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临床试验/NCT06458491
NCT06458491已完成不适用

Evolution of Urinary Symptoms After Use of TENSI+ Posterior Tibial Nerve Stimulation for Overactive Bladder

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Evolution of urinary symptoms

研究概览

简要总结

Overactive bladder (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin.

Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. However, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness.

In the event of persistent symptoms, the management of OAB is essentially based on the prescription of an anticholinergic medication. The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. But the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation).

The principle of the posterior tibial nerve stimulation (TNS) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session.

TNS is also possible transcutaneously (TENS) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. This treatment modality seems equivalent to the percutaneous approach.

Given its numerous advantages, the use of TENS is therefore expanding, and is currently recommended by many learned societies (SIFUD, AFU).

In this study, we wish to evaluate the TENSI+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women over 18
  • patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder
  • intervention between April 2023 and February 2024
  • person having expressed his non-opposition

排除标准

  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

结局指标

主要结局

Evolution of urinary symptoms

时间窗: 3 months after the start of treatment

change in the "overactive bladder" score obtained by the USP questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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