Trocarless system for mesh attachment in pelvic organ prolapse repair 1-year evaluation

Transcription

1 DOI /s ORIGINAL ARTICLE Trocarless system for mesh attachment in pelvic organ prolapse repair 1-year evaluation Menachem Alcalay & Michel Cosson & Miron Livneh & Jean-Philippe Lucot & Peter Von Theobald Received: 12 October 2010 / Accepted: 7 December 2010 # The International Urogynecological Association 2010 Abstract Introduction and hypothesis EndoFast Reliant system is a novel technology for pelvic organ prolapse (POP) repair that attaches mesh directly with metal fasteners. Methods This was a prospective multicenter study in 20 women who underwent vaginal POP repair to evaluate safety and efficacy. The patients were followed for 12 months, using POP-Q measures, questionnaires on symptoms (PFDI), and sexual function (FSFI). Results No intraoperative complications occurred. Prolapse has been anatomically resolved (< stage 2) in 85% at 1-year follow-up (17/20 patients). Pelvic Floor Distress Inventory (PFDI) scores showed significant improvement for 1 year in symptoms related to prolapse ( , p<0.001) and bladder ( , p=0.06) but not to rectum. Female Sexual Function Index (FSFI) scores did not change significantly. One case of mesh exposure was found (5%) and treated conservatively. No migration of fasteners was observed on X-ray. M. Alcalay (*) Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Ramat Gan 52621, Israel malcalay@netvision.net.il M. Cosson : J.-P. Lucot CHRU de Lille, Lille, France M. Livneh IBI Israel Biomedical Innovations Ltd., Haogen, Israel P. Von Theobald CHU de Caen, Caen, France Conclusions The EndoFast Reliant system was found safe and efficacious. Future studies are needed to evaluate its advantages over techniques using trocars. Keywords Pelvic organ prolapse repair. Trocarless mesh attachment. Vaginal mesh Introduction Pelvic organ prolapse (POP) represents significant global health problem with negative impact on women's quality of life. In the Women's Health Initiative study, out of 27,342 postmenopausal women, 41.3% with uterus and 38% without uterus were found to have some degree of POP [1]. This common problem leads to numerous surgical repairs, with an estimated lifetime risk of undergoing POP surgery in American population to be 11.1% [2]. However, the classical repair of cystocele and rectocele by endopelvic fascia plication was reported prospectively to have high recurrence rate, up to 45% in 1 3 years of follow-up [3, 4]. The new techniques, using tension-free polypropylene mesh interposition, were reported to be safe and reduce recurrence rates [5]. Those techniques are based on blind trocar passage through the obturator foramen or the ischiorectal fossa, in order to anchor the mesh stripes into the anatomical landmarks of the pelvic floor support, such as the sacrospinous ligament and the obturator muscle and fascia. Serious adverse events of visceral injury due to trocar passage, including rectal, bladder, or major blood vessel trauma, were reported with this technique [6, 7]. The EndoFast Reliant system (Endogun Medical Systems Ltd., Israel) is a minimally invasive system that was developed for mesh attachment in POP repair. It enables direct mesh attachment into connective tissue through

2 single incision during vaginal surgery, avoiding trocar passage. The aims of this study were to evaluate the safety and the efficacy of this novel technology during 1-year follow-up. Materials and methods This was a prospective multi center study, with 1-year followup of the patients. All patients underwent a preoperative evaluation, including physical examination, vaginal examination (POP-Q system), subjective symptom assessment, using the Pelvic Floor Distress Inventory [8] (PFDI SF-20 questionnaire) and The Female Sexual Function Index [9] (FSFI questionnaire). The PFDI-short form 20 is based on the structure and content of two previously validated questionnaires the Urinary Distress Inventory [UDI] and the Incontinence Impact Questionnaire (IIQ). Anatomical efficacy was assessed by POP-Q grading system at 3, 6, and 12 months postoperatively. Grade 0 or 1 was related as cure and grade 2 or more were related as recurrence. The relative change in the patient's symptoms by the PFDI and FSFI were used for subjective outcome measures. Physician's satisfaction was also documented with scoring scale of 1 5 (1, very dissatisfied; 5, very satisfied). The study population consisted of 20 female patients with POP. Parents were allowed to enroll in the study if their age was ranged between 40 and 80. They did not need hysterectomy at the current surgery, and urinary stress incontinence was excluded in physical examination with full bladder. Patients were recruited for the study between March 2007 and June This multicenter, multinational study was approved by the local ethics committees and regulatory bodies in each site, and all patients signed an informed consent. The system consists of a pre-cut monofilament polypropylene mesh (BMS-Biomedical Structures, USA) and a deployment system, preloaded with soft tissue fasteners (Fig. 1a). The system includes an extraction device that allows fastener removal, and therefore, intraoperative reversibility of fixation without causing damage to the tissue or the mesh (Fig. 1b). The fasteners are deployed through the mesh into soft tissue, and are generating initial pullout force of 1.6 kg each. Each fastener has six arms, 1.4 cm in diameter that penetrates 2 mm in depth into the tissue (Fig. 2). The procedure was performed according to these steps: 1. Anterior and/or posterior midline longitudinal vaginal wall incision. 2. Para-vesical or para-rectal deep dissection between the vaginal epithelium and the bladder or the rectum accordingly, to set anatomical landmarks. Fig. 1 a Deployment system that includes a handle and a fastener canister. The fastener is connected to a suture for optimal retrieval. b Extraction device allows non-traumatic removal of a deployed fastener In the anterior vaginal wall repair, the proximal part of the mesh (at the apical portion of the vagina) was attached into the fascia and muscles, lateral to the ischial spines, and the medial portion of the mesh (at the bladder neck) was attached into the obturator interus muscle and fascia, lateral to the ischiopubic rami. Posterior vaginal wall correction was carried out by anchoring the mesh into the coccygeus muscle and fascia that covers the sacrospinous ligament (proximal part of the mesh) and the distal portion of the puborectalis muscle, 3 4 cm from midline (distal part of the mesh). 3. Vaginal epithelium was closed with continuous suture (Vicryl 2/0). Fig. 2 Stainless steel fastener in an open and closed modes

3 Safety was assessed in terms of the incidence of major complications during the procedure and up to 1-year follow-up. To evaluate possible migration of the fasteners, the patients underwent radiographs of the bony pelvis prior to discharge and 3 months postoperatively. The following statistical tests were used in the analysis of the data presented in this study:the paired t-test and non-parametric signed-rank test were applied for testing differences between the visits. All tests applied were two-tailed, and p value of 5% or less was considered statistically significant. The data was analyzed using the SAS version 9.1 for Windows (SAS Institute, Cary, NC, USA). Results The surgical procedure was performed under general or regional anesthesia. All the 20 patients reached 1-year follow-up. No intraoperative complications were observed, neither other complications were reported up to discharge. No need for blood transfusion due to surgery. During 1-year follow-up, no migration of fasteners has been observed. Thirty-two vaginal wall reinforcement procedures (12 cases of double compartment correction) using the Endo- Fast Reliant system were performed. Data has been collected for 20 patients. Mean age was 61.2 years±11.4 (range ) and mean BMI was 25.7±3.9 (range ). Mean parity was 3±1.3 (range 1 7). One hundred percent of the patients were Caucasians. Patients preoperative prolapse findings included 90% with anterior vaginal wall prolapse, 40% with posterior vaginal wall prolapse, and 40% with central prolapse. Ten out of 20 patients presented with more than one defect. Based on POP-Q grading scale for prolapse, 11 patients were diagnosed as stage 2 prolapse (55%), 8 patients were diagnosed as stage 3 prolapse (40%), and 1 patient was diagnosed as stage 4 prolapse (5%). The preoperative and postoperative POP-Q grading scores are found in Table 1. Satisfactory anatomical outcome (stage 0 or 1) was reached in 90% at 6 months and in 85% at 1-year follow-up (17 out of 20 patients). The three patients that were found to have recurrence were asymptomatic of prolapse symptoms and were diagnosed preoperatively as stage 3 and stage 4. Table 2 shows the different POP-Q measurements at each of the preoperative and postoperative visits. POP measures over time show that the anatomical correction is maintained. The statistically significant changes were measured in the anterior and posterior vaginal wall, and also at the vaginal apex (POP-Q points C and D). Consistent improvement in the scoring system of the PFDI questionnaire was noted. The improvement was significant in pelvic floor symptoms related to prolapse (p<0.01 for repeated measures). In addition, a nearly significant (p=0.09) improvement in pelvic floor symptoms related to bladder function has been observed by the PFDI repeated measures, but no change in pelvic floor symptoms related to bowel function (Table 3). Ninety-five percent of the patients felt a bulge or something falling out ofthevaginabeforesurgery,andonlyone(5%)reported sensation of prolapse out of the vagina at 1-year followup. De novo stress urinary incontinence was reported by two patients (10%) at 1 year. Urinary urgency and frequency was found in 35% before surgery and in 15% at 1-year follow-up, and urge incontinence was found in 20% of our patients before surgery and 15% at 1-year follow-up (Table 4). Sexual function evaluation by FSFI questionnaire was available for all the 20 patients. Twelve patients refrained from sexual intercourse, before and after the procedure. One patient that was not sexually active prior to the procedure became sexually active, following the procedure. Of the eight patients that were sexually active before and after the procedure, sexual function did not change significantly during 6 and 12 months with respect to desire, arousal, lubrication, orgasm, pain, and the mean total score. Out of these eight patients, pain during intercourse was reported by two subjects before and 6 months after surgery. However, total pain score did not change significantly following the procedure at 6 and 12 months. One device-related complication occurred as a result of too medial misplacement of a single fastener in a posterior correction, causing dyspareunia. The fastener was removed 4 weeks after the procedure under local anesthesia and Table 1 Number of patients (%) with POP-Q staging in different follow-up periods Preoperative 3 months follow-up 6 months follow-up 12 months follow-up Stage 0 15 (75) 16 (80) 12 (60) Stage 1 5 (25) 2 (10) 5 (25) Stage 2 10 (55) 2 (10) 3 (15) Stage 3 9 (40) Stage 4 1 (5)

4 Table 2 POP-Q anatomical measurements over time (mean ± SD, significant changes are marked with *) * p<0.01, ** p=0.06 Preoperative 3 months follow-up 6 months follow-up 12 months follow-up Aa ± ±0.9 * 2.6±1.1 * Ap ± ± ±0.7 ** Ba 0.8± ± ±1.1 * 2.2±1.4 * Bp 1.6± ± ± ±0.8 * C 2.6± ± ± ±2.2 * D 4.5± ± ± ±3.9 ** GH 4.3± ± ± ±0.7 PB 4.3± ± ± ±0.7 TVL 8.4± ± ± ±1.1 sedation; the mesh was found to be in place and well integrated in the surrounding tissues, and no recurrence of the prolapse was observed 12 months following the procedure. Additionally, one procedure-related complication occurred suture line in the vagina was found open at the 2-week follow-up visit followed with secondary closure of the incision line. This case had mesh exposure at 6 months, which was resolved following local treatment. De novo stress urinary incontinence occurred in two cases. Other non-device-related minor complications were also reported such as low Hb (1 case), urinary tract infection (1 case), abdominal pain (1 patient), and in one patient symptom related to popliteal nerve entrapment due to the posture of the patient during the procedure. All adverse events were resolved spontaneously, or followed appropriate treatment. According to the physician's feedback, overall physician satisfaction was high (very satisfied 65.0%, somewhat satisfied 30.0%), and the procedure was perceived as safe (very satisfied 75.0%, somewhat satisfied 25.0%). Discussion This is the first clinical report that evaluated the EndoFast Reliant system for mesh attachment in POP repair. We followed prospectively 20 patients in three centers for 1 year, and found 85% satisfactory anatomical outcome, and 95% resolving of prolapse symptoms. The procedure was safe with no major intraoperative complications, no need for blood transfusion, and no visceral injury. One case of mesh exposure (5%) was treated conservatively. Visceral injury to the bladder or rectum has been described during trocar use for mesh attachment [5 7]. This complication may lead to cancelation of mesh interposition during surgery, or to a late severe complication of vesicovaginal fistula. Our technique uses direct application of the mesh into anatomical set points, and avoiding blind trocar passage, minimizing this option. The concept of mesh attachment to connective tissue during prolapse surgery might raise questions among surgeons, as we are dealing with loose and abnormal connective tissue. Several studies have already strengthen the hypothesis that the weakness of urogenital tissues, which is attributed to changes in synthesis and degradation of different types of collagen and elastin, are responsible to POP development [10, 11]. This was the reason to the concept of the TVM group to attach the mesh to a more solid structure, such as the sacrospinous ligament [5]. The concept of EndoFast Reliant system is that the initial attachment of the mesh into connective tissue is strong enough, to enable holding the mesh on the right site, until the tissue scarification and healing process will reach its plateau. Our preclinical animal studies showed that mesh attachment with this technique was generating force that is gradually increased to 3 kg (around 30 N) for 15 days, when a plateau is reached (nonpublished data). Similarly, Boukerrou et al. [12] studied the mechanical gain in Table 3 PFDI symptoms scoring in different follow-up periods. The scoring system was divided to symptoms originated from vaginal prolapse, bladder symptoms or anorectal symptoms (mean ± SD) Preoperative 3 months follow-up 6 months follow-up 12 months follow-up Repeated measures Prolapse symptoms 4.1± ±1.3 * 0.8±2.1 * 0.7±1.2 * P<0.001 Bladder symptoms 1.4± ± ± ±1.2 ** P=0.09 Anorectal symptoms 0.3± ± ± ±0.8 *** * p<0.001, ** p=0.067, *** Non-significant

5 Table 4 Sample of pre and postoperative bladder and prolapse symptoms (from PFDI). The numbers are percent of the total group (n=20) Preoperative (%) 3 months follow-up (%) 6 months follow-up (%) 12 months follow-up (%) Experience dullness or heaviness in vagina Have a bulge or something falling out of vagina Feeling incomplete bladder emptying Experience difficulty emptying your bladder Experience frequent urination Urine leakage with urgency Urine leakage with coughing resistance by healing after implantation of a Prolene mesh in a mouse model. They found that the resistance increased progressively at the beginning of tissue inclusion up to a maximal plateau of 27 N that was reached around the 25th day. The maximal tearing forces and the time to plateau in both studies were similar. Various techniques have been suggested for lateral support of mesh implants through the vagina. The interposition of mesh with lateral tunneling without suturing or anchoring system, was suggested and studied by Nieminen and Hiltunen [4], and showed better anatomical outcome compared to the classical repair. However, they failed to show significant difference in prolapse-related symptoms. When lateral fixation of the mesh is used by transobturator trocars, significant improvements in both anatomical results and subjective symptoms were demonstrated in the mesh group compared to the classical repair following 1 year of the procedure [3]. We think that this lateral attachment is important for better surgical results, and our anchoring system with metal fasteners offers an alternative to the trocar-guided mesh implant with potential advantages of safety. Other commercial options for trocarless mesh systems are available in the market now, but no comparative prospective studies are available yet to compare between those kits. However, in the Elevate system (American Medical Systems, Minnetonka, MN, USA), the depth of penetration of the plastic harpoon is 8 mm, and in our metal fastener, the tissue penetration is only 2 mm. This superficial penetration makes nerve injury of the pudendal or obturator nerves very unlikely. Therefore, the main advantages of our anchoring system are the potential reversibility, the better generated holding force in a sheep model compared to tunneling technique, and the low potential for nerve or visceral injury. The side effect that was device-related in our study was dyspareunia that occurs in one patient. This side effect was treated with surgical removal of a distal fastener near the perineal body. We concluded from this side effect that the distal fasteners on the posterior vaginal wall should be deployed lateral and deeply into the puborectalis muscle. The effect of prolapse surgery with vaginal mesh augmentation on women's sexual life has been reported in several studies with conflicting results. Su et al. [13] studied 33 sexually active women before and 6 months after vaginal mesh surgery, and showed that the procedure provided an effective anatomic cure of POP, but it had an adverse effect on sexual function. Similarly, Altman et al. [14] followed 84 sexually active patients who underwent trocar-guided transvaginal mesh procedure for 1 year with the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and found that there was an overall worsening of all symptoms in the behavioralemotive and partner-related items, whereas improvements were observed in physical function. However, the rates and severity of dyspareunia were neither improved nor worsened. On the contrary, Gauruder-Burmester et al. [15] reported that 1 year after vaginal mesh surgery in 120 patients, no interference with a healthy sex life was found. Dyspareunia was reported in 15 women before surgery, which was related to vaginal prolapse, and no woman complained of dyspareunia at 1-year follow-up. Nguyen and Burchette [3] even showed that de novo dyspareunia rate was lower with vaginal mesh overlay compared to traditional surgery. Our study supports previous findings that dyspareunia is not deteriorated by mesh implant, and the EndoFast Reliant technology was not a cause for this complication if the fastener is deployed on the right location. De novo stress urinary incontinence was developed in two of our patients (10%). This incidence is low compared to other reported studies with vaginal mesh application, of which, 24.3% of the patients developed de novo stress urinary incontinence [16]. Our low incidence of de novo stress urinary incontinence is most probably due to the fact that we excluded patients with preoperative symptoms and signs of urinary stress incontinence. We think that the value of preoperative assessment of stress urinary incontinence prior to prolapse surgery is important, especially for better

6 consultation of the patient. The mechanism for de novo stress incontinence following repair of anterior vaginal wall prolapse with mesh has been studied by Ek et al. [17] who showed that this surgery results in a lowering of maximal urethral closure pressure and increases the risk for de novo stress urinary incontinence compared with regular anterior colporrhaphy. The limitations of this study are the small number of patients and the follow-up for 1 year only. However, since it is the first prospective study of this technique, we are encouraged with our results. The EndoFast Reliant system has been developed in order to enable direct and safe mesh attachment into pelvic soft tissue, hence, potentially reducing intraoperative complications and postoperative morbidity. Our preliminary results support this hypothesis, though larger studies are needed to strengthen these conclusions. Conflicts of interest Dr Alcalay is a consultant of Endogun Medical Systems. Dr. Livneh was employed by IBI. References 1. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A (2002) Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol 186 (6): Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL (1997) Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 89(4): Nguyen JN, Burchette RJ (2008) Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 111 (4): Nieminen K, Hiltunen R, Takala T, Heiskanen E, Merikari M, Niemi K, Heinonen PK (2010) Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol 203(3):235.e Caquant F, Collinet P, Debodinance P, Berrocal J, Garbin O, Rosenthal C, Clave H, Villet R, Jacquetin B, Cosson M (2008) Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients. J Obstet Gynaecol Res 34(4): Elmér C, Altman D, Engh ME, Axelsen S, Väyrynen T, Falconer C (2009) Trocar-guided transvaginal mesh repair of pelvic organ prolapsed. Obstet Gynecol 113(1): Abdel-Fattah M, Ramsay I, West of Scotland Study Group (2008) Retrospective multicentre study of the new minimally invasive mesh repair devices for pelvic organ prolapse. BJOG 115(1): Barber MD, Walters MD, Bump RC (2005) Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 193(1): Rosen R, Brown C, Heiman J, Leiblum S, Meston CM, Shabsigh R, Ferguson D, D'Agostino R Jr (2000) The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 26: Gabriel B, Denschlag D, Gobel H, Fittkow C, Werner M, Gitsch G et al (2005) Uterosacral ligament in postmenopausal women with or without pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 16: Lin SY, Tee YT, Ng SC, Chang H, Lin P, Chen GD (2007) Changes in the extracellular matrix in the anterior vagina of women with or without prolapse. Int Urogynecol J Pelvic Floor Dysfunct 18: Boukerrou M, Rubod DC, Boodhum R, Nayama M, Cosson M (2008) Tissue resistance of the tension-free procedure: what about healing? Int Urogynecol J Pelvic Floor Dysfunct 19(3): Su TH, Lau HH, Huang WC, Chen SS, Lin TY, Hsieh CH, Yeh CY (2009) Short term impact on female sexual function of pelvic floor reconstruction with the Prolift procedure. J Sex Med 6 (11): Altman D, Elmér C, Kiilholma P, Kinne I, Tegerstedt G, Falconer C; Nordic Transvaginal Mesh Group (2009) Sexual dysfunction after trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol 113(1): Gauruder-Burmester A, Koutouzidou P, Tunn R (2009) Effect of vaginal polypropylene mesh implants on sexual function. Eur J Obstet Gynecol Reprod Biol 142(1): Aungst MJ, Friedman EB, von Pechmann WS, Horbach NS, Welgoss JA (2009) De novo stress incontinence and pelvic muscle symptoms after transvaginal mesh repair. Am J Obstet Gynecol 201(1):73.e Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, Altman D (2010) Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh. Neurourol Urodyn 29(4):