NCT01530620已完成3 期
Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Reflex volume (cystometry)
研究概览
简要总结
The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Caucasian patients aged ≥18 and ≤70 years
- •Voluntarily signed informed consent
- •Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
- •Reflex volume of ≤250 mL
- •Intact reflex arcs in the area of segments S2-S4
排除标准
- •Patients suffering from multiple sclerosis under unstable conditions
- •Augmented reflex bladder
- •Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible
- •Acute urinary tract infection
- •Electrostimulation therapy (within 4 weeks propir to Visit 1)
- •Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)
- •Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma
- •Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)
- •Pre-existing medical contraindications for anticholinergics
- •Cardiac insufficiency (NYHA stage III/ IV)
- •Therapy with botulinum toxin within the last 12 months
- •Evidence of severe renal, hepatic or metabolic disorders
- •History of drug or alcohol abuse
- •Concomitant medication known to have a potential to interfere with the trial medication
- •Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively
- •Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method
- •Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study
研究组 & 干预措施
Propiverine hydrochloride ER
Experimental
45 mg
干预措施: Propiverine hydrochloride ER (extended release) (Drug)
Propiverine hydrochloride IR
Active Comparator
15 mg
干预措施: Propiverine hydrochloride IR (immediate release) (Drug)
结局指标
主要结局
Reflex volume (cystometry)
时间窗: three weeks
Change in reflex volume compared to baseline and compared between the two treatment arms
次要结局
- Maximum cystometric capacity(three weeks)
- Leak point pressure(three weeks)
- Leak point volume(three weeks)
- Maximum detrusor pressure(three weeks)
- Bladder compliance(three weeks)
- Change in number of incontinence episodes(three weeks)
- State of Well-Being Questionnaire(three weeks)
- Post void residual volume(three weeks)
- Incidence and severity of adverse events(three weeks)
研究者
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