NCT02983461进行中（未招募）1 期
Use of Sildenafil for Treatment of Urinary Incontinence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Urinary Incontinence as measured by Pad Test
研究概览
简要总结
The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related to pelvic floor dysfunction.
详细描述
Aim: To determine the effect of sildenafil on urinary incontinence.
- Episodes of urinary incontinence will be recorded using a 3 day bladder diary.
- Quantitative assessment of urinary incontinence will be performed at baseline and after treatment using a Pad Test.
- Muscle strength will be assessed through use of a perineometer.
- To evaluate macrocirculatory blood flow in pelvic organs, women will be assessed with noninvasive imaging before and after randomization to sildenafil.
- Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal females, 50-80 years of age, at the time of consent
- •Have stress or mixed urinary incontinence, with at least 3 episodes/week
- •Willing and able to comply with study procedures
- •Willing and able to provide written informed consent
排除标准
- •Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease (history of Hashimoto's thyroiditis is not exclusionary if stable and thyroid replacement is being administered. Thyroid testing will be performed at screening and as needed during study visits. )
- •Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90 after repeated evaluation with proper cuff. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (>90/50 and <170/110)
- •Diabetes mellitus or other untreated endocrine disease
- •Active cancer
- •Currently using and planning to continue use of urinary incontinence medications during study period
- •BMI > 40
- •HIV, Hepatitis B, or Hepatitis C
- •Use of systemic nitrates, anabolic steroids or corticosteroids in the past 6 months
- •Use of alpha blockers
- •Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
- •Known allergic reaction to any agent under investigation or required by the protocol.
- •History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
- •Females who are pregnant or lactating.
研究组 & 干预措施
Sildenafil
Active Comparator
Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.
干预措施: Sildenafil (Drug)
Placebo
Placebo Comparator
Double Blind Placebo 3 times a day for 10 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary Incontinence as measured by Pad Test
时间窗: 10 weeks
Pad tests quantitatively measures urine leakage
次要结局
未报告次要终点
研究者
研究点 (1)
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