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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort A Vibegron Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.
  • Drug: Vibegron
    Vibegron to be administered.
    Other names:
    • GEMTESA
Cohort B Vibegron Participants with previous mirabegron monotherapy or mirabegron plus solifenacin or combination therapy experience will receive vibegron as per the U.S. label.
  • Drug: Vibegron
    Vibegron to be administered.
    Other names:
    • GEMTESA

More Details

Status
Active, not recruiting
Sponsor
Urovant Sciences GmbH

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.