Recruiting

Silodosin

Sponsor:

Atlantic Health System

Code:

NCT07614321

Conditions

Multiple Sclerosis

Lower Urinary Track Symptoms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Silodosin 8 mg

Placebo

Study Details

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

Conditions

Multiple Sclerosis

Lower Urinary Track Symptoms

Study ID

NCT07614321

Start date

Apr, 2026

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Silodosin

Silodosin 8mg PO daily

placebo comparator: Placebo

Identical placebo capsule, 1 capsule PO daily

Interventions

Silodosin 8 mg

Silodosin 8mg PO qd x8 weeks

Placebo

Identical placebo capsule, 1 capsule PO daily x8 weeks

Primary outcome measure

  • Change in American Urological Association Symptom Score (AUASS) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts and Locations

Central contacts

Mariah McKevitt, MD

973-971-7267mariah.mckevitt@atlantichealth.org

Locations

Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Mariah McKevitt, MD

973-971-7267mariah.mckevitt@atlantichealth.org

More Information

Sponsor

Atlantic Health System

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2026-05-29.