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Table 1 Enrollment criteria of the COMPOSUR study

From: Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder

Inclusion criteria

Exclusion criteria

Male or female, ≥ 18 years of age

Any contradiction to the use of vibegron per US label

Able to provide informed consent

History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)

Diagnosis of OAB with or without UUI by the treating healthcare provider or previous healthcare provider

Patients at risk of urinary retention (as determined by the investigator)

Symptoms of OAB ≥ 3 months before baseline visit

Neurologic conditions associated with OAB symptoms (eg, multiple sclerosis)

Initiating of new course of vibegron and able to complete electronic PRO questionnaires monthly for a minimum of 1 year

Pregnant or breastfeeding or plans to do so during the study

Previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination

Participation in another clinical trial with investigational product or device

Commercial or government-issued insurance coverage

History of OAB treatment with botulinum toxin A, SNM, PTNS, external beam radiation therapy, or urinary stents ≤ 6 months; pelvic or lower urinary tract surgery ≤ 6 months; and urethral catheterizations ≤ 3 months before baseline visit

 

Use of vibegron before baseline visit either prescribed or in a previous vibegron clinical trial where patient was on vibegron

 

Anyone who, at investigator discretion, is not suitable for treatment with a β3-adrenergic agonist for OAB for any reason

  1. OAB, overactive bladder; PRO, patient-reported outcome; PTNS, percutaneous tibial nerve stimulation; SNM, sacral neuromodulation; UUI, urge urinary incontinence