Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Parkinson's Disease: Results from a Phase II Randomized Control Trial (STRIPE)

IF 7.6 1区医学 Q1 CLINICAL NEUROLOGY Movement Disorders Pub Date : 2025-04-17 DOI:10.1002/mds.30186

Matthew D. Smith BMBS, PhD, Gabriella E. Portlock BSc, Anisha Cullen MEng, Anahita Nodehi PhD, Marcus J. Drake BMBCh, DM, Yoav Ben-Shlomo MBBS, PhD, Emily J. Henderson MBChB, PhD

{"title":"Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Parkinson's Disease: Results from a Phase II Randomized Control Trial (STRIPE)","authors":"Matthew D. Smith BMBS, PhD, Gabriella E. Portlock BSc, Anisha Cullen MEng, Anahita Nodehi PhD, Marcus J. Drake BMBCh, DM, Yoav Ben-Shlomo MBBS, PhD, Emily J. Henderson MBChB, PhD","doi":"10.1002/mds.30186","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Lower urinary tract symptoms (LUTS) are common Parkinson's disease (PD), causing great impact.</p>\n </section>\n \n <section>\n \n <h3> Objective</h3>\n \n <p>The goal was to undertake a phase II randomized control trial of transcutaneous tibial nerve stimulation (TTNS) delivered by Geko device for LUTS related to overactive bladder (OAB) in PD, an easy to use of the shelf solution.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Participants were randomized to active/sham stimulation. Primary outcome measure was the International Consultation on Incontinence Questionnaire-Overactive Bladder score (ICIQ-OAB) at 12 weeks.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A total of 148 participants were allocated to active (73) and sham arms (75). No difference was seen between arms (coefficient, 0.48; 95% CI, −0.2 to 1.2; <i>P</i> = 0.17), although both active and sham showed improvements over baseline. Pain was the most common adverse event.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>No difference was seen between active and sham arms. Symptom improvements seen in both groups are consistent with a placebo effect, however, we cannot exclude a biological effect from the sham intervention. Although negative, this result should be taken only in context of Geko use rather TTNS in general. © 2025 The Author(s). <i>Movement Disorders</i> published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</p>\n </section>\n </div>","PeriodicalId":213,"journal":{"name":"Movement Disorders","volume":"40 7","pages":"1291-1296"},"PeriodicalIF":7.6000,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/mds.30186","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Movement Disorders","FirstCategoryId":"3","ListUrlMain":"https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.30186","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Lower urinary tract symptoms (LUTS) are common Parkinson's disease (PD), causing great impact.

Objective

The goal was to undertake a phase II randomized control trial of transcutaneous tibial nerve stimulation (TTNS) delivered by Geko device for LUTS related to overactive bladder (OAB) in PD, an easy to use of the shelf solution.

Methods

Participants were randomized to active/sham stimulation. Primary outcome measure was the International Consultation on Incontinence Questionnaire-Overactive Bladder score (ICIQ-OAB) at 12 weeks.

Results

A total of 148 participants were allocated to active (73) and sham arms (75). No difference was seen between arms (coefficient, 0.48; 95% CI, −0.2 to 1.2; P = 0.17), although both active and sham showed improvements over baseline. Pain was the most common adverse event.

Conclusion

No difference was seen between active and sham arms. Symptom improvements seen in both groups are consistent with a placebo effect, however, we cannot exclude a biological effect from the sham intervention. Although negative, this result should be taken only in context of Geko use rather TTNS in general. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

经皮胫神经刺激治疗帕金森病患者膀胱过度活动症状：来自II期随机对照试验（STRIPE）的结果

背景下尿路症状（LUTS）是帕金森病（PD）常见的症状，影响很大。目的：开展Geko装置经皮胫神经刺激（TTNS）治疗PD患者膀胱过动症（OAB）相关LUTS的II期随机对照试验，这是一种易于使用的现成解决方案。方法随机分为主动刺激组和假刺激组。主要结局指标为12周时国际尿失禁问卷调查-膀胱过度活动评分（ICIQ-OAB）。结果148名受试者被分为活动组（73人）和假组（75人）。两组间无差异(系数0.48；95% CI, -0.2 ~ 1.2；P = 0.17)，但治疗组和假手术组均较基线有所改善。疼痛是最常见的不良反应。结论活动组与假活动组间无明显差异。两组的症状改善与安慰剂效应一致，然而，我们不能排除假干预的生物学效应。虽然是否定的，但是这个结果应该只在Geko使用的上下文中使用，而不是一般的TTNS。©2025作者。Wiley期刊有限责任公司代表国际帕金森和运动障碍学会出版的《运动障碍》。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Movement Disorders 医学-临床神经学

CiteScore

13.30

自引率

8.10%

发文量

371

审稿时长

12 months

期刊介绍： Movement Disorders publishes a variety of content types including Reviews, Viewpoints, Full Length Articles, Historical Reports, Brief Reports, and Letters. The journal considers original manuscripts on topics related to the diagnosis, therapeutics, pharmacology, biochemistry, physiology, etiology, genetics, and epidemiology of movement disorders. Appropriate topics include Parkinsonism, Chorea, Tremors, Dystonia, Myoclonus, Tics, Tardive Dyskinesia, Spasticity, and Ataxia.

期刊最新文献

Respiratory Function in Friedreich's Ataxia Correction to “Development and Validation of a Patient‐Reported Outcome Measure of Ataxia” Issue Information Movement Disorders: Volume 40, Number 12, December 2025 December Infographic