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

BMC Urology

Table 2 Schedule of baseline and follow-up assessments

Assessment	Baseline (day 1)	Follow-up (monthly*)
Pregnancy status	X	X
Concomitant medications^†	X	X
Details of new course of vibegron^‡	X	X
Medication compliance question	X	X
OAB-q-SF	X	X
OAB-SAT-q		X
WPAI:US	X	X
Incontinence pad use over last 7 days	X	X
Provider visits for OAB	X	X
UTIs	X	X
Nocturia episodes	X	X
Hours of uninterrupted sleep before waking to use restroom	X	X

OAB, overactive bladder; OAB-q-SF, Overactive Bladder Questionnaire-short form; OAB-SAT-q, Overactive Bladder Satisfaction questionnaire; UTI, urinary tract infection; WPAI:US, Work Productivity and Activity Impairment‒urinary symptoms
^*Visit window, ± 7 days. Visits 1, 3, 4, and 5 are in person or via telehealth; visits 2 and 6 are phone calls
^†Taking any new medication and reason for discontinuing any other medications
^‡Still on vibegron and reason for discontinuation of vibegron if stopped

ISSN: 1471-2490