Phase 4
Completed N=223
A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
Source: ClinicalTrials.gov NCT01745094 ↗Enrolled (actual)
223
Serious AEs
4.9%
Results posted
Feb 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 23; 21; 42; 69 Participants
Summary
The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
23; 21; 42; 69; 22; 20 | — |
| SECONDARY Change From Baseline in OABSS Total Score |
-3.5; -2.1; -3.5; -2.5; -3.5; -3.9 | — |
| SECONDARY Number of Participants Who Achieved Normalization for OABSS Total Score |
19; 8; 28; 26; 18; 16 | — |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score |
-19.46; -12.52; -15.29; -10.39; -21.00; -22.25 | — |
| SECONDARY Change From Baseline in OAB-q SF Total HRQL Score |
15.14; 9.31; 12.43; 6.14; 17.54; 16.72 | — |
| SECONDARY Change From Baseline in the Number of Micturitions Per 24 Hours |
-0.34; -0.98; -1.33; -1.02; -1.69; -1.31 | — |
| SECONDARY Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours |
10; 17; 23; 40 | — |
| SECONDARY Change From Baseline in the Number of Urgency Episodes Per 24 Hours |
-1.15; -1.26; -1.45; -1.43; -1.77; -1.49 | — |
| SECONDARY Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours |
16; 13; 31; 38 | — |
| SECONDARY Change From Baseline in the Number of Incontinence Episodes Per 24 Hours |
-0.85; -0.55; -1.12; -0.64; -1.06; -0.73 | — |
| SECONDARY Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours |
10; 21; 19; 46 | — |
| SECONDARY Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours |
-0.87; -0.50; -0.77; -0.82; -1.17; -0.65 | — |
| SECONDARY Change From Baseline in the Volume Voided Per Micturition |
22.120; 19.380; 33.781; 24.821; 28.532; 33.031 | — |
| SECONDARY Change From Baseline in the Number of Nocturia Episodes Per Night |
0.17; -0.07; -0.45; -0.27; -0.38; -0.21 | — |
| SECONDARY Change From Baseline in Postvoid Residual (PVR) Volume |
-4.95; 5.88; 13.78; 4.36; -2.83; 5.07 | — |
Eligibility Criteria
Inclusion Criteria
- Female: postmenopausal OAB outpatient
- Male: OAB outpatient who did not wish to have children at all
- Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
- Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points
Exclusion Criteria
- Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
- Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
- Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period
Data sourced from ClinicalTrials.gov (NCT01745094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.