Department of Urology, Medical University of South Carolina, Charleston, South Carolina.
J Urol. 2013 Dec;190(6):2243-50. doi: 10.1016/j.juro.2013.06.042. Epub 2013 Jun 21.
In this clinical trial we evaluated the efficacy, safety and tolerability of a novel pressure attenuation device for the reduction or elimination of female stress urinary incontinence using a prospective, randomized, single-blind, multicenter design.
A total of 166 female patients with stress urinary incontinence were randomized 2:1 to treatment with an intravesical pressure attenuation device (112) or sham procedure (54). In the treatment arm the device was replaced every 90 days and in the sham arm device replacement was simulated every 90 days. The primary outcome measure was Stamey score improvement of 1 or more at 6 months. An additional outcome measure evaluated at 6 months was a composite score combining data from a provocative pad test and patient impression of symptom improvement.
In the treatment arm 40.9% of women achieved the primary end point, compared to only 22.4% in the sham arm (p=0.046 in per protocol analysis). In an intent to treat analysis, 28.6% of women in the treatment arm reached the primary end point vs 22.2% of women in the sham arm (p=0.455). 50.8% of women in the treatment arm reached the composite end point compared to 16.3% of women in the control arm (p<0.001, intent to treat analysis). Three-day voiding diaries revealed a mean reduction in total daily leakage events after 6 months from 4.4 per day to 2.5 per day (43.2%) in the treatment group vs 5.4 per day to 4.1 per day (24.1% reduction) in the control group (p<0.001).
Minimally invasive treatment for female stress urinary incontinence with a first-generation intravesical pressure attenuation device was safe and effective when evaluated by a composite end point. For those patients that can tolerate the device, the concept of pressure attenuation as a therapy for stress urinary incontinence is valid and feasible. Further modifications are anticipated for this device potentially resulting in improved outcomes.
本临床试验采用前瞻性、随机、单盲、多中心设计，评估一种新型压力衰减装置在减少或消除女性压力性尿失禁中的疗效、安全性和耐受性。
共纳入 166 例女性压力性尿失禁患者，按 2:1 随机分为膀胱内压力衰减装置治疗组（112 例）或假手术组（54 例）。治疗组每 90 天更换 1 次装置，假手术组每 90 天模拟更换 1 次装置。主要终点是 6 个月时 Stamey 评分改善 1 分或更多。次要终点是 6 个月时的综合评分，结合尿垫试验和患者对症状改善的印象数据。
治疗组 40.9%的女性达到主要终点，而假手术组仅为 22.4%（意向治疗分析中 p=0.046）。在按计划治疗分析中，治疗组 28.6%的女性达到主要终点，而假手术组为 22.2%（p=0.455）。治疗组 50.8%的女性达到复合终点，而对照组为 16.3%（意向治疗分析中 p<0.001）。3 天排尿日记显示，治疗组 6 个月后总漏尿事件从每天 4.4 次减少到每天 2.5 次（减少 43.2%），对照组从每天 5.4 次减少到每天 4.1 次（减少 24.1%）（p<0.001）。
第一代膀胱内压力衰减装置治疗女性压力性尿失禁是安全有效的，采用复合终点评估时效果更佳。对于那些能够耐受该装置的患者，压力衰减作为治疗压力性尿失禁的一种方法是有效且可行的。预计该装置将进一步改进，从而可能改善治疗效果。
