A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

Overview

A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)

Full Title of Study: “A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 4, 2017

Interventions

  • Drug: mirabegron
    • oral
  • Drug: antimuscarinic medication
    • oral

Arms, Groups and Cohorts

  • 1. patients diagnosed with OAB taking mirabegron
    • patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice
  • 2. patients diagnosed with OAB taking an antimuscarinic
    • patients diagnosed with OAB whose physician has decided to prescribe an antimuscarinic as part of routine clinical practice

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in OAB-related QoL and symptom bother
    • Time Frame: Baseline, Month 1, 3, 6 and 12
    • Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores

Secondary Measures

  • Effectiveness as measured by impression of severity of OAB
    • Time Frame: Baseline, Month 1, 3, 6 and 12
    • Via the Patient Perception of Bladder Condition [PPBC]
  • Effectiveness as measured by general health related QoL
    • Time Frame: Baseline, Month 1, 3, 6 and 12
    • via the EuroQol 5D [EQ-5D]
  • Persistence with OAB drug treatment
    • Time Frame: Baseline till End of Study (ESV) (up to month 12)
    • The duration of time a patient continues to take the prescribed medication
  • Use of additional (add-on) medications
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP
  • Switching of medication
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP
  • OAB drug treatment satisfaction
    • Time Frame: Baseline, month 1, 3, 6 and 12
    • Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)
  • Reasons for switching of medication
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP for each specific medication, number and percent
  • Reasons for discontinuation of medication
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP for each specific medication, number and percent
  • Reasons for add-on medication
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP for each specific medication, number and percent
  • Reasons for dose titration
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP for each specific medication
  • Frequency of dose titration
    • Time Frame: Baseline till ESV (up to month 12)
    • As reported by patients and HCP for each specific medication
  • Safety profile as assessed by recording AEs and SAEs
    • Time Frame: Baseline till ESV (up to month 12)
    • Adverse Events (AEs), Serious Adverse Events (SAEs)

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with OAB (with or without urgency incontinence) by the treating HCP, with symptoms for at least three months prior to study enrollment – Initiating a new course of treatment with mirabegron or antimuscarinic medication (including patch formulation) for OAB, which may be first course of any treatment for OAB, restart or switch from one drug to another – Willing and able to complete PRO questionnaires with minimal assistance Exclusion Criteria:

  • Current participation in clinical trials of OAB – Use of more than one OAB medication at time of enrollment – Patients whose OAB has been treated with onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment – Neurologic conditions associated with OAB symptoms – Patients residing in a nursing home

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Scientific & Medical Affairs, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director Urology, Study Director, Astellas Scientific & Medical Affairs, Inc.

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