Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Mean Number of Micturition Episodes Per 24 Hours
研究概览
简要总结
The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).
详细描述
Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.
The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.
Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 20 ≤ and < 70 years
- •History of OAB symptoms for ≥ 3 months
- •International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
- •An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
排除标准
- •Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
- •Any condition that would contraindicate their usage of anticholinergics or alpha blockers
- •History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
- •History of stress urinary incontinence or urinary retention
- •History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
- •Pregnant or nursing women
- •Current urinary tract infection
- •Neurological bladder dysfunction
- •Treatment with drugs that may interfere with CYP3A4 metabolic function
- •Significant hepatic or renal disease
- •Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
研究组 & 干预措施
Solifenacin
干预措施: Solifenacin (Drug)
Solifenacin plus Tamsulosin
干预措施: Solifenacin plus Tamsulosin (Drug)
结局指标
主要结局
Change in Mean Number of Micturition Episodes Per 24 Hours
时间窗: at week 24 relative to baseline
次要结局
- Change of PVR(at week 24 relative to baseline)
- Change of Qmax(at week 24 relative to baseline)
- Numeric Change of Urgency Episodes Per 24 Hours(at week 24 relative to baseline)
- Change in Total Score of OABSS(at week 24 relative to baseline)
- Change in Score of IPSS(at week 24 relative to baseline)
研究者
Kwang-Woo Lee, MD
Clinical Professor
Soonchunhyang University Hospital