Actively Recruiting
Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial
Led by Atlantic Health System · Updated on 2026-05-29
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether silodosin can help treat lower urinary tract symptoms (LUTS) in female patients with multiple sclerosis (MS). The study aims to find out if silodosin improves symptoms based on questionnaires and changes uroflowmetry measurements compared to a placebo. This randomized controlled trial is sponsored by Atlantic Health System and focuses on female patients with moderate to severe LUTS related to MS. Participants will be randomly assigned to take either silodosin 8 mg or a placebo capsule once daily for 8 weeks. The study uses a quadruple-blind design, meaning neither participants nor researchers know which treatment is given. Before starting the medication and after 8 weeks, patients will visit the clinic for questionnaires and tests to assess urinary symptoms and voiding function. During the study, participants will complete symptom questionnaires including the American Urological Association Symptom Score (AUASS), Urinary Distress Inventory, and Overactive Bladder Symptom Score. Uroflowmetry tests will measure urine flow patterns, volume, and residual urine after voiding. Researchers will monitor medication adherence and any side effects throughout the treatment period. The total participation involves the initial visit, 8 weeks of daily medication, and a final evaluation visit.
CONDITIONS
Brief Title
Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with a diagnosis of multiple sclerosis
- Age over 18 years
- Moderate to severe lower urinary tract symptoms with an AUASS score greater than 8
- No current urinary tract infection
You will not qualify if you...
- 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 creatinine clearance less than 30
- Postvoid residual urine volume greater than 300
- Diagnosed orthostatic hypotension
- Pregnancy or breastfeeding
- Severe liver impairment (Child-Pugh class C)
- Current symptomatic kidney stones
- Recent multiple sclerosis relapse within the last 3 months
- Recent steroid treatment within the last 3 months (except one-time pre-treatment for immunologic drug administration)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants take Silodosin 8 mg or placebo daily for 8 weeks to treat lower urinary tract symptoms.
Daily medication with periodic assessments
Trial Site Locations
Total: 1 location
1
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
Research Team
M
Mariah McKevitt, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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