Alessio Miceli1, Manuel Fernández-Sánchez1,2, Juan Polo-Padillo3, José-Luis Dueñas-Díez4,5,6. 1. Department of Surgery, Obstetrics & Gynecology Area, Faculty of Medicine, University of Seville, Seville, Spain. 2. Instituto Valenciano de Infertilidad, IVIRMA-Seville, Seville, Spain. 3. Biostatistics Unit, Department of Public Health and Preventive Medicine, Faculty of Medicine, University of Seville, Seville, Spain. 4. Department of Surgery, Obstetrics & Gynecology Area, Faculty of Medicine, University of Seville, Seville, Spain. jlduenas@us.es. 5. Department of Obstetrics & Gynecology, "Virgen Macarena" University Hospital (H.U.V.M), Seville, Spain. jlduenas@us.es. 6. Departamento de Cirugía, Área de Obstetricia y Ginecología, Facultad de Medicina Universidad de Sevilla, Avda. Dr. Fedriani, s/n, 41009, Sevilla, Spain. jlduenas@us.es.
Abstract
INTRODUCTION AND HYPOTHESIS: The study was aimed at evaluating the safety and efficacy of ring pessaries without support under continuous use without periodic removal or replacement for the treatment of advanced pelvic organ prolapse (POP) in women for 2 consecutive years. METHODS: This study was a prospective observational study. A total of 123 women were recruited in a tertiary hospital from January 2013 to January 2016. The primary objective was the percentage of patients maintaining the use of the pessary after 24 months. The secondary objectives were the reasons for discontinuation and the adverse events in patients with successful fittings. RESULTS: A total of 115 patients (93.5%) had a successful fitting. Four patients died of non-pessary-related causes during the study and, one patient dropped out the follow-up so that finally, 110 patients were included in the efficacy analysis. Pessary use was maintained by 91.8% of the women at the end of the study. The adverse events rate was low (27.0%). The two main factors of interruption in the pessary use were: age (OR 0.93; 95% CI 0.87-0.99) and history of urinary urge incontinence (OR 0.33; 95% CI 0.11-0.96]). CONCLUSIONS: A high success rate and low adverse events rate were achieved in patients with advanced-stage POP with continuous pessary use for 24 months, indicating that a ring pessary could also be used without periodic removal for at least the first 2 years. This practice could reduce the number of control visits.
INTRODUCTION AND HYPOTHESIS: The study was aimed at evaluating the safety and efficacy of ring pessaries without support under continuous use without periodic removal or replacement for the treatment of advanced pelvic organ prolapse (POP) in women for 2 consecutive years. METHODS: This study was a prospective observational study. A total of 123 women were recruited in a tertiary hospital from January 2013 to January 2016. The primary objective was the percentage of patients maintaining the use of the pessary after 24 months. The secondary objectives were the reasons for discontinuation and the adverse events in patients with successful fittings. RESULTS: A total of 115 patients (93.5%) had a successful fitting. Four patients died of non-pessary-related causes during the study and, one patient dropped out the follow-up so that finally, 110 patients were included in the efficacy analysis. Pessary use was maintained by 91.8% of the women at the end of the study. The adverse events rate was low (27.0%). The two main factors of interruption in the pessary use were: age (OR 0.93; 95% CI 0.87-0.99) and history of urinary urge incontinence (OR 0.33; 95% CI 0.11-0.96]). CONCLUSIONS: A high success rate and low adverse events rate were achieved in patients with advanced-stage POP with continuous pessary use for 24 months, indicating that a ring pessary could also be used without periodic removal for at least the first 2 years. This practice could reduce the number of control visits.
Entities:
Keywords:
Advanced POP; Continuous use; Efficacy; Ring pessary without support; Safety
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