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NCT Number: NCT07614321

Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Lower Urinary Track Symptoms Nervous System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Atlantic Health

Morristown, New Jersey, 07960, United States

Location status: Recruiting

Location contact

Mariah McKevitt, MD

CONTACT

[email protected]

973-971-7267

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Silodosin 8 mg

Drug

Silodosin 8mg PO qd x8 weeks

Placebo

Drug

Identical placebo capsule, 1 capsule PO daily x8 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Urinary Distress Inventory Short Form (UDI-6) score

    Time frame: From enrollment to the end of treatment at 8 weeks

    Score 0-18, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement

  2. Change in Overactive Bladder Symptom Score (OABSS)

    Time frame: From enrollment to the end of treatment at 8 weeks

    Score 0-15, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement

  3. Change in Hesitancy question score

    Time frame: From enrollment to the end of treatment at 8 weeks

    Score 0-5, higher score indicating worse symptoms therefore higher change from baseline indicating better improvement

  4. Global Response Assessment

    Time frame: After 8 weeks of treatment

    Questionnaire to assess change in symptoms after treatment, scale 1-5 with higher score indicating higher improvement in symptoms.

  5. Uroflowmetry- voided volume

    Time frame: From enrollment to the end of treatment at 8 weeks

    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

  6. Uroflowmetry- Pattern

    Time frame: From enrollment to the end of treatment at 8 weeks

    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

  7. Uroflowmetry- Maximum flow rate (Qmax)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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

  8. Uroflowmetry- Postvoid residual (PVR)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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

  9. Adherence

    Time frame: After 8 weeks of treatment

    Patients will bring their pill bottle to final study visit to assess how well they adhered to the study intervention.

  10. Adverse Events

    Time frame: After 8 weeks of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Mariah McKevitt, MD

CONTACT

[email protected]

973-971-7267

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Official study title

Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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