Treatment of Anterior Vaginal Wall Prolapse Using Transvaginal Anterior Mesh With Apical Fixation: A Prospective Multicenter Study With up to 2 Years of Follow-up

• Published in: International neurourology journal Vol. 22; no. 3; pp. 177 - 184
• Main Authors: Palma, Paulo César Rodrigues, Monteiro, Marilene Vale de Castro, Ledesma, Marta Alicia, Altuna, Sebastián, Sardi, Juan José Luis, Riccetto, Cássio Luís Zanettini
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Continence Society 01-09-2018; 대한배뇨장애요실금학회
• Subjects: Cystocele; Original; Pelvic floor; Pelvic organ prolapse; Surgical mesh; Urinary incontinence; Uterine prolapse; 비뇨기과학; Urinary incontinence; Pelvic floor; Surgical mesh; Pelvic organ prolapse; Cystocele; Uterine prolapse
• DOI: 10.5213/inj.1836036.018
• EISSN: 2093-6931
• ISSN: 2093-4777; 2093-6931

To evaluate the safety and efficacy of a surgical polypropylene mesh for correction of anterior vaginal prolapse, with or without apical defects, by providing simultaneous reinforcement at the anterior and apical aspects of the vagina with a single-incision approach.
This was a prospective, multicenter, single-arm study involving women with baseline stage ≥2 anterior and/or apical vaginal wall prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system. The primary endpoint was defined as achievement of POP-Q stage ≤1 status. Additionally, patient-reported outcomes were assessed using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS). The device under evaluation was Calistar A, which is fixed posteriorly to the sacrospinous ligaments with a novel tissue-anchoring system (TAS) and anteriorly to the obturator internus muscles. Postoperative follow-ups were scheduled at 7 days and at 6, 12, and 24 months.
Ninety-seven women were treated and assessed for the primary outcome. They were followed for up to 2 years (n=43), with a median of 12 months. Objective cure was achieved in 86 of the 97 patients (88.7%) (P<0.0005). The mean reduction in the ICIQ-VS scores was in the range of 70%-90% for every time point (P<0.05). No bleeding or surgical revision was reported. Mesh exposure occurred in 7 patients (7.2%), urinary retention in 5 (5.2%), de novo dyspareunia in 3 (3.1%), and urinary tract infections in 7 (7.2%).
This midterm follow-up showed that apical and anterior vaginal reinforcement with a polypropylene implant fixed with a TAS provided good anatomical correction, with no major complications.