非处方一次性阴道内支持装置治疗压力性尿失禁的不良事件报告特征。

IF 1.4 4区 医学 Q3 OBSTETRICS & GYNECOLOGY
Stephanie A Sansone, Michelina D Stoddard, Ahra Cho, Tirsit S Asfaw, Art Sedrakyan, Bilal Chughtai
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引用次数: 0

摘要

目的:近年来,针对压力性尿失禁的新型阴道内支持装置已被引入市场。虽然研究证明了它们的安全性和有效性,但很少有研究检查了使用它们的不良事件。本研究的目的是描述非处方阴道内支持装置报告的不良事件,并确定是否需要进一步的医学治疗来控制不良事件。方法:检索2015年1月至2020年9月的制造商和用户设备体验数据库,获取相关报告的不良事件,包括唯一报告密钥、事件日期、报告日期、事件文本描述和由此产生的疗程。根据制造商和用户设备体验数据库的强制性要求,制造商在收到消费者自愿提交的报告后30天内提交了所有报告。结果:共纳入257份报告进行分析。最常见的不良事件报告与器械串有关,器械串在取出或插入时断裂(257例中有230例[89.5%])。大多数需要医疗护理的患者(257名患者中的133名[51.8%])在办公室环境中进行了评估和管理(133名患者中的85名[63.9%]),而37%(257名患者中的95名)患者能够自我治疗。结论:大多数归因于器械使用的并发症是自我管理或在门诊环境中管理的。没有紧急住院或死亡归因于其使用,支持其总体低风险和高耐受性。本综述的局限性包括无法解释这些报告的不良事件的分母,以及消费者自愿报告的潜在偏差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

Objectives: In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event.

Methods: We searched the Manufacturer and User Device Experience database from January 2015 to September 2020 for pertinent reported adverse events, which included the unique report key, event date, report date, event text descriptions, and resulting course of treatment. Per Manufacturer and User Device Experience database mandatory requirements, all reports were submitted by the manufacturer within 30 days of receiving the consumer's voluntary submission.

Results: A total of 257 reports were included for analysis. The most common reported adverse event was related to the string of the device, which broke with either removal or insertion of the device (230 of 257 [89.5%]). The majority of patients who required medical attention (133 of 257 [51.8%]) were evaluated and managed in the office setting (85 of 133 [63.9%]), whereas 37% (95 of 257) of patients were able to self-treat.

Conclusions: Most complications attributed to device use were self-managed or managed in the outpatient setting. No emergent hospitalizations or deaths were attributed to their use, supporting their generally low-risk profile and high tolerability. Limitations of this review include the inability to decipher a denominator for these reported adverse events and the potential bias attributed to voluntary consumer reporting.

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来源期刊
CiteScore
2.10
自引率
12.50%
发文量
228
期刊介绍: Female Pelvic Medicine & Reconstructive Surgery, official journal of the American Urogynecologic Society, is a peer-reviewed, multidisciplinary journal dedicated to specialists, physicians and allied health professionals concerned with prevention, diagnosis and treatment of female pelvic floor disorders. The journal publishes original clinical research, basic science research, education, scientific advances, case reports, scientific reviews, editorials and letters to the editor.
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