Thyssen H, Sander P, Lose G
Glostrup County Hospital, University of Copenhagen, Glostrup, Denmark.
Int Urogynecol J Pelvic Floor Dysfunct. 1999;10(4):219-22. doi: 10.1007/s001920050049.
The aim of the study was to assess the efficacy of a disposable vaginal device in the management of urge incontinence. A total of 38 women with urge incontinence and uninhibited bladder contractions during cystometry were included. They wore the device from morning to night. Before, and again after, using the device for 1 month the women were assessed by pelvic examination, uroflowmetry, postvoid residual urine, two 24-hour pad-tests, a 3-day voiding diary and vaginal and urine cultures. A questionnaire about the subjective effect and adverse events was completed. Thirty women (79%) completed the study. Two (6.7%) were subjectively cured when using the device, 15 (50%) were improved, and 13 (43.3%) experienced unchanged incontinence. The 24-hour pad-test leakage showed a statistically significant decrease (P=0.001) - in 11 women (36.7%) the decrease was more than 50%. The other urodynamic results were unchanged. A significant decrease in the number of daily micturitions was found in the group of responders (P=0.02). No vaginal infections were found; 4 women (13%) had uncomplicated urinary tract infection during the test-period. Subjective complaints were few, and 21 women (70%) wanted to continue the treatment with the device. The vaginal device constitutes a new option in the management of urge incontinence, with a subjective and objective cure/improvement rate of 56.7%. The device is easy to use and well accepted.
本研究的目的是评估一种一次性阴道装置治疗急迫性尿失禁的疗效。共有38名在膀胱测压时有急迫性尿失禁和膀胱无抑制性收缩的女性纳入研究。她们从早到晚佩戴该装置。在使用该装置1个月之前和之后，通过盆腔检查、尿流率测定、排尿后残余尿量、两项24小时护垫试验、一份3天排尿日记以及阴道和尿液培养对这些女性进行评估。完成了一份关于主观效果和不良事件的问卷。30名女性（79%）完成了研究。使用该装置时，2名（6.7%）主观上治愈，15名（50%）有所改善，13名（43.3%）尿失禁情况未变。24小时护垫试验漏尿量有统计学意义的下降（P=0.001）——11名女性（36.7%）下降超过50%。其他尿动力学结果未变。在有反应的组中，每日排尿次数显著减少（P=0.02）。未发现阴道感染；4名女性（13%）在试验期间发生了单纯性尿路感染。主观不适较少，21名女性（70%）希望继续使用该装置进行治疗。该阴道装置是治疗急迫性尿失禁的一种新选择，主观和客观治愈率/改善率为56.7%。该装置使用方便且易于接受。
