Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Lower Urinary Track Symptoms
• Intervention / Treatment: Drug: Silodosin 8 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mariah McKevitt, MD; Phone Number: 973-971-7267; Email: mariah.mckevitt@atlantichealth.org

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Health
      • Contact: Mariah McKevitt, MD; Phone Number: 973-971-7267; Email: mariah.mckevitt@atlantichealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients with a diagnosis of multiple sclerosis
2. Age > 18
3. Moderate to severe lower urinary tract symptoms as defined by an AUASS score > 8
4. No UTI

Exclusion Criteria:

1. Treatment with alpha-blocker, B3 agonist, or anticholinergic medication within the last 6 weeks
2. Treatment with sacral neuromodulation, bladder Botox, or posterior tibial nerve stimulation within the last 9 months
3. Renal impairment with CrCl < 30
4. PVR > 300
5. Diagnosed orthostatic hypotension
6. Pregnancy or breastfeeding
7. Severe liver impairment (Child-Pugh class C)
8. Current symptomatic kidney stones
9. Recent MS relapse within the last 3 months
10. Recent treatment with steroids in the last 3 months (this does not include one-time pre-treatment with steroids for administration of immunologic drug)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silodosin; Silodosin 8mg PO daily	Drug: Silodosin 8 mg; Silodosin 8mg PO qd x8 weeks
Placebo Comparator: Placebo; Identical placebo capsule, 1 capsule PO daily	Drug: Placebo; Identical placebo capsule, 1 capsule PO daily x8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in American Urological Association Symptom Score (AUASS)	Score 0-35, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Urinary Distress Inventory Short Form (UDI-6) score	Score 0-18, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement	From enrollment to the end of treatment at 8 weeks
Change in Overactive Bladder Symptom Score (OABSS)	Score 0-15, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement	From enrollment to the end of treatment at 8 weeks
Change in Hesitancy question score	Score 0-5, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement	From enrollment to the end of treatment at 8 weeks
Global Response Assessment	Questionnaire to assess change in symptoms after treatment, scale 1-5 with higher score indicating higher improvement in symptoms.	After 8 weeks of treatment
Uroflowmetry- voided volume	Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. Voided volume to be assessed in mL	From enrollment to the end of treatment at 8 weeks
Uroflowmetry- Pattern	Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. Pattern will be characterized as normal, intermittent, interrupted, or unable to be interpreted based on low volume	From enrollment to the end of treatment at 8 weeks
Uroflowmetry- Maximum flow rate (Qmax)	Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. Maximum flow rate will be reported in mL/sec	From enrollment to the end of treatment at 8 weeks
Uroflowmetry- Postvoid residual (PVR)	Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. PVR will be assessed in mL via bladder scanner	From enrollment to the end of treatment at 8 weeks
Adherence	Patients will bring their pill bottle to final study visit to assess how well they adhered to the study intervention.	After 8 weeks of treatment
Adverse Events		After 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; silodosin
• Other Study ID Numbers: 2376323-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No