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Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair

OBJECTIVE: To evaluate the safety and short term outcomes of a new, truly minimally-invasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair. METHODS: A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effect...

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Autores principales: Weintraub, Adi Y., Zvi, Masha Ben, Yohay, David, Neymeyer, Joerg, Reuven, Yonatan, Neuman, Menahem, Tsivian, Alex
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Sociedade Brasileira de Urologia 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5462146/
https://www.ncbi.nlm.nih.gov/pubmed/28191790
http://dx.doi.org/10.1590/S1677-5538.IBJU.2016.0356
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author Weintraub, Adi Y.
Zvi, Masha Ben
Yohay, David
Neymeyer, Joerg
Reuven, Yonatan
Neuman, Menahem
Tsivian, Alex
author_facet Weintraub, Adi Y.
Zvi, Masha Ben
Yohay, David
Neymeyer, Joerg
Reuven, Yonatan
Neuman, Menahem
Tsivian, Alex
author_sort Weintraub, Adi Y.
collection PubMed
description OBJECTIVE: To evaluate the safety and short term outcomes of a new, truly minimally-invasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair. METHODS: A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients’ six months-follow-up and evaluation are reported. RESULTS: The mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant. CONCLUSIONS: This new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications.
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spelling pubmed-54621462017-06-19 Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair Weintraub, Adi Y. Zvi, Masha Ben Yohay, David Neymeyer, Joerg Reuven, Yonatan Neuman, Menahem Tsivian, Alex Int Braz J Urol Original Article OBJECTIVE: To evaluate the safety and short term outcomes of a new, truly minimally-invasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair. METHODS: A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients’ six months-follow-up and evaluation are reported. RESULTS: The mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant. CONCLUSIONS: This new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications. Sociedade Brasileira de Urologia 2017 /pmc/articles/PMC5462146/ /pubmed/28191790 http://dx.doi.org/10.1590/S1677-5538.IBJU.2016.0356 Text en http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Weintraub, Adi Y.
Zvi, Masha Ben
Yohay, David
Neymeyer, Joerg
Reuven, Yonatan
Neuman, Menahem
Tsivian, Alex
Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
title Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
title_full Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
title_fullStr Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
title_full_unstemmed Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
title_short Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
title_sort safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5462146/
https://www.ncbi.nlm.nih.gov/pubmed/28191790
http://dx.doi.org/10.1590/S1677-5538.IBJU.2016.0356
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