Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
研究概览
简要总结
The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.
The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.
All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.
详细描述
This study has been terminated.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women will need to be 20 years or older
- •diagnosed with stress urinary incontinence (SUI).
排除标准
- •women with:
- •urge or mixed incontinence
- •pelvic organ prolapse
- •previous surgical treatment for incontinence
- •current treatment for SUI (including medications)
- •current pregnancy
- •six months or less postpartum
- •body mass index of ≥ 30
- •recurrent vulvovaginitis
- •current/recurrent urinary tract infections (UTI)
- •non-English speaking.
结局指标
主要结局
Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
时间窗: baseline, 4 weeks, and 8 weeks
Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine.
次要结局
- Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study(Baseline, 4 weeks, and 8 weeks)
- Change in quality of life from the baseline to the midpoint and completion of the study(Baseline, 4 weeks, and 8 weeks)
研究者
Elaine Trudelle-Jackson
PhD Advisor
Texas Woman's University