Int Neurourol J.  2018 Sep;22(3):177-184. 10.5213/inj.1836036.018.

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

• Palma PC
• de Castro Monteiro MV
• Ledesma MA
• Altuna S
• Sardi JJ
• Riccetto C

• KMID: 2422505
• DOI: http://doi.org/10.5213/inj.1836036.018

Abstract

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.

Keyword

Cystocele; Pelvic organ prolapse; Surgical mesh; Uterine prolapse; Pelvic floor; Urinary incontinence

MeSH Terms

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
Polypropylenes