NMAHP RU, Glasgow Caledonian University, Glasgow G4 0BA, UK.
Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow G4 0BA, UK.
Age Ageing. 2022 Jun 1;51(6). doi: 10.1093/ageing/afac114.
non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed.
two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome.
TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.
膀胱功能障碍等非运动症状在帕金森病患者中很常见（80%），增加了跌倒的风险，对健康相关成本和生活质量产生负面影响。我们开展了 STARTUP 研究，以评估使用粘性电极刺激经皮胫神经刺激（TTNS）治疗帕金森病患者膀胱功能障碍的临床和成本效益。
研究设计、材料和方法：STARTUP 是一项平行双臂、多中心、实用、双盲、随机对照试验。每位参与者参加一次就诊，以完成同意书、使用计算机生成的系统进行随机分组，并学习如何使用设备。该试验有两个主要结局指标：国际尿失禁咨询问卷-尿失禁简短表和国际前列腺症状评分（IPSS）。这些在基线、6 周和 12 周时完成。还完成了膀胱频率图表和资源问卷。
共随机分配了 242 名参与者。约 59%的参与者为男性，平均年龄为 69 岁，确诊后平均时间为 6 年。问卷回收率在 79%至 90%之间。在 IPSS 问卷中，活跃组在 6 周时的评分明显较低（平均差异（标准差，SD）12.5（6.5）vs 10.9（5.5），效应大小-1.49，95%CI-2.72，-0.25）。其他任何结果均无统计学显著变化。
TTNS 被证明是安全的，具有较高的依从性。在治疗结束时（即 6 周），其中一个主要结局指标发生了显著变化，这可能表明存在获益。需要进一步进行充分的、有影响力的 RCT 以确定有效的治疗方法。
Zotero 插件