Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder
Abstract Background Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of O...
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| Format: | Article |
| Language: | English |
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BMC
2023-04-01
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| Series: | BMC Urology |
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| Online Access: | https://doi.org/10.1186/s12894-023-01240-7 |
| _version_ | 1827956521485467648 |
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| author | Roger R. Dmochowski Eric S. Rovner Michael J. Kennelly Diane K. Newman Laleh Abedinzadeh Daniel Snyder Elizabeth Thomas Cornelia Haag-Molkenteller Matt T. Rosenberg |
| author_facet | Roger R. Dmochowski Eric S. Rovner Michael J. Kennelly Diane K. Newman Laleh Abedinzadeh Daniel Snyder Elizabeth Thomas Cornelia Haag-Molkenteller Matt T. Rosenberg |
| author_sort | Roger R. Dmochowski |
| collection | DOAJ |
| description | Abstract Background Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. Methods This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. Discussion OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021. |
| first_indexed | 2024-04-09T15:06:22Z |
| format | Article |
| id | doaj.art-711a67b9010f4f20bebd247731097445 |
| institution | Directory Open Access Journal |
| issn | 1471-2490 |
| language | English |
| last_indexed | 2024-04-09T15:06:22Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Urology |
| spelling | doaj.art-711a67b9010f4f20bebd2477310974452023-04-30T11:29:37ZengBMCBMC Urology1471-24902023-04-012311710.1186/s12894-023-01240-7Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladderRoger R. Dmochowski0Eric S. Rovner1Michael J. Kennelly2Diane K. Newman3Laleh Abedinzadeh4Daniel Snyder5Elizabeth Thomas6Cornelia Haag-Molkenteller7Matt T. Rosenberg8Department of Urologic Surgery, Vanderbilt University Medical CenterDepartment of Urology, Medical University of South CarolinaCarolinas Medical CenterPerelman School of Medicine, University of PennsylvaniaUrovant SciencesUrovant SciencesUrovant SciencesUrovant SciencesMid-Michigan Health CentersAbstract Background Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. Methods This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. Discussion OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.https://doi.org/10.1186/s12894-023-01240-7AdherenceAdrenergic beta-3 receptor agonistsAnticholinergicAntimuscarinicMedication persistenceMicturition |
| spellingShingle | Roger R. Dmochowski Eric S. Rovner Michael J. Kennelly Diane K. Newman Laleh Abedinzadeh Daniel Snyder Elizabeth Thomas Cornelia Haag-Molkenteller Matt T. Rosenberg Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder BMC Urology Adherence Adrenergic beta-3 receptor agonists Anticholinergic Antimuscarinic Medication persistence Micturition |
| title | Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder |
| title_full | Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder |
| title_fullStr | Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder |
| title_full_unstemmed | Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder |
| title_short | Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder |
| title_sort | study design of a phase 4 real world study composur to evaluate vibegron in patients with overactive bladder |
| topic | Adherence Adrenergic beta-3 receptor agonists Anticholinergic Antimuscarinic Medication persistence Micturition |
| url | https://doi.org/10.1186/s12894-023-01240-7 |
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