Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Silodosin
Alpha-1a adrenergic receptor antagonist
Placebo or sham
- Placebo
What it measured
Main measures
Change in American Urological Association Symptom Score (AUASS)
From enrollment to the end of treatment at 8 weeks
Other measures (10)
Change in Urinary Distress Inventory Short Form (UDI-6) score
From enrollment to the end of treatment at 8 weeks
Bladder, bowel and sexual functionChange in Overactive Bladder Symptom Score (OABSS)
From enrollment to the end of treatment at 8 weeks
Bladder, bowel and sexual functionChange in Hesitancy question score
From enrollment to the end of treatment at 8 weeks
Global Response Assessment
After 8 weeks of treatment
Uroflowmetry- voided volume
From enrollment to the end of treatment at 8 weeks
Bladder, bowel and sexual functionUroflowmetry- Pattern
From enrollment to the end of treatment at 8 weeks
Bladder, bowel and sexual functionUroflowmetry- Maximum flow rate (Qmax)
From enrollment to the end of treatment at 8 weeks
Bladder, bowel and sexual functionUroflowmetry- Postvoid residual (PVR)
From enrollment to the end of treatment at 8 weeks
Bladder, bowel and sexual functionAdherence
After 8 weeks of treatment
Quality of life (reported by participants)Adverse Events
After 8 weeks of treatment
Safety
Who could take part
MS (type not specified) · 18 and over
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
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History
Started
Apr 2026
Main results due
Mar 2028
Finished
Apr 2028
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