Trospium Chloride XR in Obese Female Patients With Overactive Bladder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 127
- 主要终点
- Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
研究概览
简要总结
This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
- •Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
排除标准
- •Chronic kidney failure
- •Abdominal bypass surgery for obesity
- •Moderate or severe memory impairment
- •Uncontrolled narrow angle glaucoma
- •Uncontrolled systemic disease
- •Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia
研究组 & 干预措施
trospium chloride XR 60 mg
Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
干预措施: Trospium Chloride, Extended Release (XR) (Drug)
trospium chloride XR 60 mg
Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
干预措施: placebo (Other)
placebo
Placebo capsule taken orally once daily for 14 weeks.
干预措施: placebo (Other)
结局指标
主要结局
Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
时间窗: Baseline (Week 2), Week 14
Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.
次要结局
- Percent Change From Baseline in Urgency Severity Associated With Toilet Voids(Baseline (Week 2), Week 14)
- Percent Change From Baseline in Voided Volume(Baseline (Week 2), Week 14)
- Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score(Baseline (Week 2), Week 14)
- Percent Change From Baseline in Percentage of Patients Continent(Baseline (Week 2), Week 14)