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

Completed

• Conditions: Urinary Bladder Overactive; Overactive Bladder; Urinary Bladder Diseases; Urologic Diseases
• Interventions: Drug: antimuscarinic medication; Drug: mirabegron

• Registration Number: NCT02386072
• Lead Sponsor: Astellas Scientific & Medical Affairs, Inc.

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-05
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-11
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Status Verified: 2018-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1524

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in OAB-related QoL and symptom bother	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 Outcome Measures

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

Trial Locations

Locations (92)

Site US1051; 🇺🇸 Birmingham, Alabama, United States

Site US1094; 🇺🇸 Birmingham, Alabama, United States

Site US1010; 🇺🇸 Huntsville, Alabama, United States

Site US1020; 🇺🇸 Mobile, Alabama, United States

Site US1006; 🇺🇸 Goodyear, Arizona, United States

Site US1036; 🇺🇸 Mesa, Arizona, United States

Site US1028; 🇺🇸 Phoenix, Arizona, United States

Site US1100; 🇺🇸 Tucson, Arizona, United States

Site US1083; 🇺🇸 Tucson, Arizona, United States

Site US1114; 🇺🇸 Little Rock, Arkansas, United States

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