Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Mirabegron; Placebo
Intervention description: see detailed information in associated Arm Description; Sugar pill manufactured to mimic Mirabegron 25mg tablet.
Intervention MeSH terms: Mirabegron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Overactive Bladder; Incontinence; Voiding; Bladder Urgency; Pelvic Floor Exercises

Summary:

      The purpose of this study is to determine if treatment with Mirabegron will improve urinary
      urgency control beyond that achieved with pelvic floor exercises alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Multiple Sclerosis (MS) (no sub-type restrictions)

          -  Age ≥18

          -  No change in disease modifying therapy in 60 days.

          -  Patient willing and able to complete micturition diary

          -  Urinary urgency (8 or more entries of bladder urgency score ≥2) in 72hr voiding diary
             recorded during screening period

          -  Micturition frequency ≥ 8 / day or incontinence ≥ 2 episodes in 72 hour voiding diary
             recorded during screening period

          -  At least 36 hours of voiding activity recorded in 72 hour voiding diary during
             screening period

          -  Non-antimuscarinic medications that are likely to influence bladder function may not
             be initiated between screening and study completion. They may be continued with no
             dose changes during the study.

          -  Discontinued use of antimuscarinics at least two weeks prior to screening

          -  Able to give informed consent

        Exclusion Criteria:

          -  Females who are breast-feeding, pregnant or have potential to become pregnant during
             the course of the study (fertile and unwilling/unable to use effective contraceptive
             measures)

          -  Multiple Sclerosis exacerbation within 30 days of screening

          -  Cognitive deficits that would interfere with the subject's ability to give informed
             consent or perform study testing

          -  Screening blood pressure > 165 systolic or 100 diastolic

          -  History of allergy to Mirabegron

          -  Screening post-void residual > 200ml

          -  Evidence of urinary tract infection at screening

          -  Evidence of chronic inflammation such as interstitial cystitis, bladder stones,
             previous pelvic radiation therapy, or previous or current malignant disease of the
             pelvic organs

          -  Intravesical botulinum toxin treatment within the previous six months of screening.

          -  Presence of InterStim device

          -  Use of indwelling catheter or self-catheterization

          -  Concurrent use of thioridazine(Mellaril® or Mellaril-S®, flecainide (Tambocor®),
             propafenone (Rythmol®) or digoxin (Lanoxin®)

          -  Concurrent use of antimuscarinics: oxybutynin (Ditropan®, Ditropan XL ®), tolterodine
             (Detrol®, Detrol LA®), fesoterodine extended-release (Toviaz®), solifenacin
             (Vesicare®), trospium (Sanctura®, Sanctura XR®), darifenacin extended release
             (Enablex®)

          -  Screening estimated glomerular filtration rate (eGFR) < 60, aspartate aminotransferase
             (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal

          -  Any other serious and/or unstable medical condition