3-Month Interim Results of a Phase 4, Real-World Study (COMPOSUR) to Evaluate Vibegron in Patients With Overactive Bladder

MacDiarmid S1, Dmochowski R2, Rovner E3, Kennelly M4, Newman D5, Abedinzadeh L6, Snyder D6, Thomas E6

Research Type


Abstract Category

Overactive Bladder

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Abstract 32
Overactive Bladder and Neuromodulation
Scientific Podium Short Oral Session 6
Wednesday 27th September 2023
14:52 - 15:00
Theatre 102
Clinical Trial Overactive Bladder Urgency Urinary Incontinence Urgency/Frequency
1. Alliance Urology Specialists, 2. Vanderbilt University Medical Center, 3. Medical University of South Carolina, 4. Carolinas Medical Center, 5. Perelman School of Medicine, University of Pennsylvania, 6. Urovant Sciences

Scott A MacDiarmid



Hypothesis / aims of study
Vibegron (GEMTESA®), a β3-adrenergic receptor agonist approved in the US for the treatment of overactive bladder syndrome (OAB), was efficacious, safe, and well tolerated in the 12-week EMPOWUR trial [1] and its 40-week double-blind extension [2]. Currently, there are no real-world data on vibegron. To assess vibegron in a real-world setting, the COMPOSUR study evaluated patient treatment satisfaction, tolerability, and safety (NCT05067478). Here we present the results of a planned 3 month interim analysis of selected endpoints.
Study design, materials and methods
This ongoing, 12-month, prospective, observational, real-world study of vibegron is enrolling patients ≥18 years old with OAB with or without urgency urinary incontinence (UUI) who were starting a new course of vibegron and who had previous exposure to anticholinergics (Cohort A) or mirabegron with or without anticholinergics (Cohort B). Enrollment inclusion and exclusion criteria follow the vibegron US product label to more closely reflect a real-world setting. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly; the primary endpoint is patient satisfaction assessed as a composite of OAB-SAT-q questions 1‒3, which are scored on a 6-point Likert scale (normalized score range: 0 [extremely dissatisfied] to 100 [extremely satisfied]). Safety is assessed by adverse events (AEs) and reasons for study discontinuation.
As of the 3-month interim analysis, 183 patients have been enrolled (Cohort A, n=50; Cohort B, n=133), and 35 patients have discontinued (Cohort A, n=12; Cohort B, n=23) The most common reasons for discontinuation were AEs (n=4 and 7, respectively) and lack of efficacy (n=3 and 10, respectively). Across both cohorts, mean (SD) age was 54.9 (11.2) years, and 69% were female. As of month 3, a total of 106 patients have completed the OAB-SAT-q. Mean (SD) OAB-SAT-q satisfaction scale score was 62.5 (22.0), and 66% of patients were consistently satisfied with treatment (ie, selected satisfied or better on OAB-SAT-q questions 1, 2, and 3). Of the 98 patients who expressed a preference for treatment, 81 (83%) responded that they preferred vibegron compared with the treatment they received before entering the study (ie, selected slightly preferred or better on OAB-SAT-q question 8). Overall, 23% of patients experienced a treatment-emergent AE; no patient experienced a serious AE. The most commonly reported AEs (occurring in ≥2% of patients in the combined cohorts) were urinary tract infection (2.7%), dizziness (2.2%), and hot flush (2.2%).
Interpretation of results
As of the 3-month interim analysis of the phase 4 COMPOSUR trial, most patients receiving vibegron were satisfied with treatment. Treatment with vibegron was generally safe and well tolerated.
Concluding message
Treatment with vibegron was associated with patient satisfaction with treatment and showed a safety profile consistent with previous randomized controlled trials. Patient satisfaction has the potential to lead to improved outcomes for patients who remain on treatment longer.
  1. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN, Jr. J Urol. 2020;204(2):316-324.
  2. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN, Jr. J Urol. 2021;205(5):1421-1429.
Funding Urovant Sciences Clinical Trial Yes Registration Number ClinicalTrials.gov, NCT05067478 RCT Yes Subjects Human Ethics Committee Central IRBs: WIRB, WCG IRB, Advarra IRB; and additional local IRBs at various study cites Helsinki Yes Informed Consent Yes

Continence 7S1 (2023) 100750
DOI: 10.1016/j.cont.2023.100750

05/05/2024 06:11:23