A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Mean Number of Micturition Episodes Per 24 Hours
研究概览
简要总结
To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
- •OAB patients dissatisfied with their prior therapy with tolterodine
排除标准
- •Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
- •Patients with significant hepatic and renal disease or other significant unstable diseases.
- •OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
研究组 & 干预措施
Open Label-fesoterodine
Single treatment study arm.
干预措施: fesoterodine fumarate (Drug)
结局指标
主要结局
Mean Number of Micturition Episodes Per 24 Hours
时间窗: Baseline and Week 12
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
时间窗: Baseline and Week 12
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Mean Number of Urgency Episodes Per 24 Hours
时间窗: Baseline and Week 12
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
时间窗: Week 12
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
次要结局
- Severe Urgency Episodes Per 24 Hours(Baseline and Week 12)
- Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)(Baseline and Week 12)
- Urgency Perception Scale (UPS)(Baseline and Week 12)
- Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)(Baseline and Week 12)
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain(Baseline and Week 12)
- Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale(Baseline and Week 12)
- Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale(Baseline and Week 12)
- Patient Perception of Bladder Condition (PPBC) Score(Baseline and Week 12)
- Nocturnal Micturitions Per 24 Hours(Baseline and Week 12)
- Mean Rating on the Urinary Sensation Scale(Baseline and Week 12)
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain(Baseline and Week 12)
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain(Baseline and Week 12)
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain(Baseline and Week 12)
- "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)(Week 12)
- Sum Rating on the Urinary Sensation Scale(Baseline and Week 12)
- Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)(Week 12)