van Kerrebroeck Philip E V, van Voskuilen Anco C, Heesakkers John P F A, Lycklama á Nijholt August A B, Siegel Steven, Jonas U, Fowler Clare J, Fall Magnus, Gajewski Jerzy B, Hassouna Magdy M, Cappellano Francesco, Elhilali Mostafa M, Milam Douglas F, Das Anurag K, Dijkema H E, van den Hombergh Ubi
Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands.
J Urol. 2007 Nov;178(5):2029-34. doi: 10.1016/j.juro.2007.07.032. Epub 2007 Sep 17.
This 5-year, prospective, multicenter trial evaluated the long-term safety and efficacy of sacral neuromodulation in patients with refractory urge incontinence, urgency frequency and retention.
A total of 17 centers worldwide enrolled 163 patients (87% female). Following test stimulation 11 patients declined implantation and 152 underwent implantation using InterStim. Of those treated with implantation 96 (63.2%) had urge incontinence, 25 (16.4%) had urgency frequency and 31 (20.4%) had retention. Voiding diaries were collected annually for 5 years. Clinical success was defined as 50% or greater improvement from baseline in primary voiding diary variable(s).
Data for all implanted cases were reported. For patients with urge incontinence mean leaking episodes per day decreased from 9.6 +/- 6.0 to 3.9 +/- 4.0 at 5 years. For patients with urgency frequency mean voids per day decreased from 19.3 +/- 7.0 to 14.8 +/- 7.6, and mean volume voided per void increased from 92.3 +/- 52.8 to 165.2 +/- 147.7 ml. For patients with retention the mean volume per catheterization decreased from 379.9 +/- 183.8 to 109.2 +/- 184.3 ml, and the mean number of catheterizations decreased from 5.3 +/- 2.8 to 1.9 +/- 2.8. All changes were statistically significant (p <0.001). No life threatening or irreversible adverse events occurred. In 102 patients 279 device or therapy related adverse events were observed. At 5 years after implantation 68% of patients with urge incontinence, 56% with urgency frequency and 71% with retention had successful outcomes.
This long-term study demonstrates that InterStim therapy is safe and effective for restoring voiding in appropriately selected cases refractory to other forms of treatment.
这项为期5年的前瞻性多中心试验评估了骶神经调节对难治性急迫性尿失禁、尿频和尿潴留患者的长期安全性和有效性。
全球共有17个中心招募了163例患者（87%为女性）。在进行测试刺激后，11例患者拒绝植入，152例患者使用InterStim进行了植入。在接受植入治疗的患者中，96例（63.2%）患有急迫性尿失禁，25例（16.4%）患有尿频，31例（20.4%）患有尿潴留。每年收集5年的排尿日记。临床成功定义为主要排尿日记变量较基线改善50%或更多。
报告了所有植入病例的数据。对于急迫性尿失禁患者，5年时每天的平均漏尿次数从9.6±6.0降至3.9±4.0。对于尿频患者，每天的平均排尿次数从19.3±7.0降至14.8±7.6，每次排尿的平均尿量从92.3±52.8增加至165.2±147.7毫升。对于尿潴留患者，每次导尿的平均尿量从379.9±183.8降至109.2±184.3毫升，平均导尿次数从5.3±2.8降至1.9±2.8。所有变化均具有统计学意义（p<0.001）。未发生危及生命或不可逆的不良事件。在102例患者中，观察到279例与设备或治疗相关的不良事件。植入后5年，68%的急迫性尿失禁患者、56%的尿频患者和71%的尿潴留患者取得了成功的治疗效果。
这项长期研究表明，InterStim疗法在适当选择的对其他治疗形式难治的病例中，对于恢复排尿是安全有效的。
