Elevate Anterior/Apical: 12-Month Data Showing Safety and Efficacy in Surgical Treatment of Pelvic Organ Prolapse

ORIGINAL ARTICLE Elevate Anterior/Apical: 12-Month Data Showing Safety and Efficacy in Surgical Treatment of Pelvic Organ Prolapse Edward J. Stanford, MD, MS,* Robert D. Moore, DO,Þ Jan-Paul W.R. Roovers, MD, PhD,þ Christophe Courtieu, MD, James C. Lukban, DO, Eduardo Bataller, MD, Bernhard Liedl, MD,# and Suzette E. Sutherland, MD** Objective: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. Methods: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q Q stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated qualityof-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. Results: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%Y93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%Y99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P G 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P G 0.001). Conclusions: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes. Key Words: apical-descent, cystocele, mesh, polypropylene, prolapse (Female Pelvic Med Reconstr Surg 2013;19: 79Y83) Nearly 11% of women will undergo pelvic organ prolapse (POP), urinary or fecal incontinence surgery in their lifetime 1 and the reoperation rate may be 12% to 30%. 1,2 Pelvic organ prolapse may involve the anterior, posterior, and apical compartments of the vagina alone or, more commonly, in combination. Recent research using imaging of the pelvic floor has led to a much better understanding of the anatomy of pelvic organ support. 3 Anterior compartment prolapse (cystocele) is From the *Private Practice, Western Colorado; Atlanta Medical Research Institute, Atlanta, GA; Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; CMC Beausoleil, Montpellier, France; Division of Urogynecology, Eastern Virginia Medical School, Norfolk, VA; Hospital Clínic i Provincial de Barcelona, Universidad de Barcelona, Spain; #Pelvic Floor Center, Munich, Germany; and **Metro Urology, Centers for Continence Care and Female Urology, Center for Pelvic Floor Disorders, Mpls/St Paul, MN. Reprints: Edward J. Stanford, MD, MS. E-mail: ejs222@aol.com. The authors have declared they have no conflicts of interest. Supported by the American Medical Systems, Inc, Minnetonka, MN. Copyright * 2013 by Lippincott Williams & Wilkins DOI: 10.1097/SPV.0b013e318278cc29 associated with apical connective tissue support defects 3 and levator muscle tears resulting in a larger genital hiatus. 4 With the introduction and acceptability of synthetic mesh use for midurethral slings, mesh was increasingly adopted for use for POP repairs. 5,6 In addition, there is a commonly held understanding that traditional native tissue POP repairs lack durability and the use of mesh or graft implants may reduce the risk of recurrent prolapse 7 particularly in the anterior compartment. Different types of surgical meshes have been used for POP surgery, however, lightweight, macroporous (975 Km) polypropylene is the preferred synthetic graft at present. Perhaps, more importantly, the techniques to deliver the synthetic mesh prosthesis have also evolved. Trocar-based systems introducing mesh through the transobturator and ischiorectal fossa approaches were quite popular. The anatomic success of these procedures ranges between 60% and 96%, 8,9 however, these techniques do not provide good apical support. 9,10 To address this deficiency, the Elevate Anterior and Apical (EAA) technique was developed in which a synthetic mesh implant is secured transvaginally to the obturator internus muscle distally and apically to both sacrospinous ligaments thus providing apical support. The objective of this prospective, multicenter study was to determine the safety and efficacy of the EAA at 1-year follow-up. MATERIALS AND METHODS This study enrolled 142 women with POP at 10 US and 6 European centers between April 2009 and February 2010. Inclusion criteria for participation were age 21 years or older, symptomatic primary or recurrent anterior or apical vaginal compartment prolapse POP-Q stage II or greater requiring surgical repair. Patients could have posterior compartment prolapse but were excluded if a posterior apical procedure was performed concomitantly due to the confounding aspect of 2 apical support procedures done simultaneously. Exclusion criteria were a prior prolapse implant procedure (previous traditional, native tissue repairs were allowed), active or latent infection, restricted leg motion, pregnancy or intention to conceive during the study period, prior pelvic radiation, pelvic cancer or chemotherapy within the 12-months before study enrollment, uncontrolled diabetes, immune suppression or the use of immune modulators, and the ability and willingness to give a valid informed consent. Study Design Before enrollment, all investigator surgeons met to establish a standardized surgical technique described in the Methods section. Prolapse evaluation using the POP-Q 11 method was also standardized to ensure uniformity by the researchers. All of the surgeons had performed at least 5 EAA procedures before enrolling. Symptomatic genital prolapse was staged preoperatively and postoperatively 6 and 12 months according to the POP-Q staging. 11 The primary outcome was anatomic correction of anterior or apical prolapse with success being defined as POP-Q less than Female Pelvic Medicine & Reconstructive Surgery & Volume 19, Number 2, March/April 2013 www.fpmrs.net 79

Stanford et al Female Pelvic Medicine & Reconstructive Surgery & Volume 19, Number 2, March/April 2013 or equal to stage I. Secondary outcomes included quality-of-life (QOL) results and patient/device safety outcomes. Subjective, QOL were assessed using the prolapse/urinary incontinence sexual questionnaire (PISQ-12), 12 pelvic floor distress inventory (PFDI), 13 and pelvic floor impact questionnaire (PFIQ-7) 14 at 6 and 12 months. Patient safety was assessed by reported general, procedure-, and device-related adverse outcomes. Surgical Technique The initial step required to implant the EAA mesh is hydrodistention of the vesicovaginal space with a local anesthetic and vasoactive agent mixed in saline or saline alone. This is followed by full-thickness vaginal dissection to effectively implant the mesh into the relatively avascular vesicovaginal space. A vertical anterior vaginal wall incision from just proximal to the level of the bladder neck extending toward the apex is made. The depth is enough to ensure full thickness after which sharp and blunt dissection laterally and apically to identify the arcus tendineus, ischial spines, and sacrospinous ligaments bilaterally. This dissection is usually bloodless if the proper plane is entered and the surgical field is unaltered by prior surgery. After the anterior compartment dissection is complete, an absorbable distal fixation suture is placed near the urethrovesical junction which is attached to the midportion of the distal end of the synthetic mesh. The distal arms of the graft are attached to the obturator internus muscle just proximal to the ischial pubic ramus in the obturator foramen using the attached self-fixating tips. The vaginal apex either with or without a uterus is identified and 2 absorbable sutures are placed and held to fix to the proximal portion of the graft. A polypropylene strip with a barbed apical fixation tip is loaded onto an apical needle. This self-fixating tip mates to the needle such that the tines are always in a vertical orientation. The combined elements are covered with the curved plastic sheath which is inserted into each sacrospinous ligament 2 cm medial to the ischial spine. The depth of penetration is controlled by the plastic sheath. Care to sweep the lateral midvaginal and apical tissue out of the way is important to avoid kinking of the ureter(s) or viscus damage. The apical tail of the graft is trimmed as appropriate to fit the patient s vaginal length and the previously placed apical sutures are affixed to the apical portion of the graft. The apical portion of the graft is loaded onto the polypropylene mesh strips by inserting the strips through open eyelets on the body of the mesh. An adjustment tool with 1-cm incremental markings is used to slide the mesh along the apical strips until the desired mesh tension and position is obtained. Ultimately, the graft is placed in a supportive yet tension-free manner. The graft is locked in position with 1-way locking eyelets that are inserted over the mesh strips and prevent the graft from sliding back. The excess polypropylene mesh strips are trimmed such that at least 1 cm of mesh extends beyond the locking eyelets to decrease the possibility of dislodging or slipping. The vagina is closed using absorbable suture. Vaginal trimming is surgeon specific but is not usually needed due to the fibroelastic qualities of the vagina. The vaginal compartment should resemble a stage I prolapse at the conclusion of the procedure. Statistical Analysis Wilcoxon signed rank test was used to compare the POP-Q measurements between baseline and at 12 months. Proportions were compared using Fisher exact test. The exact 95% confidence interval (CI) of the anatomic success rates was calculated using binomial method. Missing data were treated using Last Failure Carried Forward (LFCF) method. Statistical analyses were performed using SAS Version 9.1.3. (SAS Institute, Inc). Statistical significance was assessed at P G 0.05. RESULTS One hundred forty-two women who met the criteria were enrolled after institutional approval and consenting to participate. Fourteen (9.9%) were excluded due to receiving a concomitant apical support procedure at the time of posterior repair. Of the 128 who received the transvaginal device, 112 (87.5%) completed their 12-month follow-up visit. Baseline demographics are presented in Table 1. Mean operative time was 53.6 (22.3) minutes. Anterior compartment prolapse of POP-Q stage II or greater was diagnosed in all patients, whereas apical prolapse of stage II or greater was found in only 87 (68.0%) patients. Anatomic success using the LFCF method was 87.7% for the anterior compartment and 95.9% for the apical compartment (Table 2). Anterior compartment reconstruction may predispose to posterior compartment prolapse. Our results show that at baseline, 54.2% (77/142), whereas at 12 months, only 14.4% (18/125) had POP-Q stage greater than or equal to 2 posterior compartment prolapse. At 12 months, 28 (22.4%) of the 112 subjects had POP-Q stage greater than or equal to 2 in any compartment with 4 (3.6%) extending beyond the hymen. There was statistically significant improvement in all parameters of interest Aa, Ba, C, and D (Table 3). Total vaginal length was not changed [8.5 (1.2) cm at baseline; 8.6 (1.2) cm at 12 months] (P = 0.331). A total of 42 patients experienced 61 adverse events. Procedure- or device-related complications are reported in Table 4. The most common complications were mesh exposure to the vagina (6.3%) with onset noted between 37 and 370 days, and urinary tract infection (UTI) (5.5%) with onset of 4 and 185 days, respectively. Treatment of the mesh exposures in this study involved local excision in the office (3/8), excision in the operating theatre (3/8), 1 received topical estrogen, and 1 resolved without treatment. No viscus mesh perforation was found, however, 1 mesh was explanted during repair of a recurrent cystocele. Hematoma was diagnosed between 6 and 11 days in 3 (2.3%) patients, all of which resolved spontaneously. Only 1 patient underwent reoperation for prolapse during the 12-month period. Quality-of-life questionnaire outcomes showed statistically significant improvement for all total and domain scores and are listed in Table 5. Self-reported satisfaction showed that 6.3% were only slightly or not satisfied, whereas 93.7% were moderately, very, or extremely satisfied with the outcome of TABLE 1. Patients Demographics at Baseline n = 128 [95% CI] or n (%) Age, mean (SD), y 64.7 (9.4) [63.1Y66.4] Height, mean (SD), in 163.2 (7.7) [161.9Y164.6] Weight, mean (SD), kgs 71.9 (13.9) [69.4Y74.3] Body mass index, mean (SD), kg/m 2 27.0 (5.0) [26.1Y27.9] Postmenopausal 115 (89.8) Noninsulin dependent diabetes 10 (7.8) Vaginal estrogen therapy (VET)* 67 (52.3) Prior hysterectomy 56 (43.8) Concomitant hysterectomy 25 (19.5) General anesthesia 105 (82.0) Other anesthesia 23 (18.0) *VET prescribed within 4 weeks before treatment. Other: local, sedation, spinal, or epidural. 80 www.fpmrs.net * 2013 Lippincott Williams & Wilkins

Female Pelvic Medicine & Reconstructive Surgery & Volume 19, Number 2, March/April 2013 Elevate Anterior/Apical TABLE 2. Anatomic Success Baseline Anterior, 12 mo Apical, 12 mo POP-Q No. Subjects No. Success Success, % No. Subjects No. Success Success, % Stage II 29 25 86.2 41 39 95.1 Stage III 82 74 90.2 26 26 100 Stage IV 3 1 33.3 6 5 83.3 Total 114 100 87.7 73 70 95.9 their prolapse surgery. At baseline, 89.4% of subjects reported any bulge symptom on the PFDI (either Q4 or Q5). At 12 months, 8.8% of subjects reported any bulge symptom. Accounting for missing data, 9.6% reported bulge using LFCF. DISCUSSION The EAA transvaginal mesh placement method compares favorably to the trocar-based anterior compartment prolapse procedures, sacrospinous fixation, iliococcygeus suspension, and sacrocolpopexy. The data presented from this study using synthetic mesh show excellent anatomic correction of prolapse at both anterior and apical compartments. The primary end point of anatomic success at 12 months was 95.9% for the apical compartment and 87.7% for the anterior compartment. These results compare favorably to 61% to 96% success of trocar-based anterior compartment mesh POP repairs 15 and nontrocar transvaginal mesh implantation. 16 Vaginal apical support procedures are successful in approximately 94% to 97% 17,18 for the sacrospinous fixation and uterosacral ligament suspensions. The apical anatomic success rate for the sacrocolpopexy, consider by many to be the gold standard apical support method, is 91% to 100%. 6 Trocar-based systems deliver the synthetic mesh using trocars that pass through either the obturator spaces, transgluteally (via the ischiorectal fossa), or both. These approaches involve anatomical areas generally unfamiliar to pelvic surgeons. Further, the trocars pass through and under lateral pelvic muscles (iliococcygeus, pubococcygeus, puborectalis, and coccygeus), fascial support tissue (arcus tendineus fascia pelvis), and ligaments (sacrospinous) and deposit permanent nonabsorbable mesh. There is an inherent risk of intraoperative injury to vessels (pudendal, internal iliac, uterine, inferior gluteal, and vaginal), nerves (pudendal and sciatic), and pelvic organs (bladder and rectum). 19,20 Postoperative complications are common to all POP procedures whether grafts are used or not. 15 The complications one would anticipate for any POP repair include UTI, voiding dysfunction, de TABLE 3. POP-Q Variable Baseline Mean (SD) [min, max] POP-Q Variable [95% CI] (n) [95% CI] (n) P Aa 1.2 (1.3) [j2, +3] j2.3 (0.9) [j3, +1] G0.001 [0.9Y1.4] [j2.5 to j2.2] Ba 2.6 (1.9) [0, +8] j2.2 (0.9) [j3, +3] G0.001* [2.3Y3.0] [j2.4 to j2.1] Ap j1.3 (1.4) [j3, +3] j2.1 (1.0) [j3, +1] G0.001 [j1.6 to j1.1] [j2.3 to j1.9] Bp j1.1 (1.8) [j3, +6] j2.1 (1.0) [j3, +1] G0.001 [j1.4 to j0.7] [j2.3 to j1.9] C j0.5 (3.6) [j7, +10] j7.1 (1.8) [j10, +1] G0.001 [j1.2 to 0.2] [j7.4 to j6.8] D j4.9 (3.0) [j10, +6] j8.1 (1.3) [j10, j5] G0.001 [j5.9 to j4.0] [j8.6 to j7.7] (43) (43) TVL 8.5 (1.2) [5.5, 12] 8.6 (1.2) [5, 12] 0.331 [8.3-8.8] [8.4-8.8] *P value from paired t test. P value from Wilcoxon signed rank test. 12 mo Mean (SD) [min, max] * 2013 Lippincott Williams & Wilkins www.fpmrs.net 81

Stanford et al Female Pelvic Medicine & Reconstructive Surgery & Volume 19, Number 2, March/April 2013 TABLE 4. Device/Procedure Complications No. Event Resolved Events Serious Adverse Events Days to Onset No. Patients (Total = 128) Adverse Event n n % n % Med Min Max n % Extrusion 8 7 87.5 82 37 370 8 6.3 UTI 8 7 87.5 32 4 185 7 5.5 Pain/discomfortVbuttock 5 4 80.0 2 0 49 5 3.9 Urinary incontinencevde novo stress 5 2 40.0 2 40.0 15 3 184 5 3.9 Urinary retention 5 5 100 2 40.0 1 1 2 5 3.9 Dyspareunia 3 3 100 2 66.7 127 90 298 3 2.3 Hematoma 3 3 100 6 0 11 3 2.3 Granuloma formation 2 1 50.0 48 42 54 2 1.6 Pain/discomfortVvaginal 2 2 100 136 83 189 2 1.6 Urinary retentionvtransient 2 2 100 1 50.0 5 1 9 2 1.6 Constipation 1 20 20 20 1 0.8 DyspareuniaVpartner 1 1 100 110 110 110 1 0.8 Infection 1 1 100 3 3 3 1 0.8 Pain/discomfortVpelvic 1 1 100 43 43 43 1 0.8 Pain/discomfortVurethral 1 1 100 12 12 12 1 0.8 Pain/discomfortVurogenital 1 14 14 14 1 0.8 ProlapseVrecurrence, enterocele 1 45 45 45 1 0.8 Ureteral obstruction 1 1 100 1 100 21 21 21 1 0.8 Urinary frequency 1 352 352 352 1 0.8 Urinary incontinencevde novo urge 1 6 6 6 1 0.8 Urinary incontinencevpersistent 1 1 100 1 100 2 2 2 1 0.8 Urinary incontinencevworsening mixed 1 1 100 1 100 11 11 11 1 0.8 Urinary incontinencevworsening stress 1 1 100 1 100 145 145 145 1 0.8 Urinary incontinencevworsening urge 1 1 100 35 35 35 1 0.8 Urinary urgency 1 1 100 188 188 188 1 0.8 Wound dehiscence 1 1 100 29 29 29 1 0.8 Adverse event is defined as any negative medical change (worsening) from the subject s baseline condition that is related to the subject s pelvic floor, could impact the subject s treatment course or outcome, or is related to the study device or procedure. A serious adverse event is death, life threatening, hospitalization, or significant disability. TABLE 5. QOL Results QOL Measurements Baseline 12 mo No. Any Improvement From Mean (SD) Score [n] Mean (SD) Score [n] Baseline, n (%) P, Signed Rank Test PFDI scales POPDI_General 42.7 (26.1) [125] 5.8 (12.1) [125] G0.001 POPDI 101.2 (62.0) [112] 25.4 (37.9) [112] 104 (92.9) G0.001 UDI 81.2 (49.7) [112] 22.3 (29.3) [112] 102 (91.1) G0.001 CRADI 71.2 (62.6) [106] 30.1 (46.5) [106] 85 (78.0) G0.001 PFIQ scales POPIQ 17.8 (25.2) [111] 3.4 (13.3) [111] 54 (48.6) G0.001 UIQ 25.0 (22.8) [112] 6.5 (16.6) [112] 80 (71.4) G0.001 CRAIQ 12.1 (22.6) [110] 5.2 (15.8) [110] 38 (34.5) G0.001 PFIQ 54.1 (60.5) [110] 15.2 (40.9) [110] 87 (79.1) G0.001 PISQ-12 PISQ score 31.7 (8.4) [42] 37.2 (6.0) [42] 33 (78.6) 0.001* *Paired t test. 82 www.fpmrs.net * 2013 Lippincott Williams & Wilkins

Female Pelvic Medicine & Reconstructive Surgery & Volume 19, Number 2, March/April 2013 Elevate Anterior/Apical novo urinary incontinence, hematoma, dyspareunia, infection, ileus, and possibly buttock pain. Mesh-related complications involve primarily exposure or erosion with some reports of viscus erosion. Mesh exposure for the anterior compartment is reported in 1to19% 6 and 0% to 12% for the sacrocolpopexy. 21 In this study, mesh exposure occurred in 8 (6.3%) patients and was diagnosed at a median interval of 82 days. Vaginal estrogen therapy was prescribed in 67 (52.3%) of patients in this study, however, it does not seem that estrogen supplementation plays much of a role preventing or the spontaneous healing with mesh exposure. 22 Pelvic hematoma is a complication associated with any POP procedure or hysterectomy; however, it is likely more common when trocar insertion is used. 23,24 Three (2.3%) patients in this trial experienced a transient hematoma. Only one required a transfusion and the rest resolved spontaneously. Fortunately uncommon, the EAA avoids blind trocar passage. In this procedure, the hematomas most likely occurred during dissection in the paravesical space, with penetration of the coccygeus muscle, or in association with a concomitant hysterectomy. The most common complaint after sacrospinous fixation is buttock pain which rarely requires suture removal. 25 Transient pain was reported in the buttock in 5 (3.9%) and in the vagina in 2 (1.6%) patients. The mechanism of this transient pain is likely local entrapment of pudendal branches such as the perforating cutaneous nerve. 26 De novo dyspareunia was reported by 3 (2.3%) patients with complete resolution; 2 received local infiltration and 1 received no intervention. Almost all POP trials show subjective improvement in questionnaire scores. The self-reported QOL outcomes in this study using the PSIQ-12, PFDI, and PFIQ-7 all revealed statistically significant improvement at 12 months. CONCLUSIONS This prospective observational study shows that EAA yields favorable objective and subjective outcomes. Key findings are comparably low complication rates and low mesh exposure rates. Future comparative studies need to assess whether EAA should be the treatment of first choice in patients with apical and/or anterior vaginal wall prolapse. REFERENCES 1. Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;8:501Y506. 2. Clark AL, Gregory T, Smith VJ, et al. Epidemiologic evaluation of reoperation for surgically treated pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 2003;189(5):1261Y1267. 3. Chen L, Ashton-Miller JA, DeLancey J. 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Retrovesical haematoma after anterior Prolift procedure for cystocele correction. Int Urogynecol J 2007;18(12):1495Y1497. 25. Maher CF, Murray CJ, Carey NP, et al. Iliococcygeus or Sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol 2001; 98(1):40Y44. 26. Bohrer JC, Chen CC, Walters MD. Pudendal neuropathy involving the perforating cutaneous nerve after cystocele repair with graft. Obstet Gynecol 2008;112(2 Pt 2):496Y498. * 2013 Lippincott Williams & Wilkins www.fpmrs.net 83