human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men . PATIENTS AND METHODS In this multicenter , double-blind trial performed between March 29 , 2004 , and June 22 , 2005 , 420 men aged 45 years or older with a total International Prostate Symptom Score ( IPSS ) of 13 or more and IPSS for storage of 8 or more were r and omized to receive tamsulosin ( 0.4 mg/d ) with either extended-release oxybutynin ( 10 mg/d ) or placebo for 12 weeks . Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions . Postvoid residual volume and peak flow rates at weeks 4 , 8 , and 12 were measured . The primary end point was change from baseline in total IPSS after 12 weeks of treatment . Secondary outcomes included change in IPSSs for storage and quality of life . RESULTS Tamsulosin combined with extended-release oxybutynin result ed in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 ( P=.03 ) and 12 ( P=.006 ) weeks of treatment , and improved IPSS for storage and quality of life at all assessment points ( P<.01 ) . The incidence of postvoid residual volume higher than 300 mL was 2.9 % ( 6/209 ) in patients receiving combination therapy compared with 0.5 % ( 1/209 ) in patients receiving tamsulosin alone ( P=.12 ) . Occurrence of peak flow rates below 5 mL/s was 3.8 % ( 8/209 ) for combination therapy and 5.7 % ( 12/209 ) for tamsulosin alone ( P=.49 ) . CONCLUSION In men with substantial storage symptoms , combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction ( ED ) and lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH/LUTS ) . The trial was conducted in hospitals in Beijing , Shanghai , Changsha , Wuhan and Guangzhou , five major cities in China . A total of 250 patients diagnosed with ED and BPH/LUTS aged 50 - 75 years , and who had International Index of Erection Function-5 ( IIEF-5 ) scores ≤21 and International Prostate Symptom Score ( IPSS ) ≥10 points , were enrolled and r and omly divided into Group A ( 168 cases ; doxazosin GITS 4 mg once daily plus sildenafil 25 - 100 mg on dem and ) and Group B ( 82 cases ; sildenafil 25 - 100 mg on dem and ) . Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life ( QoL ) question naire , and adverse effects were evaluated during the treatment period . There were no statistically significant differences in mean age , and IIEF-5 , IPSS and QoL scores pre-treatment between the two groups . After treatment , IIEF-5 , IPSS and QoL scores were significantly improved in Group A , while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment . There were no significant differences in side effects between the two groups . The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy OBJECTIVES To assess the pharmacodynamic effects of coadministered vardenafil and tamsulosin in patients with benign prostatic hyperplasia ( BPH ) undergoing stable tamsulosin therapy . METHODS In this Phase 1 , placebo-controlled , two-stage , two-way , crossover study , 22 patients undergoing stable ( longer than 4 weeks ) tamsulosin therapy for BPH ( 18 using 0.4 mg and 4 using 0.8 mg tamsulosin daily ) received vardenafil 10 mg ( or placebo ) , followed by vardenafil 20 mg ( or placebo ) , simultaneously with tamsulosin . The mean maximal change from baseline with vardenafil use versus placebo was evaluated for supine and st and ing blood pressure and heart rate for up to 6 hours after dosing . RESULTS In patients receiving vardenafil 10 mg , the mean maximal change from baseline versus placebo in supine systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and heart rate was -4.5 mm Hg ( 95 % confidence interval [ CI ] -8.2 to -0.8 ) , -2.3 mm Hg ( 95 % CI -4.9 to 0.4 ) , and 3.7 beats per minute ( 95 % CI 1.1 to 6.3 ) , respectively . In patients receiving vardenafil 20 mg , the mean maximal change from baseline versus placebo in supine SBP , DBP , and heart rate was -4.0 mm Hg ( 95 % CI -6.3 to -1.8 ) , -2.9 mm Hg ( 95 % CI -5.6 to -0.2 ) , and 0.8 beats per minute ( 95 % CI -1.2 to 2.9 ) , respectively . These hemodynamic changes were similar to those obtained in the st and ing position . Two placebo patients and 1 vardenafil 10-mg patient had a drop of 20 mm Hg or more in st and ing DBP ; 1 vardenafil 10-mg patient had a st and ing SBP drop of 30 mm Hg or more . No patient exhibited symptomatic hypotension ( SBP less than 85 mm Hg with dizziness ) . Three patients receiving vardenafil 20 mg/tamsulosin 0.4 mg reported dizziness , but never had an SBP of less than 95 mm Hg . No serious adverse events were reported . CONCLUSIONS In this study , no evidence was found that coadministered vardenafil and tamsulosin induced clinical ly significant hypotension in patients with BPH INTRODUCTION The high incidence of erectile dysfunction ( ED ) and lower urinary tract symptoms ( LUTS ) in aging men and the same pathophysiology make probable to treat both disorders with the same treatment . Numerous authors evaluated the actions of PDE5i in improving the LUTS/(benign prostate hyperplasia ) BPH . AIM To assess the efficacy and safety of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day in patients with LUTS in a crossover design study . MAIN OUTCOMES MEASURES International Prostate Symptoms Score ( IPSS ) , IPSS Quality of Life ( IPSS-QOL ) , maximum flow rate ( Qmax ) , post-void residual volume ( PVR ) , International Index of Erectile Function-Erectile Function Domain ( IIEF-EF ) , Global Assessment Quality ( GAQ ) . For the statistical analysis , a Tukey-Kramer multicomparison test was used . METHODS A r and omized , double-blind , crossover study was conducted from September 2007 to February 2008 in one center . Thirty men , older than 50 years old , with a history of LUTS/BPH of at least 6 months , were r and omized into two groups to receive tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day for 45 days , and then switched to the other treatment mode for other 45 days . RESULTS Twenty-seven patients completed the study . Improvements of IPSS score and IPSS-QOL were significant with both treatments but greater with the drug combination . Both regimens similarly improved the Qmax and decreased the PVR volume from baseline ( P < 0.001 ) with no significant differences between tamsulosin alone vs. tamsulosin and tadalafil ( P > 0.05 ) . The IIEF improved with tamsulosin plus tadalafil ( P < 0.001 ) but not with tamsulosin alone ( P > 0.05 ) . The GAQ showed that all patients preferred the combination scheme . Both treatments were well tolerated . CONCLUSION ; Tamsulosin 0.4 mg/day plus tadalafil 20 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS and erectile dysfunction and was also well tolerated . Large-scale , r and omized , placebo-controlled studies are needed to further assess the long-term safety and effectiveness of these agents in treating LUTS/BPH with or without ED BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo .  Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . D 
    Output:
    
agent
This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for > 1 yr ; when given for < 1 yr , α1-blockers alone are just as effective .
The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events .
It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after > 6 yr .
The α1-blocker/muscarinic receptor antagonist ( antimuscarinic ) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy .
Inconsistent data derive from heterogeneous study population s and different study design s. Currently , the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy .
The combination seems to be safe in men with postvoid residual < 200 ml .
The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports .
CONCLUSIONS An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for > 1 yr .
Based on short-term follow-up studies , add-on of antimuscarinics to α1-blockers is an option when postvoid residual is < 200 ml
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men . PATIENTS AND METHODS In this multicenter , double-blind trial performed between March 29 , 2004 , and June 22 , 2005 , 420 men aged 45 years or older with a total International Prostate Symptom Score ( IPSS ) of 13 or more and IPSS for storage of 8 or more were r and omized to receive tamsulosin ( 0.4 mg/d ) with either extended-release oxybutynin ( 10 mg/d ) or placebo for 12 weeks . Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions . Postvoid residual volume and peak flow rates at weeks 4 , 8 , and 12 were measured . The primary end point was change from baseline in total IPSS after 12 weeks of treatment . Secondary outcomes included change in IPSSs for storage and quality of life . RESULTS Tamsulosin combined with extended-release oxybutynin result ed in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 ( P=.03 ) and 12 ( P=.006 ) weeks of treatment , and improved IPSS for storage and quality of life at all assessment points ( P<.01 ) . The incidence of postvoid residual volume higher than 300 mL was 2.9 % ( 6/209 ) in patients receiving combination therapy compared with 0.5 % ( 1/209 ) in patients receiving tamsulosin alone ( P=.12 ) . Occurrence of peak flow rates below 5 mL/s was 3.8 % ( 8/209 ) for combination therapy and 5.7 % ( 12/209 ) for tamsulosin alone ( P=.49 ) . CONCLUSION In men with substantial storage symptoms , combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction ( ED ) and lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH/LUTS ) . The trial was conducted in hospitals in Beijing , Shanghai , Changsha , Wuhan and Guangzhou , five major cities in China . A total of 250 patients diagnosed with ED and BPH/LUTS aged 50 - 75 years , and who had International Index of Erection Function-5 ( IIEF-5 ) scores ≤21 and International Prostate Symptom Score ( IPSS ) ≥10 points , were enrolled and r and omly divided into Group A ( 168 cases ; doxazosin GITS 4 mg once daily plus sildenafil 25 - 100 mg on dem and ) and Group B ( 82 cases ; sildenafil 25 - 100 mg on dem and ) . Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life ( QoL ) question naire , and adverse effects were evaluated during the treatment period . There were no statistically significant differences in mean age , and IIEF-5 , IPSS and QoL scores pre-treatment between the two groups . After treatment , IIEF-5 , IPSS and QoL scores were significantly improved in Group A , while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment . There were no significant differences in side effects between the two groups . The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy OBJECTIVES To assess the pharmacodynamic effects of coadministered vardenafil and tamsulosin in patients with benign prostatic hyperplasia ( BPH ) undergoing stable tamsulosin therapy . METHODS In this Phase 1 , placebo-controlled , two-stage , two-way , crossover study , 22 patients undergoing stable ( longer than 4 weeks ) tamsulosin therapy for BPH ( 18 using 0.4 mg and 4 using 0.8 mg tamsulosin daily ) received vardenafil 10 mg ( or placebo ) , followed by vardenafil 20 mg ( or placebo ) , simultaneously with tamsulosin . The mean maximal change from baseline with vardenafil use versus placebo was evaluated for supine and st and ing blood pressure and heart rate for up to 6 hours after dosing . RESULTS In patients receiving vardenafil 10 mg , the mean maximal change from baseline versus placebo in supine systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and heart rate was -4.5 mm Hg ( 95 % confidence interval [ CI ] -8.2 to -0.8 ) , -2.3 mm Hg ( 95 % CI -4.9 to 0.4 ) , and 3.7 beats per minute ( 95 % CI 1.1 to 6.3 ) , respectively . In patients receiving vardenafil 20 mg , the mean maximal change from baseline versus placebo in supine SBP , DBP , and heart rate was -4.0 mm Hg ( 95 % CI -6.3 to -1.8 ) , -2.9 mm Hg ( 95 % CI -5.6 to -0.2 ) , and 0.8 beats per minute ( 95 % CI -1.2 to 2.9 ) , respectively . These hemodynamic changes were similar to those obtained in the st and ing position . Two placebo patients and 1 vardenafil 10-mg patient had a drop of 20 mm Hg or more in st and ing DBP ; 1 vardenafil 10-mg patient had a st and ing SBP drop of 30 mm Hg or more . No patient exhibited symptomatic hypotension ( SBP less than 85 mm Hg with dizziness ) . Three patients receiving vardenafil 20 mg/tamsulosin 0.4 mg reported dizziness , but never had an SBP of less than 95 mm Hg . No serious adverse events were reported . CONCLUSIONS In this study , no evidence was found that coadministered vardenafil and tamsulosin induced clinical ly significant hypotension in patients with BPH INTRODUCTION The high incidence of erectile dysfunction ( ED ) and lower urinary tract symptoms ( LUTS ) in aging men and the same pathophysiology make probable to treat both disorders with the same treatment . Numerous authors evaluated the actions of PDE5i in improving the LUTS/(benign prostate hyperplasia ) BPH . AIM To assess the efficacy and safety of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day in patients with LUTS in a crossover design study . MAIN OUTCOMES MEASURES International Prostate Symptoms Score ( IPSS ) , IPSS Quality of Life ( IPSS-QOL ) , maximum flow rate ( Qmax ) , post-void residual volume ( PVR ) , International Index of Erectile Function-Erectile Function Domain ( IIEF-EF ) , Global Assessment Quality ( GAQ ) . For the statistical analysis , a Tukey-Kramer multicomparison test was used . METHODS A r and omized , double-blind , crossover study was conducted from September 2007 to February 2008 in one center . Thirty men , older than 50 years old , with a history of LUTS/BPH of at least 6 months , were r and omized into two groups to receive tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day for 45 days , and then switched to the other treatment mode for other 45 days . RESULTS Twenty-seven patients completed the study . Improvements of IPSS score and IPSS-QOL were significant with both treatments but greater with the drug combination . Both regimens similarly improved the Qmax and decreased the PVR volume from baseline ( P < 0.001 ) with no significant differences between tamsulosin alone vs. tamsulosin and tadalafil ( P > 0.05 ) . The IIEF improved with tamsulosin plus tadalafil ( P < 0.001 ) but not with tamsulosin alone ( P > 0.05 ) . The GAQ showed that all patients preferred the combination scheme . Both treatments were well tolerated . CONCLUSION ; Tamsulosin 0.4 mg/day plus tadalafil 20 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS and erectile dysfunction and was also well tolerated . Large-scale , r and omized , placebo-controlled studies are needed to further assess the long-term safety and effectiveness of these agents in treating LUTS/BPH with or without ED BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo .  Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . D 
    Output:
    