NCT00928070已完成4 期
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
研究概览
简要总结
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female subjects 65 years of age or older
- •OAB symptoms for at least 3 months
- •score 3 or greater on Vulnerable Elderly Survey (VES-13)
- •adequate mobility for independent toileting
- •mean number of at least 2 UUI episodes per 24 hours
- •mean urinary frequency of 8 or more micturitions per 24 hours
- •able to independently complete the bladder diaries
排除标准
- •PVR urinary volume greater than 200 ml
- •MMSE score less than 20
- •greater than 15 UUI episodes per 24 hours
- •creatinine clearance less than 30 ml/min
- •an average resting heart rate of greater than or equal to 90 beats per minute
研究组 & 干预措施
Fesoterodine
Experimental
干预措施: Fesoterodine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
时间窗: Baseline
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
时间窗: Baseline, Week 12
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
次要结局
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4(Baseline, Week 4)
- Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Mean Number of Micturitions Per 24 Hours(Baseline)
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Mean Number of Micturition-related Urgency Episodes Per 24 Hours(Baseline)
- Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours(Baseline)
- Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Frequency-Urgency Sum Rating Per 24 Hours(Baseline)
- Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12(Baseline, Week 4, 12)
- Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12(Screening, Week 4, 12)
- Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score(Baseline)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12(Baseline, Week 4, 12)
- Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)(Baseline)
- Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12(Baseline, Week 4, 12)
- Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control(Week 12)
- Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response(Week 12)
- Mini Mental State Examination (MMSE)(Screening)
- Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12(Screening, Week 12)
- Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12(Baseline, Week 4, 12)
研究者
研究点 (1)
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