PURPOSE: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.
Cystocele ; Dyspareunia ; Female ; Follow-Up Studies* ; Hemorrhage ; Humans ; Ligaments ; Muscles ; Pelvic Floor ; Pelvic Organ Prolapse ; Polypropylenes ; Prolapse* ; Prospective Studies* ; Reoperation ; Surgical Mesh ; Urinary Incontinence ; Urinary Retention ; Urinary Tract Infections ; Uterine Prolapse ; Vagina