RecruitingPhase 4MS (type not specified)NCT07614321

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Silodosin

    Alpha-1a adrenergic receptor antagonist

Placebo or sham

  • Placebo

What it measured

Main measures

  • Change in American Urological Association Symptom Score (AUASS)

    From enrollment to the end of treatment at 8 weeks

Other measures (10)

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

    From enrollment to the end of treatment at 8 weeks

    Bladder, bowel and sexual function
  • Change in Overactive Bladder Symptom Score (OABSS)

    From enrollment to the end of treatment at 8 weeks

    Bladder, bowel and sexual function
  • Change in Hesitancy question score

    From enrollment to the end of treatment at 8 weeks

  • Global Response Assessment

    After 8 weeks of treatment

  • Uroflowmetry- voided volume

    From enrollment to the end of treatment at 8 weeks

    Bladder, bowel and sexual function
  • Uroflowmetry- Pattern

    From enrollment to the end of treatment at 8 weeks

    Bladder, bowel and sexual function
  • Uroflowmetry- Maximum flow rate (Qmax)

    From enrollment to the end of treatment at 8 weeks

    Bladder, bowel and sexual function
  • Uroflowmetry- Postvoid residual (PVR)

    From enrollment to the end of treatment at 8 weeks

    Bladder, bowel and sexual function
  • Adherence

    After 8 weeks of treatment

    Quality of life (reported by participants)
  • Adverse Events

    After 8 weeks of treatment

    Safety

Who could take part

MS (type not specified) · 18 and over

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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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History

    1. Started

      Apr 2026

    2. Main results due

      Mar 2028

    3. Finished

      Apr 2028

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