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

Urovant Sciences

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Vibegron

Study type: Observational

Funder types: Industry

Identifiers

NCT05067478

URO-901-4001

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

403 participants in 2 patient groups

Cohort A Vibegron

Description:

Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.

Treatment:

Drug: Vibegron

Cohort B Vibegron

Description:

Participants with previous mirabegron monotherapy or mirabegron plus solifenacin or combination therapy experience will receive vibegron as per the U.S. label.

Treatment:

Drug: Vibegron