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Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up
INTRODUCTION AND HYPOTHESIS: Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical succes...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8754555/ https://www.ncbi.nlm.nih.gov/pubmed/35022836 http://dx.doi.org/10.1007/s00192-021-05045-w |
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author | Levy, Gil Padoa, Anna Marcus, Naama Beck, Anat Fekete, Zoltan Cervigni, Mauro |
author_facet | Levy, Gil Padoa, Anna Marcus, Naama Beck, Anat Fekete, Zoltan Cervigni, Mauro |
author_sort | Levy, Gil |
collection | PubMed |
description | INTRODUCTION AND HYPOTHESIS: Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented. METHODS: A prospective multicenter trial was conducted using two consecutive identical protocols of the use of the SRS implant in women with symptomatic anterior compartment prolapse extending their follow-up to 36 months. Anatomical success (Pelvic Organ Prolapse Quantification stage 0 or 1 or a Ba ≤ −2) was recorded along with subjective success as defined by regular quality-of-life (PFDI-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) assessments. RESULTS: Sixty-seven patients completed 36 months of follow-up. Mean Ba measurements improved from 3.1 (−1 to 6) cm to −2.8 (−1 to −3) cm and C point from 0.4 (−8 to 6) cm to −6.9 (−10 cm to 1) cm. accumulating to a significant anatomical success rate of 94.3%. Subjective success based on question #3 of the PFDI-20, analyzed for the index surgical compartment, reached 95.7%. Post-operative complications included 2 cases of urinary retention, 1 minor frame exposure, 1 case of delayed voiding dysfunction, and 2 cases of de novo stress urinary incontinence. Untreated pre-operative second-degree Bp measurements had increased in 27% at follow-up. CONCLUSION: The long-term outcome of the SRS implant shows an excellent subjective and objective success with minimal risk of complications or need for reintervention. |
format | Online Article Text |
id | pubmed-8754555 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-87545552022-01-13 Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up Levy, Gil Padoa, Anna Marcus, Naama Beck, Anat Fekete, Zoltan Cervigni, Mauro Int Urogynecol J Original Article INTRODUCTION AND HYPOTHESIS: Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented. METHODS: A prospective multicenter trial was conducted using two consecutive identical protocols of the use of the SRS implant in women with symptomatic anterior compartment prolapse extending their follow-up to 36 months. Anatomical success (Pelvic Organ Prolapse Quantification stage 0 or 1 or a Ba ≤ −2) was recorded along with subjective success as defined by regular quality-of-life (PFDI-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) assessments. RESULTS: Sixty-seven patients completed 36 months of follow-up. Mean Ba measurements improved from 3.1 (−1 to 6) cm to −2.8 (−1 to −3) cm and C point from 0.4 (−8 to 6) cm to −6.9 (−10 cm to 1) cm. accumulating to a significant anatomical success rate of 94.3%. Subjective success based on question #3 of the PFDI-20, analyzed for the index surgical compartment, reached 95.7%. Post-operative complications included 2 cases of urinary retention, 1 minor frame exposure, 1 case of delayed voiding dysfunction, and 2 cases of de novo stress urinary incontinence. Untreated pre-operative second-degree Bp measurements had increased in 27% at follow-up. CONCLUSION: The long-term outcome of the SRS implant shows an excellent subjective and objective success with minimal risk of complications or need for reintervention. Springer International Publishing 2022-01-13 2022 /pmc/articles/PMC8754555/ /pubmed/35022836 http://dx.doi.org/10.1007/s00192-021-05045-w Text en © The International Urogynecological Association 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Original Article Levy, Gil Padoa, Anna Marcus, Naama Beck, Anat Fekete, Zoltan Cervigni, Mauro Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
title | Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
title_full | Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
title_fullStr | Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
title_full_unstemmed | Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
title_short | Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
title_sort | surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8754555/ https://www.ncbi.nlm.nih.gov/pubmed/35022836 http://dx.doi.org/10.1007/s00192-021-05045-w |
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