Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Vaginal Pressure Measurement with Perineometer
研究概览
简要总结
In our study, we aimed to evaluate the effects of core stabilization exercises added to traditional Kegel exercises on incontinence and quality of life in women with stress and stress dominant mixed 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18 - 55
- •Diagnosis of stress and stress predominant mixed urinary incontinence
- •Pelvic floor muscle strength ≥ 3
- •BMI ≤ 35 kg/m2
- •≥ 1 complaint of urinary incontinence in the last month
排除标准
- •Pregnancy and postpartum first 6 weeks
- •Other types of incontinence and stress type 3 incontinence
- •Urinary tract infection
- •Pelvic organ prolapse advanced stage (Stage ≥ 2)
- •History of pelvic surgery or pelvic tumor
- •Surgical treatment for urinary incontinence
- •History of serious systemic or neurological disease (Severe cardiovascular disease, advanced COPD, CVO and/or Cancer, Parkinson's etc.)
- •Severe low back and/or pelvic pain
结局指标
主要结局
Change in Vaginal Pressure Measurement with Perineometer
时间窗: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
The periometer is a manometer attached to a vaginal pressure probe that evaluates pelvic floor muscle (PTC) contraction with an objective result in cmH2O. Normal vaginal pressure value is 30-60 cm H2O. The probe is advanced 3-5 cm towards the vagina and the patient is asked to contract the perineal muscles. 3 separate measurements are made and a score is created by taking the average of these measurements.
Change in Incontinence Severity Index (ISI)
时间窗: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
ISI is a simple questionnaire consisting of questioning the frequency and amount of urine leakage, and the score consists of multiplying the answers given to these two groups of questions. Incontinence severity according to scores; mild (score 1-2), moderate (score 3-6), severe (score 8-9), and very severe (score 12).
次要结局
- Change in King's Health Questionnaire (KHQ)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Muscle Strength Examination with Digital Palpation(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Pad Test (24 hours)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Bladder Diary (3 days)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Incontinence Impact Questionnaire (IIQ-7)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Urogenital Distress Inventory (UDI-6)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
研究者
Merve Dikici Yağlı
Principal Investigator
Istanbul University