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Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

NCT02216214•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is willing and able to complete the micturition diary and questionnaires correctly.
•Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening.
•Subject agrees not to participate in another interventional study from the time of screening until the final study visit.
•Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary.
•Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary.
•Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary.

Exclusion Criteria

•Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled.
•Subject has Post-Void Residual Volume (PVR) greater than 150 mL.
•Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply.
•Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test.
•Subject has an indwelling catheter or practices intermittent self-catheterization.
•Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator's discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
•Subject 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; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).
•Subject resides in a nursing home.
•Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator.
•Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
+19 more criteria

Locations (120)

Site US00066

Huntsville, Alabama, United States

Site US00148

Mobile, Alabama, United States

Site US00009

Anchorage, Alaska, United States

Site US00020

Tucson, Arizona, United States

Site US00019

Tucson, Arizona, United States

Site US00063

Little Rock, Arkansas, United States

Site US00081

Little Rock, Arkansas, United States

Site US00176

Anaheim, California, United States

Site US00048

Beverly Hills, California, United States

Site US00142

Beverly Hills, California, United States

Key Dates

Start Date

October 7, 2014

Primary Completion Date

November 29, 2017

Completion Date

January 2, 2018

Last Updated

November 22, 2024

Enrollment

888

ACTUAL participants

Conditions

Overactive Bladder (OAB)

Interventions

Mirabegron

DRUG

Placebo

DRUG

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RECRUITINGNA

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ENROLLING_BY_INVITATIONNA

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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: November 22, 2024Data 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

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects 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

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BlueWind RENOVA iStim™ System for the Treatment of OAB