Aboseif Sherif R, Franke Ethan I, Nash Steven D, Slutsky Joel N, Baum Neil H, Tu Le Mai, Galloway Niall T, Pommerville Peter J, Sutherland Suzette E, Bresette John F
Department of Urology, Kaiser Permanente, Los Angeles, California 90027, USA.
J Urol. 2009 May;181(5):2187-91. doi: 10.1016/j.juro.2009.01.039. Epub 2009 Mar 17.
We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence.
Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events.
A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p <0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p <0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate.
The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.
我们确定了可调节性控尿治疗装置（Uromedica公司，明尼苏达州普利茅斯）治疗复发性女性压力性尿失禁的疗效、安全性、可调节性及技术可行性。
将复发性压力性尿失禁的女性患者纳入研究，并遵循一系列明确的排除标准。进行基线及定期随访检查以确定入选资格，并测量主观及客观改善情况。在荧光镜引导下并通过数字阴道引导，将套管针经大阴唇和小阴唇之间的小切口插入至尿道膀胱交界处。置入可调节性控尿治疗装置，并向球囊内注入等渗造影剂。球囊充盈的注射端口置于两侧大阴唇的皮下囊袋中。术后在门诊经皮进行装置调节。遵循美国食品药品监督管理局批准的研究性器械豁免方案记录所有不良事件。
共有162例患者接受了植入手术，140例有1年的可用数据。76.4%（140例中的107例）的患者平均Stamey评分提高了1级或更多。平均尿失禁生活质量问卷评分改善至36.5至70.7（p<0.001）。平均泌尿生殖系统困扰量表评分（从60.3降至33.4）及尿失禁影响问卷评分（从54.4降至23.4）也有所降低（p<0.001）。平均激发试验垫重量从49.6克降至11.2克（p<0.001）。52%（130例中的67例）的患者在1年时达到干爽（激发试验垫重量测试小于2克），80%（126例中的102例）有所改善（激发试验垫重量测试减少超过50%）。24.4%（156例中的38例）的患者出现并发症。18.3%（153例中的28例）的患者在1年内需要取出装置。就并发症而言，96.0%被认为是轻度或中度。
Uromedica可调节性控尿治疗装置是一种治疗复发性女性压力性尿失禁的有效、简单、安全且微创的方法。它可经皮轻松调节以提高疗效，并发症通常易于处理。取出装置并不妨碍日后再次植入。
