Lower Urinary Track Symptoms, Multiple Sclerosis
Conditions
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
Interventions
DRUGSilodosin 8 mg
Silodosin 8mg PO qd x8 weeks
DRUGPlacebo
Identical placebo capsule, 1 capsule PO daily x8 weeks
Sponsors
Atlantic Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in American Urological Association Symptom Score (AUASS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Distress Inventory Short Form (UDI-6) score | 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 |
| Change in Overactive Bladder Symptom Score (OABSS) | 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 |
| Change in Hesitancy question score | 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 |
| Global Response Assessment | After 8 weeks of treatment | Questionnaire to assess change in symptoms after treatment, scale 1-5 with higher score indicating higher improvement in symptoms. |
| Uroflowmetry- voided volume | 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 |
| Uroflowmetry- Pattern | 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 |
| Uroflowmetry- Maximum flow rate (Qmax) | 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 |
| Uroflowmetry- Postvoid residual (PVR) | 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 |
| Adherence | 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. |
| Adverse Events | After 8 weeks of treatment | — |
Countries
United States
Contacts
CONTACTMariah McKevitt, MD
Outcome results
None listed