NCT00979472已完成4 期
Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 主要终点
- change of micturition frequency on a 3-day voiding diary
研究概览
简要总结
The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the without-urgency group:
- •urinary frequency ≥ 8 micturitions per 24 hours no urgency on voiding diary (1 or 2 on a 5 urgency scale)
- •For the with-urgency group:
- •urinary frequency ≥ 8 micturitions per 24 hours symptoms of urinary urgency≥ 2/day on the voiding diary (3 to 5 on a 5 urgency scale)
- •Symptoms lasting for more than 3 months
排除标准
- •Clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test
- •Total daily urine volume of > 3000 mL as verified on the micturition diary before randomization
- •Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra
- •Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- •Symptomatic acute urinary tract infection (UTI) during the run-in period
- •Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
- •Diagnosed or suspected of interstitial cystitis
- •Uninvestigated hematuria or hematuria secondary to a malignant disease
- •Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care (residual urine> 100mL of functional bladder capacity)
- •Patients with marked cystocele or other clinically significant pelvic prolapse
- •Treatment within 14 days preceding randomization, or expected to initiate treatment during the study with:
- •Any anticholinergic drugs other than a randomized trial drug
- •Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed
- •On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
- •Receipt of any electrostimulation or bladder training within 14 days before randomization, or expected to start such treatment during the study
- •An indwelling catheter or practicing intermittent self-catheterization
- •Use of any investigational drug within 1 month prior to the start of the study
- •Patients with chronic constipation or history of severe constipation
- •Pregnant or nursing women
- •Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to the start of the study and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy)
- •Patients who have bladder cancer or prostate cancer
- •Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
- •Patients who have neurological disease
- •Patients who have psychological disease
- •Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
研究组 & 干预措施
with urgency
Experimental
干预措施: Solifenacin (Drug)
without urgency
Experimental
干预措施: Solifenacin (Drug)
结局指标
主要结局
change of micturition frequency on a 3-day voiding diary
时间窗: after 12-week treatment
次要结局
- change in patient's perception of bladder condition(after 12-week treatment)
- change in OAB symptom scores(after 12-week treatment)
- patient's satisfaction with the treatment(after 12-week treatment)
研究者
Myung-Soo Choo
Professor
Asan Medical Center
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