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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

Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women

Authors :
Lei Chu
Huaifang Li
Xueyu Zhang
Junhua Liang
Tian Gao
Rujun Chen
Yiqin Ouyang
Li Li
Xiaowen Tong
Source :
Medicine
Publication Year :
2020
Publisher :
Lippincott Williams & Wilkins, 2020.

Abstract

Supplemental Digital Content is available in the text<br />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 .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.

Details

Language :
English
ISSN :
15365964 and 00257974
Volume :
99
Issue :
38
Database :
OpenAIRE
Journal :
Medicine
Accession number :
edsair.doi.dedup.....a0462d51cd415e762398d26aa3db98cb