The Role of In-person Focus Groups in the Management of Urinary Incontinence in Women From a Mixed-methods, Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in urinary tract condition severity
研究概览
简要总结
The purpose of this study is to investigate how a support group with other individuals who share the condition urinary incontinence (UI) impacts patients experience with management of urinary incontinence.
详细描述
Focus groups in various settings have demonstrated the ability to alleviate psychological and physiological distress in focus group participants. The exploration of focus groups is warranted to measure the potential benefit for patients with urinary incontinence. Researchers aimed to assess the feasibility and acceptability of in-person focus groups as a potential intervention for female patients with urinary incontinence from a mixed methods approach. A mixed methods pilot study will be conducted to investigate whether in-person focus group demonstrate meaningful significance in quantitative outcomes measured by validated questionnaires and qualitative outcomes analyzed from focus group transcripts and post-session surveys. This study was an initial assessment to determine whether in-person focus groups for females with UI is strong enough to warrant further research and clinical implementation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •English-speaking
- •Have the ability to commute to the meeting facility without institutional assistance
排除标准
- •Those unable to attend all three focus group sessions
结局指标
主要结局
Change in urinary tract condition severity
时间窗: Baseline, 12 weeks
Measured using the Patient Global Impression of Severity (PGI-S) questionnaire which consists of one question that asks subject to describe urinary tract condition currently on a scale of 1=normal, 2=mild, 3=moderate, 4=severe.
Change in physical activity
时间窗: Baseline, 12 weeks
Measured using the International Physical Activity Questionnaire (IPAQ) to assess physical activity as part of everyday life.
Change in sexual quality of life
时间窗: Baseline, 12 weeks
Measured using the Sexual Quality of Life Questionnaire- Female (SQoL-F) which consists of 18 questions to assess the relationship of sexual dysfunction and quality of life on a scale of 1-6 (1=completely agree; 6=completely disagree. Higher total scores indicate greater quality of life.
Change in urinary tract condition improvement
时间窗: Baseline, 12 weeks
Measured using the Patient Global Impression of Improvement (PGI-I) questionnaire which consists of one question that asks subject to rate urinary tract condition currently, compared with how it was before taking medication on a scale of 1-7 (1=very much better; 7=very much worse)
Change in Patient Health Questionnaire
时间窗: Baseline, 12 weeks
Measured using the Patient Health Questionnaire (PHQ-9) which consists of 9 questions to assess depressive symptoms using a scale of 0-3 (0=not at all; 3=nearly every day). Higher total scores indicate greater severity depression.
Change in mixed urinary incontinence symptoms
时间窗: Baseline, 12 weeks
Measured using the Medical, Epidemiological, and Social Aspects of Aging (MESA) incontinence questionnaire which consists 15 questions to measure urgency of urinary incontinence and stress urinary incontinence on a 0-3 scale (0=Never, 3=Often). Higher total scores indicating higher severity of urge and stress incontinence.
Change in urinary distress
时间窗: Baseline, 12 weeks
Measured using the Urogential Distress Inventory-6 (UDI-6) questionnaire which consists of 6 questions that rate urinary distress experience and how much it subjects are bothered by them on a 0-3 scale (0=not at all; 3=greatly).
Change in overactive bladder satisfaction with treatment
时间窗: Baseline, 12 weeks
Measured using the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q) which consists of 11 questions rating satisfaction or dissatisfaction with treatment for overactive bladder.
次要结局
- Measure feasibility and acceptability of focus group(Baseline, 2 weeks, 4 weeks)
研究者
Aqsa A. Khan
MD, Assistant Professor Department of Urology
Mayo Clinic