Evaluation of the single-incision Elevate system to treat pelvic organ prolapse: follow-up from 15 to 45 months

Int Urogynecol J (2015) 26:1341 1346 DOI 10.1007/s00192-015-2693-x ORIGINAL ARTICLE Evaluation of the single-incision Elevate system to treat pelvic organ prolapse: follow-up from 15 to 45 months Kuan-Hui Huang 1 & Li-Yi Huang 1 & Li-Ching Chu 1 & Fei-Chi Chuang 1 & Ming-Ping Wu 2,3 & Fu-Tsai Kung 1 Received: 27 November 2014 /Accepted: 12 March 2015 /Published online: 30 April 2015 # The International Urogynecological Association 2015 Abstract Introduction and hypothesis The aim of this study was to assess the 2-year clinical outcomes of pelvic reconstructive surgery with the single-incision Elevate system (American Medical Systems, Minnetonka, MN, USA). Methods This retrospective study was conducted from November 2010 to August 2013, and included 210 patients with pelvic organ prolapse stage 3 or 4 who underwent pelvic reconstructive surgery with an Elevate system and were followed for 1 to 3 years postoperatively. Assessments included preand postoperative Pelvic Organ Prolapse Quantification (POP-Q) stage, Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and multi-channel urodynamic examinations. Anatomical success was defined as postoperative POP-Q stage 0 or I. Results The anatomical success rates were 95 % for the anterior vaginal wall, 99 % for the posterior vaginal wall and 94 % for the apical vaginal wall after a median 27 months of followup. POP-Q, UDI-6 and IIQ-7 scores, maximal flow rate and post-voiding residual urine all improved significantly after surgery. Complications included 1 case of internal bleeding, 4 cases of mesh exposure, 5 cases of recurrent prolapse that * Kuan-Hui Huang hui2207@gmail.com 1 2 3 Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123, Ta Pei Road, Niao Sung Hsiang, Kaohsiung Hsien 83305, Taiwan Division of Urogynecology and Pelvic Floor Reconstruction, Department of Obstetrics and Gynecology, Chi Mei Foundation Hospital, Tainan, Taiwan Department of Obstetrics and Gynecology, College of Medicine, Taipei Medical University, Taipei, Taiwan required salvage operations, and 3 cases of urine retention that required intermittent catheterization. There were no bladder or bowel injuries during surgery. Conclusions Pelvic reconstructive surgery with the Elevate system yielded good anatomical outcomes and symptom improvement after 2 years of follow-up. Keywords Transvaginal mesh. Pelvic organ prolapse. Elevate system Introduction Pelvic organ prolapse (POP), also called uterovaginal prolapse, is the downward descent of the pelvic organs causing vaginal protrusion [1]. This disorder can affect the anterior and posterior vaginal wall, and the uterus/apex of the vagina, usually in some combination [2]. In an Australian prevalence survey, 46 % of women aged 15 97 had symptoms of pelvic floor dysfunction, among them 23.7 % had undergone a previous pelvic floor repair [3]. According to an American epidemiology study, the life-time risk for women (up to 80 years) of undergoing surgery for POP and or urinary incontinence is up to 11 %, with a re-operation rate of 29 % [4]. The high risk of recurrence with the anterior vaginal wall [5 7] and the success observed with the use of mesh for hernia repair in general surgery have led to the development of new surgical approaches and pelvic floor support materials in gynecology. In 2004, the Food and Drug Administration approved the use of commercial kits that delivered polypropylene mesh through a transvaginal technique. Since then, many transvaginal commercial graft kits have been developed for more serious genital prolapse and the desire for minimally invasive surgery. The Elevate system (American Medical Systems, Minnetonka, MN, USA) is a single-incision, transvaginal commercial

1342 Int Urogynecol J (2015) 26:1341 1346 surgical kit. It is a trocar-free, single-incision transvaginal procedure and the potential benefits of the Elevate system are shortened surgical time, reduced nerve and vascular tissue injury, and decreased pelvic pain and dyspareunia [8]. We used the Elevate Anterior and Posterior Kits for women with stage 3 or 4 POP. The aim of this study was to evaluate the outcomes, peri- and post-operative complications and morbidity after a follow-up period of 2 years. Our primary outcome measure was prolapse at +1 at 2 years postoperatively. Materials and methods Ethical approval was obtained from the Institutional Review Board of our hospital for retrospective data analysis. Charts were reviewed from November 2010 to August 2013, we reviewed the charts of patients with Pelvic Organ Prolapse Quantification (POP-Q) stage 3 or 4 who underwent Elevate prolapse repair and were followed up to 45 months, with at least 15 months of follow-up. Two hundred and ten patients were identified from medical records. All patients were operated on by a single senior pelvic surgeon (Huang KH). All the patients with stage 3 or 4 POP were treated with Elevate during this period. During the same study period, other patients with stage 3 or 4 patients being treated with a laparoscopic colpopexy or transvaginal sacrospinous ligament suspension were excluded from this study. Ten patients were excluded for personal reasons, e.g., refusal to cooperate with postoperative assessments (n=5), living too far away from the hospital to attend follow-up visits (n=3), and suffering from concomitant cancer (n=2;1 with breast cancer and 1 with colon cancer). Ninety-five percent of patients (200 out of 210) continued the outpatient clinic follow-up visit for 2.5 years. The patients were interviewed to identify urinary and prolapse symptoms, then received the Elevate Anterior and/or Posterior systems according to site-specific repair principles. The pre- and postoperative assessments included the short forms of the Urogenital Distress Inventory (UDI-6), the Incontinence Impact Questionnaire (IIQ-7), pelvic and digital examinations, POP- Q staging, urodynamic examinations, the one-hour pad test, and the cough stress test after repositioning of the prolapsed compartment. All the postoperative questionnaires were recorded over a period of 15 to 45 months postoperatively. All of the examinations were carried out in accordance with the procedures of the International Continence Society (ICS). Preoperative POP-Q values and stages were measured at the outpatient clinic. Also, we redo the POP-Q measurement in the operating room before anesthesia for teaching purposes, while postoperative POP-Q values and stages were measured at each follow-up visit at our clinic. All the patients provided informed consent with regard to the risks of transvaginal mesh, including the FDA warning letter. We informed and discussed with the patients planning to receive transvaginal mesh the potential serious complications, e.g., bladder or colon injury in addition to chronic pelvic pain and mesh erosion. All patients underwent pelvic reconstruction surgery with the Elevate systems using the techniques outlined by the manufacturer, with only subtle differences in that 2-O PDS sutures were inserted at the anterior and posterior vaginal vault in the patients without a uterus. After the mesh had been implanted without wrinkles, the vaginal wall was closed with double layers of sutures using absorbable sutures [9].The patients with confirmed urodynamic stress incontinence were advised to receive a concomitant anti-incontinence sling with a singleincision sling of Mini-Arc tape (American Medical System, Minnetonka, MN, USA). After the surgery, cystoscopic and digital examinations were routinely performed intraoperatively to exclude bladder and colorectal injuries, and to confirm the patency of bilateral ureters. The following pre- and postoperative data were also recorded: urinalysis, hemoglobin 18 24 h before and after surgery, operative time, estimated blood loss, days with a urine indwelling catheter, length of hospitalization, and preoperative complications. All of the patients without postmenopausal bleeding, abnormal cervical smears, previous cervical intraepithelial neoplasms, or uterine diseases were offered the option to preserve the uterus. All of the patients were given antibiotic prophylaxis (intravenous cefazolin 1 g; Chi-sheng Chemical Co., Hsinchu, Taiwan) administered 30 min before surgery and subsequently for 2 to 3 days. The patients with diabetes mellitus were also given another antibiotic (gentamicin 80 g; Gentle Pharma Co., Yunlin, Taiwan) for 3 days after surgery. General anesthesia or spinal anesthesia was applied depending on the anesthesiologist. Postoperative follow-up was scheduled at 1 week, 1, 3, 6, and 12 months, and annually thereafter. Postoperative urodynamic examinations were performed after 6 months or later. Mesh extrusion was confirmed by routine follow-up pelvic examination. Urinary symptoms of complications included urgency, urgency incontinence, urine retention, overactive bladder, post-voiding dribbling, confirmed urinary tract infection, and stress urinary incontinence using the 2002 ICS definitions [10]. Symptoms or signs that did not fit these descriptions were classified as other complications. Recurrence was defined as the most distal portion at more than POP-Q stage 2. This retrospective study was carried out by chart review with the participation of all the authors. Continuous variables are expressed as means and standard deviations, and pre- and postoperative comparisons were made using the Student s t test. Categorical variables are expressed as counts and percentages. Changes between preand postoperative POP-Q values were assessed using the paired Student s t test. All data analyses were performed using SPSS version 17.0 for Windows (SPSS Inc., Chicago, IL, USA), and differences were considered statistically significant when p<0.05.

Int Urogynecol J (2015) 26:1341 1346 1343 Results Baseline demographic data, including age, parity, body mass index, obstetric and gynecological history, and medical and surgical history are presented in Table 1. Forty-nine(24.5%) patients had previously undergone surgery, including transabdominal hysterectomy, supracervical hysterectomy, transvaginal hysterectomy, laparoscopy-assisted vaginal hysterectomy, anterior posterior colporrhaphy, and pelvic reconstruction surgery. Forty-eight (24 %) patients had diabetes mellitus that was controlled with medication. Thirty-one (15.5 %) patients underwent implantation with an Elevate Anterior Kit, 4 (2 %) with an Elevate Posterior Kit, and 165 (82.5 %) with both Elevate Anterior and Posterior Kits. The 200 pelvic organ prolapse patients included 163 uterine prolapse patients, 35 vaginal wall prolapse patients and 2 cervical stump prolapse patients. Of the 163 uterine prolapse patients, 110 patients (67.5 %) received concomitant transvaginal hysterectomy during the transvaginal mesh procedure and 53 (32.5 %) received uterine-sparing surgery. A total of 57 suburethral single-incision Mini-Arc tape slings (28.5 %) were fitted during prolapse repair treatment. The primary postoperative outcome analysis comparing the pre- and postoperative POP-Q stages of prolapse are summarized in Table 2. All parameters of the POP-Q values (Aa, Ba, C, Ap, Bp, genital hiatus, perineal body and total vaginal length) and POP-Q stages were significantly improved (p<0.001) after surgery except for total vaginal length. Objective cure of vaginal anatomy was defined as the distal portion of the anterior, Table 2 Preoperative and postoperative POP-Q values and stages (n= 200) POP-Q variables (cm) Mean±SD Preoperatively Postoperatively p value a Aa +2.6±0.9 2.8±0.5 <0.001* Ba +4.2±1.8 2.8±0.7 <0.001* C +4.1±2.1 7.0±1.7 <0.001* Ap +2.0±1.4 2.8±0.8 <0.001* Bp +3.4±2.1 2.9±0.4 <0.001* gh 4.8±0.8 3.3±1.1 <0.001* pb 2.9±0.7 3.2±0.5 <0.001* tvl 7.4±0.9 7.5±1.0 0.242 Anterior Stage 0, Ι 190 (95 %) Stage II 10 (5 %) Stage III 112 (56 %) Stage IV 88 (44 %) Posterior Stage 0, Ι 198 (99 %) Stage II 2(1%) Stage III 122 (61 %) Stage IV 78 (39 %) Apical Stage 0, Ι 194 (97 %) Stage II 6(%) Stage III 104 (52 %) Stage IV 96 (48 %) Table 1 Variable Patient s demographics (n=200) Mean±SD or n Data are means±standard deviations gh genital hiatus, pb perineal body, tvl total vaginal length *p<0.05, statistically significant Age (years) 65.2±9.9 Parity 3.4±1.3 BMI (kg/m 2 ) 24.6±3.7 Menopause 156 (78 %) Diabetes mellitus 48 (24 %) History of hysterectomy 37 (18.5 %) SH 2 ATH 25 VTH 4 LAVH 6 A-P repair 14 (7 %) History of POP repair 16 (8 %) Concomitant MUS 57 (28.5 %) Follow-up time (months) 28.1±11.9 (15-45) Data are means±standard deviations, or n, or BMI body mass index SH supracervical hysterectomy, ATH abdominal total hysterectomy, VTH vaginal total hysterectomy, LAVH laparoscopy-assisted vaginal hysterectomy, A-P repair anterior posterior colporrhaphy, MUS mid-urethral sling with Mini-Arc posterior and apical vaginal wall not greater than POP-Q stage 2. The mean follow-up duration was 28 months (range 15 45 months). The anterior vaginal wall was corrected successfully in 190 patients (95 %), the posterior vaginal wall was corrected successfully in 198 patients (99 %), and the apical vaginal wall was corrected successfully in 194 patients (94 %). After prolapse surgery, significant improvements in incontinence-related quality of life were noted (Table 3; p< 0.001 for UDI-6 and II-Q7). Comparisons of pre- and postoperative uroflowmetry and post-voiding residual volume showed significant improvements in maximal flow rate and post-voiding residual volume (Table 3; p=0.013 and 0.002 for maximum flow rate and residual post-voiding urine volume respectively). The perioperative outcomes and complications were shown in Table 4. The mean operative time was 120.5±31 min (range 65 205 min), the mean estimated blood loss was 115±96 ml (range 25 500 ml), and the mean duration of urine indwelling catheter was 2.4±0.8 days (range 1 5 days). No bladder or

1344 Int Urogynecol J (2015) 26:1341 1346 Table 3 Comparison of the pre- and postoperative incontinence-related quality of life (UDI-6 and II Q-7) with uroflowmetry and post-voiding residual urine volume Preoperative Postoperative p UDI-6 6.1±3.5 2.2±2.4 <0.001* II Q-7 7.5±4.7 1.3±3.1 <0.001* Q max (ml/s) 20.9±12.9 25.1±10.6 0.013 RU (ml) 98.3±96.2 36.9±01.1 0.002 Data are means±standard deviations UDI Urogenital Distress Inventory, II-O-7 Incontinence Impact Questionnaire, Qmaxmaximum flow rate, RU post-voiding residual urine volume *p<0.05, statistically significant bowel injuries were noted during surgery. One patient was noted to have internal bleeding 8 h after concomitant transvaginal hysterectomy and Elevate Anterior/Posterior procedures. This patient had multiple uterine myomas at a gestational size of around 12 weeks in size, vaginal prolapse POP- Q stage 3, and a urodynamic examination showed bladder outlet obstruction. She received a transvaginal operation with ligation of the identified bleeding point; then, the Elevate Anterior/Posterior Kits were retained. Four (2 %) patients had pelvic hematomas postoperatively and received conservative treatment without further invasive procedures. The postoperative course and follow-up were smooth. The postoperative complications are shown in Table 5. The mesh extrusion rate was 2 % (4 patients), of whom 2 needed surgery for excision, and 2 were treated with transvaginal estrogen cream. The recurrent prolapse rate was 5 % (10 patients), 3 of whom received transvaginal right sacrospinous ligament suspension surgery, 2 received transvaginal hysterectomy and anterior vaginal wall bridge repair surgery, and 5 with POP-Q stage 2 prolapse without discomforting symptoms or signs refused any further treatment. The postoperative urgency and urgency incontinence rates were 9.5 % and 24 % respectively. These patients were given overactive bladder medications during the follow-up period. Postoperative urine Table 4 Variable Perioperative outcomes and complications Mean±SD Hospital stay (days) 5.4±2.2 (2 8) Operative time (min) 120±31 (65 245) Blood loss (ml) 115±96 (25 500) Duration of urine indwelling catheter (days) 2.4±1.8 (1 5) Bladder/bowel injury 0 Internal bleeding 1 (0.5 %) Pelvic hematoma 3 (1.5 %) Perineal skin ecchymosis 5 (2.5 %) Data are means±standard deviations, or n, or n (lower border to upper border) Table 5 retention was noted in 6 patients, 3 of whom took alphablockers combined with smooth relaxation medications during the follow-up period and had a post-voiding residual volume below 100 ml. The remaining 7 patients complained of postoperative vaginal spotting due to vaginal granulation tissue, and local treatment was performed at our outpatient clinic. Six patients complained of postoperative vaginal pain, and 4 complained of postoperative buttock pain. These 10 patients received analgesic medication for 1 to 2 months postoperatively. Three patients had postoperative urine retention, 2 with a neurogenic bladder diagnosed before surgery who kept using a catheter, as before surgery. The other patient had urine retention after surgery and was treated with intermittent selfcatheterization at home. Discussion Postoperative complications Variable n (%) Mesh extrusion/need operation 4 (2)/2 (1) Re-prolapse/need operation 10 (5)/5 (2.5) UI 48 (24) Urgency 19 (9.5) Urine retention 3 (1.5) Intermittent voiding 5 (2.5) Constipation 12 (6.0) Granulation 7 (3.5) Vaginal pain 6 (3.0) Buttock pain 4 (2.0) In this study, the use of the single-incision Elevate system for POP repair resulted in high success rates for anterior, apical and posterior vaginal prolapse correction of 95 %, 97 % and 99 % respectively. These findings are consistent with those of other studies utilizing synthetic mesh for POP repair. Vaiyapuri et al. reported using a Gynecare Prolift system in surgery for POP. After 1 year of follow-up, the subjective and objective cure rates were higher than 92 %; however, the Prolift system was withdrawn from the market [11]. Stanford et al. reported that 112 patients with anterior vaginal wall prolapse (POP-Q stage 2) received Elevate Anterior Kits. After 12 months of follow-up, the anatomical success rate was 87.7 % for anterior vaginal wall prolapse correction and 95.7 % for apical vaginal prolapse correction [12]. Lukban et al. presented 60 patients with anterior and/or apical vaginal prolapse greater than POP-Q stage 2 who underwent repair with Elevate Anterior Kits with an average of 13.4 months of follow-up, and reported an objective cure rate of 91.7 % [13]. Therefore, the success rates in these previous reports using Elevate Kits for POP repair were high. Our study further

Int Urogynecol J (2015) 26:1341 1346 1345 strengthened the finding with a larger case number and longer follow-up period. With the limitation of reporting bias that the surgeon performed his own postoperative examinations, the success rate is still high and reliable owing to the objective nature of the POP-Q. There were few perioperative and immediate postoperative complications in this study, and did not cause long-term morbidity. There were no colo-rectal or bladder injuries as a result of the procedure. The patient with postoperative internal bleeding was managed uneventfully. The mesh exposure rate (2.0 %) was lower than that in our previous report with the use of the Perigee and Apogee systems (12.8 % in the hysterectomy group; 3.8 % in the uterine preservation group) [14], and others Prolift (12.7 %) in Collinet et al. [15], 13 % overall rate comparing Prolift versus Apogee/Perigee in Long et al. [16], and 10.2 % in meta-analysis comparing the full range of mesh device types in Jia et al. [17]. This comparable lower mesh exposure rate may be due to accumulated experience in transvaginal mesh; however, other factors also existed, e.g., reporting bias, short follow-up, and a lack of validated questionnaires to evaluate postoperative sexual function and pain. The Food and Drug Administration approved the first surgical mesh product specifically designed for the surgical treatment of POP in 2001. Since then, many commercial surgical kits have been developed for POP surgery. Unfortunately, the increased use of vaginal synthetic mesh has been reported to cause adverse events. In October 2008, the FDA issued a public health notification informing physicians and patients of adverse events related to vaginal reconstructive surgery using synthetic mesh, and provided recommendations with regard to counseling patients about the inherent risks appropriately http://www.fda.gov/medical-devices/safety/ AlertstandNotices/ucm262435.htm. Therefore, many surgeons stopped using mesh for vaginal reconstructive surgery. However, the high risk of recurrence with native tissue makes a better procedure using adjuvant material necessary, e.g., synthetic mesh. The issue concerning the use of synthetic mesh during vaginal pelvic reconstruction is important. Recently, Abed et al. conducted a systematic review of mesh devices and adverse events. The metaanalysis reported an overall erosion rate (among 110 studies) of 10.3 % (95 % CI, 9.7 10.9 %; range, 0 29.7 %; synthetic, 10.3 %; biological, 10.1 %). The wound granulation rate (among 16 studies) was 7.8 % (95 % CI, 6.4 9.5 %; range, 0 19.1 %; synthetic, 6.8 %; biological, 9.1 %), while the dyspareunia rate (among 70 studies) was 9.1 % (95 % CI, 8. 2 10.0 %; range, 0 66.7 %; synthetic, 8.9 %; biological, 9. 6 %). A wide range of erosions, wound granulation, and dyspareunia occur after vaginal prolapse repair with graft materials [18]. The safety issue is worthy of long-term and continuous monitoring. In conclusion, POP reconstruction with the Elevate system yielded an anatomical cure rate of 95 % after 2 years of follow-up. Further studies are needed to clarify the advantages and disadvantages of mesh for vaginal pelvic reconstructive surgery. Finanicial disclaimer/conflict of interest This study was not sponsored by any surgical device company. The authors have stated explicitly that there are no conflicts of interest in connection with this article. None of the authors has received any financial support for this study. Institutional Review Board (IRB) approval from Kaohsiung Chang Gung Memorial Hospital was obtained. Authors contributions Kuan-Hui Huang: project development, manuscript writing, manuscript editing; Li-Yi Huang: data collection and analysis; Li-Ching Chu: data collection and analysis; Fei-Chi Chuang: data collection and analysis; Ming-Ping Wu: manuscript editing; Fu-Tsai Kung: patient recruitment, manuscript editing. References 1. Jelovsek JE, Maher C, Barber MD (2007) Pelvic organ prolapse. Lancet 369(9566):1027 1038 2. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Am J Obstet Gynecol 187(1):116 126 3. MacLennan AH, Taylor AW, Wilson DH, Wilson D (2000) The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. 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