Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 60
- 主要终点
- Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)
研究概览
简要总结
This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system (EQ-5D-5L).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient willing and able to complete the questionnaires
- •Diagnosis of OAB
- •Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:
- •number of micturitions > 8/24 h or
- •decrease in urgency urinary incontinence (UUI) or incontinence episodes / 24 h less than 50% or
- •decrease in urgency episodes / 24 h less than 50% or
- •decrease in number of micturitions / 24 h less than 20% or
- •not acceptable tolerability
- •Eligible to start Vesicare™ 5 or 10 mg according to Summary of Product Characteristics (SmPC)
排除标准
- •History of stress incontinence
- •Active urinary tract infection (confirmed by positive urine analysis)
- •Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Peak urinary flow rate (Qmax) < 10ml/sc and/or Postvoid residual urine volume (PVR) > 150 ml
- •Uncontrolled Diabetes Mellitus
- •History of drug and/or alcohol abuse at the time of enrolment
- •History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk for these conditions.
- •Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor
- •Previous treatment with solifenacin
- •Likely to participate in another study during study period of 12 months from study entry
研究组 & 干预措施
Patients with residual OAB symptoms
Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics
干预措施: Solifenacin (Drug)
结局指标
主要结局
Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)
时间窗: baseline, month 6 and 12
Change from baseline in EuroQol Group system (EQ-5D-5L) score
时间窗: baseline, month 6 and 12
Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score
时间窗: baseline, month 6 and 12
次要结局
- Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)(baseline, month 1, 3, 6 and 12)
- Occurence of adverse drug reaction(12 months)
- Change from baseline in OAB symptoms assessed by micturition diary(baseline, month 1, 3, 6 and 12)
- Persistence to therapy (measured by proportion of Days Covered (PDC, threshold of 80 percent during the measurement period), median length of therapy (days))(12 months)