Multiple SclerosisPhase 4NCT07614321
Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis
A Phase 4 study testing Silodosin 8 mg in people with Multiple Sclerosis and Lower Urinary Track Symptoms, run by Atlantic Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Lower Urinary Track Symptoms
- What is being tested?
- Silodosin 8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atlantic Health
Morristown, New Jersey, 07960
Mariah McKevitt, MD, 973-971-7267, mariah.mckevitt@atlantichealth.org
About this study
Official title: Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial
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.
Read more
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
- Conditions
- Multiple Sclerosis, Lower Urinary Track Symptoms
- Being tested
- Silodosin 8 mg, Placebo
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silodosin 8 mgDrug
Silodosin 8mg PO qd x8 weeks
PlaceboDrug
Identical placebo capsule, 1 capsule PO daily x8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Experimental | Silodosin 8mg PO daily Receives: Drug: Silodosin 8 mg |
| Placebo | Placebo comparator | Identical placebo capsule, 1 capsule PO daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Urological Association Symptom Score (AUASS)
Score 0-35, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: After 8 weeks of treatment
Adverse Events
Measured: After 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Botros, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614321
- Sponsor's protocol ID
- 2376323-2
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07614321
- Acronym / sponsor ID
- 2376323-2
- Conditions
- Multiple Sclerosis, Lower Urinary Track Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Experimental | Drug: Silodosin 8 mgSilodosin 8mg PO daily |
| Placebo | Placebo comparator | Drug: PlaceboIdentical placebo capsule, 1 capsule PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silodosin 8 mgSilodosin 8mg PO qd x8 weeks | Drug | Silodosin |
| PlaceboIdentical placebo capsule, 1 capsule PO daily x8 weeks | Drug | Placebo |
Primary outcome
Change in American Urological Association Symptom Score (AUASS)
Time frame: From enrollment to the end of treatment at 8 weeks
Score 0-35, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin 8 mg in people with Multiple Sclerosis and Lower Urinary Track Symptoms, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariah McKevitt, MD (973-971-7267, mariah.mckevitt@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in American Urological Association Symptom Score (AUASS) (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.