REVEAL-OAB. Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Sexual matters
研究概览
简要总结
The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and overall quality of life.
详细描述
The REVEAL-OAB (Real-world Experiences and Voices Exploring the Actual Lived burden of Overactive Bladder) study is a large, international, mixed-methods research program designed to capture both the measurable burden and the lived experience of overactive bladder (OAB).Quantitatively, it uses structured surveys and validated patient-reported outcome measures to assess symptom severity (e.g., urgency, frequency, incontinence), health-related quality of life, healthcare utilization, and treatment patterns across diverse populations. Qualitatively, it incorporates in-depth patient interviews, open-ended survey responses, and narrative data to explore how OAB affects emotional wellbeing, social functioning, relationships, and daily decision-making. By integrating these quantitative metrics with rich qualitative insights, the study aims to provide a comprehensive, patient-centered understanding of OAB, identify unmet needs in care, and inform more effective clinical management and health policy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If they are over 18 years old.
- •They have been told by a doctor or other healthcare professional that they have symptoms that match OAB, or have been given a diagnosis of OAB.
- •They live in France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, or the UK.
- •They have received the Patient Information Sheet from their health care provider, during an appointment, via email, or postal mail.
- •They can confirm they understand the Patient Information Sheet and that they want to take part in this study.
排除标准
- •They have not received information on this study from their own health care provider
- •They have a confirmed neurological condition known to affect bladder function (for example: multiple sclerosis, Parkinson's disease, spinal cord injury).
- •They have undergone major surgery directly involving the bladder, prostate, urethra, or pelvic structures that affect urinary function.
- •They presently have a urinary tract infection (UTI).
- •They have or have had cancer in their bladder, kidneys, prostate, or other urinary or reproductive organs
结局指标
主要结局
Sexual matters
时间窗: Past four weeks
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a lot)
OAB symptom severity and frequency
时间窗: Pats four weeks
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a great deal)
Quality of Life relating to bladder symptoms
时间窗: Past four weeks
1 is equivalent to 'none of the time' and 6 is equivalent to 'all of the time'
OAB symptom severity and frequency
时间窗: Past four weeks
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a great deal)
次要结局
未报告次要终点