The Effect of Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men With Overactive Bladder: 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
- 60
- 试验地点
- 2
- 主要终点
- A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
研究概览
简要总结
Multiple studies have shown that education based on the IMB model is effective at bringing about health-related behavior change. The IMB model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct nutrition in iron deficiency anemia, and using condoms to prevent HIV. There are no studies in the literature regarding the adaptation of the IMB model to behavioral therapy in patients with OAB or urinary incontinence. To address this, there we aimed to investigate the effect of the IMB model on urinary incontinence and quality of life in men with OAB.
详细描述
This study aimed to investigate the effect of the Information, Motivation, Behavioral Skills Model (IMB) on urinary incontinence and quality of life in men with overactive bladder.
This is a single-center, parallel-group, open-label, randomized controlled clinical trial.
This study was conducted between February 2018 and February 2019, with a total of 60 male patients admitted to the urology clinic of a training and research hospital. Patients over the age of 18, male, and with overactive bladder were included in the study.
Participants were randomized into two equal groups: the intervention group (n=30) and control group (n=30). Structured bladder training with the IMB model was applied to the intervention group. This model was not applied to the control group. The primary outcome was the mean score change over the severity of incontinence measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The other outcomes were measured by the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Urinary Incontinence Information Rating scores. All outcome measures were evaluated before and 6 months after the training. Bladder training with IMB model was found to be effective at ameliorating urinary incontinence and improving quality of life in patients with an overactive bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient
- •Over 18 years old
- •Overactive Bladder
- •Urge urinary incontinence
- •Voluntarily agreed to participate in the research
排除标准
- •Benign prostatic hyperplasia
- •Prostate cancer
- •Congenital urinary anomalies
- •Neurological or spinal cord injury,
- •Diabetes mellitus
- •Hypertension
- •A mental disability
- •Receive medical treatment for incontinence
研究组 & 干预措施
No Intervention: Control group
Patients in the control group were given usual care by a health professional who was not involved in the study and who worked in the Department of Urology. After the end of the study, the patients in the control group were also given structured bladder training similar to the patients in the intervention group.
the IMB model
Structured bladder training was applied to the patients in the intervention group via the IMB model.
干预措施: Assigned Interventions (Other)
结局指标
主要结局
A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
时间窗: 20 minutes before and 6 months after the training
The primary outcome measure was the mean score change from baseline incontinence severity at 6 months measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The ICIQ-SF consists of a total of six items, including the birth date, gender and urinary incontinence characteristics. The score range of this scale is 0-21. High scores indicate increased urinary incontinence severity.
次要结局
- The Urogenital Distress Inventory (UDI-6)(20 minutes before and 6 months after the training)
- The Incontinence Impact Questionnaire-7 (IIQ-7)(20 minutes before and 6 months after the training)