Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theodore R. Brown, MD MPH
• Collaborator: Astellas Pharma Inc
• Treatments: Mirabegron

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