From the Department of Obstetrics and Gynecology, West Virginia University Medical School, Morgantown, WV.
Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.
The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.
A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight.
Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events.
The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.
本研究旨在评估一种非处方设备治疗女性压力性尿失禁（SUI）的疗效和安全性。
这是一项多中心、干预性、单臂研究，涉及 5 个不同的地点，包括使用自行插入的阴道塞设备诊断为有症状的 SUI 的女性。在为期 1 周的基线期后，进行为期 2 周的佩戴设备期。我们研究的主要结果是确定该设备是否能够将漏尿事件和护垫重量减少至少 50%。
在所有研究地点，共招募了 73 名受试者，其中 51 名完成了研究。对改良意向治疗人群（n=48）进行了疗效分析，而安全性分析则对所有同意参与的参与者进行。基线时护垫重量平均增加 0.9 克/小时，治疗期间增加 0.5 克/小时。每天漏尿次数从基线时的 2 次减少到治疗期间的 0.9 次（P<0.0001）。71%的研究人群漏尿量、漏尿次数或两者均减少了 50%以上。生活质量评分平均提高了 4.35 分（P<0.0001）。共记录了 40 起不良事件，仅有 4 名受试者因不良事件退出。
本研究评估的自部署阴道塞设备是寻求非处方方法治疗 SUI 症状的女性的另一种选择。需要进一步研究以确定该设备的长期效果和使用依从性。
