Versi E, Griffiths D J, Harvey M A
Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02215, USA.
Obstet Gynecol. 1998 Aug;92(2):286-91. doi: 10.1016/s0029-7844(98)00165-3.
Determine the efficacy of a new external anti-incontinence urethral device.
A before-after 1 month trial, open longitudinal study of 155 women complaining of urinary incontinence recruited from a referral urogynecology practice and local media advertising was performed. Primary outcomes included assessing the efficacy of the device using visual analogue scales, quality-of-life questionnaires, 1- and 48-hour standardized pad tests, and voiding diary. Secondary outcomes consisted of the evaluation of the adverse effects and the clinical profile of patients willing to use the device after study completion.
Ninety-six (62%) of 155 women enrolled completed the study. Scores on the visual analogue scales improved for the symptoms of stress incontinence, urgency, and urge incontinence (P < .001). The score for irritation/discomfort increased (P < .001). Data from diaries showed that 38 (44%, n = 86) patients were dry. Of 454 recorded patient-days, 325 (72%) were dry days. On pad testing, incontinence was cured in 49% (1-hour pad test, n = 59, P < .001) and 44% (48-hour pad test, n = 32, P < .001) of patients. Quality-of-life scores were significantly improved in 48% (n = 96, Incontinence Impact Questionnaire, P < .001) and 32% (n = 96, Urogenital Distress Inventory, P < .001) of patients. There was no increase in bacteriuria. After study completion, 61 (39%) women chose to continue using the device, but this was not predictable from baseline data.
Use of this device resulted in a significant reduction in incontinence and improvement in quality-of-life issues with minimal adverse events in the majority of women. This new anti-incontinence device could become a useful addition to the armamentarium of nonsurgical options.
确定一种新型外部抗尿失禁尿道装置的疗效。
进行了一项为期1个月的前后对照试验，对从转诊的妇科泌尿学诊所和当地媒体广告中招募的155名主诉尿失禁的女性进行了开放性纵向研究。主要结局包括使用视觉模拟量表、生活质量问卷、1小时和48小时标准化尿垫试验以及排尿日记来评估该装置的疗效。次要结局包括评估不良反应以及研究结束后愿意使用该装置的患者的临床特征。
155名入组女性中有96名（62%）完成了研究。压力性尿失禁、尿急和急迫性尿失禁症状的视觉模拟量表评分有所改善（P < 0.001）。刺激/不适评分增加（P < 0.001）。日记数据显示，38名（44%，n = 86）患者无尿失禁。在记录的454个患者日中，325个（72%）为无尿失禁日。在尿垫试验中，49%（1小时尿垫试验，n = 59，P < 0.001）和44%（48小时尿垫试验，n = 32，P < 0.001）的患者尿失禁得到治愈。48%（n = 96，尿失禁影响问卷，P < 0.001）和32%（n = 96，泌尿生殖系统困扰量表，P < 0.001）的患者生活质量评分显著改善。菌尿症没有增加。研究结束后，61名（39%）女性选择继续使用该装置，但这无法根据基线数据预测。
使用该装置可使大多数女性的尿失禁显著减少，生活质量问题得到改善，且不良事件极少。这种新型抗尿失禁装置可能成为非手术治疗手段中的一种有用补充。
