An observational study in Urinary Bladder Overactive, Overactive Bladder and Urinary Bladder Diseases, sponsored by Astellas Scientific & Medical Affairs, Inc.. Completed at 92 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Astellas Scientific & Medical Affairs, Inc. (part of Astellas Pharma Inc) · Observational
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)
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 1,524 is above the median of 120 across 169 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →This is the only study on the registry with Astellas Scientific & Medical Affairs, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Sites that include medical specialties involved in the treatment of OAB, such as general practice/internal medicine, nurse practitioners, obstetricians/ gynecologists, urologists, and uro-gynecologists
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice
Drug: mirabegron
patients diagnosed with OAB whose physician has decided to prescribe an antimuscarinic as part of routine clinical practice
Drug: antimuscarinic medication
oral
Also known as: YM178, Betanis, Myrbetriq, Betmiga
oral
Also known as: Ditropan XL, Gelnique, Enablex, Trosec, Sanctura, Oxybutynin IR, Vesicare, Oxytrol, Toviaz, Detrol
Change from baseline in OAB-related QoL and symptom bother
Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores
Time frame: Baseline, Month 1, 3, 6 and 12
Effectiveness as measured by impression of severity of OAB
Via the Patient Perception of Bladder Condition \[PPBC\]
Time frame: Baseline, Month 1, 3, 6 and 12
Effectiveness as measured by general health related QoL
via the EuroQol 5D \[EQ-5D\]
Time frame: Baseline, Month 1, 3, 6 and 12
Persistence with OAB drug treatment
The duration of time a patient continues to take the prescribed medication
Time frame: Baseline till End of Study (ESV) (up to month 12)
Use of additional (add-on) medications
As reported by patients and HCP
Time frame: Baseline till ESV (up to month 12)
Switching of medication
As reported by patients and HCP
Time frame: Baseline till ESV (up to month 12)
OAB drug treatment satisfaction
Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)
Time frame: Baseline, month 1, 3, 6 and 12
Reasons for switching of medication
As reported by patients and HCP for each specific medication, number and percent
Time frame: Baseline till ESV (up to month 12)
Reasons for discontinuation of medication
As reported by patients and HCP for each specific medication, number and percent
Time frame: Baseline till ESV (up to month 12)
Reasons for add-on medication
As reported by patients and HCP for each specific medication, number and percent
Time frame: Baseline till ESV (up to month 12)
Reasons for dose titration
As reported by patients and HCP for each specific medication
Time frame: Baseline till ESV (up to month 12)
Frequency of dose titration
As reported by patients and HCP for each specific medication
Time frame: Baseline till ESV (up to month 12)
Safety profile as assessed by recording AEs and SAEs
Adverse Events (AEs), Serious Adverse Events (SAEs)
Time frame: Baseline till ESV (up to month 12)
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Ran from Jan 2015 to primary completion in Aug 2017, 30 months.
Of 59 observational studies under Urinary Bladder, Overactive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 30 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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