The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.
The study consisted of two double-blind treatment periods with a wash-out period in between.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
376
Oral
Oral
Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)
The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.
Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug."
Time frame: Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.
Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control
OAB control was scored from 0 to 100, with higher scores indicating better OAB control.
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Site US10002 Urology Centers of Alabama
Homewood, Alabama, United States
Site US10004 Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Site US10001 Urological Associates of Southern Arizona
Tucson, Arizona, United States
Site US10003 Genesis Research
San Diego, California, United States
Site US10010 Skyline Urology
Sherman Oaks, California, United States
Site US10028 Clinical Research Consulting
Milford, Connecticut, United States
Site US10024 Coastal Connecticut Research, LLC
New London, Connecticut, United States
Site US10033 Eastern Research
Hialeah, Florida, United States
Site US10023 Advanced Clinical Research of Miami
Miami, Florida, United States
Site US10007 Pinellas Urology, Inc
St. Petersburg, Florida, United States
...and 20 more locations
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control
Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations
The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB
Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication
Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication
Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication
Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.
Time frame: Week 8 (End of Period 1) and Week 18 (End of Period 2)
Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)
Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours
Time frame: Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)
Number of Participants With Adverse Events
Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests \[LFTs\]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.
Time frame: Baseline to EOT (Week 18) and follow up (Week 20)