Effectiveness of Bladder Training Supported by Alarm Reminders and Distraction Techniques in Women With Persistent Mixed Urinary Incontinence Following Pelvic Floor Muscle Exercise Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Urinary Incontinence Severity
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of bladder training supported by smartphone alarm reminders and distraction techniques in women with persistent mixed urinary incontinence who continued to experience symptoms despite completing pelvic floor muscle exercise (PFME) therapy at least six months previously. Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before randomization to either an intervention group or a control group. The intervention group received an 8-week bladder training program supported by alarm reminders and distraction techniques, while the control group received routine care. Outcomes included urinary incontinence severity, symptom distress, quality of life, urinary incontinence episodes, voiding intervals, treatment satisfaction, and adherence to bladder training.
详细描述
Mixed urinary incontinence is a common condition that negatively affects women's physical, psychological, and social well-being. Although pelvic floor muscle exercise (PFME) is recommended as the first-line conservative treatment, many women continue to experience urinary incontinence despite completing therapy. Effective management strategies for women with persistent symptoms after PFME remain limited.
The purpose of this randomized controlled trial was to evaluate whether bladder training supported by smartphone alarm reminders and distraction techniques improves urinary incontinence severity, symptom distress, quality of life, urinary incontinence episodes, voiding intervals, treatment satisfaction, and adherence in women with persistent mixed urinary incontinence following completed PFME therapy.
Participants were stratified according to age, educational level, body mass index, mode of delivery, and baseline urinary incontinence severity before randomization to an intervention group or a control group. The intervention group received an individualized 8-week bladder training program supported by smartphone alarm reminders and distraction techniques, whereas the control group received routine outpatient care. Clinical outcomes were assessed using validated questionnaires, bladder diaries, and the standardized one-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
- None
盲法说明
This was an open-label trial because participants and investigators were aware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-65 years.
- •Physician-diagnosed mixed urinary incontinence.
- •Previously received pelvic floor muscle exercise (PFME) as the sole treatment for urinary incontinence.
- •Completed PFME therapy at least six months before enrollment.
- •Continued to experience urinary incontinence symptoms after completion of PFME therapy.
- •Owned and were able to use a smartphone.
- •Were not receiving any active treatment for urinary incontinence during the study period.
- •Provided written informed consent.
排除标准
- •Urinary tract infection.
- •Neurological disorders affecting bladder function.
- •Pregnancy.
- •Active treatment for urinary incontinence.
- •Previous bladder training.
- •Previous biofeedback therapy.
- •Previous magnetic chair therapy.
- •Cognitive impairment.
- •Any medical condition that could interfere with participation or completion of the study.
结局指标
主要结局
Urinary Incontinence Severity
时间窗: Baseline and Week 8
Urinary incontinence severity was assessed using the Incontinence Severity Index (ISI). Higher scores indicate greater urinary incontinence severity.
次要结局
- Objective Urine Loss(Baseline and Week 8)
研究者
Perihan ÇETİN
Assistant Professor
Izmir Katip Celebi University
