NCT01942681已完成不适用
Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Occurrence of incontinence
研究概览
简要总结
This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with mixed urinary incontinence (MUI)
- •Patients having symptoms of urinary incontinence for at least 3 months
- •Patients having at least one episode of urge urinary incontinence per week and 4 episodes of stress urinary incontinence per week in a bladder diary.
- •20 years old or older
- •Patients who meet all the following criteria in ICIQ-SF (1) "2-3 times or more in one week" was selected at Q
- •(2) "Small or more" was selected at Q
- •(3) "leak at the time of cough or sneeze" or "leak at the time of exercise" was selected at Q
- •Less than 100mL of residual urine volume
- •Written informed consent.
排除标准
- •Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract
- •Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis)
- •Patients with advanced lower urinary tract obstruction or urinary retention
- •Patients without urinary sensation
- •Patients with overflow incontinence
- •Patients with history or complications of pelvic organ prolapse
- •Patients with pyloric, duodenal or intestinal obstruction
- •Patients with gastric or intestinal atony
- •Patients with angle-closure glaucoma
- •Patients with myasthenia gravis
- •Patients with severe heart disease
- •Patients with severe constipation
- •Patients with dementia who are not able to complete the questionnaires
- •Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine
- •Patients with history of surgery that affect urination such as Trans-Obturator Tape（TOT）or Tension-free Vaginal Tape（TVT）
- •Women who are pregnant, lactating, potentially pregnant or willing to get pregnant
- •Patients with previous surgery of the abdomen and pelvis or radiation within 6 months
- •Patients who started pelvic floor muscle exercise within 3 months
- •Patients who took Propiverine Hydrochloride or other similar medicine within 2 weeks before entry
- •Judged as being unsuitable for the trial by physician.
研究组 & 干预措施
Propiverine Hydrochloride Administration
Other
Administration of Propiverine Hydrochloride for 12 weeks
干预措施: Propiverine Hydrochloride (Drug)
结局指标
主要结局
Occurrence of incontinence
时间窗: during a twelve-week treatment period
Change in occurrence of incontinence during a twelve-week treatment
次要结局
- The number of protective pad used(during a twelve-week treatment period)
- Reduction ratio of the occurrence for incontinence(during a twelve-week treatment period)
- ICIQ-Short Form(SF) scores(during a twelve-week treatment period)
- I-QOL scores(during a twelve-week treatment period)
- IPSS-QOL scores(during a twelve-week treatment period)
- IPSS symptom scores(during a twelve-week treatment period)
- OABSS symptom scores(during a twelve-week treatment period)
- Blood pressure(during a twelve-week treatment period)
- Pulse rate(during a twelve-week treatment period)
- Safety assessment(during a twelve-week treatment period)
研究者
研究点 (1)
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