Effects of Voluntary Pre-contraction of the Pelvic Floor Muscles (the Knack) on Female Stress Urinary Incontinence - Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- One-hour pad test
研究概览
简要总结
The aim of the present study is to test the hypothesis that voluntary pelvic floor muscle pre-contraction (the Knack) (alone) can be a treatment for urine leakage during efforts. For this purpose, the following parameters will be analysed and compared amongst 1) the Knack, 2) pelvic floor muscle training and 3) the Knack + pelvic floor muscle training groups: urine leakage as assessed by the pad test, urinary symptoms, muscle function, quality of life, subjective cure, adherence to exercises in the outpatient setting and at home and perceived self-efficacy of pelvic floor muscle exercises.
The study population will comprise women with mild to moderate stress urinary incontinence or mixed urinary incontinente (with predominant stress urinary incontinence) as assessed by means of the one-hour pad test (leakage ≥2 g). Leakage up to 10 grams will be rated mild stress urinary incontinence and of 11 to 50 grams as moderate stress urinary incontinence. The sample will also include women with grade 2 muscle strength (normal contraction with elevation of the anterior vaginal wall) on the two-finger assessment rated according to the Oxford scale.
The primary outcome measure will be the objective cure of urinary incontinence as assessed by means of the one-hour pad test three months after randomization.
Secondary outcome measures: three-day bladder diary, 1 hour pad test, International Consultation on Incontinence Questionnaire - Short Form, Incontinence Quality of Life Questionnaire, Subjective cure of stress urinary incontinence, Self-efficacy/outcome expectation to pelvic floor muscle exercises, Frequency of the outpatient sessions, adherence to home exercises and pelvic floor muscle function, morphometry, strength and vaginal squeeze pressure.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mild to moderate stress urinary incontinence or mixed urinary incontinence (with predominance of stress urinary incontinence) as assessed by means of the one-hour pad test (leakage ≥2 g). Mild stress urinary incontinence will be defined as leakage up to 10 g and moderate stress urinary incontinence as leakage of 11 to 50 g.
- •Able to have a gynaecological examination
排除标准
- •Symptoms of overactive bladder alone
- •Chronic degenerative, uncontrolled metabolic, neurological or psychiatric diseases
- •Previous participation in a pelvic floor re-education programe and/or previous pelvic floor surgery or currently receiving other treatment for urinary incontinence
- •Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
- •Use of medication for urinary incontinence or medication that interferes with the musculoskeletal system
- •Loss of stools or mucus
- •Active urinary or vaginal infection in the past three months
- •Body mass index ≥35 Kg/m2
结局指标
主要结局
One-hour pad test
时间窗: The primary outcome measure will be the objective cure of urinary incontinence as assessed by means of the one-hour pad test three months after randomization.
The objective cure of urine loss after intervention will be defined as leakage \<2 grams.
次要结局
- Self-efficacy/outcome expectation to pelvic floor muscle exercises(Three and six after months after randomization.)
- International Consultation on Incontinence Questionnaire - Short Form.(Three and six after months after randomization.)
- Incontinence Quality of Life Questionnaire.(Three and six after months after randomization.)
- One-hour pad test.(Three and six after months after randomization.)
- Subjective cure of stress urinary incontinence.(Three and six after months after randomization.)
- Pelvic floor muscle morphometry(After three and six months of treatment.)
- Three-day bladder diary(Three and six after months after randomization.)
- Frequency of the outpatient sessions(After three and six months of treatment.)
- Pelvic floor muscle function(After three and six months of treatment.)
- Pelvic floor muscle strength(After three and six months of treatment.)
- Vaginal squeeze pressure(After three and six months of treatment.)
研究者
Fatima Fitz
Physiotherapist
Federal University of São Paulo