NCT07614321 Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis
| NCT ID | NCT07614321 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Atlantic Health System |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2026-04 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07614321 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07614321 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07614321 currently recruiting?
Yes, NCT07614321 is actively recruiting participants. Contact the research team at mariah.mckevitt@atlantichealth.org for enrollment information.
Where is the NCT07614321 trial being conducted?
This trial is being conducted at Morristown, United States.
Who is sponsoring the NCT07614321 clinical trial?
NCT07614321 is sponsored by Atlantic Health System. The trial plans to enroll 60 participants.
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