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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Mirabegron

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Overactive Bladder, Incontinence, Voiding, Bladder Urgency, Pelvic Floor Exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

EvergreenHealth MS Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirabegron

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Secondary Outcome Measure based on voiding diary: Average daily Overactive Bladder Symptom Composite Score (OAB-SCS) Baseline compared to Titration 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.

Mean # of Micturitions/Day Based on Voiding Diaries

Secondary Outcome Measure based on voiding diary: Baseline vs Final Visit: mean # of micturitions/day

Mean # of Incontinence Episodes/Day

Secondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean # of incontinence episodes/day

Mean Volume Voided/Micturition

Secondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean volume voided/micturition

Qualiveen Questionnaire

Secondary Outcome Measures based on the Qualiveen Questionnaire at Final Visit compared to Baseline Qualiveen questionaire is used, including 8 questions about aspects of bladder problems. Each question is rated 0 (not at all)- 4 (extremely). Overall score is averaged (average score per question)

Subject Global Impression (Single Question)

Secondary Outcome Measures based on the Subject Global Impression (single question) at Final Visit compared to Baseline This is a single question: "How would you rate your level of bladder control during the past week?" 1-7 analog scale, 1 = "terrible'" 7 = "delighted."

Full Information

NCT ID

NCT02086188

First Posted

March 11, 2014

Last Updated

September 25, 2023

Sponsor

Theodore R. Brown, MD MPH

Collaborators

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT02086188

Brief Title

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

Acronym

MIRROR

Official Title

Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Theodore R. Brown, MD MPH

Collaborators

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed Description

A randomized 1:1 placebo controlled 10-week study of mirabegron as add-on therapy to an educational intervention on behavioral modification including pelvic floor exercise (BM-PFE) to a cohort of 40 Multiple Sclerosis (MS) subjects with overactive bladder (OAB). Trial will last approximately 12 weeks for each subject, including screening period and treatment period. Active drug will be mirabegron 25mg daily with optional up-titration to 50mg daily after approximately 5 weeks. Subjects will be randomized at the Baseline Visit based on recordings in a voiding diary kept for 72 continuous hours in the screening period. Voiding diaries of a 72 hour period each will be utilized during the screening period, between Phone Visit 1 and Titration and between Phone Visit 2 and Final Visit. In the diaries, subjects will record the time of each micturition and/or urgency episode, urine volume with each void (when available), any episode of incontinence, and the severity of urgency (Overactive Bladder Symptom Composite Score, mean of 72 hour total daily cumulative score. Primary outcome will be average daily OAB-SCS total score, Final Visit vs. Baseline. This accounts for the frequency, urgency and incontinence components of OAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mirabegron

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mirabegron

Other Intervention Name(s)

MBG, Myrbetriq

Intervention Description

see detailed information in associated Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sugar pill manufactured to mimic Mirabegron 25mg tablet.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

5 weeks

Title

Mean # of Micturitions/Day Based on Voiding Diaries

Description

Secondary Outcome Measure based on voiding diary: Baseline vs Final Visit: mean # of micturitions/day

Time Frame

10 weeks

Title

Mean # of Incontinence Episodes/Day

Description

Secondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean # of incontinence episodes/day

Time Frame

10 weeks

Title

Mean Volume Voided/Micturition

Description

Secondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean volume voided/micturition

Time Frame

10 weeks

Title

Qualiveen Questionnaire

Description

Time Frame

10 weeks

Title

Subject Global Impression (Single Question)

Description

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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) < 60, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal Any other serious and/or unstable medical condition

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Theodore R Brown, MD, MPH

Organizational Affiliation

EvergreenHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

EvergreenHealth MS Center

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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