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A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)

A Prospective, Double-Blind, Randomized, Two-Period Crossover, Multi-Center Study to Evaluate the Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)

NCT02138747•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.

Detailed Description

The study consisted of two double-blind treatment periods with a wash-out period in between.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant is willing and able to complete the micturition diary and questionnaires correctly.
•Participant has symptoms of OAB (urinary frequency and urgency with or without incontinence) for greater than or equal to 3 months prior to Screening.
•Participant must be treatment-naïve to pharmaceutical agents for OAB.
•Female participant must not donate ova starting at Screening and throughout the study period, and for 30 days after the final study drug administration.
•Male participant must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration.
•Participant agrees not to participate in another interventional study from the time of screening until the final study visit.
•* Participant must experience at least 3 episodes of urgency (grade 3 or 4) during the 3 day micturition diary.
•* Participant must experience an average of greater than or equal to 8 micturitions/day on the 3 day micturition diary

Exclusion Criteria

•Female participant who is lactating or is intending to breastfeed during the study period and for 30 days after the final study visit.
•The participant has clinically significant bladder outlet obstruction (BOO) posing a risk of urinary retention.
•Participant has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor.
•Participant has evidence of Urinary Tract Infection (UTI) (urine culture greater than 100,000 cfu/mL) as assessed at Screening (Visit 1). The participant can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
•Participant has a neurological cause for detrusor overactivity (e.g., neurogenic bladder, diabetic neuropathy or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease).
•Participant has an indwelling catheter or practices intermittent self-catheterization.
•Participant has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females); or of the lower gastrointestinal tract.
•Participant has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe colitis ulcerosa, toxic megacolon, myasthenia gravis, polio or any other medical condition which makes the use of anticholinergics contraindicated.
•Participant has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
•Participant has received invasive treatment including electro-stimulation therapy.
+11 more criteria

Locations (30)

Site US10002 Urology Centers of Alabama

Homewood, Alabama, United States

Site US10004 Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Site US10001 Urological Associates of Southern Arizona

Tucson, Arizona, United States

Site US10003 Genesis Research

San Diego, California, United States

Site US10010 Skyline Urology

Sherman Oaks, California, United States

Site US10028 Clinical Research Consulting

Milford, Connecticut, United States

Site US10024 Coastal Connecticut Research, LLC

New London, Connecticut, United States

Site US10033 Eastern Research

Hialeah, Florida, United States

Site US10023 Advanced Clinical Research of Miami

Miami, Florida, United States

Site US10007 Pinellas Urology, Inc

St. Petersburg, Florida, United States

Key Dates

Start Date

July 24, 2014

Primary Completion Date

October 29, 2015

Completion Date

November 11, 2015

Last Updated

February 26, 2020

Enrollment

376

ACTUAL participants

Conditions

Overactive Bladder (OAB)

Interventions

Mirabegron

DRUG

Tolterodine ER

DRUG

INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407

Overactive Bladder (OAB)

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RECRUITINGNA

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

NCT07195656

Overactive Bladder (OAB)

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ENROLLING_BY_INVITATIONNA

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

NCT06765629

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)

Inclusion Criteria

Exclusion Criteria

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.

Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial

BlueWind RENOVA iStim™ System for the Treatment of OAB