Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
2026年8月27日 更新者：University Hospital Ostrava
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation (Peroneal eTNM) in the Real-world Clinical Practice
The aim of the project is to study neuromodulation treatment in patients with idiopathic overactive bladder syndrome (OAB) in real clinical practice.
研究概览
详细说明
A relatively new method of neuromodulation treatment of idiopathic OAB will be studied in the form of peroneal electrical transcutaneous neuromodulation (peroneal eTNM). Its principle is completely non-invasive, but highly selective stimulation of the peroneal nerve. Neuromodulation is performed using a surface electrode attached to the laterocaudal region of the popliteal fossa, where this nerve can be very well influenced due to its relatively superficial course. Nerve stimulation is performed intermittently in a doctor's office, the duration of application is 30 min., it is usually repeated once a week for at least 12 weeks.
The study is designed as a prospective, multicentre, non-interventional, observational study. Only data that is part of the standard examination and treatment process based on an extract from the standard medical documentation prepared by the attending physician will be collected and subsequently evaluated.
研究类型
观察性的
注册 (估计的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jiří Hynčica
- 电话号码：2587 +42059737
- 邮箱：jiri.hyncica@fno.cz
研究联系人备份
- 姓名：Jan Krhut, prof.,MD,Ph.D.
- 电话号码：2731 +42059737
- 邮箱：jan.krhut@fno.cz
学习地点
-
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Moravian-Silesian Region
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Ostrava、Moravian-Silesian Region、捷克语、70852
- University Hospital Ostrava
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients with OAB.
描述
Inclusion Criteria:
- Subjects (male and female) aged 18 years and over
- Subjects diagnosed with OAB or mixed urinary incontinence with a predominant urge component who were indicated for treatment with peroneal eTNM
- Subjects who consent to the processing of anonymized demographic data and anonymized treatment data with peroneal eTNM
Exclusion Criteria:
- Subjects with contraindications to treatment with peroneal eTNM
- Subjects who express their disagreement with the processing of anonymised demographic data and anonymised treatment data with peroneal eTNM
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Peroneal eTNM
Patients with OAB who will undergo treatment with peroneal electrical transcutaneous neuromodulation (peroneal eTNM).
|
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient improvement measured using PGI-I tool
大体时间：12 weeks
|
Patient improvement will be measured using validated PGI-I tool.
PGI-I is a psychometric rating tool used to measure patient treatment satisfaction on a ranked scale.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall treatment effect (OAB-V8)
大体时间：12 weeks
|
The overall treatment effect will be measured using the OAB-V8 tool.
It is an 8-question medical screening tool used to identify symptoms severity of an overactive bladder (OAB) and measure how much those symptoms bother a patient.
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12 weeks
|
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Overall treatment safety
大体时间：12 weeks
|
Overall treatment safety will be measured by the number and severity of adverse events.
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12 weeks
|
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Predictive factors for clinical treatment success (PGI-I)
大体时间：12 weeks
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Multivariate analysis of predictive factors for clinical treatment success (sex, age, comorbidities, concomitant medication, stimulation parameters).
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12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jan Krhut, prof.,MD,Ph.D.、University Hospital Ostrava
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
- Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
- Krhut J, Rejchrt M, Slovak M, Dvorak RV, Peter L, Blok BFM, Zvara P. Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naive Patients With Overactive Bladder. J Urol. 2023 Apr;209(4):734-741. doi: 10.1097/JU.0000000000003141. Epub 2022 Dec 29.
- Rejchrt M, Krhut J, Gartner M, Blok BFM, Zvara P. Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder. World J Urol. 2023 Jun;41(6):1629-1634. doi: 10.1007/s00345-023-04394-z. Epub 2023 Apr 7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年8月27日
首先提交符合 QC 标准的
2026年8月27日
首次发布 (实际的)
2026年9月1日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- FNO Peroneal eTNM
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no plan to make individual participant data available to other researchers.
The data may be provided upon reasonable request.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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