Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Atlantic Health
Morristown, New Jersey 07960
Contact:
Mariah McKevitt, MD
973-971-7267
mariah.mckevitt@atlantichealth.org

More Details

Status
Recruiting
Sponsor
Atlantic Health System

Study Contact

Mariah McKevitt, MD
973-971-7267
mariah.mckevitt@atlantichealth.org