Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Atlantic Health System
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients with a diagnosis of multiple sclerosis
- •Moderate to severe lower urinary tract symptoms as defined by an AUASS score > 8
Exclusion Criteria
- •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)
Investigators
Carolyn Botros
Urogynecologist
Atlantic Health System