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Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study
The pelvic organ prolapse (POP) repair systems used in China are imported and expensive. Our aim was to compare the efficacy and safety of a self-developed pelvic floor repair system versus the Avaulta system. This was a multicenter, randomized, parallel-group, noninferiority trial of 132 patients w...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505298/ https://www.ncbi.nlm.nih.gov/pubmed/32957403 http://dx.doi.org/10.1097/MD.0000000000022332 |
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author | Ouyang, Yiqin Chen, Rujun Chu, Lei Liang, Junhua Zhang, Xueyu Li, Li Gao, Tian Li, Huaifang Tong, Xiaowen |
author_facet | Ouyang, Yiqin Chen, Rujun Chu, Lei Liang, Junhua Zhang, Xueyu Li, Li Gao, Tian Li, Huaifang Tong, Xiaowen |
author_sort | Ouyang, Yiqin |
collection | PubMed |
description | The pelvic organ prolapse (POP) repair systems used in China are imported and expensive. Our aim was to compare the efficacy and safety of a self-developed pelvic floor repair system versus the Avaulta system. This was a multicenter, randomized, parallel-group, noninferiority trial of 132 patients with POP stage ≥II from the Tongji Hospital Affiliated to Tongji University and the General Hospital of Ningxia Medical University enrolled from 02/2014 to 03/2015. The patients were randomized 1:1 to POP repair using the self-developed system or the Avaulta system. Perioperative conditions, POP quantification, pelvic floor impact questionnaire-7, and prolapse quality of life questionnaires, gynecological ultrasound, and postoperative complications were compared. Patients were followed at 1.5, 3, and 6 months. According to the POP quantification scores obtained at 6 months after surgery, the cure rates of the self-developed and Avaulta groups were 98.3% and 100.0%, respectively (P > .999). At 6 months follow-up, the pelvic floor impact questionnaire-7 scores of the self-developed and Avaulta groups were both improved (P < .001 vs baseline), with no between-group difference observed (P = .488). There were no differences between the 2 groups for subjective symptoms of POP (all P > .05). There were no significant differences between the 2 groups regarding complications (all P > .05). The self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients’ quality of life, without difference compared to the Avaulta system. |
format | Online Article Text |
id | pubmed-7505298 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-75052982020-09-24 Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study Ouyang, Yiqin Chen, Rujun Chu, Lei Liang, Junhua Zhang, Xueyu Li, Li Gao, Tian Li, Huaifang Tong, Xiaowen Medicine (Baltimore) 5600 The pelvic organ prolapse (POP) repair systems used in China are imported and expensive. Our aim was to compare the efficacy and safety of a self-developed pelvic floor repair system versus the Avaulta system. This was a multicenter, randomized, parallel-group, noninferiority trial of 132 patients with POP stage ≥II from the Tongji Hospital Affiliated to Tongji University and the General Hospital of Ningxia Medical University enrolled from 02/2014 to 03/2015. The patients were randomized 1:1 to POP repair using the self-developed system or the Avaulta system. Perioperative conditions, POP quantification, pelvic floor impact questionnaire-7, and prolapse quality of life questionnaires, gynecological ultrasound, and postoperative complications were compared. Patients were followed at 1.5, 3, and 6 months. According to the POP quantification scores obtained at 6 months after surgery, the cure rates of the self-developed and Avaulta groups were 98.3% and 100.0%, respectively (P > .999). At 6 months follow-up, the pelvic floor impact questionnaire-7 scores of the self-developed and Avaulta groups were both improved (P < .001 vs baseline), with no between-group difference observed (P = .488). There were no differences between the 2 groups for subjective symptoms of POP (all P > .05). There were no significant differences between the 2 groups regarding complications (all P > .05). The self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients’ quality of life, without difference compared to the Avaulta system. Lippincott Williams & Wilkins 2020-09-18 /pmc/articles/PMC7505298/ /pubmed/32957403 http://dx.doi.org/10.1097/MD.0000000000022332 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) |
spellingShingle | 5600 Ouyang, Yiqin Chen, Rujun Chu, Lei Liang, Junhua Zhang, Xueyu Li, Li Gao, Tian Li, Huaifang Tong, Xiaowen Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study |
title | Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study |
title_full | Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study |
title_fullStr | Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study |
title_full_unstemmed | Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study |
title_short | Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study |
title_sort | safety and efficacy of a self-developed chinese pelvic repair system and avaulta repair system for the treatment of pelvic organ prolapse in women: a multicenter, prospective, randomized, parallel-group study |
topic | 5600 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505298/ https://www.ncbi.nlm.nih.gov/pubmed/32957403 http://dx.doi.org/10.1097/MD.0000000000022332 |
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