A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])
研究概览
简要总结
This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
- •Subjects must be recommended for inclusion by the investigator
排除标准
- •Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
- •Predominant stress incontinence as determined by the investigator
研究组 & 干预措施
Fesoterodine 4 mg
Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
干预措施: Fesoterodine (Drug)
Fesoterodine 8 mg
Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
干预措施: Fesoterodine (Drug)
结局指标
主要结局
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])
时间窗: End of Treatment (up to Week 82)
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (\>=) 3 divided by the total number of days that diary data was collected at that visit. 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
- Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Mean Number of Micturition-Related Urgency Episodes Per 24 Hours(Baseline, Month 3, 6, 9, 12, 15, 18)
- Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Mean Number of Micturitions Per 24 Hours(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Mean Number of Nocturnal Micturitions Per 24 Hours(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Daily Sum Rating on the Urinary Sensation Scale (USS)(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Percentage of Incontinent Participants at Baseline(Baseline)
- Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode(Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82))
- Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)(Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82))
- King's Health Questionnaire (KHQ) Domain Scores(Baseline, End of Treatment (EOT) (Week 82))