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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silodosin | Experimental | Silodosin 8mg PO daily |
|
| Placebo | Placebo Comparator | Identical placebo capsule, 1 capsule PO daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin 8 mg | Drug | Silodosin 8mg PO qd x8 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in American Urological Association Symptom Score (AUASS) | Score 0-35, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 8 weeks |
| Change in Overactive Bladder Symptom Score (OABSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariah McKevitt, MD | Contact | 973-971-7267 | mariah.mckevitt@atlantichealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Health | Recruiting | Morristown | New Jersey | 07960 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
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| Drug |
Identical placebo capsule, 1 capsule PO daily x8 weeks |
|
Score 0-15, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement |
| 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 | 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. | 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 | 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 | 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 | 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 | 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. | After 8 weeks of treatment |
| Adverse Events | After 8 weeks of treatment |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |