Combination therapy studies of third-line treatments were rare and centered on medication with PTNS .
Combination therapy , with certain first , second , and third-line OAB therapies , appears to be efficacious .
AIMS Overactive bladder ( OAB ) affects over 17 % of the population and significantly effect the health-related quality of life .
The treatments for OAB include first line ( lifestyle modification , pelvic floor muscle training ) , second line ( anticholinergic or beta-3 agonist medications ) , and third line therapies ( intradetrusor botulinum toxin injection , sacral neurostimulation [ SNM ] , or percutaneous tibial nerve stimulation [ PTNS ] ) .
For those with urinary incontinence secondary to OAB , complete continence is the goal of therapy , though cure rates are only 5 % to 40 % .
The use of combination therapies can be employed in refractory OAB , however , the efficacy of pooled modalities is relatively unknown .
Our objective was to determine the volume of data supporting combination therapy in treating OAB .
Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II).
BACKGROUND The long-term potential of solifenacin and mirabegron combination treatment for patients with overactive bladder ( OAB ) has not been previously assessed . OBJECTIVES To evaluate the safety and efficacy of solifenacin succinate 5 mg plus mirabegron 50 mg tablets ( combination treatment ) versus solifenacin or mirabegron monotherapy in patients with OAB over 12 mo . DESIGN , SETTING , AND PARTICIPANTS R and omised , double-blind , multicentre , phase 3 trial ( SYNERGY II ) of patients with " wet " OAB symptoms ( urinary frequency and urgency with incontinence ) for ≥3 mo . The study was conducted from March 2014 to September 2016 ; with 1829 patients r and omised . The full analysis set was comprised of 1794 patients . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary objective was safety , measured as treatment-emergent adverse events ( TEAEs ) . Efficacy was measured as the change from baseline to the end of treatment in the mean number of incontinence episodes/24h and micturitions/24h . RESULTS AND LIMITATIONS The median age was 60 yr ( range 19 - 86 yr ) and 1434 patients ( 80 % ) were female . Overall , 856 patients ( 47 % ) experienced ≥1 TEAE . TEAE frequency was slightly higher in the combination group ( 596 patients , 49 % ; mirabegron 126 patients , 41 % ; solifenacin 134 patients , 44 % ) . Serious TEAEs were reported by 67 patients ( 3.7 % ) ; one was considered possibly treatment-related ( mirabegron group , atrial fibrillation ) . Dry mouth was the most common TEAE ( combination 74 patients , 6.1 % ; solifenacin 18 patients , 5.9 % ; mirabegron 12 patients , 3.9 % ) . Combination therapy was statistically superior to mirabegron and solifenacin  for the number of incontinence episodes ( vs mirabegron : adjusted mean difference [ AMD ] -0.5 , 95 % confidence interval [ CI ] -0.7 to -0.2 , p<0.001 ; vs solifenacin : AMD -0.1 , 95 % CI -0.4 to 0.1 , p=0.002 ) and micturitions ( vs mirabegron : AMD -0.5 , 95 % CI -0.8 to -0.2 , p<0.001 ; vs solifenacin : AMD -0.4 , 95 % CI -0.7 to -0.1 , p=0.004 ) . CONCLUSIONS Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 mo and led to efficacy improvements over each monotherapy . This innovative combination is a treatment option that could become widely used in the clinic . PATIENT SUMMARY This study looked at the safety and efficacy of a combination of solifenacin succinate 5 mg plus mirabegron 50 mg tablets over 12 mo in patients with the overactive bladder ( OAB ) symptoms of increased urination frequency , heightened urgency to urinate , and unintentional passing of urine .  We compared this treatment with solifenacin succinate 5 mg or mirabegron 50 mg alone , and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms . This novel combination could be an improved treatment option in the clinical setting for patients with OAB . This study is registered at Clinical Trials.gov as NCT02045862
Combination therapy studies of third-line treatments were rare and centered on medication with PTNS .
Combination therapy , with certain first , second , and third-line OAB therapies , appears to be efficacious .
AIMS Overactive bladder ( OAB ) affects over 17 % of the population and significantly effect the health-related quality of life .
The treatments for OAB include first line ( lifestyle modification , pelvic floor muscle training ) , second line ( anticholinergic or beta-3 agonist medications ) , and third line therapies ( intradetrusor botulinum toxin injection , sacral neurostimulation [ SNM ] , or percutaneous tibial nerve stimulation [ PTNS ] ) .
For those with urinary incontinence secondary to OAB , complete continence is the goal of therapy , though cure rates are only 5 % to 40 % .
The use of combination therapies can be employed in refractory OAB , however , the efficacy of pooled modalities is relatively unknown .
Our objective was to determine the volume of data supporting combination therapy in treating OAB .