Evaluation and Comparison of Short-term Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment
研究概览
简要总结
The aim of this prospective, randomized controlled study is to evaluate and compare efficacy between the most available conservative treatment (magnetic stimulation and Kegel exercise) for stress urinary incontinence in Croatia. We will assess quality-of-life, patient global improvement, and vaginal pressure measured with perineometer in three different time points: at the enrollment, after 8 weeks of treatment and 3 months after the both treatments are done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history.
排除标准
- •urinary tract malignancies, vulvovaginitis, current uroinfection, previous pelvic surgeries, neurologic and psychiatric diseases, previous conservative treatment of stress urinary incontinence in less than 6 months, Stage III and IV of genital prolapse, latex allergy.
结局指标
主要结局
Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment
时间窗: 8 weeks from the start of the treatment
We assume that after 8 weeks of treatment, in magnetic stimulation arm of study, we will observe more treatment ''responders'' - with at least 4-point reduction in overall ICIQ-SF score
次要结局
- Greater proportion of better patient global improvement in magnetic stimulation arm group(3 months from treatment finish)
- Greater proportion of increased perineometry value in magnetic stimulation arm group(8 weeks)