with symptomatic cystocele were included in the study. Symptomatic cystocele was described as a sensation of a vaginal mass or bulge, pain, and/or dyspareunia. Preoperative assessment included a history and physical examination as well as urodynamics studies (UDS) with and without prolapse reduction. For patients with stage III or IV cystocele, vaginal packing was used for prolapse reduction during UDS in order to reveal any occult stress urinary incontinence (SUI). The Pelvic Organ Prolapse Quantification (POP-Q) staging system [10] was used for prolapse evaluation. Cystoscopy was performed, when indicated including cases with storage lower urinary tract symptoms, hematuria, suspected intrinsic sphincter deficiency (ISD) by UDS (Valsalva leak point pressure less than 60 cmH2O with or without a maximum urethral closure pressure of less than 20 cmH2O), or history of lower tract pathology. Patients who had poor vaginal estrogenization were first treated by local estrogen cream for at least 4 weeks prior to surgery. Cystocele repair was performed by the same surgeon (GG) using the Perigee® kit (American Medical Systems,
Minnetonka, MN) with the porcine dermal graft (InteXen®; American Medical Systems, Minnetonka, MN). Briefly, an anterior vaginal wall incision is made starting at the bladder neck and extended for approximately 4 cm toward the apex of the vagina. Using both blunt and sharp dissection, the bladder is separated from the vagina. The paravesical fossa is opened on both sides in order to introduce the surgeon’s index finger behind the ischeopubic ramus. Four stab incisions, two on each side, are used for passage of the mesh arms. The upper two incisions are made at the level of the clitoris, just below the lower border of the adductor longus tendon and lateral to the pubic bone. The lower two incisions are localized 3.5 cm below and 2 cm lateral to the upper ones. The passers are then inserted and rotated around and below the inferior pubic rami and guided by the tip of the surgeon’s index finger to puncture the obturator membrane and externalize to the vaginal incision. The Perigee® arms are then connected to the corresponding passers and brought out through the skin incisions (Fig. 1). This is followed by cystoscopy to exclude any inadvertent bladder injury caused by the passers and to confirm intact ureters, visualized by the pre-injected indigo carmine freely effluxing from both ureteric orifices. The porcine dermis mesh is then trimmed and positioned under the bladder and held in place with 3–0 polyglycolic sutures proximally and distally. The vaginal mucosa is closed using absorbable sutures. Gentle traction is placed over the mesh arms, which are cut flush with the skin. The skin incisions are closed using Dermabond® and vaginal packing is placed for 24 h. In our series, patients with concomitant SUI underwent a mid-urethral sling procedure using TOT/Aris® (Coloplast Corp., Minneapolis, MN, USA) The tape was inserted through a separate vaginal incision and exited the skin through separate skin stabs (one on each side) just above those for the two upper perigee arms. Associated posterior or apical prolapse was also treated simultaneously.
Fig. 1 The arms are pulled through the skin incisions and the graft is positioned in place
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All patients were discharged 1 day after surgery. Patient follow up intervals were 2 and 6 weeks and then at 6, 12 and 18 months postoperatively. Patients who did not complete a follow up period of at least 6 months were excluded from the study. Patient follow up included a history and physical examination and prolapse evaluation using the POP-Q system. Success was defined as cystocele stages 0 or I. Vaginal length was measured using a measuring stick and a vaginal length of 7.5 cm or more was considered normal.
Results Thirty two patients were included in this study with a mean age of 64 (32–85) years, a mean BMI of 26.4(18.3– 34.8) kg/m2, and a mean parity of 2.5. Table 1 summarizes the preoperative patients’ characteristics. All patients had lateral defect either unilateral or bilateral with or without central defect. Ten (31.25%) of the 32 patients in this study underwent only Perigee®/InteXen® repair with a mean operative time of 72 (65–80) min; the remaining 22 (68.75%) patients underwent one or more concomitant procedures, including transobturator tape in 12 (37.5%), enterocele repair in 14 (43.75%), rectocele repair in six (18.75%), and perineorrhaphy in three (9.3%; Table 2). A total of 26 patients (81.25%) satisfied the inclusion criterion of a minimum of 6 months follow up. Those patients were available for a median follow up period of 8.72 (6–31) months. Twenty five patients (96.1%) had successful repair: 14 (54%) were stage 0 and 11 (42%) were stage I cytsocele after surgery (Table 1). There was a tendency towards stage I (versus stage 0) postoperative
Table 1 Preoperative characteristics Patient character
Number (%)
Previous hysterectomy Failed previous cystocele repair Preoperative cystocele II stage III IV Concomitant posterior vaginal wall prolapse Concomitant urinary Total incontinence Urge urinary incontinence Stress urinary incontinence Mixed urinary incontinence Occult stress urinary incontinencea Poor vaginal estrogen status
18 (56.25) 14 (43.75) 8 (25) 21 (65.6) 3 (9.4) 19 (59.4) 21 (65.6%) 9 (28%) 8 (25%) 3 (9.4) 1 (3%)
a
17 (53%)
Incontinence revealed after prolapse reduction during urodynamic studies
Table 2 Operative data and postoperative results Operative procedure Perigee alone Perigee with concomitant procedure(s): TOT Enterocele repair Rectocele repair Perineorrhaphy Intraoperative complications Bladder perforation Incidental cystotomy Postoperative complications Graft erosion Wound dehiscence Postoperative POP-Q staging (26 cases) Stage 0 Stage I Stage II
Number (%) 10 22 12 14 6 3 2 1 1 2 1 1
(31.25) (68.75) (37.5) (43.75) (18.75) (9.3) (6) (3) (3) (7.7) (3.8) (3.8)
14 (54) 11 (42) 1 (3.8)
prolapse with older age and with failed previous repairs. Of the 11 patients with postoperative grade I cystocele, seven (63.6%) had previous failed repairs and nine (81.8%) were 70 years of age or older. None of the patients in this study had vaginal length less than 9 cm after surgery, neither any of them developed postoperative voiding difficulty. Intraoperative complications in the 32 patients who underwent the procedure included bladder perforation, detected by cystoscopy, in one (3%) and incidental cystotomy during dissection in another (3%; Table 1). Both patients had distorted anatomy and tissue adhesion as a result of previous attempts at prolapse repair. Intraoperative removal and correct reinsertion of the passer was performed in the former case while closure of the cystotomy was performed in the latter. In both cases, an indwelling catheter was left in place for 1 week after surgery and a cystogram confirmed an intact bladder prior to catheter removal. The patient with an incidental cystotomy presented 6 months later with grade II cystocele and dyspareunia, representing the only failure in our study. Mesh-related postoperative complications occurred in two (7.7%) patients; one developed erosion and dyspareunia while the other had wound dehiscence (Table 1). The patient who developed erosion had recurrent grade III cystocele and grade III enterocele after failed previous surgery. The erosion site was incidentally discovered and related to the upper left (Riv Fix) part of the mesh, which connects the synthetic arms to the biocompatible graft. This patient was successfully treated with trimming of the exposed part and application of silver nitrate. The patient with wound dehiscence was conservatively treated and healed by secondary intention with no further surgical intervention.
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Discussion Since the advent of sling materials for tissue support in female POP, no specific tissue substitutes have been considered ideal. Synthetic materials for cystocele repair have been reported with variable success rates ranging between 75 to 100% [3, 5, 11–15]. Although synthetic materials have the advantages of strength and durability, their major drawback is host tissue reaction and graft encapsulation with subsequent infection, rejection, and erosion. Similarly, autologous grafts have now fallen out of favor because of the additional incisions and longer operative time associated with graft harvest. The use of allograft material including cadaveric fascia lata and dermis was presumed to have superior graft/host tissue reaction with a lower incidence of erosion and rejection. However, these types of grafts are not as strong as the synthetic grafts, with a reported early failure rate of 20% [16]. Furthermore, it has recently been debated whether the DNA found in allograft is transmissible or infectious [17]. Soft tissue reconstruction using xenografts has been reported for many years, but with minimal use in pelvic surgery [4]. There are many types of xenografts used in reconstructive surgery; the porcine dermis is the most common because of its strength and non-allergenic collagen content that is 95% homologous to human collagen. Porcine dermis has been used in sling procedures for SUI with short-term results similar to autologous fascial slings with only isolated complications reported [18]. The literature is scarce regarding the clinical use of porcine dermis in cystocele repair and no reports to date have been published using the Perigee®/InteXen® kit for cystocele repair. In a prospective multicenter comparative trial by Meschia et al. in 2007 [19], 100 patients had anterior vaginal wall prolapse repair using the crosslinked porcine dermis graft. The authors reported 7% recurrence (point Ba-1 or more) rate with one patient (1%) having mesh extrusion and graft bacterial colonization. In this study, the graft used was hexamethylene diisocyanate crosslinked porcine dermis (Pelvicol®). Chemical cross-linking makes the grafts nonporous and not colonized by host cells. This limits the host response to the graft surface with subsequent graft encapsulation in a manner similar to that of type 2 synthetic mesh [7]. The first report using the noncrosslinked porcine dermis (InteXen®) graft in cystocele repair was published by Gomelsky et al. in 2004 [4], which included 70 women with a median follow up of 24 months. The authors reported 87.1% success and 12.9% failure rates. Another study published by Wheeler et al. [9] included 36 women who underwent a high transvaginal uterosacral vault suspension and cystocele repair using porcine dermis. After a median follow up of 17 months, the authors reported significant improvement in all cases with 50% of the cases
being POP-Q point Ba stage II. The third study included 56 patients and reported a success rate of 64% after a median follow up of 17 months [3]. In our study, the success rate was 96.1%, which is relatively higher than the aforementioned studies. This higher success rate can be attributed to various aspects; first, we used the Perigee® mesh fixation system in which the mesh is secured by four arms to the arcus tendineus fascia pelvis through the transobturator approach. This provides a more efficient fixation mechanism than the free mesh cystocele repair, which is based on fibrotic tissue reaction after mesh implant [20]. Second; we provided the option of graft repair to all patients with symptomatic cystocele, regardless of the prolapse stage. This is in opposition to Wheeler’s study in which the authors limited the use of graft only to cases with poor tissue support [9] and Gomelsky’s study [4] wherein use of the graft was limited to high grade cystocele. Third, is the short-term median follow up (8.72 months) in our study compared with others (17–24 months). This is in addition to the smaller number of cases in our study in comparison to previous studies. On reference to measures of success in the aforementioned studies, only Handel et al. have clearly defined cure being grade 0 cystocele and improvement being grade I or less cystocele [3]. In the other two studies [4, 9], the authors considered that grade II cystocele as recurrence. Therefore, we could not find an impact of success measures on our outcome compared with others. The concept behind the use of porcine dermis is to decrease the incidence of erosion, a major problem facing the synthetic grafts [5, 12]. In our study, the only case of graft erosion (3%) was closely related to the synthetic arm that fixes the graft in place (Riv Fix), denoting that the biocompatible graft is not the cause of erosion. This minimal risk for graft erosion with porcine dermis has been supported by other studies [4, 9]. In a study by Handel et al. [3], the authors reported a high incidence (22%) of wound dehiscence and mesh exposure with porcine dermis graft. They attributed this high incidence to the nonporous nature of the porcine dermis graft, which led to hematoma formation and subsequent infection, wound dehiscence, and mesh exposure. In our study, no cases of graft infection have been encountered, which may likely be due to the technical steps we have developed to avoid this complication. Specifically, the graft is routinely soaked in antibiotic solution for a period of at least 15 min prior to interposition. In addition, we meticulously control as many visible bleeding points as possible, either by cauterization or by suture ligature prior to mesh application. Thorough irrigation with antibiotic solution is also done immediately before and after final reposition of the graft and, finally, during vaginal mucosal closure, we partially close the
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vaginal wound in continuous manner, leaving the last 2 cm of vaginal incision to be closed in an interrupted manner in order to provide a window for drainage of blood that may have collected during or early after the procedure. Another important factor to consider is the use of a “ready-to-wear” kit that facilitates the procedure with minimal tissue manipulation and trauma. This has been corroborated by Debodinance et al. [21] who concluded that the use of full kits in prolapse surgery are safer, easier to use, and minimize complications. Mesh retraction is an important issue related to mesh interposition techniques, which may affect vaginal length. Although we did not evaluate mesh retraction in our study, none of our patients had vaginal length less than 9 cm after the procedure. In a study by Gaurder-Burmester et al. [11] using a synthetic polypropylene mesh in 72 patients, the authors reported a 63% mesh retraction rate, with a 2-cm retraction occurring intraoperatively. However, the authors found no relationship between vaginal length and mesh retraction after surgery. To our knowledge, this is the first study in the literature in which the biocompatible porcine dermis graft was used for cystocele repair by the transobturator approach. We showed the feasibility and relative safety of cystocele repair using the Perigee®/InteXen® graft with high success and low complication rates, and that it could be combined with suburethral sling procedures for SUI through the same obturator route. In addition, we found that older age and failed previous attempts at prolapse repair may have a negative impact on the outcome of this procedure. Despite our good results, we do think that this study has some shortcomings including its retrospective nature with inherent bias, the relatively small number of patients, and the short-term follow up. Thus, long-term prospective studies for comparison with various graft materials are needed in order to validate our short-term results.
Conclusions The short-term results of Perigee® with the biocompatible matrix (InteXen®) for cystocele repair showed a high success rate with lower graft-related morbidity, especially vaginal wall erosion. Long-term prospective studies comparing the outcome of various graft materials in prolapse repair are required.
Conflicts of interest Ayman Mahdy: none; Mostafa Elmissiry: none; Gamal Ghoniem: Astellas Pharma US, Inc. (investigator and meeting participant/lecturer), Coloplasty (consultant/advisor), Uroplasty, Inc. (investigator).
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