Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if silodosin works to treat lower urinary tract symptoms (LUTS) in female patients with multiple sclerosis (MS). It will also learn about the effect of the drug on voiding parameters. The main questions it aims to answer are:
Does silodosin improve lower urinary tract symptoms based on questionnaires? Does silodosin change Uroflowmetry parameters in female patients with MS? Researchers will compare silodosin to a placebo (a look-alike substance that contains no drug) to see if silodosin works to treat LUTS in female patients with MS.
Participants will:
Take silodosin or a placebo every day for 8 weeks Visit the clinic before initiating the medication and after 8 weeks of taking the medication for questionnaires and tests
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with a diagnosis of multiple sclerosis
- •Moderate to severe lower urinary tract symptoms as defined by an AUASS score > 8
排除标准
- •Treatment with alpha-blocker, B3 agonist, or anticholinergic medication within the last 6 weeks
- •Treatment with sacral neuromodulation, bladder Botox, or posterior tibial nerve stimulation within the last 9 months
- •Renal impairment with CrCl < 30
- •Diagnosed orthostatic hypotension
- •Pregnancy or breastfeeding
- •Severe liver impairment (Child-Pugh class C)
- •Current symptomatic kidney stones
- •Recent MS relapse within the last 3 months
- •Recent treatment with steroids in the last 3 months (this does not include one-time pre-treatment with steroids for administration of immunologic drug)
研究者
Carolyn Botros
Urogynecologist
Atlantic Health System