An Observational Study on the Efficacy and Complications of a Transvaginal Single-Incision Mesh for Pelvic Organ Prolapse

Abstract

Objective:

The aim of this study was to evaluate a new-generation, single-incision transvaginal mesh (TVM) procedure on anatomical and functional outcomes and complication rates in women with symptomatic cystoceles.

Materials and Methods:

Sixty-five patients with symptomatic cystoceles (POP-Q stage ≥2) were included in a prospective, multicenter study in the Netherlands to evaluate the TVM procedure using the Nuvia^® Anterior Device (Bard Medical, Crawley, UK). The primary endpoint was anatomical cure after 12 months (Pelvic Organ Prolapse Quantification [POP-Q] points Aa and Ba at −2 cm or higher). Secondary endpoints were subjective reduction of pelvic organ prolapse (POP) noted on 3 disease-specific quality-of-life (QoL) questionnaires (Urogenital Distress Inventory [UDI], Incontinence Impact Questionnaire [IIQ], and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire [PISQ-12]); complications; and serious adverse events during and after surgery up to 12 months later. Repeated-measurement analyses were used for POP-Q scores and QoL outcomes.

Results:

Anterior and apical measurements improved after surgery with anatomical success rates of 70.6% and 60.8% after 6 and 12 months, respectively. Four patients (7.7%) developed vaginal mesh exposure and 2 (3.8%) developed significant pain related to the mesh. Three (5.7%) needed reintervention due to these complications. The apical recurrence rate was 4%, and 2 patients underwent repeat POP surgery. Functional outcomes on UDI, IIQ, and PISQ-12 were satisfactory with significant improvements in QoL reported on all questionnaires.

Conclusions:

This study demonstrated significant improvement in anatomical and functional outcomes with low complication rates. The single-incision approach to TVM surgery can be a valid option for patients with complex recurrent prolapse. (J GYNECOL SURG 38:232)