Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients

NCT02044510 | Terminated Phase 2 Results

• 1 other identifier: SG193
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

The proposed study is a randomized, double blind placebo controlled multicenter study to determine the effectiveness of mirabegron in the treatment of neurogenic bladder dysfunction. Patients will be randomized into one of two trial arms: mirabegron 25mg for two weeks, with escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two weeks, with placebo escalation for the remaining 8 weeks. Each of these trial arms will be stratified based on whether the patient is already taking an anticholinergic medication or not. The study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The study hypothesis is that mirabegron will result in a statistically superior (increased) urodynamic bladder capacity. The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo treatment will be administered. The primary outcome measure will be based on an increase in urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic parameters, urinary symptom scales, urinary quality of life indices, and voiding diary results. Patients who are over 18 years of age with a diagnosis of multiple sclerosis (MS) or spinal cord injury (SCI) will be eligible to participate. All eligible patients will have urodynamic studies performed within 4 weeks of trial enrollment, and at the end of study (week 9-10). Adverse events and study outcomes will be assessed at predefined study time points.

Conditions

Urinary Bladder, Neurogenic

Keywords

Multiple Sclerosis; Spinal Cord Injuries; mirabegron; Urodynamics

Outcome Measures

Primary Outcomes (1)

• Bladder Capacity

  Urodynamic bladder capacity

  10 weeks

Secondary Outcomes (12)

• 3 Day Voiding Diary

  10 weeks

• 24hr Urinary Pad Weights

  10 weeks

• Quality of Life (Bladder Specific)

  10 weeks

• Quality of Life (Incontinence)

  10 weeks

• Patient Reported Outcome Measure-NBSS

  10 weeks

Study Arms (2)

Mirabegron

EXPERIMENTAL

Patients randomised to this arm start with mirabegron 25mg PO daily for two weeks, and then at 2 weeks titrate to 50mg PO daily, and maintain that dose for the duration of the study (8 additional weeks).

Drug: Mirabegron

Placebo

PLACEBO COMPARATOR

Inert placebo pill, matching active treatment pill.

Drug: Placebo

Interventions

Mirabegron DRUG

Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.

Also known as: MYRBETRIQ

Mirabegron

Placebo DRUG

Matched placebo capsules to the intervention arm

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of traumatic or nontraumatic suprasacral spinal cord injury (SCI) or multiple sclerosis (MS, based on a neurologist assessment and/or the McDonald criteria)(28)
• Age \>18 years
• Stable method of bladder management for \>3months (either spontaneous or provoked voiding, or intermittent catheterization).
• Bothersome urinary symptoms (urinary frequency, urgency, or urgency incontinence based on standard ICS definitions(29)) and completed 3 day voiding diary demonstrating at least 1 episode of non-stress based urinary incontinence over the 72hr period (this may be urgency based incontinence or unaware incontinence).
• Patient is able to read and speak English

You may not qualify if:

• Based on Screening visit history:
• Participation in another drug or device study in the 60 days prior to the screening visit.
• Previous urologic surgery: Transurethral prostatectomy, bladder augmentation, sphincterotomy, bladder neck sling, artificial urinary sphincter, catheterizable channel, implantable electrostimulator/neuromodulator
• Current use of suprapubic catheter/foley catheter
• Unstable cardiac disease (uncontrolled hypertension, myocardial infarction, unstable angina, severe congestive heart failure (NYHA 3 or 4), ventricular arrhythmia (such as torsades de pointes), or stroke within the last 6 months)
• Clinically significant abnormal ECG
• The investigator believes the patient has an increased risk of QT prolongation (based on review of the screening ECG and patients concurrent medications)
• History of significant renal dysfunction within 1 year, or serum creatinine \>150umol/L at screening visit (visit 1).
• History of significant liver disease within 1 year, or serum AST/ALT \>2 times upper limit of normal, GGT \>3 times upper limit of normal, total bilirubin \>2 times upper limit of normal at screening visit (visit 1).
• History of pelvic radiation
• History of bladder cancer
• History of a concurrent malignancy or cancer (except noninvasive skin cancer) within the last 5 years. Subjects with a history of cancer are considered eligible if the subject has undergone potentially curative therapy and the subject has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin).
• Patient has a history of interstitial cystitis/pelvic pain syndrome
• Patient has a history of acute or chronic urinary retention within the last 3 months, and is currently not using intermittent catheters
• Patient has a history of a tachyarrhythmia

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (5)

Rehabiliation Center, Health Sciences Center

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Kingston General Hospital and Hotel Dieu Hospital (Queens University)

Kingston, Ontario, K7L 5G2, Canada

Location

Western University

London, Ontario, N6A 4V2, Canada

Location

University of Ottawa

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Multiple Sclerosis; Spinal Cord Injuries

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Mary McKibbon
• Organization: Lawson Research Institute

mary.mckibbon@sjhc.london.on.ca

5196466367

Study Officials

• Blayne Welk, MD MSc

  Western University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 5, 2019
• Results First Posted: January 7, 2019

Record last verified: 2019-01

Locations

CA (5)