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BioMed Research International
Volume 2015, Article ID 479610, 7 pages
http://dx.doi.org/10.1155/2015/479610
Clinical Study

Comparison of Clinical Outcomes Using “Elevate Anterior” versus “Perigee” System Devices for the Treatment of Pelvic Organ Prolapse

1Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, 100 Ziyou 1st Road, Kaohsiung City 80756, Taiwan
2Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, 100 Ziyou 1st Road, Kaohsiung City 80756, Taiwan
3Department of Obstetrics and Gynecology, Chi Mei Foundation Hospital, Tainan, Taiwan

Received 8 October 2014; Revised 11 January 2015; Accepted 12 January 2015

Academic Editor: Stefan Rimbach

Copyright © 2015 Cheng-Yu Long et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. This study aims to compare clinical outcomes using the Perigee versus Elevate anterior devices for the treatment of pelvic organ prolapse (POP). Study Design. One hundred and forty-one women with POP stages II to IV were scheduled for either Perigee () or Elevate anterior device (). Preoperative and postoperative assessments included pelvic examination, urodynamic study, and a personal interview about quality of life and urinary symptoms. Results. Despite postoperative point C of Elevate group being significantly deeper than the Perigee group (median: −7.5 versus −6; ), the 1-year success rates for two groups were comparable (). Apart from urgency incontinence, women with advanced POP experienced significant resolution of irritating and obstructive symptoms after both procedures (), generating the improvement in postoperative scores of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) (). On urodynamics, only the residual urine decreased significantly following these two procedures (). Women undergoing Perigee mesh experienced significantly higher visual analogue scale (VAS) scores and vaginal extrusion rates compared with the Elevate anterior procedure (). Conclusions. With comparable success rates, the Elevate procedure has advantages over the Perigee surgery with lower extrusion rate and postoperative day 1 VAS scores.

1. Introduction

It has been estimated that a lifetime risk of undergoing primary surgery for pelvic organ prolapse (POP) or urine incontinence for a woman is about 11% [1]. Despite the fact that anterior colporrhaphies have been the empirical treatment of POP for a long time, it carries a higher failure rate [1]. Thus, surgery with mesh or graft materials has gained more and more popularity over the last decade due to the excellent short-term cure rate, especially in the anterior compartment [2, 3].

The Perigee (AMS, Inc., Minnetonka, MN, USA) system is one kind of the synthetic mesh kits recently launched and adopted in pelvic reconstruction for the treatment of anterior vaginal wall prolapse. The Elevate anterior (AMS, Inc., Minnetonka, MN, USA) device is the next generation of the Perigee system, claiming the use of a type I polypropylene Intepro Lite mesh and single vaginal incision in this newer procedure. The Perigee mesh is anchored using trocar passes through the obturator foramen and the latter mesh with hooks is reached with direct penetration to the obturator fascia and sacrospinous ligament [4, 5]. Therefore, the Elevate anterior mesh provides both anterior and apical support, which is important due to the notable reports of compensatory recurrence rates after POP surgery [6].

However, the United States Food and Drug Administration (FDA) announced a public health notification regarding “serious complications associated with transvaginal placement of surgical mesh in repair of POP and stress urinary incontinence (SUI)” in 2011 July [7]. Indeed, the FDA warning has caused further caution when selecting the type of mesh kits. We had published a pilot study comparing clinical outcomes using “Perigee and/or Apogee” versus “Prolift anterior and/or posterior” devices for the treatment of POP [8]. This time, we wonder whether the newer Elevate device offers a safer and less painful procedure and whether this would be more durable. In reviewing the literature, limited data are available on the comparisons of efficacy and safety between these two graft-reinforced POP surgeries. Accordingly, we evaluated our experience with the focus on safety, clinical outcomes, and urodynamic findings following these two procedures.

2. Materials and Methods

From June 2004 to December 2012, two hundred consecutive symptomatic women with stage II or greater anterior/apical compartment prolapse defined by the POP quantification (POP-Q) staging system [9] were referred for cystocele repair using Perigee or Elevate anterior system devices (120 Perigee; 80 Elevate devices) to our hospital. Concomitant anti-incontinence sling surgeries, including tension-free vaginal tape (TVT; Gynecare TVT, Ethicon, Inc., Piscataway, NJ, USA), TVT-O (Gynecare TVT-Obturator System, Ethicon, Inc., Somerville, NJ, USA), Monarc (AMS, Inc., Minnetonka, MN, USA), and Ajust (C.R. Bard, Inc., Murray Hill, NJ, USA), were performed in patients with current or occult urodynamic stress incontinence (USI). Fifty-nine women were excluded from our study due to various reasons, including incomplete medical records (; fifteen women in the Perigee group, nine in the Elevate group) and inadequacy or loss of follow-up (; twenty-five women in the Perigee group, ten in the Elevate group). Finally, the remaining 141 women were divided into the Perigee group () and the Elevate group ().

Preoperative and postoperative assessments included pelvic examination using the POP-Q staging system, urodynamic study, and a personal interview to evaluate the short forms of Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) [10], and urinary symptoms with the standardized questionnaire taking into account the 2002 ICS definitions [11]. Women were asked to fill out the VAS (visual analogue scale) scores during the postoperative day 1 rounds. Urodynamic studies were performed according to the recommendations by the International Continence Society [12] with a 6-channel urodynamic monitor (MMS; UD2000, Enschede, Netherlands). USI was defined as involuntary urinary loss with cough in the absence of detrusor contractions during cystometry. The diagnosis of occult USI was made by the occurrence of urinary leakage during the reduction of prolapse. Any uninhibited detrusor contraction during filling cystometry was deemed positive for idiopathic detrusor overactivity (DO).

2.1. Operative Technique: Perigee Device

Firstly, an anterior vaginal vertical incision was opened from the bladder neck toward the anterior fornix of the vagina. After hydrodissection, the paravesical space was created on both sides in order to put the index finger behind the obturator foramen. During the Perigee procedure, superior trocars were inserted through the upper medial angle of the obturator foramen at the level of the clitoris, and the inferior trocars were inserted 2 cm inferior and 1 cm lateral to the upper incisions. All trocars were passed through the arcus tendineus fascia pelvis and emerge in the vaginal wound. The mesh arms of Perigee devices were attached to the corresponding passers and brought out of the skin wounds [4].

2.2. Operative Technique: Elevate Device

After hydrodissection and separation of the paravesical fascia and vaginal mucosa, the Elevate anterior mesh with bilateral upper and lower arms was pushed to the obturator fascia and sacrospinous ligaments, respectively. Graft anchorage was performed via self-fixating tips, which avoided blind trocar passage through the obturator and perirectal fossa seen in Perigee mesh kit techniques. Then, cystoscopy was performed to exclude any bladder injury and to confirm intact ureters.

The synthetic mesh was put under the bladder base and anchored with 2-0 PDS (polydioxanone) sutures proximally and distally. The vaginal wound was closed with 3-0 polyglactin sutures. The skin wounds were closed using Dermabond and vaginal packing was placed for 24–48 hours. Operative time was calculated from the first incision of anterior vaginal wall to the end of wound closure. All patients were administered antibiotics (intravenous Cefazolin 1 g; Cefamezin, Fujisawa, Tokyo, Japan) before operation. The surgeries were carried out with the women under spinal, epidural, or general anesthesia. All procedures were finished mainly by the first author (Cheng-Yu Long), with individual experience of over 400 transvaginal mesh repairs.

Postoperative follow-up was scheduled at 1, 3, 6, and 12 months and then yearly thereafter. All POP-Q measurements were made by the first author. Surgical failure was defined as the most distal portion of prolapse over stage II or more, regardless of primary or de novo site. The International Urogynecological Association (IUGA)/International Continence Society (ICS) scale is used for the classification of the mesh-related complications [13]. Ethical approval by the Institutional Review Board of our hospitals had been obtained for data analysis. Statistical calculations were performed using Student’s -test, Mann-Whitney test, McNemar’s or Wilcoxon signed rank test for continuous variables, and the chi-square or Fisher’s exact test for categorical variables. A was considered statistically significant.

We assessed the power of tests for differentiating the surgical outcome between groups, and power analysis showed that around 50–60 women in each group would have a power of 80%. Although some comparisons, such as DO rates, could not reach sufficient power due to the limited numbers of the Elevate group, we utilized multiple parameters of POP-Q system to evaluate the postoperative change. We found with >40 women in each group that there was a power of over 85% for discrimination.

3. Results

Participant characteristics of both groups are compared in Table 1. There was no difference between the two groups with regard to age, parity, current hormone use, diabetes, hypertension, prior history of hysterectomy or POP repair, POP stages, and concomitant procedures (). As for the POP-Q analysis, there was a significant improvement at points Aa, Ba, C, Ap, and Bp () in both groups except for total vaginal length (; Table 2). Moreover, postoperative point C of the Elevate group was significantly deeper than that in the Perigee group () (Figure 1). Other POP-Q points between the two groups did not differ significantly (). The 1-year success rate was comparable in both groups (; Table 2).
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