Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)

Completed

Conditions studied: Overactive Bladder

In brief

This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.

Key facts

Study ID

NCT05067478

Run by

Urovant Sciences GmbH

People needed

403

Starts

2021-10-28

Expected to finish

2024-07-26

Last updated by the study team

2024-12-27

Who can join

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

You may qualify if…

• Diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• Symptoms of OAB for at least 3 months prior to the Baseline Visit
• Willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year
• Previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination therapy prior to initiation of vibegron

You may not qualify if…

• Any contraindication to the use of vibegron per the United States label
• History of OAB treatment with botulinum toxin A; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the Baseline Visit
• History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
• Participants at risk of urinary retention (as determined by the investigator)
• Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• Pregnant or breastfeeding or plans to do so during the study
• Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
• Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason

Where it is running

• 43rd Medical Associates — Phoenix, Arizona, United States
• Fiel Family and Sports Medicine, PC — Tempe, Arizona, United States
• Arkansas Urology Associates, PA — Little Rock, Arkansas, United States
• Golden Gate Urology — Berkley, California, United States
• Urology Associates of Norwalk — Norwalk, Connecticut, United States
• Urological Research Network — Hialeah, Florida, United States
• University of Florida Health Jacksonville Facility Clinic — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• South Florida Research Phase I-IV, Inc. — Miami Springs, Florida, United States
• Tampa Urology Partners LLP — Tampa, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Clinical Research of Central Florida - Winter Haven — Winter Haven, Florida, United States
• Georgia Urology — Cartersville, Georgia, United States
• WR-Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• Idaho Urologic Institute — Meridian, Idaho, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• American Health Network of Indiana, LLC — Avon, Indiana, United States
• The University of Kansas Health System — Kansas City, Kansas, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Owings Mills, Maryland, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Bay State Clinical Trials, Inc. — Watertown, Massachusetts, United States
• Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.