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 .
A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
INTRODUCTION Safety and efficacy of tamsulosin and vardenafil are well established : however , there is no report regarding combined therapy with these drugs for  lower urinary tract symptoms ( LUTSs ) secondary to benign prostatic hyperplasia ( BPH ) . AIM To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a r and omized trial with 12-week follow-up . METHODS We conducted a r and omized , double-blind , placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin .  MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS-bother , International Index of Erectile Function , Version 5 ( IIEF-5 ) and Over Active Bladder question naire ( OAB-q ) scores , uroflowmetry data ( Qmax , Qave ) , and postvoiding residual urine were recorded after run-in ( baseline ) , and 2 and 12 weeks after treatment . Differences between vardenafil and placebo at different times were calculated with unpaired sample s t-test . Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance . RESULTS We found a between-group significant difference from baseline to 12 weeks in the following : ( i ) Qmax ( placebo : + 0.07 , vardenafil : + 2.56 , P = 0.034 ) ; ( ii ) Qave  ( placebo : -0.15 , vardenafil : + 1.02 , P = 0.031 ) ; ( iii ) irritative-IPSS subscores ( placebo : -1.67 , vardenafil : -3.11 , P = 0.039 ) ; and ( iv ) IIEF ( placebo : + 0.06 , vardenafil : + 2.61 , P = 0.030 ) . No patient reported any serious ( grade ≥ 2 ) adverse event ( AE ) . There were no differences in the incidence of common , treatment-related AEs between men undergoing combined therapy or tamsulosin alone . CONCLUSIONS The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function , as compared with tamsulosin alone . Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH
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 .