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Recruiting NCT07614321

Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

Phase IV Interventional Multiple Sclerosis Lower Urinary Track Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silodosin 8 mg, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Lower Urinary Track Symptoms. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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

Interventions

  • Drug Silodosin 8 mg
    Silodosin 8mg PO qd x8 weeks
  • Drug Placebo
    Identical placebo capsule, 1 capsule PO daily x8 weeks

Primary outcome measures

  • Change in American Urological Association Symptom Score (AUASS) [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (10)
  • Change in Urinary Distress Inventory Short Form (UDI-6) score [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Change in Overactive Bladder Symptom Score (OABSS) [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Change in Hesitancy question score [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Global Response Assessment [Time frame: After 8 weeks of treatment]
  • Uroflowmetry- voided volume [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Uroflowmetry- Pattern [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Uroflowmetry- Maximum flow rate (Qmax) [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Uroflowmetry- Postvoid residual (PVR) [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Adherence [Time frame: After 8 weeks of treatment]
  • Adverse Events [Time frame: After 8 weeks of treatment]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Diagnosed orthostatic hypotension
  • Pregnancy or breastfeeding
  • Severe liver impairment (Child-Pugh class C)
  • Current symptomatic kidney stones
  • Recent MS relapse within the last 3 months
  • Recent treatment with steroids in the last 3 months (this does not include one-time pre-treatment with steroids for administration of immunologic drug)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Atlantic Health — Morristown

Identifiers

NCT: NCT07614321 · 2376323-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗