Abdominal-Kegel Exercise in Patients With Stress Urinary Incontinence and the Effect of Telemedicine Applications on Adaptation to Lifestyle Changes: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Telemedicine success
研究概览
简要总结
Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. The application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. In this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.
详细描述
The study is a randomized controlled study to be conducted in female patients between the ages of 20-65 who applied to the Eskişehir City Hospital urology outpatient clinic and diagnosed with stress urinary incontinence.
When type 1 (α) error was 5%, type 2 error (1-β) was 95%, and the effect size was accepted as 0.5, it was calculated that there should be at least 47 people in the groups.
Stratified and block randomization will be used to recruit patients into study groups.
The patients will be evaluated with the QUID test, risk assessment questionnaire in patients with stress urinary incontinence, incontinence short test, bladder diary, daily urinary incontinence, a notebook to record the duration of the exercises to be performed, quality of life scale and lifestyle changes questioning form.
The intervention group will be re-evaluated as a result of the intervention with measurement tools.
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •having symptoms of UI for at least the last 6 months,
- •QUID stress score is ≥ 4,
- •diagnosed with SUI as a result of the evaluation made by a specialist physician, have minimal skills in using new technologies
- •Those who have the opportunity to access the web page to be prepared can participate in the research.
排除标准
- •History of using medical therapy for UI,
- •existing urinary infection,
- •diabetes mellitus,
- •nervous system disease (such as multiple sclerosis, cerebrovascular disease),
- •psychiatric illness or dementia,
- •genitourinary malignancy,
- •having limited range of motion in the foot or pelvic region,
结局指标
主要结局
Telemedicine success
时间窗: 1 year
Changes in the "frequency of incontinence episodes patients" and "adaptation to lifestyle changes (Body mass index status, smoking, exercise, fluid intake) " in the intervention and control group after the study
Quality of life score
时间窗: 1 year
Changes in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score. The questionnaire includes questions such as the frequency of urinary incontinence, the amount of leakage, its impact on daily lifestyle, and in what situation the patient leaks urine. The score that can be obtained from the scale is distributed between 0-21. As the total score decreases, the quality of life increases.
次要结局
未报告次要终点
研究者
SEVDA SUNGUR
Research Assistant
Eskisehir Osmangazi University