PRELIMINARY ANALYSIS OF 18-MONTHEFFICACY AND SAFETY OF THE ELEVATE AND CALISTAR ANTERIOR MESHPROCEDURES
A. ROGOWSKI1, P.BIENKOWSKI 2, M. SZAFAROWSKA 1, K. SOBOCINSKI1, W. BARANOWSKI 1, P. KAMINSKI 1;
1Department of Gynecology and Oncological Gynecology,Military Inst. of Med., Warsaw, Poland, 2Department ofPsychiatry, Med. Univ. of Warsaw, Warsaw, Poland.
Introduction: Transvaginal mesh(TVM) in the treatment of pelvic organ prolapse (POP) may provide ananatomical improvement, particularly in the anterior compartment (1,2). A placement of both the Elevate and Calistar mesh systemsrequires a single incision (1). However, the Calistar system has 6milimeter diameter orifices in the implant to improve tissue ingrowthand to provide flexibility. It may be associated with less meshexposure rate. Moreover the loosening loops in the Calistar areattached to a fixation arms for a better suburethral adjustment (2).It has been hypothesized that specially designed loops allows forhighly precise implantation which may be associated with lowerincidence of urine retention, de novo overactive bladder (OAB) and denovo stress urinary incontinence (SUI).
Objective: Thepurpose of the present study was to compare an 18-month operativesuccess in patients who had undergone anterior POP surgery with theCalistar or Elevate mesh. Both subjective (bulge symptoms) andobjective measures (POP-Q anterior stage 0 or I, absence of anterioror apical descent beyond the hymen, no-retreatment for POP) were usedas the efficacy outcomes as recommended by the internationalguidelines. Rates of postoperative pelvic floor pain, dyspareunia, denovo OAB and SUI, and mesh exposures were used as the safetyoutcomes.
Methods: The study methods and definitionsconformed to the standards jointly recommended by the InternationalUrogynecological Association and the International ContinenceSociety. The study groups included patients with symptomatic anteriorcompartment and/or apical prolapse, stages III and IV, based on thePOP-Q system, who had undergone implantation of the Elevate anteriormesh (American Medical Systems, Minnetonka, MN, USA) or Calistaranterior mesh (Promedon, Argentine). The database contained recordsof a total of 94 Caucasian women operated between May 2012 and May2015 i.e. the Elevate (n=54) and the Calistar patients (n=40). Forall the patients, a follow-up assessment was performed at 18±2months postoperatively. The vaginal bulge symptoms were assessedusing a question selected from the Pelvic Floor Distress Inventory(“Do you usually have a bulge or something falling out that you cansee or feel in your vaginal area?”). Retreatment for POP wasdefined as any repeat surgery or the use of pessary for a recurrentanterior and/or apical descent. The patients were interviewed aboutSUI symptoms using the Stamey Incontinence Score. The OAB symptomswere assessed using questions selected from the Pelvic Floor DistressInventory (“Do you usually experience frequent urination?“, “Doyou usually experience a strong feeling of urgency to empty yourbladder?”, “Do you usually experience urine leakage associatedwith feeling of urgency, that is, a strong sensation of needing to goto the bathroom?”). The postoperative pain severity was estimatedby the patient using a five point scale based on the IUGA/ICS gradingsystem for the assessment of mesh-related pain. Dyspareunia wasassessed with the question “Do you have pain withintercourse?”
Results: There were no between-groupdifferences in measures of efficacy (bulge symptoms, POP-Q anteriorstage 0 or I, absence of anterior or apical descent beyond the hymenand no retreatment for POP). The mean anterior POP-Q stage assessedon the follow-up evaluation did not differ between the groups (pvalues >0.05).
The χ2 test showed no between-group differencesin the proportion of women reporting de novo SUI, and de novo OABsymptoms, vaginal exposures, urinary retention (p values >0.05).The proportion of patients with pelvic floor pain was significantlyhigher in the Elevate (4/54, 7.4%) as compared to the Calistar group(1/40, 2.5%; p<0.02). Similarly, the proportion of patients withpelvic floor pain was significantly higher in the Elevate (5/54,9.2%) as compared to the Calistar group (1/40, 2.5%;p<0.02).
Conclusions: Our study showed the high andcomparable objective and subjective efficacy rate in two groups ofwomen following the the anterior Elevate and Calistar mesh procedure.Our results suggest also that the use of Calistar system in patientswith anterior POP may results in fewer dyspareunia and postoperativepelvic floor pain, but similar efficacy, as compared to the Elevatemesh. Further prospective studies on single-incision vaginal approachimplants are mandatory to validate the results of the presentstudy.
References: 1. Moore RD, Mitchell GK, Miklos JR.Single-incision vaginal approach to treat cystocele and vaultprolapse with an anterior wall mesh anchored apically to thesacrospinous ligaments. Int Urogynecol J. 2012;23(1):85-91.
2.Palma P, Ricetto C, Barreiro T, Altuna S, Ledesma M, Herrmann V.Simultaneous single-incision transvaginal mesh to treat anterior andapical prolapses - a midterm results. IUGA 38th Annual Meeting 2013.Dublin, Ireland. Abstract 470.