Health TrialsbyHealthPanel

Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

ConditionsMultiple SclerosisLower Urinary Track Symptoms
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAtlantic Health System

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients with a diagnosis of multiple sclerosis

Age > 18

Moderate to severe lower urinary tract symptoms as defined by an AUASS score > 8

No UTI

Disqualifiers

Treatment with alpha-blocker, B3 agonist, or anticholinergic medication within the last 6 weeks

Treatment with sacral neuromodulation, bladder Botox, or posterior tibial nerve stimulation within the last 9 months

Renal impairment with CrCl < 30

PVR > 300

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silodosin 8 mg

    Drug

    Silodosin 8mg PO qd x8 weeks

  • Placebo

    Drug

    Identical placebo capsule, 1 capsule PO daily x8 weeks

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SilodosinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in American Urological Association Symptom Score (AUASS)

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

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

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

Time frame
From enrollment to the end of treatment at 8 weeks
2

Change in Overactive Bladder Symptom Score (OABSS)

Score 0-15, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement

Time frame
From enrollment to the end of treatment at 8 weeks
3

Change in Hesitancy question score

Score 0-5, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement

Time frame
From enrollment to the end of treatment at 8 weeks
4

Global Response Assessment

Questionnaire to assess change in symptoms after treatment, scale 1-5 with higher score indicating higher improvement in symptoms.

Time frame
After 8 weeks of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atlantic Health System

Lead sponsor

Source ClinicalTrials.gov
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