Phase 4
Completed N=28
Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis
Source: ClinicalTrials.gov NCT02086188 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit — 3.01; 2.56 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit |
3.01; 2.56 | — |
| SECONDARY Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit |
2.8; 2.23 | 0.1911 |
| SECONDARY Mean # of Micturitions/Day Based on Voiding Diaries |
6.82; 8.72 | 0.4271 |
| SECONDARY Mean # of Incontinence Episodes/Day |
0.7; 1.05 | 0.1723 |
| SECONDARY Mean Volume Voided/Micturition |
356; 282 | 0.6340 |
| SECONDARY Qualiveen Questionnaire |
0.96; 0.71 | 0.0091 sig |
| SECONDARY Subject Global Impression (Single Question) |
5.71; 4.86 | — |
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) 2x upper limit of normal
- Any other serious and/or unstable medical condition
Data sourced from ClinicalTrials.gov (NCT02086188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.