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 therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial.
BACKGROUND Storage symptoms are particularly bothersome in men with lower urinary tract symptoms ( LUTS ) but may not be adequately treated by α-blocker monotherapy . OBJECTIVE To assess the efficacy and safety of a fixed-dose combination ( FDC ) of solifenacin and an oral controlled absorption system ( OCAS ) formulation of tamsulosin compared with placebo and compared with tamsulosin OCAS ( TOCAS ) monotherapy in men with moderate to severe storage symptoms and voiding symptoms . DESIGN , SETTING , AND PARTICIPANTS A double-blind 12-wk phase 3 study in 1334 men with storage and voiding LUTS : total International Prostate Symptom Score ( IPSS ) ≥ 13 , maximum urinary flow rate ( Qmax ) 4.0 - 12.0 ml/s , two or more urgency episodes per 24 h of Patient Perception of Intensity of Urgency Scale grade 3 or 4 , and eight or more micturitions per 24h . INTERVENTION Patients were r and omised to placebo , TOCAS 0.4 mg , FDC solifenacin 6 mg plus TOCAS 0.4 mg , or FDC solifenacin 9 mg plus TOCAS 0.4 mg . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary efficacy end points were ( 1 ) total IPSS and ( 2 ) Total Urgency and Frequency Score ( TUFS ) . An FDC met the success criteria if it demonstrated superiority compared with placebo and noninferiority compared with TOCAS for total IPSS , as well as superiority compared with TOCAS for TUFS . RESULTS AND LIMITATIONS Reductions in total IPSS and TUFS were observed with both solifenacin 6 mg plus TOCAS ( -7.0 and -8.1 , respectively ) and solifenacin 9 mg plus TOCAS ( -6.5 and -7.6 , respectively ) compared with TOCAS ( -6.2 and -6.7 , respectively ) and placebo ( -5.4 and -4.4 , respectively ) . Solifenacin 6 mg plus TOCAS met all prespecified success criteria for both primary end points , while solifenacin 9 mg plus TOCAS met success criteria compared with placebo but not compared with TOCAS . Both FDCs improved quality of life ( QoL ) measures and were well tolerated , with low incidences of acute urinary retention . CONCLUSIONS The FDC of solifenacin 6 mg plus TOCAS significantly improved storage and voiding symptoms , as well as QoL parameters , compared with placebo . This FDC also improved storage symptoms and QoL compared with TOCAS alone in men with moderate to severe storage symptoms and voiding symptoms  , and it was well tolerated
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 .