The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- severity of stress urinary incontinence (SUI) symptoms.
研究概览
简要总结
the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI.
详细描述
We have two groups: control group (A) and experimental group (B) are two matched post-menopausal stress urinary incontinence. Group A will receive PFMT-associated EMG biofeedback, whereas Group B will receive PFMT-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. Our primary outcome measures will be the severity of SUI symptoms, while the secondary outcome measures will involve QOL, self-esteem, patient's global impression of improvement, maximum voluntary isometric contraction (MVIC) of pelvic floor muscles, pelvic floor muscle resting tone, and the endurance of pelvic floor muscles,
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
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post-menopausal women, defined by the absence of vaginal bleeding for 12 months,
- •body mass index (BMI) < 30
- •They should have faced at least two leakage episodes each week and fall into the mild to moderate range of urinary incontinence, measured by (ICIQ-UI SF).
- •Two standard questions about stress and urgency UI were used to determine the patient's eligibility.
排除标准
- •pelvic organ prolapse greater than grade II on Baden-Walker classification system
- •previous treatment for UI or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorder, or inability to perform the proposed procedures.
- •anyone with past or current injuries to the pelvis, hip joint, or spine, as well as those with uncontrolled diabetes, or those with prior experience in pelvic floor muscle training .
- •the presence of uncontrolled hypertension.
- •patients with a history of deep venous thrombosis (DVT), varicose Veins, cardiac disease, or lymphedema.
研究组 & 干预措施
control group
Control group will receive Pelvic floor muscle training-associated EMG biofeedback.
干预措施: pelvic floor muscle training -associated EMG-biofeedback. (Other)
experimental group
experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh.
干预措施: pelvic floor muscle training -associated EMG-biofeedback. (Other)
experimental group
experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh.
干预措施: blood flow restriction (Other)
结局指标
主要结局
severity of stress urinary incontinence (SUI) symptoms.
时间窗: baseline,10 weeks, 16 weeks
severity of SUI symptoms, measured by the Arabic version of the International consultation on incontinence questionnaire-short form (ICIQ-UI SF)
次要结局
- Quality of life (QOL)(baseline,10 weeks, 16 weeks)
- self-esteem(baseline,10 weeks, 16 weeks)
- patient's global impression of improvement(baseline,10 weeks, 16 weeks)
- maximum voluntary isometric contraction (MVIC) of pelvic floor muscles(baseline,10 weeks, 16 weeks)
- pelvic floor muscle endurance(baseline,10 weeks, 16 weeks)
- pelvic floor muscle resting tone(baseline,10 weeks, 16 weeks)
研究者
Hamdiah Mohmmed Altuwjry
physical therapist
Kafrelsheikh University