TY - JOUR
T1 - An Observational Study on the Efficacy and Complications of a Transvaginal Single-Incision Mesh for Pelvic Organ Prolapse
AU - Jeffery, Stephen T.
AU - Maljaars, Lennart P.
AU - Diedrich, Chantal M.
AU - Kastelein, Arnoud W.
AU - van Eijndhoven, Hugo W. F.
AU - Schweitzer, Karlijn J.
AU - Roovers, Jan-Paul W. R.
N1 - Funding Information: Dr. van Eijndhoven reports personal fees from Coloplast, outside the submitted work. Prof. Roovers reports personal fees from Coloplast, and Promedon, as well as grants from Coloplast, outside the submitted work. All other authors have no financial conflicts of interest. Funding Information: The study was funded by an unrestricted research grant from the manufacturer of the Nuvia Anterior Device, Bard Medical, Crawley, UK. This funder had no active roles in the data collection, analysis, and interpretation of data; writing this report; and decision to submit this article for publication. Publisher Copyright: © Copyright 2022, Mary Ann Liebert, Inc., publishers 2022.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - 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.
AB - 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.
KW - anatomical cure
KW - prolapse surgery
KW - sexual function
KW - single-incision procedure
KW - transvaginal mesh
KW - urogynecology
UR - http://www.scopus.com/inward/record.url?scp=85132143582&partnerID=8YFLogxK
U2 - https://doi.org/10.1089/gyn.2021.0124
DO - https://doi.org/10.1089/gyn.2021.0124
M3 - Article
SN - 1042-4067
VL - 38
SP - 232
EP - 240
JO - Journal of Gynecologic Surgery
JF - Journal of Gynecologic Surgery
IS - 3
ER -