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Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 8 visits
  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether silodosin helps with bladder symptoms and urine flow in women over 18 who have multiple sclerosis (MS). Researchers will compare it with a placebo, a look-alike pill with no drug. Participants take a pill daily for 8 weeks and visit the clinic before and after treatment for questions and tests.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and diagnosed with multiple sclerosis (MS).
  • Older than 18.
  • Moderate to severe bladder symptoms, with a score above 8 on the AUASS symptom survey.
  • No urinary tract infection (UTI).

Who can't join

  • Used an alpha-blocker, B3 agonist, or anticholinergic medicine (types of bladder medicines) in the past 6 weeks.
  • Had bladder Botox or nerve stimulation treatment for bladder control in the past 9 months.
  • Poor kidney function, with a creatinine clearance (CrCl) below 30, or urine left in the bladder after peeing (PVR) above 300.
  • Diagnosed with orthostatic hypotension, a drop in blood pressure when standing.
  • Pregnant or breastfeeding.
  • Severe liver problems (Child-Pugh class C), or kidney stones that are causing symptoms now.
  • An MS flare-up in the past 3 months.
  • Steroid treatment in the past 3 months, except a one-time steroid dose given before an immune-system drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NJ