Tensi+ European Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Subjective improvement
研究概览
简要总结
Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. Preliminary studies have shown a favorable safety and efficacy profile. The goal of the present registry is to collect data among an important number of patients to assess the efficacy, safety and potential predictive factors of success in a current clinical setting over a total period of 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients suffering from idiopathic or neurological overactive bladder
排除标准
- •Patients with pacemaker, defibrillator, or any other electronic implant;
- •Patients with metal implant near the stimulation area;
- •Pregnant women;
- •People suffering from ankle joint problems, swollen ankles or a dermatological condition or damaged skin in the area where the electrodes are to be placed;
- •Patient with cognitive impairment;
- •Inability to complete a voiding diary;
- •No social security cover (for applicable countries).
结局指标
主要结局
Subjective improvement
时间窗: 3 and 12 months
The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows: 1. = Very much better 2. = Much better 3. = A little better 4. = No change 5. = A little worse 6. = Much worse 7. = Very much worse. For analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement.
次要结局
- Patient-reported Outcomes Measures (PROMs)(0; 3 and 12 months)
- Quality of life measures(0; 3 and 12 months)