Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer
研究概览
简要总结
The purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms.
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
- 否
入选标准
- •Adult women (> 18 years) seeking care for stress urinary incontinence at the URMC in Rochester, NY, DUMC in Durham, NC, Western New York (WNY) Urology Associates in Cheektowaga, NY, or at the UTMB in Galveston, TX.
- •English-speaking
- •Possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries
排除标准
- •Women who decline to participate in the study
- •Women were unable to complete electronic patient reported outcome questionnaires
- •Women with greater than stage II uterovaginal prolapse or post-hysterectomy prolapse.
- •Women considered citizens of the European Union (EU), including EU citizens living in the United States.
结局指标
主要结局
number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer
时间窗: 6 weeks
Each participant will be asked to complete the Urinary Distress Inventory 6 (UDI-6) after enrollment and again after 6 weeks. This is a short validated disease-specific patient reported outcome measuring urinary incontinence severity. The UDI-6 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100. The higher the score the greater perceived negative impact on an individual's quality of life. The question "Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?" and provide a yes/no answer. Statistical analysis will then be performed to determine the threshold score at which one is likely to consider their symptoms to be acceptable, PASS "yes". Participants whose UDI score matches their PASS answer will be considered predicted and counted for this outcome measure.
次要结局
- Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the anchor-based method of analysis(baseline to 6 weeks)
- Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the distribution-bases method of analysis(6 weeks)
- Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the anchor-based method of analysis(baseline to 6 weeks)
- Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the distribution-bases method of analysis(6 weeks)
研究者
Erin Duecy
Professor
University of Rochester
