Yamanishi T, Yasuda K, Sakakibara R, Hattori T, Ito H, Murakami S
Department of Urology, Chiba University School of Medicine, Japan.
J Urol. 1997 Dec;158(6):2127-31. doi: 10.1016/s0022-5347(01)68176-x.
We designed an investigational study and a placebo controlled, double-blind study to evaluate the usefulness of electrical pelvic stimulation in stress incontinence.
We studied 44 patients with stress incontinence (six men and 38 women, age 63 +/- 13), including 9 patients in the investigational study and 35 in the double-blind study. We used 50 Hz. square waves of 1 ms. pulse duration for stimulation. A vaginal electrode was used in women and an anal electrode in men. Urethral pressure profile before, during and after 15-minute stimulation was measured in the investigational study. In the double-blind trial an active device and a dummy device were used, and efficacy was judged from patient impressions, records in frequency/volume chart, results of 1-hour pad test and urodynamic parameters after 4-week treatment.
In the investigational study maximum urethral closure pressure (mean plus or minus standard deviation) before, during and after stimulation was 44.4 +/- 17.5, 64.5 +/- 28.8 and 46.8 +/- 25.6 cm. water, respectively. This parameter significantly increased (p = 0.0275) during stimulation. In the double-blind trial patient impressions were good in 60% of the active device group and 8% of the dummy device group (p = 0.0051). For the pad test significant improvement was noted in the active device group (p = 0.0100). Cure rate was 45% in the active device group and 7.7% in the dummy device group. There were significantly more cured or improved patients for frequency of leakage (p = 0.0196) and pad test (p = 0.0100).
Electrical stimulation is effective for the treatment of stress incontinence.
我们设计了一项研究性研究以及一项安慰剂对照双盲研究，以评估电刺激盆腔对压力性尿失禁的治疗效果。
我们研究了44例压力性尿失禁患者（6名男性和38名女性，年龄63±13岁），其中9例参与研究性研究，35例参与双盲研究。我们采用50Hz、脉宽1ms的方波进行刺激。女性使用阴道电极，男性使用肛门电极。在研究性研究中，测量了刺激前、刺激15分钟期间及刺激后的尿道压力曲线。在双盲试验中，使用了有源装置和模拟装置，根据患者的主观感受、频率/尿量图表记录、1小时护垫试验结果以及4周治疗后的尿动力学参数来判断疗效。
在研究性研究中，刺激前、刺激期间及刺激后的最大尿道闭合压（均值±标准差）分别为44.4±17.5、64.5±28.8和46.8±25.6cm水柱。该参数在刺激期间显著增加（p = 0.0275）。在双盲试验中，有源装置组60%的患者主观感受良好，模拟装置组为8%（p = 0.0051）。对于护垫试验，有源装置组有显著改善（p = 0.0100）。有源装置组的治愈率为45%，模拟装置组为7.7%。在漏尿频率（p = 0.0196）和护垫试验（p = 0.0100）方面，治愈或改善的患者明显更多。
电刺激对压力性尿失禁的治疗有效。
