EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination .
This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression .
Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy .
The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron .
This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events .
The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful .
For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy .
This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient .
PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women
CONTEXT Several drugs are approved and available for the treatment of lower urinary tract symptoms ( LUTS ) in men and women .
However , the vast majority of available data , upon which the approval and recommendation in guidelines are based , considered only the role of the monotherapies and did not evaluate possible combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS .
Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY)
Purpose This large dose-ranging study explored the benefits of different combinations of mirabegron and solifenacin on health-related quality of life ( HRQoL ) , based on patient-reported outcomes ( PROs ) , and patients ( ‘ responders ’ ) achieving clinical ly meaningful improvements in efficacy and HRQoL. Methods SYMPHONY ( NCT01340027 ) was a Phase II , placebo- and monotherapy-controlled , dose-ranging , 12-week trial . Adult patients with overactive bladder ( OAB ) for ≥3 months were r and omized to 1 of 12 groups : 6  combination ( solifenacin 2.5/5/10 mg + mirabegron 25/50 mg ) , 5 monotherapy ( solifenacin 2.5/5/10 mg , or mirabegron 25/50 mg ) , or placebo . Change from baseline to end of treatment was assessed , versus placebo and solifenacin 5 mg in : PROs ( OAB-q [ Symptom Bother/total HRQoL ] and Patient Perception of Bladder Condition score ) , and responders achieving minimally important differences ( MIDs ) in PROs and predetermined clinical ly meaningful improvements in efficacy ( e.g. < 8 micturitions/24 h ) . Changes in PROs and responders were analysed using an ANCOVA model and logistic regression , respectively . Results The Full Analysis Set included 1278 patients . Combination therapy of solifenacin 5/10 mg + mirabegron 25/50 mg significantly improved PROs  versus solifenacin 5 mg and placebo , and significantly more responders achieved MIDs in PROs and efficacy . Micturition frequency normalization was approximately twofold greater with 10 + 25 mg ( OR 2.06 [ 95 % CI 1.11 , 3.84 ; p = 0.023 ] ) and 5 + 50 mg ( OR 1.91 [ 95 % CI 1.14 , 3.21 ; p = 0.015 ] ) versus solifenacin 5 mg . Conclusion Combining mirabegron 25/50 mg and solifenacin 5/10 mg improves objective and subjective efficacy outcomes compared with placebo or solifenacin 5 mg
EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination .
This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression .
Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy .
The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron .
This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events .
The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful .
For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy .
This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient .
PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women
CONTEXT Several drugs are approved and available for the treatment of lower urinary tract symptoms ( LUTS ) in men and women .
However , the vast majority of available data , upon which the approval and recommendation in guidelines are based , considered only the role of the monotherapies and did not evaluate possible combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS .