Factors Associated with Improvements in Patient-Reported Outcomes During Mirabegron or Antimuscarinic Treatment of Overactive Bladder Syndrome: A Registry Study (PERSPECTIVE)

Abstract

Introduction: Patient-reported outcomes (PROs) provide valuable insights about the effectiveness of overactive bladder (OAB) treatments. The aim of PERSPECTIVE (a Prospective, non-intErventional Registry Study of PatiEnts initiating a Course of drug Therapy for overactIVE bladder) was to provide real-world evidence from the USA and Canada on patient-perceived effectiveness and safety of mirabegron and antimuscarinics for treating OAB symptoms.

Methods: This prospective, non-interventional registry followed adult patients with OAB who were starting treatment with mirabegron or antimuscarinics. All treatment decisions were made at the discretion of the treating healthcare provider with no mandatory visits after enrollment. The primary objective was to identify factors associated with improved treatment effectiveness from a patient perspective mainly using the OAB Questionnaire Short-Form (OAB-q SF). The form was sent to patients via email link at baseline and months 1, 3, 6, and 12. Treatment-emergent adverse event (TEAE) data were collated from investigator reports.

Results: Overall, 1514 patients were included (female 73.5%, mean age 62.2 years). Mirabegron was initiated by 613 patients and antimuscarinics by 901 patients. A PRO response rate of approximately 60% was achieved (575 patients did not complete baseline PROs). Similar improvements in OAB-q SF symptom bother score and health-related quality of life (HRQoL) total score were observed for mirabegron and antimuscarinic initiators. Covariate-adjusted models demonstrated that worse baseline PRO score, Hispanic ethnicity, being treatment naïve, and use of complementary/supportive OAB therapies at baseline were significantly associated with greater improvements in both scores. The most frequent TEAEs were gastrointestinal disorders (dry mouth, constipation, and nausea) and nervous system disorders (headache, somnolence, and dizziness).

Conclusion: There are no differences between mirabegron and antimuscarinics in terms of patient-reported OAB symptom bother and HRQoL.

Trial registration: ClinicalTrials.gov identifier, NCT02386072.

Funding: Astellas Pharma Global Development, Inc. Plain language summary available for this article.

Keywords: Antimuscarinic; Mirabegron; Overactive bladder syndrome; Patient-reported outcomes; Registry; Urology.

Figures

Fig. 1

Patient disposition

Fig. 2

Mean (SD) changes in OAB-q SF questionnaire symptom bother score (a), total HRQoL score (b), and coping (c), sleep (d), and emotional/social (e) subscalesa. CI confidence interval, HRQoL health-related quality of life, OAB overactive bladder, OAB-q SF OAB Questionnaire Short-Form, SD standard deviation, SE standard error. aAll scores are transformed scores. If < 50% of the scale items were missing, the scale was retained with the mean scale score of the items present used to impute a score for the missing items. Higher symptom bother scores indicate greater symptom bother. Higher HRQoL subscale and total scores indicate better HRQoL. If ≥ 50% of the items were missing, no scale score was calculated. bBaseline: mirabegron initiators, n = 336; antimuscarinic initiators, n = 602. Last reported score: mirabegron initiators, n = 335; antimuscarinic initiators, n = 603. cGenerated from an analysis of covariance (ANCOVA) model with treatment group, sex, age, and treatment-naïve status as covariates. dChanges in the HRQoL subscales were assessed from baseline to month 12, not last reported score. Baseline: mirabegron initiators, n = 336; antimuscarinic initiators, n = 602. Month 12: mirabegron initiators, n = 310; antimuscarinic initiators, n = 548