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Partially Absorbable Mesh (SERATOM® PA) for Vaginal Pelvic Organ Prolapse Surgery is a Safe and Effective Option: A Multi-Center and Prospective Study

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Objectives: This prospective multi-center pilot study evaluated the safety, efficacy, and quality of life (QoL) outcomes associated with the use of a transvaginal mesh kit utilizing partially absorbable mesh (PAM) in Korean women with pelvic organ prolapse (POP). Methods: Thirty patients with symptomatic POP stage II or higher underwent surgical repair using the SERATOM® PA mesh between March 2013 and February 2015. The primary endpoint was the objective surgical success rate, assessed by POP-Q stage and the need for repeat surgery within six months postoperatively. Secondary endpoints included QoL assessment using validated questionnaires (King’s Health Questionnaire, PFDI-20, PFIQ-7, and PISQ-12) and monitoring of complications. Results: The mean participant age was 65.6 years, with 97% being postmenopausal. Preoperative POP-Q staging revealed that most patients (87%) had stage III or IV prolapse. The average surgical time was 96.4 minutes, and hospital stay averaged 4.9 days. No intraoperative or postoperative complications were reported. Of the 24 patients who completed follow-up, 23 achieved POP-Q stage 0 at six months, with the remaining patient at stage I but asymptomatic, requiring no further intervention. No cases of healing abnormalities or reoperations were noted. Significant improvements in pelvic floor dysfunction symptoms and sexual function were observed, as evidenced by marked improvements in PFDI-20, PFIQ-7, and PISQ-12 scores at six months postoperatively. Conclusions: The use of PAM in transvaginal POP surgery demonstrated high efficacy, excellent safety outcomes, and significant improvement in QoL, suggesting it is a viable surgical option for advanced POP in this patient population.

Abstract

Objectives: This prospective multi-center pilot study evaluated the safety, efficacy, and quality of life (QoL) outcomes associated with the use of a transvaginal mesh kit utilizing partially absorbable mesh (PAM) in Korean women with pelvic organ prolapse (POP). Methods: Thirty patients with symptomatic POP stage II or higher underwent surgical repair using the SERATOM® PA mesh between March 2013 and February 2015. The primary endpoint was the objective surgical success rate, assessed by POP-Q stage and the need for repeat surgery within six months postoperatively. Secondary endpoints included QoL assessment using validated questionnaires (King’s Health Questionnaire, PFDI-20, PFIQ-7, and PISQ-12) and monitoring of complications. Results: The mean participant age was 65.6 years, with 97% being postmenopausal. Preoperative POP-Q staging revealed that most patients (87%) had stage III or IV prolapse. The average surgical time was 96.4 minutes, and hospital stay averaged 4.9 days. No intraoperative or postoperative complications were reported. Of the 24 patients who completed follow-up, 23 achieved POP-Q stage 0 at six months, with the remaining patient at stage I but asymptomatic, requiring no further intervention. No cases of healing abnormalities or reoperations were noted. Significant improvements in pelvic floor dysfunction symptoms and sexual function were observed, as evidenced by marked improvements in PFDI-20, PFIQ-7, and PISQ-12 scores at six months postoperatively. Conclusions: The use of PAM in transvaginal POP surgery demonstrated high efficacy, excellent safety outcomes, and significant improvement in QoL, suggesting it is a viable surgical option for advanced POP in this patient population.

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