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

NCT02086188 | Completed Phase 4 Results

• 1 other identifier: TRB2013
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Overactive Bladder; Incontinence; Voiding; Bladder Urgency; Pelvic Floor Exercises

Outcome Measures

Primary Outcomes (1)

• Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit

  Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.

  10 weeks

Secondary Outcomes (6)

• Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit

  5 weeks

• Mean # of Micturitions/Day Based on Voiding Diaries

  10 weeks

• Mean # of Incontinence Episodes/Day

  10 weeks

• Mean Volume Voided/Micturition

  10 weeks

• Qualiveen Questionnaire

  10 weeks

Study Arms (2)

Mirabegron

EXPERIMENTAL

Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily

Drug: Mirabegron

Placebo

PLACEBO COMPARATOR

Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration

Drug: Placebo

Interventions

Mirabegron DRUG

see detailed information in associated Arm Description

Also known as: MBG, Myrbetriq

Mirabegron

Placebo DRUG

Sugar pill manufactured to mimic Mirabegron 25mg tablet.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Theodore R. Brown, MD MPH: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

EvergreenHealth MS Center

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Theodore Brown, MD
• Organization: EvergreenHealth

TRBrown@evergreenhealthcare.org

4258995350

Study Officials

• Theodore R Brown, MD, MPH

  EvergreenHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director - MS Neuro-Rehabilitation

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 18, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)