Effects of Surface EMG-biofeedback on Pelvic Floor Muscle Training Among Women With Post-partum Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pelvic floor muscle(PFM) Strength
研究概览
简要总结
This study intends to determine the effects of Electromyographic biofeedback on performance of pelvic floor muscles in urinary incontinence.
详细描述
This is a single blinded randomized controlled trial ,will be conducted at Ripha Rehab Clinic,Rawalpindi. (EMG) biofeddback is a adjunct therapy to standard exercise regime for increasing muscle strength,this study is planned to determine the effects of electromyographic biofeedback on performance of pelvic floor muscles, strength,endurance ,rate of biofeedback and its impact on the qulatiy of life (QOL).The sample size was calculated to be n=28 through open-epitool version 3 ,with 95%confidence interval (CI),and power 80%.
After completion of therapeutic protocols, the participant will be assessed with the help EMG-biofeedback, Pelvic Floor distress inventory, King's Health Questionnaire.
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 (Participant)
盲法说明
Participants will be selected through purposive sampling technique per inclusion & exclusion criteria. Further, Randomization will be done by sealed envelope method.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-partum females
- •Persistent urinary leakage at 3 months post-partum period
- •Urine leakage with coughing, sneezing or exercise
排除标准
- •Neurogenic bladder
- •History of pelvic surgeries, pelvic tumors, UTI, urge incontinence, uncontrolled diabetes, cerebral stroke, previous injuries within pelvic
研究组 & 干预措施
EMG BF Group
Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback.
干预措施: Electromographic Biofeedback (Device)
Control Group
Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds.
干预措施: PFM exercises (Other)
结局指标
主要结局
Pelvic floor muscle(PFM) Strength
时间窗: Post 8th weeks
To quantify PFM strength, the evaluator will insert the first two phalanges of the second and third fingers smeared in lubricant gel with a gloved hand into the anterior third of the vaginal opening and requested a maximal voluntary contraction by giving the command "squeeze my fingers". Muscle strength will be classified according to the modified Oxford scale into: 0 (nil), 1 (flicker), 2 (weak), 3 (moderate), 4 (good) to 5 (strong)
Pelvic distress inventory Questionnaire-20
时间窗: post 8th week
The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory. The total score is out of 20.
Pelvic floor muscle(PFM) Strength
时间窗: Baseline
To quantify PFM strength, the evaluator will insert the first two phalanges of the second and third fingers smeared in lubricant gel with a gloved hand into the anterior third of the vaginal opening and requested a maximal voluntary contraction by giving the command "squeeze my fingers". Muscle strength will be classified according to the modified Oxford scale into: 0 (nil), 1 (flicker), 2 (weak), 3 (moderate), 4 (good) to 5 (strong)
Pelvic distress inventory Questionnaire-20
时间窗: Baseline
The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory. The total score is out of 20.
次要结局
- Kings health Questionnaire(KHQ)(Post 8th weeks)
- Kings health Questionnaire(KHQ)(Baseline)