Silodosin for urinary symptoms in women with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial enrolls adult women with MS and moderate to severe LUTS to receive either silodosin 8 mg daily or a placebo for 8 weeks. Researchers will use questionnaires and uroflowmetry tests to assess changes in urinary symptoms and voiding parameters. The study compares the active drug to placebo to determine if silodosin can improve LUTS in this population while monitoring safety and tolerability. Participants will have an initial clinic visit before starting treatment and a follow-up visit after 8 weeks for assessments.

Why it matters

Who can join: the full rules

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)

Where it's running

• Atlantic Health
  Morristown, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Mariah McKevitt, MD
• Email: mariah.mckevitt@atlantichealth.org
• Phone: 973-971-7267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.