A Novel Biofeedback Device to Improve Adherence to Pelvic Floor Muscle Training in Women With Urinary Incontinence: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
A three-armed randomized pilot trial will be conducted with 51 women having stress urinary incontinence, to evaluate the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth. Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device. Study outcome measures include, feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.
详细描述
Objectives: (1) to compare the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth; (2) to investigate the effects of conventional biofeedback, the new biofeedback, and pelvic floor muscle training (PFMT) alone on urinary incontinence and adherence to PFMT.
Hypotheses: (1) The new biofeedback will be easier to use and women will more readily accept it than the conventional biofeedback. (2) Women assigned to the new biofeedback group will report better adherence to PFMT and greater improvements in urinary incontinence than women assigned to participate in the conventional biofeedback group.
Design and subjects: A three-armed randomized pilot trial will be conducted with 51 women who have stress urinary incontinence.
Interventions: Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device.
Outcome measures: Feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.
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
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women in the age group of 35 to 60 years of age;
- •non-pregnant;
- •having stress urinary incontinence;
- •experiencing mild to moderate urinary incontinence (obtaining a score of ≤ 12 on the short-form of the International Consultation on Incontinence Questionnaire (ICIQ-sf); and
- •obtaining a mini-mental state examination (MMSE) score of ≥ 24.
排除标准
- •being in the postpartum stage of < 6 months;
- •having severe pelvic organ prolapse (stages 3 and 4 on the Baden and Walker grading tool);
- •women taking any medications that might cause urine retention;
- •women having complicated UI due to radiation to pelvic region;
- •obesity with a body mass index ≥ 30;
- •women with incontinence secondary to other medical conditions or previous surgeries;
- •women with severe psychological problems impairing participation in the study; and
- •women having mixed or urge UI.
结局指标
主要结局
Adherence
时间窗: Post-intervention at 6 months
The 0-10-point scale of the reliable tool (Cronbach's α=0.7059) developed to monitor long-term adherence to PFMT in women with UI (that quantifies adherence to home exercise as "low," "moderate," or "high") will be used to evaluate adherence to PFMT with and without the biofeedback device
Retention rate
时间窗: Post-treatment at 1, 3 and 6 months
This will be calculated as the percentage of participants who completed assessments at 1, 3, and 6 months.
Recruitment rate
时间窗: At the end of recruitment period
Number of participants recruited/screened in a week, the time taken for recruitment of participants, and reasons for declining to participate will be recorded.
次要结局
- International Consultation on Incontinence Questionnaire-short form(Baseline (pre-intervention), post-treatment at 1, 3 and 6 months)
- Modified Oxford scale(Baseline (pre-intervention), post-treatment at 1, 3 and 6 months)
- one-hour pad test with stress test(Baseline (pre-intervention), post-treatment at 1, 3 and 6 months)
研究者
Dr. Priya Kannan
Assistant Professor
The Hong Kong Polytechnic University