A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Completed · Phase 3 · Has a placebo group

Conditions studied: Urinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases

In brief

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Key facts

Study ID: NCT01908829
Run by: Astellas Pharma Europe Ltd.
People needed: 2174
Starts: 2013-07-10
Expected to finish: 2014-11-25
Last updated by the study team: 2024-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Main Inclusion at Screening:
Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for >= 3 months prior to the screening visit
Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.
Main Inclusion at Run-in (Visit 2):
Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.
Main Inclusion at Randomization (Visit 3):
Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.

You may not qualify if…

Main Exclusion at Screening:
Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).
Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
Subject has an indwelling catheter or practices intermittent self catheterization.
Subject has evidence of a UTI.
Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
Subject has moderate to severe hepatic impairment
Subject has severe renal impairment or End Stage Renal disease
Subject has a clinically significant abnormal Electrocardiogram (ECG)
Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
Main Exclusion at Randomization (visit 3):
Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
Subject does not desire an increase in study medication.
Subject has an average total daily urine volume > 3000ml as recorded in the micturition diary.
Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
Subject has a clinically significant abnormal ECG

Where it is running

Associated Pharmaceutical Research Center, Inc. — Buena Park, California, United States
The American Institute of Research — Los Angeles, California, United States
Bayview Research Group — Valley Village, California, United States
Meridien Research — Brooksville, Florida, United States
Innovative Research of West FL — Clearwater, Florida, United States
Best Quality Research Inc. — Hialeah, Florida, United States
Palmetto Professional Research — Hialeah, Florida, United States
Urology Center of Central Florida — Kissimmee, Florida, United States
Meridien Research — Tampa, Florida, United States
Stedman Clinical Trials — Tampa, Florida, United States
Private Practice — West Palm Beach, Florida, United States
Meridian Clinical Research, LLC — Savannah, Georgia, United States
Herman Clinical Research — Suwanee, Georgia, United States
North Idaho Urology — Coeur d'Alene, Idaho, United States
First Urology, PSC — Jeffersonville, Indiana, United States
Deaconess Gateway Health Center — Newburgh, Indiana, United States
MedStar Health Research Institute — Hyattsville, Maryland, United States
Bay State Clinical Trials, Inc. — Watertown, Massachusetts, United States
Beyer Research — Kalamazoo, Michigan, United States
Quality Clinical Research — Omaha, Nebraska, United States
Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
Brooklyn Urology Research Group — Brooklyn, New York, United States
Advanced Urology Centers of New York — Garden City, New York, United States
Premier Medical Group of the Hudson Valley PC — Kingston, New York, United States
Genova Clinical Research — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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