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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    400
  • sponsor
    Urovant Sciences GmbH
Updated on 5 July 2022
mirabegron
incontinence
solifenacin
vibegron

Summary

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.

Details
Condition Overactive Bladder
Treatment vibegron
Clinical Study IdentifierNCT05067478
SponsorUrovant Sciences GmbH
Last Modified on5 July 2022

Eligibility

Yes No Not Sure

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 mirabegron monotherapy and/or mirabegron plus solifenacin and/or previous exposure to anticholinergics 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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