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

Completed · Phase 4 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT02086188

Run by

Theodore R. Brown, MD MPH

People needed

28

Starts

2014-05-01

Expected to finish

2019-06-01

Last updated by the study team

2023-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• EvergreenHealth MS Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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