Effectiveness of Pelvic Floor Muscle Training Including 360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence: Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change of Pelvic floor muscle contraction during Valsalva
研究概览
简要总结
This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being a woman,
- •Participating in the research voluntarily,
- •Being between the ages of 18-62,
- •Ability to read and write Turkish,
- •Not having any mental problems that would prevent cooperation and understanding,
- •Having a complaint of stress urinary incontinence or stress-predominant mixed urinary incontinence.
排除标准
- •Having received pelvic floor training before,
- •Having a neurological disease,
- •Pelvic organ prolapse stage is stage 2 or higher,
- •Having fecal incontinence,
- •Being pregnant,
- •Lower extremity problems that may affect the pelvic structure (conditions such as lower extremity inequality, total hip arthroplasty)
- •Having an active lower urinary tract infection,
- •Having respiratory system diseases such as chronic obstructive pulmonary disease and asthma,
- •Having undergone hysterectomy surgery.
结局指标
主要结局
Change of Pelvic floor muscle contraction during Valsalva
时间窗: at baseline, at 8th week
Pelvic floor muscle contraction during Valsalva will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. The evaluation will be carried out as stated in previous studies, and the women are told: "Take as deep a breath as possible, pinch your nose with your thumb and index finger and close your mouth, try to breathe out against the now closed respiratory system." instructions will be given. For a clearer understanding, the expression "pretend to strain" will also be used. The probe will be manually supported by the investigator throughout the testing procedure to prevent the pressure probe from moving and losing contact with the PTK during evaluation. 2 seconds of reflex PFM activity will be recorded in μV.
次要结局
- Change of quality of life score(at baseline, at 8th week)
- Change of urinary symptoms(at baseline, at 8th week)
- Change of Pelvic floor muscle maximum voluntary contraction(at baseline, at 8th week)
- Change of maximum inspiratory pressure(at baseline, at 8th week)
- Change of maximum expiratory pressure(at baseline, at 8th week)
- Subjective perception of improvement(at 8th week)
- Change of Social Activity Participation(at baseline, at 8th week)
- Change of Pelvic floor muscle strength(at baseline, at 8th week)
- Change of average number of urinary incontinence(at baseline, at 8th week)
研究者
Seda Yakit Yesilyurt
Assistant Prof.
Izmir University of Economics