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. Issue 38 (18th September 2020)

• Record Type: Journal Article
• Authors: Ouyang, Yiqin; Chen, Rujun; Chu, Lei; Liang, Junhua; Zhang, Xueyu; Li, Li; Gao, Tian; Li, Huaifang; Tong, Xiaowen
• Other Names: Comim. Fabio section editor.
• Is Part Of: Medicine. Volume 99:Issue 38(2020)
• Publication Date: 2020-09-18
• Subjects: mesh -- pelvic floor functional recovery -- pelvic organ prolapse -- pelvic reconstruction -- prospective study -- quality of life; Medicine -- Periodicals; Medicine -- Periodicals; Médecine -- Périodiques; Geneeskunde; Medicine; Periodicals; Periodicals; 610.5
• DOI: 10.1097/MD.0000000000022332
• Languages: English
• ISSNs: 0025-7974

Abstract

Abstract : Abstract: 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. Abstract : Supplemental Digital Content is available in the text