Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
研究概览
简要总结
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra.
Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.
详细描述
Women without urinary incontinence or bladder symptoms (healthy controls)will undergo urethral testing prior to randomization to one of 5 medications or placebo. Participants will take an oral medication for 2 weeks and then return for repeat testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Females only
- •Ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months
- •Able to take oral medication for 2 weeks
- •For women of child bearing potential,willing to use an approved method of birth control during the study
排除标准
- •Urinary Incontinence or other bladder symptoms
- •Known neurologic disease that may impair urethral tone or sensation
- •Currently taking a class of medication that is being tested (alpha-antagonists, anticholinergics, sympathomimetics, tricyclic antidepressants, or skeletal muscle relaxants)
- •History of QTc prolongation or cardiac arrhythmia
- •Pregnant, breastfeeding, or are less than 6 months postpartum
- •Known hypersensitivity to or other contraindications to taking any of the study medications
研究组 & 干预措施
Pseudoephedrine
Pseudoephedrine 120mg extended release tablets
干预措施: Pseudoephedrine (Drug)
Solifenacin
Solifenacin 5mg capsule
干预措施: Solifenacin (Drug)
Tamsulosin
Tamsulosin 0.4mg capsule
干预措施: Tamsulosin (Drug)
Imipramine
Imipramine 25mg tablet
干预措施: Imipramine (Drug)
Cyclobenzaprine
Cyclobenzaprine 10mg tablet
干预措施: Cyclobenzaprine (Drug)
Lactose capsules
Sham
干预措施: Lactose capsule (Drug)
结局指标
主要结局
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
时间窗: 2 weeks
Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.
次要结局
未报告次要终点
研究者
Holly Richter, MD
Principal Investigator
University of Alabama at Birmingham