A Phase 4 interventional study of Silodosin 8 mg and Placebo in Multiple Sclerosis and Lower Urinary Track Symptoms, sponsored by Atlantic Health System. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Atlantic Health System · Phase 4, Interventional, and Treatment
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
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Atlantic Health System is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Silodosin 8mg PO daily
Drug: Silodosin 8 mg
Identical placebo capsule, 1 capsule PO daily
Drug: Placebo
Silodosin 8mg PO qd x8 weeks
Identical placebo capsule, 1 capsule PO daily x8 weeks
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
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
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
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
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
Uroflowmetry- voided volume
Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. Voided volume to be assessed in mL
Time frame: From enrollment to the end of treatment at 8 weeks
Uroflowmetry- Pattern
Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. Pattern will be characterized as normal, intermittent, interrupted, or unable to be interpreted based on low volume
Time frame: From enrollment to the end of treatment at 8 weeks
Uroflowmetry- Maximum flow rate (Qmax)
Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. Maximum flow rate will be reported in mL/sec
Time frame: From enrollment to the end of treatment at 8 weeks
Uroflowmetry- Postvoid residual (PVR)
Patients will perform Uroflowmetry to assess voiding parameters prior to initiating the study drug and after 8 weeks of treatment. PVR will be assessed in mL via bladder scanner
Time frame: From enrollment to the end of treatment at 8 weeks
Adherence
Patients will bring their pill bottle to final study visit to assess how well they adhered to the study intervention.
Time frame: After 8 weeks of treatment
Adverse Events
Time frame: After 8 weeks of treatment
Start is estimated for Apr 2026; primary completion for Mar 2028, 23 months later.
Of 69 phase 4 interventional studies under Multiple Sclerosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Silodosin
Atlantic Health System