Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

Phase 4RecruitingNCT07614321

Atlantic Health System60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis Lower Urinary Track Symptoms

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in American Urological Association Symptom Score (AUASS)

Score 0-35, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement