Monocentric Prospective, Randomized, Non-blinded, Active-controlled Trial to Evaluate the Non-inferiority of Functional Magnetic Stimulation (FMS) on the Tesla Chair Compared to Physiotherapy in First or Second-degree Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in ICIQ-SF UI Score
研究概览
简要总结
100 patients with mild to moderate urinary incontinence will be randomly divided into two groups. One half will receive functional magnetic stimulation with the Tesla Chair for three months, while the other half will be treated with pelvic floor physiotherapy for the same period. After three and six months, a comparison will be made to determine which patient groups experience an improvement in urinary incontinence and how their muscle strength improves.
详细描述
Urinary incontinence is a debilitating condition that significantly impacts patients' quality of life, contributing to anxiety, depression, and social withdrawal. The severity of stress urinary incontinence (SUI) is directly correlated with increased physical and psychological burden. Although lifestyle modifications can offer moderate symptom relief, the current gold-standard first-line treatment is pelvic floor physiotherapy, with surgical intervention reserved for refractory cases.
Functional magnetic stimulation (FMS) has demonstrated positive effects in patients with urinary incontinence, including improvements in urodynamic parameters. However, limited research has directly compared the efficacy of FMS as a first-line therapy with standard pelvic floor physiotherapy. Addressing this gap is essential for informing clinical practice and expanding evidence-based therapeutic options. The efficacy of pelvic floor physiotherapy is commonly evaluated using the Oxford Scale, which provides an objective measure of pelvic floor muscle contraction strength. Additionally, patient-reported outcomes are assessed using validated instruments, including the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF UI) and the German Pelvic Floor Questionnaire (Deutscher Beckenbodenfragebogen), capturing symptom severity and quality of life. Together, these endpoints-objective assessments and patient-reported outcomes-offer a comprehensive evaluation of treatment effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years
- •Urinary incontinence of first or second degree
- •Written informed consent
- •German speaking (Study information and IC available only in German)
排除标准
- •Pregnancy or desire to become pregnant
- •Urinary incontinence of third degree
- •Third or fourth degree pelvic organ prolapses
- •no noticeable voluntary muscle activity according to Oxford = O/5
- •Genital infections
- •Malignant tumors
- •Severe neurological diseases
- •Cardiac arrhythmia
- •Active internal medical devices e.g. cardiac pacemakers, medication pumps etc.
- •Ferromagnetic implants at or near the site of stimulation
- •Recent surgery at the site of stimulation
- •Thrombosis or thrombophlebitis
- •Epilepsy or suspected epilepsy
- •Acute stages of kidney stones
- •Gastrointestinal and internal disease at the site of stimulation
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- •Previous enrolment into the current investigation
- •Enrolment of the Sponsor or PI, their family members, employees and other dependent persons
结局指标
主要结局
Change in ICIQ-SF UI Score
时间窗: 3 months post-treatment (6 months from baseline)
Change in the International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence (ICIQ-SF UI) score from baseline to 3 months after treatment; 1-5= slight incontinence, 19-21= very severe incontinence
Change in ICIQ-SF UI Score
时间窗: 6-months post-treatment (9 months from baseline)
Change in the International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence (ICIQ-SF UI) score from baseline to 6 months after treatment
次要结局
- Change in pelvic floor muscle strength, measured by the Oxford Scale(3 months post-treatment (6 months from baseline))
- Change in pelvic floor muscle strength, measured by the Oxford Scale(6 months post-treatment (9 months from baseline))