For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Any contraindication to the use of vibegron per the United States label
  2. 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
  3. History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
  4. Participants at risk of urinary retention (as determined by the investigator)
  5. Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
  6. Pregnant or breastfeeding or plans to do so during the study
  7. Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
  8. Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Overactive Bladder

Age (in years)

18+

Participants needed

400

Est. Completion Date

Sep 30, 2024

Treatment type

Observational


Sponsor

Urovant Sciences GmbH

ClinicalTrials.gov identifier

NCT05067478

Study number

URO-901-4001

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