MIRROR
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Mirabegron
Beta-3 adrenergic receptor agonist
Placebo or sham
- Placebo
Results by group
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
10 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Mirabegron | 3.01 score on a scale | 0.48 (Standard Deviation) | 14 |
| Placebo | 2.56 score on a scale | 0.84 (Standard Deviation) | 14 |
Mirabegron
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Mirabegron | 14 | 0 (0.0%) | 0 |
| Placebo | 14 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
10 weeks
Bladder, bowel and sexual function
Other measures (6)
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
5 weeks
Bladder, bowel and sexual functionMean # of Micturitions/Day Based on Voiding Diaries
10 weeks
Bladder, bowel and sexual functionMean # of Incontinence Episodes/Day
10 weeks
Bladder, bowel and sexual functionMean Volume Voided/Micturition
10 weeks
Bladder, bowel and sexual functionQualiveen Questionnaire
10 weeks
Bladder, bowel and sexual functionSubject Global Impression (Single Question)
10 weeks
Bladder, bowel and sexual function
Who could take part
MS (type not specified) · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
May 2014
Main results due
Apr 2019
Finished
Jun 2019
Results posted
Oct 2023
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