60 Participants NeededMy employer runs this trial

Silodosin for Urinary Symptoms in Multiple Sclerosis

MM
Overseen ByMariah McKevitt, MD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether silodosin can help women with multiple sclerosis (MS) who experience moderate to severe urinary problems. The study compares silodosin to a placebo to assess improvements in symptoms and changes in urine flow. Women with MS who have significant urinary issues, no urinary tract infection, and haven't received certain recent treatments may qualify. Participants will take either the drug or a placebo for 8 weeks and complete tests and questionnaires to provide researchers with valuable insights. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how silodosin can benefit more patients with MS-related urinary issues.

Will I have to stop taking my current medications?

If you are currently taking an alpha-blocker, B3 agonist, or anticholinergic medication, you will need to stop these at least 6 weeks before joining the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What is the safety track record for this treatment?

Research has shown that silodosin is generally well-tolerated for treating lower urinary tract symptoms. Studies indicate that it can cause side effects like retrograde ejaculation (where semen goes into the bladder instead of out through the penis) and dizziness when standing up. However, these side effects are usually manageable. Evidence also suggests that silodosin effectively improves urinary symptoms and quality of life. Side effects occurred more frequently with silodosin than with a placebo. Despite this, using silodosin in conditions similar to multiple sclerosis is considered safe. Discussing potential side effects with a healthcare provider is crucial when considering participation in a clinical trial.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for urinary symptoms in multiple sclerosis involve anticholinergic drugs or beta-3 adrenergic agonists, which help relax the bladder. However, researchers are excited about Silodosin because it works differently, targeting alpha-1 adrenergic receptors. This mechanism is traditionally used for treating benign prostatic hyperplasia, but it could offer a new way to improve bladder function in multiple sclerosis patients by reducing urinary retention and frequency. This unique approach may provide relief for patients who haven't responded well to standard treatments.

What evidence suggests that silodosin might be an effective treatment for lower urinary tract symptoms in multiple sclerosis?

This trial will compare Silodosin with a placebo to evaluate its effectiveness in improving urinary symptoms in individuals with multiple sclerosis (MS). Studies have shown that silodosin can help improve urinary symptoms in patients. One study with over 2,000 participants found that silodosin did not significantly change some urinary symptom scores, but it did increase the maximum urine flow rate in certain cases. This suggests that silodosin might help people empty their bladders more effectively. Managing bladder issues is crucial for people with MS, as up to 85% experience urinary symptoms. Researchers are keen to determine if silodosin can alleviate these symptoms in MS patients.12346

Are You a Good Fit for This Trial?

This trial is for women diagnosed with multiple sclerosis who are experiencing lower urinary tract symptoms. Participants should be able to attend clinic visits and follow study instructions.

Inclusion Criteria

I have moderate to severe urinary symptoms with an AUASS score above 8.
I am a woman diagnosed with multiple sclerosis.
I am over 18 years old.
See 1 more

Exclusion Criteria

Pregnancy or breastfeeding
PVR > 300
I have been diagnosed with orthostatic hypotension.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take silodosin or a placebo daily for 8 weeks

8 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Silodosin

Trial Overview

The study tests whether silodosin, taken daily for 8 weeks, can improve urinary symptoms in women with MS compared to a placebo. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SilodosinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials
58
Recruited
9,400+

Citations

The Management of Lower Urinary Tract Dysfunction in ... - PMC

The results from a meta-analysis of studies in MS published in 2005 demonstrated that desmopressin reduced daytime frequency, urine volume, and ...

Silodosin for Urinary Symptoms in Female Patients With ...

The goal of this clinical trial is to learn if silodosin works to treat lower urinary tract symptoms (LUTS) in female patients with multiple ...

Silodosin for the treatment of lower urinary tract symptoms ...

Based on 13 studies with a total of 2129 randomized participants, silodosin may result in little to no difference in urologic symptom scores (MD ...

Management of Bladder Dysfunction in Multiple Sclerosis

Up to 85% of people with MS report urinary symptoms related to neurogenic bladder dysfunction at some point during their disease course.

722 SELECTIVE Α1A-BLOCKER “SILODOSIN” SAFETY ...

Primary outcomes were clinical efficacy and Q(max) improvement; secondary outcomes were tolerability and safety. Voiding and storage symptoms (IPSS, OABSS and ...

Efficacy and Safety of Silodosin in the Treatment of Lower ...

To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms.