Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder: A Prospective, Single-Center Study (StimHAV)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Heart rate variability
研究概览
简要总结
The goal of this observational study is to evaluate the impact of Transcutaneous Electrical Nerve Stimulation on the autonomic nervous system in adults women with overactive bladder.
The main question it aims to answer is :
Does Transcutaneous Electrical Nerve Stimulation to treat overactive bladder have an impact on the autonomic nervous system ?
To answer this question, the primary outcome measure will be heart rate variability (HRV) during transcutaneous electrical nerve stimulation therapy
Participants will:
- Receive their first and last sessions of transcutaneous electrical nerve stimulation in the hospital.
- Complete questionnaires during their first and last transcutaneous electrical nerve stimulation sessions.
- Have their heart rate variability measured during their first and last transcutaneous electrical nerve stimulation sessions.
详细描述
Rationale :
Overactive bladder (OAB) is a common condition that can have a major impact on quality of life. Transcutaneous peripheral electrical stimulation therapies are a recognized treatment option, but their mechanisms of action are still not fully understood.
Recent data suggest that their effectiveness may be related to changes in the autonomic nervous system. However, no study has yet evaluated this effect in patients with non-neurogenic overactive bladder. This study aims to better understand the physiological mechanisms involved, improve knowledge about these treatments, and contribute to their better use in clinical practice.
Objectives :
Primary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient aged 18 years or older
- •Clinical diagnosis of overactive bladder made by a urologist or gynecologist with no identified cause
- •Eligible for transcutaneous tibial nerve stimulation (TTNS) or interferential stimulation (IF) as part of the management of non-neurogenic overactive bladder
- •Body mass index (BMI) ≤ 30 kg/m²
- •Able to understand and complete the study questionnaires independently
- •No objection to participating in the study.
排除标准
- •Neurogenic overactive bladder.
- •Local irritative factors, such as bladder stones, bladder tumors, or urinary tract infection.
- •Previous treatment with transcutaneous tibial nerve stimulation (TTNS).
- •Previous treatment with interferential stimulation (IF).
- •Contraindications to electrical stimulation, including: cancer, Pacemaker, Pregnancy, Conductive prosthetic material in the area of stimulation, Heart disease, Epilepsy, Active phlebitis or thrombophlebitis, Skin lesions in the treatment area
- •Use of anticholinergic medication during the previous three weeks
- •Objection to participating in the study.
结局指标
主要结局
Heart rate variability
时间窗: Baseline and Week 12
The primary outcome measure is the change in SDNN (Standard Deviation of Normal-to-Normal intervals, expressed in ms), a time marker of heart rate variability , between the initial measurement session (Week 0) and the final measurement session (Week 12)
次要结局
- To assess the clinical effectiveness of transcutaneous electrical stimulation on anal incontinence.(Baseline and Week 12)
- To assess the clinical effectiveness of transcutaneous electrical stimulation on constipation.(Baseline and Week 12)
- To assess the clinical effectiveness of transcutaneous electrical genitosexual disorders.(Baseline and Week 12)
- To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.(Baseline and Week 12)
- To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.(Baseline and Week 12)
- To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.(Baseline and Week 12)