A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
研究概览
简要总结
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
详细描述
Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients > 18 years of age
- •OAB symptoms for > 3 months
- •Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
- •May or may not be accompanied by urinary frequency
- •May be accompanied by stress urinary incontinence where stress incontinence does not predominate
排除标准
- •Male Patients
- •Underlying cortical or spinal cord pathology including SCI, MS, or
- •Parkinson's Disease
- •Urinary retention with post-void residual > 150cc
- •Current treatment or treatment within the last 3 months with anticholinergic medications
- •Patients not able to complete the questionaires or voiding diaries in English
- •Pregnancy
- •Active urinary tract infections
- •Bladder Cancer or unevaluated hematuria
- •Known diagnosis of narrow angle glaucoma
- •Severe constipation
- •History of reduced renal function (CrCl<30ml/min)
- •History of liver disease
- •Current treatment with cytochrome P450 inhibitor medications
研究组 & 干预措施
Vesicare
Vesicare alone
干预措施: Vesicare (solifenacin) (Drug)
Vesicare/behavioral modification
Vesicare plus behavioral modification
干预措施: Vesicare (solifenacin) plus behavioral modification (Behavioral)
结局指标
主要结局
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
时间窗: 0 week - 12 weeks
次要结局
- Improvement of Symptom Severity(3 months)