Berghmans Bary, Hendriks Erik, Bernards Arnold, de Bie Rob, Omar Muhammad Imran
Pelvic care CenterMaastricht, Maastricht University Medical Centre, Maastricht, Netherlands.
Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD001202. doi: 10.1002/14651858.CD001202.pub5.
Electrical stimulation with non-implanted devices is used for patients with different types of urinary incontinence and symptoms of urgency, frequency and nocturia. The current review focused on electrical stimulation with non-implanted devices for the treatment of urinary incontinence in men.
To determine the effectiveness of electrical stimulation with non-implanted devices for men with stress, urgency or mixed urinary incontinence in comparison with no treatment, placebo treatment, or any other 'single' treatment. Additionally, the effectiveness of electrical stimulation with non-implanted devices in combination with another intervention was compared with the other intervention alone. Finally, the effectiveness of one method of electrical stimulation with non-implanted devices was compared with another method.
We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, and handsearching of journals and conference proceedings (searched 21 January 2012). We also searched other electronic and non-electronic bibliographic databases and the reference lists of the included studies as well as contacting researchers in the field to identify other relevant trials.
Randomized and quasi-randomized controlled trials.
Two review authors independently assessed all the identified trials for eligibility. Risk of bias was assessed using the Cochrane tool for determining bias. Disagreements were resolved by discussion, and a third review author was involved in the case of no consensus. Data were analysed using Cochrane methods.
Six randomized controlled trials (five full papers and one abstract) were included. There was considerable variation in the interventions used, study protocols, types of electrical stimulation parameters and devices, study populations and outcome measures. In total 544 men were included, of whom 305 received some form of electrical stimulation, and 239 a control or comparator treatment. The trials were mostly small and generally there was not sufficient information to assess risk of bias; only two trials used secure methods of randomization.There was some evidence that electrical stimulation (ES) had a short-term effect in reducing incontinence compared with sham treatment (for example risk ratio (RR) at six months 0.38, 95% CI 0.16 to 0.87) but not at 12 months. Four trials evaluated the effect of adding PFMT to ES versus pelvic floor muscle training (PFMT) alone or with biofeedback. There was no evidence of a statistically significant difference in the number of men with urinary incontinence at three months (146/239, 61% for combined treatment versus 98/156, 63% with PFMT alone; RR 0.93, 95% CI 0.82 to 1.06). However, there were more adverse effects with combined treatment (23/139, 17% versus 2/99, 2% with PFMT alone; RR 7.04, 95% CI 1.51 to 32.94) and quality of life also seemed better with PFMT alone. One small trial did not detect statistically significant differences between two methods of administration of transcutaneous electrical stimulation (anal versus perineal) but the quality of life score was lower (better) in the anal stimulation group.
AUTHORS' CONCLUSIONS: There was some evidence that electrical stimulation enhanced the effect of PFMT in the short term but not after six months. There were, however, more adverse effects (pain or discomfort) with electrical stimulation.
非植入式设备的电刺激被用于患有不同类型尿失禁以及尿急、尿频和夜尿症状的患者。本综述聚焦于非植入式设备电刺激治疗男性尿失禁。
确定与不治疗、安慰剂治疗或任何其他“单一”治疗相比,非植入式设备电刺激对患有压力性、急迫性或混合性尿失禁男性的有效性。此外,比较非植入式设备电刺激与另一干预措施联合使用时与单独使用另一干预措施的有效性。最后,比较一种非植入式设备电刺激方法与另一种方法的有效性。
我们检索了Cochrane尿失禁组专业试验注册库,其中包含从Cochrane对照试验中央注册库(CENTRAL)、MEDLINE、PreMEDLINE中识别出的试验,以及对期刊和会议论文集的手工检索(检索时间为2012年1月21日)。我们还检索了其他电子和非电子书目数据库以及纳入研究的参考文献列表,并联系该领域的研究人员以识别其他相关试验。
随机和半随机对照试验。
两位综述作者独立评估所有识别出的试验是否符合纳入标准。使用Cochrane偏倚判定工具评估偏倚风险。分歧通过讨论解决,若未达成共识则引入第三位综述作者参与。数据采用Cochrane方法进行分析。
纳入了6项随机对照试验(5篇全文和1篇摘要)。所使用的干预措施、研究方案、电刺激参数和设备类型、研究人群以及结局指标存在相当大的差异。总共纳入了544名男性,其中305名接受了某种形式的电刺激,239名接受了对照或比较治疗。试验大多规模较小,总体上没有足够信息来评估偏倚风险;只有两项试验采用了可靠的随机方法。有一些证据表明,与假治疗相比,电刺激(ES)在减少尿失禁方面有短期效果(例如6个月时风险比(RR)为0.38,95%置信区间为0.16至0.87),但在12个月时没有。四项试验评估了在电刺激基础上加用盆底肌训练(PFMT)与单独的盆底肌训练或联合生物反馈相比的效果。三个月时,尿失禁男性的数量没有统计学显著差异的证据(联合治疗组146/239,61%;单独PFMT组98/156,63%;RR 0.93,95%置信区间0.82至1.06)。然而,联合治疗的不良反应更多(23/139,17%;单独PFMT组2/99,2%;RR 7.04,95%置信区间1.51至32.94),而且单独PFMT的生活质量似乎更好。一项小型试验未检测到经皮电刺激的两种给药方法(肛门与会阴)之间有统计学显著差异,但肛门刺激组的生活质量评分更低(更好)。
有一些证据表明电刺激在短期内增强了PFMT的效果,但6个月后则不然。然而,电刺激有更多的不良反应(疼痛或不适)。