What this study is
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
What's being tested
- Silodosin 8 mg
Intervention · DRUG
Silodosin 8mg PO qd x8 weeks
- Placebo
Intervention · DRUG
Identical placebo capsule, 1 capsule PO daily x8 weeks
Study details
- Official title
- Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial
- Sponsor
- Atlantic Health System
- Conditions
- Multiple Sclerosis · Lower Urinary Track Symptoms
- Enrolling
- 60 people
- Starts
- 2026-04
- Est. completion
- 2028-04
- Design
- Quadruple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Female patients with a diagnosis of multiple sclerosis
- Age > 18
- Moderate to severe lower urinary tract symptoms as defined by an AUASS score > 8 4. No UTI
You can't join if
- 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
- PVR > 300
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openAtlantic Health
Morristown, New Jersey, United States
- Mariah McKevitt, MD · Contact973-971-7267mariah.mckevitt@atlantichealth.org
Recruiting
Study team
Sponsor
Atlantic Health System
Study ID 2376323-2
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.