Finasteride in the treatment of benign prostatic hyperplasia. Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. The effect of finasteride in men with benign prostatic hyperplasia. The Finasteride Study Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. Therapeutic effects of finasteride in benign prostatic hyperplasia: a randomized double-blind controlled trial. Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia. Endocrine therapy for benign prostatic hyperplasia in the 90's. Combined analysis of two multicenter studies of finasteride 5 mg in the treatment of symptomatic benign prostatic hyperplasia Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. Finasteride (MK-906) in the treatment of benign prostatic hyperplasia. The Finasteride Study Group. Finasteride in the treatment of benign prostatic hyperplasia. A urodynamic evaluation. Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia. Proscar: five-year experience. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. Effect of discontinuation of 5alpha-reductase inhibitors on prostate volume and symptoms in men with BPH: a prospective study. Pharmacotherapy of benign prostatic hyperplasia: Inhibitor of 5 alpha-reductase The effect of finasteride on prostate volume, urinary flow rate and symptom score in men with benign prostatic hyperplasia. Urodynamic effects of finasteride in the treatment of bladder outlet obstruction due to benign prostatic hyperplasia. Prostate tissue composition and response to finasteride in men with symptomatic benign prostatic hyperplasia. Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. Effects of finasteride on health-related quality of life in men with symptomatic benign prostatic hyperplasia. Finasteride Study Group. Finasteride for the treatment and control of benign prostatic hyperplasia: summary of phase III controlled studies. The Finasteride Study Group. Storage (irritative) and voiding (obstructive) symptoms as predictors of benign prostatic hyperplasia progression and related outcomes. [Can finasteride reverse the progress of benign prostatic hyperplasia? A two-year placebo-controlled study.]. Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study Crossover comparison study on the therapeutic effects of tamsulosin hydrochloride and naftopidil in lower urinary tract symptoms associated with benign prostatic hyperplasia. Eliciting preferences for drug treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. Sustained decrease in incidence of acute urinary retention and surgery with finasteride for 6 years in men with benign prostatic hyperplasia. Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Comparison of Tamsulosin and Finasteride for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia in Korean Patients Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride pl Impact of baseline symptom severity on future risk of benign prostatic hyperplasia-related outcomes and long-term response to finasteride. The Pless Study Group. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. Efficacy, tolerability, and effect on health-related quality of life of finasteride versus placebo in men with symptomatic benign prostatic hyperplasia: a community based study. CUSP Investigators. Community based study of Proscar. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Celecoxib for treatment of nocturia caused by benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled study. Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China. A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia Discontinuation of alpha-blockade after initial treatment with finasteride and doxazosin in men with lower urinary tract symptoms and clinical evidence of benign prostatic hyperplasia. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. Scandinavian clinical study of finasteride in the treatment of benign prostatic hyperplasia. Long-term treatment with finasteride results in a clinically significant reduction in total prostate volume compared to placebo over the full range of baseline prostate sizes in men enrolled in the MTOPS trial. Urinary Retention in Patients with BPH Treated with Finasteride or Placebo over 4 Years [Comparison of different drugs on the treatment of benign prostate hyperplasia]. Long-term treatment with finasteride in men with symptomatic benign prostatic hyperplasia: 10-year follow-up. Effects of hexanic extract of serenoa repens (permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia Ejaculatory Disorders Caused by Alpha-1 Blockers for Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Comparison of Naftopidil and Tamsulosin in a Randomized Multicenter Study Scoring the short form ICSmaleSF questionnaire. International Continence Society. Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective, randomized controlled study. Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. The influence of finasteride on the volume of the peripheral and periurethral zones of the prostate in men with benign prostatic hyperplasia.
Finasteride is an enzyme inhibitor which blocks the conversion of testosterone by 5 alpha-reductase to dihydrotestosterone , the active and rogenic metabolite in the prostate . In a double-blind , placebo-controlled study , 707 patients with moderately symptomatic BPH were treated for 2 years . The study confirmed that treatment significantly improved symptoms , reduced prostate size and increased urine flow rate . Side effects were usually mild . The authors find that finasteride can reverse the natural progression of BPH Benign prostatic hyperplasia ( BPH ) is a highly prevalent condition in aging men , which can be progressive and lead to acute urinary retention ( AUR ) and the need for surgery . It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors ( 5ARIs ) , both of which improve the symptoms of BPH . Long-term treatment with 5ARIs can also reduce the risk of developing AUR and the need for surgery . The l and mark Medical Therapy of Prostatic Symptoms ( MTOPS ) trial demonstrated that over 4 years the combination of the type 2-specific 5ARI , finasteride and the alpha-blocker doxazosin was more effective than either agent alone in reducing overall clinical progression . Since the initiation of MTOPS , it has been shown that patients with larger prostates and higher prostate-specific antigen ( PSA ) levels are at greater risk of BPH progression , and are therefore arguably more likely to benefit from combination therapy . The Combination of Avodart and Tamsulosin ( CombAT ) trial is a 4-year , global , multicenter , r and omized , double-blind , parallel-group study design ed to investigate the benefits of combination therapy with the dual 5ARI dutasteride and the alpha-blocker tamsulosin compared with each monotherapy in improving symptoms and long-term outcomes in men with moderate-to-severe symptoms of BPH and prostate enlargement .  Symptoms and long-term outcomes ( AUR and surgery ) will be assessed as separate primary endpoints at 2 and 4 years , respectively . Eligible patients were at least 50 years old with prostate volume > or = 30 cm(3 ) and PSA level > or = 1.5 ng/mL. A total of 4838 subjects have been enrolled . This paper describes the rationale , design and baseline data of the CombAT study BACKGROUND Benign prostatic hyperplasia is a progressive , and rogen-dependent disease result ing in enlargement of the prostate gl and and urinary obstruction . Preventing the conversion of testosterone to its tissue-active form , dihydrotestosterone , by inhibiting the enzyme 5 alpha-reductase could decrease the action of and rogens in their target tissues ; in the prostate the result might be a decrease in prostatic hyperplasia and therefore in symptoms of urinary obstruction . METHODS In a double-blind study , we evaluated the effect of two doses of finasteride ( 1 mg and 5 mg ) and placebo , each given once daily for 12 months , in 895 men with prostatic hyperplasia .  Urinary symptoms , urinary flow , prostatic volume , and serum concentrations of dihydrotestosterone and prostate-specific antigen were determined periodically during the treatment period . RESULTS As compared with the men in the placebo group , the men treated with 5 mg of finasteride per day had a significant decrease in total urinary-symptom scores ( P less than 0.001 ) , an increase of 1.6 ml per second ( 22 percent , P less than 0.001 ) in the maximal urinary-flow rate , and a 19 percent decrease in prostatic volume ( P less than 0.001 ) . The men treated with 1 mg of finasteride per day did not have a significant decrease in total urinary-symptom scores , but had an increase of 1.4 ml per second ( 23 percent ) in the maximal urinary-flow rate , and an 18 percent decrease in prostatic volume . The men given placebo had no changes in total urinary-symptom scores , an increase of 0.2 ml per second ( 8 percent ) in the maximal urinary-flow rate , and a 3 percent decrease in prostatic volume . The frequency of adverse effects in the three groups was similar , except for a higher incidence of decreased libido , impotence , and ejaculatory disorders in the finasteride-treated groups . CONCLUSIONS The treatment of benign prostatic hyperplasia with 5 mg of finasteride per day results in a significant decrease in symptoms of obstruction , an increase in urinary flow , and a decrease in prostatic volume , but at a slightly increased risk of sexual dysfunction PURPOSE We examined data from the Medical Therapy of Prostatic Symptoms trial to determine the relationship between baseline TPV and the effect of medical therapy in men with LUTS secondary to BPH . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to placebo , 4 to 8 mg doxazosin , 5 mg finasteride or the combination of doxazosin and finasteride . Average treatment duration was 4.5 years The primary outcome was time to overall clinical progression of BPH , defined as a confirmed 4 point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency or recurrent urinary tract infection . Secondary outcomes were the need for invasive therapy for BPH , and changes in AUA SS and the maximum urinary flow rate with time . TPV was measured by transrectal ultrasound at baseline and study end . RESULTS In patients with a small prostate ( baseline TPV less than 25 ml ) combination therapy was no better than doxazosin alone for decreasing the risk of clinical progression of BPH and need for invasive therapy as well as improving AUA SS and the maximum urinary flow rate . However , in patients with moderate size ( 25 to less than 40 ml ) or enlarged ( 40 ml or greater ) gl and s combination therapy led to a clinical benefit in these outcomes that was superior to that of doxazosin or finasteride . CONCLUSIONS Combination therapy with doxazosin and finasteride led to a greater decrease in the risk of clinical progression of BPH than either drug alone in patients with LUTS with a baseline TPV of 25 ml or greater The clinical effects of finasteride , a 5 alpha-reductase inhibitor , in patients with benign prostatic hyperplasia ( BPH ) were evaluated in a double-blind , placebo-controlled study . Forty-six patients with symptomatic BPH were r and omly assigned to 2 groups , the finasteride group and the placebo group . The finasteride group received 5 mg of finasteride daily for 6 months . Prostate volume , urinary flow , urinary symptoms , serum prostate-specific antigen ( PSA ) and adverse events were determined before and after treatment . After 6 months of treatment the patients treated with 5 mg of finasteride per day had a 30 % decrease in their total urinary symptom score , a 14 % decrease in prostate volume and a 0.9 ng/dL decrease of PSA . Their maximal urinary flow rate increased by 1.42 mL per second and the mean urinary flow rate increased by 0.64 mL per second . The patients given placebo showed no significant changes in their prostate volume , serum PSA and maximal and mean urinary flow rate . However , the symptom scores in the placebo group also decreased significantly . When compared with the placebo group , those in the finasteride group had significantly lower prostate volume , serum PSA , maximal urinary flow rate and urinary symptoms , but not mean urinary flow rate . The frequency of adverse events was low in both the finasteride and placebo groups . These results show that finasteride may be an effective and safe alternative for the treatment of patients with BPH Alpha-blockers and 5-alpha-reductase inhibitors are medical therapies that are being used as alternatives to surgical interventions to relieve symptoms of  benign prostatic hyperplasia ( BPH )  . Taken as monotherapy , alpha-blockers and 5-alpha-reductase inhibitors have each been shown to provide relief from BPH symptoms . Treatment with finasteride over 4 years has been shown to reduce both BPH symptoms and the likelihood of acute urinary retention and the need for surgery . Direct comparison of the alpha-blocker terazosin with finasteride has been done , but only for a period of 1 year . The Medical Therapy of Prostatic Symptoms ( MTOPS ) trial is a multicenter , r and omized , placebo-controlled , double-masked clinical trial design ed to evaluate the long-term efficacy of the alpha-blocker doxazosin and the 5-alpha-reductase inhibitor finasteride , whether taken as a monotherapy or in combination , in preventing or delaying the progression of BPH . We describe in this paper the design of the MTOPS trial , the concept of BPH progression , the definition and methods of determining the primary outcome events and the proposed statistical analysis methods . A unique feature of MTOPS is the inclusion of prostate biopsies on a subgroup of r and omized participants . Volunteers among r and omized participants are to undergo a biopsy of the prostate at predetermined time points during the trial . Studies that will be conducted using the tissue specimens collected in MTOPS can potentially provide information at the molecular level on the natural history of BPH among medically treated and untreated men with moderate to severe symptoms of BPH OBJECTIVES To compare the efficacy and safety of finasteride 5 mg in older ( 65 years old or older ) versus younger ( 45 to younger than 65 years old ) men with benign prostatic hyperplasia ( BPH ) . METHODS The Proscar Long-Term Efficacy and Safety Study ( PLESS ) was a 4-year , r and omized , double-blind , placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men 45 to 78 years old with symptomatic BPH , enlarged prostates , and no evidence of prostate cancer . The endpoints included urinary symptoms , prostate volume , occurrence of acute urinary retention and /or BPH-related surgery , and safety . RESULTS In both age cohorts , finasteride treatment led to a 51 % reduction ( P < 0.001 ) in the relative risk for acute urinary retention and /or BPH-related surgery , a significant ( P < 0.001 ) and durable improvement in symptom score , and a significant ( P < 0.001 ) and sustained reduction in prostate volume . Within each age cohort , no significant differences were found between the placebo and finasteride-treated patients in the incidence of cardiovascular adverse events . Significant differences were evident between the placebo and finasteride groups in the incidence of the typical , known , drug-related adverse events , but no specific differences were associated with age . No drug interactions of clinical importance were observed in the finasteride-treated patients . CONCLUSIONS The present analysis from PLESS demonstrates that in both older ( 65 years old or older ) and younger men with symptomatic BPH and enlarged prostates , finasteride is highly effective in improving symptoms and reducing prostate volume in many men and in reducing the risk of acute urinary retention and BPH-related surgery . In addition , the safety profile of finasteride in both older and younger men is similar and no drug interactions of clinical importance were observed Endocrine therapy by means of castration for benign prostatic hyperplasia was introduced already in the middle of the 19th century . The technique was never popularized and was ab and oned following the introduction of safe surgical techniques . In the second half of this century , small series of various endocrine treatments have been reported , mainly using progestational agents . The hormone dependency of the prostate is unique , since testosterone itself is not very active on the prostate cells but has to be converted to 5 alpha-dihydrotestosterone , which is almost ten times as effective an and rogen in the prostate cell . By blocking this conversion , highly specific anti and rogenic effect will be obtained in the prostate but not in other organs of the body . The first 5 alpha-reductase inhibitor , finasteride , has proven effective in reducing prostate DHT . In large clinical trials , it has shown to reduce prostate size , improve urinary flow and reduce symptom score , statistically significantly better than placebo . The effect is sustained over at least 3 years . In a double-blind , r and omized , placebo-controlled study over 2 years , patients were similarly improved in the finasteride group , whereas they deteriorated in the placebo group . This indicates that finasteride is able to halt the progression of the natural course of benign prostatic hyperplasia . Benign prostatic hyperplasia , generally believed to be a stromal disease , is potentially dependent on estrogens for its development . By blocking aromatization of testosterone to estrogen in the prostate cells , a hypothetical beneficial effect on the disease process should be gained . Results from phase II- studies have been promising . However , in placebo-controlled studies , aromatase inhibitors did not perform better than placebo . ( ABSTRACT TRUNCATED AT 250 WORDS The purpose of this paper is to examine effects of finasteride 5 mg across different age groups in an ethnically diverse population of men with symptomatic benign prostatic hyperplasia ( BPH ) seen in community urology and primary care practice s. Data were combined from two previous placebo-controlled r and omised trials of finasteride that evaluated changes in urinary symptoms , blinded global assessment s of urologic status , adverse experiences , and effects on dihydrotestosterone ( DHT ) and prostate-specific antigen ( PSA ) in over 4500 men .  Finasteride showed a favourable efficacy and tolerability profile in this large ethnically diverse population and was similarly effective in middle-aged and older men with BPH and prostate gl and enlargement PURPOSE Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker . We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms . MATERIAL S AND METHODS In an international , r and omized , double-blind , parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS ( International Prostate Symptom Score ) of 13 or greater and prostate volume 30 ml or greater , 350 were treated with placebo/finasteride  and 345 received tadalafil/finasteride for 26 weeks . Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS , erectile dysfunction improvements were assessed with the IIEF-EF ( International Index of Erectile Function-Erectile Function ) in sexually active men and safety was assessed by evaluating adverse events . RESULTS Least squares mean changes from baseline in I-PSS after 4 , 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0 , -5.2 and -5.5 , respectively . Corresponding values for placebo/finasteride coadministration were -2.3 , -3.8 and -4.5 ( p ≤ 0.022 at all visits favoring tadalafil/finasteride  coadministration ) . I-PSS subscores ( storage and voiding ) and quality of life index were also numerically improved with tadalafil/finasteride coadministration . Least squares mean changes from baseline in IIEF-EF  with tadalafil/finasteride coadministration were 3.7 after 4 weeks , and 4.7 after 12 and 26 weeks . Corresponding values for placebo/finasteride coadministration were -1.1 , 0.6 and -0.0 ( p < 0.001 at all visits favoring tadalafil/finasteride coadministration ) . Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate . CONCLUSIONS The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement . Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction The effects of finasteride , a potent 5 alpha-reductase inhibitor , were assessed in 750 patients with benign prostatic hyperplasia ( BPH ) in a multicenter , double-blind , placebo-controlled study . Patients were r and omized to finasteride , 1 or 5 mg , or placebo , daily for 12 months . The following changes were seen with finasteride 5 mg after 12 months : ( 1 ) Serum dihydrotestosterone decreased by 62 % compared to no change with placebo ( P < 0.001 ) ; ( 2 ) serum prostate-specific antigen ( PSA ) decreased by 46 % compared to no change with placebo ( P < 0.001 ) ; ( 3 ) prostate volume was reduced by 22 % compared to a 5 % decrease with placebo ( P < 0.001 ) ; ( 4 ) maximum urinary flow rate increased by 1.7 ml/sec compared to a 0.4 ml/sec increase with placebo ( P < 0.025 ) ; ( 5 ) total urinary symptom scores decreased by 3.3 points compared to a 2.0 point decrease with placebo ( P = 0.005 ) , and ( 6 ) obstructive symptom scores decreased by 2.1 points compared to a 1.4 point decrease with placebo ( P = 0.017 ) . The effects of finasteride 1 mg were similar to 5 mg , except in urinary symptoms , where no significant differences between 1 mg and placebo were seen . Patients treated with 5 mg finasteride demonstrated significantly greater improvements in urological status ( assessed by the investigator ) and the troublesome symptom score , compared to placebo . Treatment with finasteride was well tolerated . We conclude that finasteride is an effective medical therapy for a significant proportion of patients with BPH A group of 69 men with bladder outflow obstruction due to benign prostatic hyperplasia ( BPH ) were treated in a double-blind , placebo-controlled study with finasteride ( Proscar , MK-906 ) , a 5-alpha reductase inhibitor , 5 mg or 10 mg/day or placebo for 3 months ; subsequently , 20 patients received finasteride 5 mg/day for a further 9 months in an open extension study . In treated patients dihydrotestosterone declined by over 60 % , remaining unchanged with placebo . Symptom scores fell significantly in all 3 groups . Mean maximum flow rates fell slightly in placebo-treated patients but improved by 1.5 ml/s in the 10 mg group and by 3.3 ml/s in the 5 mg group . After 1 year 's treatment , the reduction in symptom score and increase in flow rate were well maintained ; the mean prostate volume was reduced by 14 % and prostatic specific antigen declined by 28 % . It was concluded that finasteride shows some efficacy in the treatment of BPH , with minimal toxicity , but 12 months of therapy or longer may be necessary to achieve maximal effect OBJECTIVES To evaluate the effects of finasteride , a specific type II 5-alpha-reductase inhibitor , on symptoms of benign prostatic hyperplasia , prostate volume , and urinary flow during a 7 to 8-year period . METHODS A total of 190 men with symptomatic benign prostatic hyperplasia and enlarged prostates entered one of two Phase II double-blind 3 to 6-month studies . Of these , 156 patients continued taking open-label finasteride  , and more than 70 patients completed 7 to 8 years of treatment . The symptoms were scored using a patient self-administered modified Boyarsky symptom question naire . Prostate volume was measured by magnetic resonance imaging or ultrasonography , and the maximal urinary flow rate was assessed noninvasively . RESULTS Treatment with finasteride for 7 to 8 years led to sustained improvement in symptoms , reduction in prostate volume ( 28 % from baseline ) , and increased urinary flow ( median 2.5 mL/s from baseline ) . Decreases in dihydrotestosterone ( 86 % ) and prostate-specific antigen ( 54 % ) levels were also maintained . Long-term finasteride treatment was safe and generally well tolerated . CONCLUSIONS Long-term treatment with finasteride was well tolerated and result ed in durable symptom relief and improvement in prostate volume and urinary flow We assessed the long-term safety and efficacy of finasteride , an orally active 5 alpha-reductase inhibitor , in 2 previously reported groups of patients with symptomatic benign prostatic hyperplasia ( BPH ) . Prostate volume was measured by magnetic resonance imaging , and the maximum urinary flow rate was assessed noninvasively . Symptoms were scored utilizing a patient self-administered symptom score question naire . Total symptom scores ranged from 0 ( or asymptomatic ) to 35 ( severely symptomatic ) . After an initial double-blind period , the patients in study 1 were treated with 10 mg finasteride for 1 year and then switched to 5 mg finasteride for an additional 4 years , whereas patients in study 2 were treated with 5 mg finasteride for the entire 5 years . A total of 190 patients were r and omized in the double-blind studies , 156 entered year 1 of the open extension and 70 patients completed 5 years of finasteride therapy . In both studies prostate volume was reduced from baseline by 30 % , dihydrotestosterone was reduced by 72 % , and the maximum urinary flow rate improved by approximately 1.5 ml/s . Prostate-specific antigen was decreased by approximately 50 % . Finasteride was well tolerated ; approximately 10 % of patients reported sexual adverse experiences during the 5-year study period , which were considered drug related by the investigators . The incidence in reporting sexual adverse experiences did not increase with the increased duration of treatment : findings consistent with previous reports . In summary treatment of BPH with finasteride for 5 years inhibits the progression of the disease with an excellent safety profile and represents a low-risk medical option for the treatment of symptomatic BPH BACKGROUND Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia ( BPH ) . METHODS This was a 6-month double-blind r and omized equivalence study that compared the effects of a plant extract ( 320 mg Permixon ) with those of a 5 alpha-reductase inhibitor ( 5 mg finasteride ) in 1,098 men with moderate BPH using the International Prostate Symptom Score ( IPSS ) as the primary end-point . RESULTS Both Permixon and finasteride decreased the IPSS ( -37 % and -39 % , respectively ) , improved quality of life ( by 38 and 41 % ) , and increased peak urinary flow rate ( + 25 % and + 30 % , P = 0.035 ) , with no statistical difference in the percent of responders with a 3 ml/sec improvement . Finasteride markedly decreased prostate volume ( -18 % ) and serum PSA levels ( -41 % ) ; Permixon improved symptoms with little effect on volume ( -6 % ) and no change in PSA levels . Permixon fared better than finasteride in a sexual function question naire and gave rise to less complaints of decreased libido and impotence . CONCLUSIONS Both treatments relieve the symptoms of BPH in about two-thirds of patients but , unlike finasteride , Permixon has little effect on so-called and rogen-dependent parameters . This suggests that other pathways might also be involved in the symptomatology of BPH INTRODUCTION Tadalafil ( TAD ) 5 mg coadministered with finasteride ( FIN ) 5 mg significantly improves lower urinary tract symptoms ( LUTS ) in men with benign prostatic hyperplasia ( BPH ) and prostatic enlargement . However , its effects on erectile/sexual function have yet to be fully described . AIM Assess the effects of TAD/FIN coadministration ( compared with placebo [PBO]/FIN ) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction ( ED ) . METHODS A r and omized , double-blind , PBO-controlled study of 695 men ( 610 sexually active ; 450 with baseline ED ; 404 sexually active with baseline ED ) conducted at 70 sites in 13 countries .  TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks . MAIN OUTCOME MEASURES International Index of Erectile Function ( IIEF ) domain and single-item scores ; proportions of patients who demonstrated minimal clinical ly important differences ( MCIDs ) in IIEF-Erectile Function domain scores ( IIEF-EF ; MCID defined as ≥4-point improvement ) ; and sexual dysfunction adverse events ( AEs ) . RESULTS Compared with PBO/FIN , TAD/FIN result ed in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED ( P ≤ 0.002 for all measures ) and among patients without baseline ED ( P ≤ 0.041 for all measures ) . Compared with PBO/FIN , significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4 , 12 , and 26 weeks of therapy ( P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints ) . The incidence of sexual AEs was low : five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs , including ED , decreased/lost libido , and ejaculation disorders . CONCLUSIONS TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated , regardless of the presence/absence of ED at treatment initiation OBJECTIVES To investigate the change in prostate volume and symptoms after discontinuation of 5alpha-reductase inhibitors ( 5ARIs ) in men with moderate to severe symptoms due to benign prostatic hyperplasia ( BPH ) . METHODS A total of 120 patients with BPH were enrolled from December 2004 to May 2008 . The patients were r and omized into 2 groups : group 1 received finasteride 5 mg plus alfuzocin 10 mg or tamsulosin 0.2 mg daily , and group 2 received dutasteride 0.5 mg plus alfuzocin 10 mg or tamsulosin 0.2 mg daily . All the patients received combination therapy for 1 year , followed by 1 year of alpha-blocker monotherapy . The prostate volume , International Prostate Symptom Score , and serum prostate-specific antigen level were determined at baseline and at 12 and 24 months after treatment . RESULTS At 1 year after treatment , the prostate volume was reduced by 24.5 % + /- 10.01 % ( P < .001 ) in group 1 and by 26.1 % + /- 5.06 % ( P < .001 ) in group 2 . One year after withdrawal of the 5ARIs , the prostate volume had increased by 20.7 % + /- 14.1 % ( P < .001 ) and 18.6 % + /- 7.4 % ( P < .001 ) in groups 1 and 2 , respectively , compared with at the end of 1 year of treatment . Furthermore , the International Prostate Symptom Score had significantly deteriorated at 1 year after cessation of the 5ARIs in both groups compared with the values at the end of 1 year of combination therapy . CONCLUSIONS Our data demonstrate that the discontinuation of 5ARIs during combination therapy induces prostate regrowth , as well as aggravation of symptoms in men with BPH . This result , therefore , suggests that the life-long use of 5ARIs should be considered for the prevention of BPH progression We studied the effects of 5 alpha-reductase inhibitor ( finasteride ) in the treatment of benign prostatic hyperplasia ( BPH ) . This study is a r and omized controlled trial . Sixty-two patients were treated with 5 alpha-reductase ( finasteride 5 mg/day ) and 61 patients  ( control group )  with placebo for one year . Prostatic volume , maximal urine flow rate , AUA symptom scoring , residual urine volume and prostate-specific antigen ( PSA ) levels were evaluated at 3 , 6 , 9 and 12 months . In the first 6 months prostatic volume decreased rapidly ( 20.5 % ) , in the second 6 months it decreased slowly and reached the maximal rate ( 23.3 % ) . Maximal urine flow rate increased in the second 6 months . AUA symptom scores decreased first at 3 months and were 4.6 points lower at the end of the 12th month . There were no significant changes in residual volume . The 5 alpha-reductase inhibitor caused a 50 % decrease in PSA levels , like in other studies .Becuase of the prolonged use of the drug , treatment with 5 alpha-reductase inhibitor is not tolerated by many patients and being expensive its future in the pharmacotherapy of BPH is unclear This study was design ed to determine the efficacy of the 5 alpha-reductase inhibitor finasteride ( Proscar , MK-906 ) in men with reduced urinary flow rates and symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia . Forty-five men were r and omized to one of three groups receiving either placebo , 1 mg/day or 5 mg/day finasteride for the first 12 months of the study period . At the end of this period all men received 5 mg/day finasteride for a further 2 years . Efficacy was determined by measurement of prostate volume , maximum urinary flow rate , and symptom score using a modified Boyarsky assessment . Prostate volume reduced by 20 and 27 % , respectively , for those on 1 and 5 mg after the first year . At 3 years the volume had reduced by 43 % . This reduction in prostate volume was associated with an improvement in maximum urinary flow rate by 50 % ( 1 mg ) , and 35 % ( 5 mg ) at 1 year , and 36 % at 3 years . The total , obstructive and non-obstructive symptom scores decreased ( improved ) for patients on 1 and 5 mg finasteride , with the total score reducing by 33 % from baseline at year 3 . The results demonstrate that finasteride causes a modest but significant clinical improvement in men with urinary outflow obstruction secondary to benign prostatic hyperplasia Urodynamic effects of the 5-alpha-reductase inhibitor , finasteride , were studied in the treatment of patients with bladder outlet obstruction due to benign prostatic hyperplasia ( BPH ) . A total of 36 patients was r and omly assigned in a double-bind manner to receive either 5 mg . finasteride daily ( 19 ) or placebo ( 17 ) for 6 months . The possible relief of bladder outlet obstruction was monitored with uroflowmetry and repeated urodynamics . The mean flow rate , detrusor opening pressure , detrusor pressure at maximum flow and maximum detrusor pressure improved significantly in the patients treated with finasteride . There were no significant differences in the improvement of symptom score or peak flow rate , or in the reduction of residual urine between the finasteride and placebo groups . The treatment result ed in 30 % average decrease in prostatic size and 46 % decrease in prostate specific antigen concentration . The efficacy of finasteride in relief of bladder outlet obstruction caused by BPH seems to be of the same degree as that achieved by chemical castration therapy but without any significant side effects . There were wide variations among BPH patient response to finasteride treatment . Further studies are needed to define the responders who benefit from this treatment PURPOSE We sought to quantify prostate tissue changes induced by finasteride and to identify a predictor of finasteride response in men with symptomatic benign prostatic hyperplasia ( BPH ) via a r and omized , placebo controlled , double-blind clinical trial . MATERIAL S AND METHODS Men with symptomatic BPH ( 52 to 78 years old ) were r and omly assigned to 6 months of treatment with finasteride ( 26 ) or placebo ( 15 ) . Outcome measures were clinical ( urinary symptom score and flow rate ) , chemical ( serum prostate specific antigen and dihydrotestosterone levels ) , volumetric ( transrectal ultrasound , and magnetic resonance imaging for whole and zonal prostate volumes ) and histological ( morphometry of prostate sextant biopsies , separated into inner and outer gl and segments , to measure the percent epithelium , stroma and gl and ular lumen ) . RESULTS In the finasteride group we found a suggestion of decreasing symptom scores and increasing flow rates ( not significant ) with significant decreases ( p < 0.01 ) in prostate specific antigen ( 48 % ) , dihydrotestosterone ( 74 % ) and prostate volume ( 21 % ) . Finasteride treatment induced a 55 % decrease in inner gl and epithelium ( p < 0.01 ) with little effect on stroma or lumina . We also found a linear correlation between pretreatment inner gl and epithelial content and prostate volume decrease induced by the drug ( tau = 0.58 , p = 0.01 ) . CONCLUSIONS Finasteride treatment results in a major suppression of prostate epithelium , which is most pronounced in the inner gl and . Moreover , a finasteride induced prostate volume decrease was predictable by quantification of epithelial tissues of the inner gl and . These data lend additional support to the emerging concept of transition zone primacy in symptomatic BPH BACKGROUND Finasteride , a 5 alpha-reductase inhibitor , has been shown to have beneficial effects in the treatment of benign prostatic hyperplasia . The long-term safety and efficacy of finasteride in the treatment of benign prostatic hyperplasia was assessed . METHODS In two multicenter , double-blind , placebo-controlled studies ( North American and international ) , patients with symptomatic benign prostatic hyperplasia were r and omly assigned to receive finasteride , 1 or 5 mg , or placebo for 1 year followed by an open-extension study in which all patients were treated with finasteride , 5 mg , regardless of original therapy . Men aged 40 to 80 years , in good physical and mental health , were eligible to enter the study . All patients were to have a maximum urinary flow rate of 15 mL/s or less with a voided volume of 150 mL or more , an enlarged prostate , and symptoms of urinary obstruction . Patients with a prostate-specific antigen level of 40 mg/mL or more or any finding suggestive of prostate cancer were excluded . RESULTS Two hundred ninety-eight patients received finasteride , 5 mg , continuously for 24 months . At the end of 24 months of finasteride therapy , the median prostate volume was reduced by 25 % , and 60 % of patients had a 20 % or greater reduction in prostate volume . Maximum urinary flow rate was improved by at least 2 mL/s , and symptoms were improved by approximately 3.5 points . Decreased libido and ejaculation disorders were the only drug-related adverse experiences reported in more than 1 % of patients . CONCLUSION These studies support the long-term safety and tolerability of finasteride , while demonstrating its continuing clinical efficacy in the treatment of patients with symptomatic benign prostatic hyperplasia BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0.001 ) was significantly greater than that associated with doxazosin ( P<0.001 ) or finasteride ( P<0.001 ) alone . The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P<0.001 ) and finasteride ( P<0.001 ) but not by doxazosin . Doxazosin ( P<0.001 ) , finasteride ( P=0.001 ) , and combination therapy ( P<0.001 ) each result ed in significant improvement in symptom scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P<0.001 ) alone . CONCLUSIONS Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy The effects of urinary symptoms on health-related quality of life ( HRQL ) are important in therapeutic decision making . Few have evaluated the treatment effects on HRQL in men with benign prostatic hyperplasia ( BPH ) , even though increased urinary symptoms are associated with greater worry , bother , and interference with living activities . We report on patient assessment s of such disease-specific measures as well as general HRQL measures from two placebo-controlled clinical trials of finasteride in the treatment of symptomatic BPH . Patients treated with finasteride appeared to have greater improvement than placebo-treated patients in disease-specific measures and in patient global assessment . The treated group appeared to have a greater mean increase in sexual domain scores . As expected , general measures ( health rating , life satisfaction , ladder of life ) changed little . Thus , treatment with finasteride appears to reduce bother , worry , and activity interference due to symptoms but in a small percentage of men may lead to slightly reduced sexual function The efficacy and safety profiles of finasteride were tested in 1,645 patients with benign prostatic hyperplasia ( BPH ) over a 12-month period . The following effects were observed : ( 1 ) a 60 - 80 % reduction in serum dihydrotestosterone levels ; ( 2 ) a 20 % reduction in prostate volume ; ( 3 ) significant increases in the maximum urinary flow rate compared with placebo ; and ( 4 ) significant improvement in urinary symptoms , particularly obstructive symptoms . All effects were well maintained for the entire duration of the study . Finasteride had a good safety profile and was well tolerated OBJECTIVES To assess the utility of voiding and filling symptom subscores in predicting features of benign prostatic hyperplasia ( BPH ) progression , including acute urinary retention ( AUR ) and prostate surgery . METHODS The Proscar Long-term Efficacy and Safety Study ( PLESS ) was a 4-year study design ed to evaluate the effects of finasteride versus placebo in men with lower urinary tract symptoms ( LUTS ) , clinical evidence of BPH , and no evidence of prostate cancer . A self-administered question naire was employed to quantify LUTS at baseline . Receiver operating characteristics ( ROC ) curves were used to assess baseline characteristics from patients treated with placebo as predictors of outcomes . The characteristics assessed included the overall symptom score ( Quasi-AUA SI ) , separate voiding and filling subscores , prostate volume ( PV ) and serum prostate-specific antigen ( PSA ) levels . RESULTS PV and PSA were superior to the symptom scores at predicting episodes of spontaneous AUR and all types of AUR . The Quasi-AUA SI and the filling and voiding subscores were effective at predicting progression to surgery ; however , PSA was more effective at predicting this outcome . To better evaluate symptoms as predictors of surgery , patients who experienced a preceding episode of AUR were excluded from the surgery analysis . In the absence of preceding AUR , the best predictors of future surgery were the Quasi-AUA SI and the filling subscore . CONCLUSIONS Among men with LUTS , clinical BPH and no history of AUR , the overall symptom score and storage subscore are useful parameters to aid clinicians in identifying patients at risk for future prostate surgery . PV and PSA were the best predictors of AUR , while PSA was the best predictor of prostate surgery ( for all indications ) OBJECTIVE To study if placebo-induced improvement in men with symptomatic benign prostatic hyperplasia ( BPH ) is maintained over two years , and to study the efficacy and safety from intervention with finasteride 5 mg for 24 months . METHODS This was a multicenter , double-blind , placeba-controlled study involving 707 patients with moderate symptoms of BPH enrolled at 59 centers in five Sc and inavian countries . Following enrollment and a four-week single-blind placebo run-in period , patients were r and omized to receive finasteride 5 mg once daily or placebo for 24 months . Urinary symptoms , urinary flow rate , prostate volume , postvoiding residual urinary volume , and serum concentrations of prostate-specific antigen together with laboratory safety parameters were measured at entry and at months 12 and 24 . Interim physical and laboratory examinations were performed when indicated clinical ly . RESULTS In finasteride-treated patients the total symptom score improved throughout the study , with a significant difference between the two groups at 24 months ( p<0.01 ) whereas in placebo-treated patients , there was an initial improvement in the symptom score but no change from baseline at 24 months . The maximum urinary flow rate decreased in the placebo group , but improved in the finasteride group , result ing in a between-group difference of 1.8 mL/s at 24 months ( p<0.01 ) . The mean change in prostate volume was + 12 % in the placebo group versus -19 % in the finasteride-treated group ( p%lt;0.01 ) . Finasteride was generally well tolerated throughout the two-year study period . CONCLUSIONS The efficacy of therapy with finasteride 5 mg in improving both symptoms and maximum urinary flow rate and reducing prostate volume has been shown to be maintained during 24 months while patients receiving placebo experienced a return to baseline or deterioration of these parameters during the study . These results demonstrate that finasteride can reverse the natural progression of BPH Background The primary objectives of the treatment for the  lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) are to produce rapid , sustained , and safe improvements in the symptoms that affect the quality of life in the majority of men over 50 . In this study , we evaluated the efficacy and safety of the combined therapy with terazosin ( & agr;1‐adrenergic receptor antagonist ) and tolterodine ( anticholinergic agent ) for LUTS associated with BPH . Methods This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores ( IPSS ) , urinary flow rate , prostate volume , urinary residual , and their serum prostate‐specific antigen levels .  Initially , 191 patients were treated with terazosin 2 mg once daily for one week . Those patients with continued LUTS after the initial treatment were allocated r and omly into two groups : terazosin group ( n=36 ) in which patients were treated with terazosin 2 mg once daily for six weeks , and combination group ( n=33 ) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks . Results The IPSS were significantly improved in both groups after treatment , and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group ( P<0.01 ) . A decrease in urgency , frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group . The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment , but were not significant between the two groups . The incidence of adverse effects in the combination group was higher than that in the terazosin group . As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine . Conclusions Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine . This study , although short term and limited numbers of patients , provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid , sustained , and safe improvements in the LUTS associated with BPH . And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation There is no consensus on the evaluated efficacy of individual alpha(1)-blockers in the treatment of lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . This study compared the clinical benefits of tamsulosin hydrochloride with those of naftopidil in BPH . Men aged 54 - 84 years with a main complaint of BPH were r and omly assigned to receive consecutive treatment with tamsulosin then naftopidil ( T-N group , 25 patients ) , or naftopidil then tamsulosin hydrochloride ( N-T group , 20 patients ) . The therapeutic effects were compared in a crossover design . Administration was continued for 28 days in each treatment period . Both groups showed similar improvements during the first treatment period . However , during the second treatment period after crossover , therapeutic effects were greater in the N-T group . Tamsulosin was more effective than naftopidil on intermittency , nocturia and quality of life scores .  Tamsulosin and naftopidil have different efficacy profiles for LUTS associated with BPH PURPOSE There are 2 main medical preparations available for lower urinary tract symptoms result ing from benign prostatic hyperplasia ( BPH ) . Choosing between an alpha-blocker and a 5alpha-reductase inhibitor requires trade-offs between their attributes or characteristics . We investigated the relative importance of and trade-offs between the attributes of the 5alpha-reductase inhibitor dutasteride and alpha-blockers in community dwelling men using a vali date d technique . MATERIAL S AND METHODS A discrete choice experiment was administered to 211 men older than 40 years who were r and omly selected from the general United Kingdom population . Attributes investigated in the discrete choice experiment were time to symptom improvement , sexual and nonsexual side effects , the risks of acute urinary retention ( AUR ) and surgery , cost and prostate size decrease . Using regression analysis the relative importance of these attributes , the trade-offs that men are willing to make between these attributes and the willingness to pay for each attribute were estimated . RESULTS All attributes were important to respondents . The most important attribute was side effects . The least preferred side effects was impotence , followed by decreased libido and dizziness . Respondents were willing to wait 13 , 2 and 8 months longer for symptom improvement in exchange for decreased prostate size , and the risks of AUR and surgery , respectively . Men reporting moderate symptoms were less concerned about sexual side effects , time to symptom improvement and the risk of AUR compared with men reporting mild symptoms . CONCLUSIONS Given the attribute levels of BPH medical treatment , overall community dwelling men preferred the 5alpha-reductase inhibitor over alpha-blockers . In the interests of shared decision making it is important to consider the importance of eliciting the preferences of patients with BPH PURPOSE We determined the effect of long-term treatment with finasteride on the incidence of acute urinary retention ( AUR ) and benign prostatic hyperplasia ( BPH ) related surgery in men with BPH . MATERIAL S AND METHODS The Proscar ( Merck and Co. , Inc. , Whitehouse Station , New Jersey ) Long-Term Efficacy and Safety Study ( PLESS ) was comprised of 3040 men with enlarged prostates , moderate to severe symptomatic BPH and no clinical evidence of prostate cancer . Patients were r and omized to placebo or 5 mg finasteride daily for 4 years . Of the 3016 r and omized patients with available efficacy data 62 % completed the original 4-year study ( 1006 on finasteride and 891 on placebo ) and 89 % of these ( 908 from the original finasteride arm and 785 from the placebo arm ) continued in a 2-year open extension on finasteride . Followup was attempted in discontinued patients . Complete 6-year outcomes data , including 6-year followup in 770 men who had discontinued treatment during years 1 to 6 , were available for 2463 ( 82 % ) of the 3016 originally r and omized patients . RESULTS For patients on continuous finasteride treatment the decrease in incidence of AUR and /or BPH related surgery in the 4-year base study was sustained during the open extension . In patients who were switched from placebo to finasteride in the extension , the incidence of AUR and /or BPH related surgery was similar to that in the continuous finasteride arm . CONCLUSIONS The 6-year data from PLESS confirmed and further extended the findings from the original 4-year trial , demonstrating that finasteride treatment led to a sustained decrease in the incidence of AUR and /or BPH related surgery in men with BPH and enlarged prostates OBJECTIVE To assess the efficacy and safety of tadalafil , a phosphodiesterase 5 ( PDE5 ) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) , in population subgroups , using pooled data from 4 international , r and omized , placebo-controlled studies in men with LUTS/BPH . METHODS The safety data base included 1500 men r and omized to tadalafil 5 mg once daily or placebo for 12 weeks . Changes in total International Prostate Symptom Score ( IPSS ) , IPSS- quality of life index , and BPH impact index were examined overall , and changes in IPSS or adverse events ( AEs ) were examined across subgroups of interest . Treatment-group differences were assessed using analysis of covariance . RESULTS Results of pooled data confirmed that tadalafil ( N = 752 ) result ed in significant improvements from baseline vs placebo ( N = 746 ) in IPSS ( mean difference -2.3 ; P < .001 ) , and also in BPH impact index and IPSS- quality of life index ( both P < .001 ) . Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity ( IPSS < 20/≥20 ) , age ( ≤65/>65 years ) , recent previous use of α-blockers or PDE5 inhibitors , total testosterone level ( < 300/≥300 ng/dL ) , or prostate-specific antigen predicted prostate volume ( < 40/≥40 mL ) . [ corrected ] Rates of treatment emergent AEs were comparable between subgroups of baseline age ( ≤65/>65 years ) , previous PDE5 inhibitor use , and the presence or absence of pre-existing diabetes , hypertension , or cardiovascular disease ( including hypertension ) , but somewhat higher for recent previous α-blocker use . CONCLUSION In these pooled data analyses , tadalafil 5 mg improved LUTS/BPH across subgroups of age , LUTS severity , testosterone levels , and prostate volume . Rates of AEs were similar across the subgroups assessed Tamsulosin ( 0.2 mg ) and finasteride ( 5 mg ) once daily for 24 weeks were compared in a single-blind , r and omized study as initial treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH ) in 205 Korean patients .  Symptom and quality of life ( QOL ) assessment by the International Prostatic Symptom Score ( I-PSS ) , maximum urinary flow rate ( Q max ) and adverse events were analysed at 4 weeks and 24 weeks . On intention-to-treat analysis , both drugs showed similar efficacy at endpoint ( decreased I-PSS , increased Q max and improved QOL score ; 34.7 % , 23.9 % and 34.1 % for tamsulosin , and 30.5 % , 22.2 % and 23.1 % for finasteride , respectively ) . However , tamsulosin produced significant improvements in I-PSS and Q max at 4 weeks compared with finasteride ( 17.6 % versus 10.0 % and 10.9 % versus 3.1 % , respectively ) , and a superior QOL score improvement during the study . Adverse events were observed significantly more frequently among finasteride than tamsulosin patients ( 23 versus four ) . Both were equally effective in long-term treatment of urinary outflow obstruction symptoms associated with BPH in Korean patients , but tamsulosin was more effective for short-term treatment , with a better safety profile OBJECTIVES To report the secondary analyses of treatment satisfaction and clinical ly meaningful improvements in a r and omized study comparing coadministration of tadalafil 5 mg with finasteride 5 mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia . METHODS An international , r and omized , double-blind , parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naïve , and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL ; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26 weeks . Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia . Responder cut-offs , analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25 % from r and omization . RESULTS Baseline patient characteristics were generally comparable between responders and non-responders . The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride , respectively , at week 4 was 57.0 % and 47.9 % ( OR 1.45 , 95 % confidence interval 1.07 - 1.97 ) , at week 12 was 68.8 % and 60.7 % ( OR 1.48 , 95 % confidence interval 1.07 - 2.05 ) and at week 26 was 71.4 % and 70.2 % ( OR 1.14 , 95 % confidence interval 0.81 - 1.61 ) ; for IPSS change ≥25 % , the corresponding proportions were 44.8 % and 32.9 % ( OR 1.66 , 95 % confidence interval 1.21 - 2.28 ) , 55.5 % and 51.9 % ( OR 1.18 , 95 % confidence interval 0.87 - 1.62 ) , and 62.0 % and 58.3 % ( OR 1.23 , 95 % confidence interval 0.89 - 1.70 ) . Treatment satisfaction at week 26 was significantly greater with tadalafil/finasteride versus placebo/finasteride  for total treatment satisfaction scale score ( P=0.031 ) and satisfaction with efficacy subscore ( P = 0.025 ) ; scores were not significantly different between treatments for satisfaction with dosing or side-effects ( both P ≥ 0.371 ) . CONCLUSIONS Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms , and in greater treatment satisfaction versus placebo/finasteride OBJECTIVES To evaluate the long-term effects of finasteride on symptoms , acute urinary retention ( AUR ) , and the need for benign prostatic hyperplasia (BPH)-related surgery  in relationship to baseline symptom severity . METHODS A total of 3040 men with BPH were treated for 4 years with finasteride or placebo . The changes from baseline in symptoms and the incidence of BPH-related surgery and AUR were determined in men with mild ( less than 8) , low-moderate ( 8 to 12 ) , high-moderate ( 13 to 19 ) , and severe ( greater than 19 ) baseline quasi-American Urological Association symptoms for all patients and for the subgroup with a baseline prostate-specific antigen ( PSA ) level of 1.4 ng/mL or greater . RESULTS In patients who completed the 4-year study , the change in symptom score , stratified by baseline symptom severity , was + 1.4 + /- 0.5 ( mild ) , -0.8 + /- 0.3 ( low-moderate ) , -3.6 + /- 0.3 ( high-moderate ) , and -7.7 + /- 0.5 ( severe ) in finasteride-treated patients and , respectively , + 3.4 + /- 0.5 , + 0.7 + /- 0.3 , -1.4 + /- 0.3 , and -5.3 + /- 0.6 in placebo-treated patients ( between-group P < 0.01 ) . The between-group differences were greater in the subgroup of patients with a baseline PSA of 1.4 ng/mL or greater . The risk of BPH-related surgery increased among placebo patients with increasing baseline symptom severity to a greater extent than the risk of AUR . Finasteride reduced the risk of AUR or the need for BPH-related surgery in all subgroups ( P < 0.001 ) , especially in men with a baseline PSA of 1.4 ng/mL or greater . CONCLUSIONS Compared with placebo , finasteride had a beneficial effect on symptoms , AUR , and BPH-related surgery in all symptom categories . BPH-related surgery , but not AUR , occurred more commonly in placebo-treated men with more severe baseline symptoms . The greatest absolute benefit of finasteride on symptoms and the reduction in risk of AUR and surgery was in men with higher baseline symptom scores and a baseline PSA level of 1.4 ng/mL or greater BACKGROUND Men with benign prostatic hyperplasia can be treated with alpha 1-adrenergic-antagonist drugs that relax prostatic smooth muscle or with drugs that inhibit 5 alpha-reductase and therefore reduce tissue and rogen concentrations . However , the effects of the two types of drugs have not been compared . METHODS We compared the safety and efficacy of placebo , terazosin ( 10 mg daily ) , finasteride ( 5 mg daily ) , and the combination of both drugs in 1229 men with benign prostatic hyperplasia .  American Urological Association symptom scores and peak urinary-flow rates were determined at base line and periodically for one year . RESULTS The mean changes from base line in the symptom scores in the placebo , finasteride , terazosin , and combination-therapy groups at one year were decreases of 2.6 , 3.2 , 6.1 , and 6.2 points , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . The mean changes at one year in the peak urinary-flow rates were increases of 1.4 , 1.6 , 2.7 , and 3.2 ml per second , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . Finasteride had no more effect on either measure than placebo . In the placebo group , 1.6 percent of the men discontinued the study because of adverse effects , as did 4.8 to 7.8 percent of the men in the other three groups . CONCLUSIONS In men with benign prostatic hyperplasia , terazosin was effective therapy , whereas finasteride was not , and the combination of terazosin and finasteride was no more effective than terazosin alone AIM To determine the efficacy of toterodine extended release ( ER ) treatment for 1 year in older men with benign prostatic hyperplasia ( BPH ) and storage symptoms treated with alpha-blockers and /or 5-alpha-reductase inhibitors ( 5ARI ) .  METHODS Men aged over 70 years with BPH/bladder outlet obstruction ( BOO ) and clinical storage symptoms were r and omly treated with or without tolterodine ER in combination with alpha-blockers and /or 5ARI for 12 months . Among them , 50 patients ( group 1 ) received additive tolterodine extended release ( ER ) 4 mg q.d . , another 87 patients ( group 2 ) did not . All patients had a baseline and 12th month post-treatment evaluation , which comprised of uroflowmetry , post-void residual ( PVR ) volume , International Prostate Symptom Score ( IPSS ) , and quality of life index ( QoL-I ) , transrectal ultrasound of the prostate and serum prostate specific antigen . RESULTS One hundred thirty-seven of 153 enrolled patients with a mean age of 74.9 years completed the study . Treatment benefit demonstrated in both groups included deceased total , voiding and storage IPSS scores , increased peak urinary flow rate and deceased QoL-I. Inter-group difference was only observed on the storage domain of IPSS score ( P = 0.012 ) . The mean PVR after treatment did not significantly differ between two groups . Two patients of group 1 and three of group 2 developed acute urinary retention . Among group 1 , six patients discontinued tolterodine ER for intolerable dry mouth ; among group 2 , three patients reported dizziness . CONCLUSIONS This longer comparative study indicated that additive treatment with tolterodine ER in older men with BPH/BOO and significant storage symptoms is a beneficial and safe therapeutic option This study sought to assess the efficacy , tolerability , and effect of finasteride on health-related quality of life ( HRQL ) in a diverse population of men with moderate-to-severe symptomatic benign prostatic hyperplasia ( BPH ) . This double-blind study evaluated finasteride and placebo for 12 months in 2342 men with BPH ( 16.2 % black , 14.5 % Hispanic , 69.3 % Caucasian/other ) in a community-based setting . At 3-month intervals , urinary symptoms were measured by use of the American Urologic Association symptom index . HRQL was assessed by use of the BPH impact index ( BII ) , which evaluated degree of bother , worry , physical discomfort , and restriction in activities as a result of urinary symptoms . Additional questions regarding activities of living were administered , and global assessment s of change in urologic status were performed by both patients and investigators . Compared with placebo , patients treated with finasteride had a statistically significant decrease in symptom scores when first measured at month 3 . Symptom scores continued to improve in finasteride-treated patients throughout the study ; at month 12 , the mean decrease in symptom scores in the finasteride-treated patients was -4.8 compared with -3.4 for placebo patients ( P = 0.0001 ) . Statistically significant differences in favor of finasteride also were noted at month 12 on the BII ( P = 0.0465 ) , and finasteride-treated patients experienced less interference with activities of living ( P = 0.0518 ) . Patient and investigator global assessment s of urologic status showed that significantly more patients in the finasteride group considered themselves improved and were considered improved by investigators at month 12 ( P = 0.000 ) . Finasteride was generally well tolerated . The incidence of drug-related sexual adverse experiences was significantly higher in the finasteride group ( P = 0.000 ) , but led to withdrawal in only 1.5 % of patients . The demonstrated efficacy and tolerability of finasteride in reducing symptoms and improving quality of life confirm observations of previous trials and make finasteride a highly desirable treatment option for many men with symptomatic BPH 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 ) OBJECTIVES Nocturia is a well-recognized symptom of benign prostatic hyperplasia ( BPH ) , which is commonly treated by alpha(1)-blockers and /or 5alpha-reductase inhibitors . However , the effectiveness of these drugs for nocturia has been reported to be only 25%-39 % . The aim of this study was to investigate the efficacy of celecoxib , a cyclooxygenase-2 inhibitor , in the treatment of patients with BPH complaining of nocturia . METHODS This was a prospect i ve , r and omized , double-blind , placebo-controlled study . A total of 80 men with lower urinary tract symptoms and BPH were entered into the study and were r and omized to receive celecoxib , 100 mg at 9 pm vs placebo for 1 month . The inclusion criteria also included a total International Prostate Symptom Score > 8 and complaints of > or=2 voids nightly . The efficacy and safety of the treatment were assessed by changes in the urinary flow and symptoms between baseline and 1 month of follow-up . RESULTS In the celecoxib group ( n = 40 ) , the mean nocturnal frequency ( + /-SD ) decreased from 5.17 + /- 2.1 to 2.5 + /- 1.9 ( P < .0001 ) , and the mean International Prostate Symptom Score ( + /-SD ) decreased from 18.2 + /- 3.4 to 15.5 + /- 4.2 ( P < .0001 ) . In the control group ( n = 40 ) , the mean nocturnal frequency ( + /-SD ) decreased from 5.30 + /- 2.4 to 5.12 + /- 1.9 ( P > .05 ) , and the mean International Prostate Symptom Score ( + /-SD ) decreased from 18.4 + /- 3.1 to 18 + /- 3.9 ( P > .05 ) . A statistically significant difference was found between the 2 groups ( P < .0001 ) . No statistically significant differences were found in the changes in the peak flow rate between the celecoxib and control groups or in celecoxib group between baseline and 1 month ( P > .05 ) . No significant side effects were reported . CONCLUSIONS Celecoxib is effective in the treatment of patients with BPH complaining of refractory nocturia . Our results suggest a novel treatment option for this common condition OBJECTIVES To evaluate the efficacy and tolerability of the selective alpha(1)-adrenergic antagonist doxazosin and the 5-alpha-reductase inhibitor finasteride , alone and in combination , for the symptomatic treatment of benign prostatic hyperplasia . METHODS In a prospect i ve , double-blind , placebo-controlled trial , 1095 men aged 50 to 80 years were r and omized to treatment for 52 weeks with doxazosin , finasteride , the combination of doxazosin and finasteride , or placebo . The dose of finasteride ( or its matched placebo ) was 5 mg/day . Doxazosin ( or its matched placebo ) was initiated at 1 mg/day , and titrated up to a maximum of 8 mg/day over approximately 10 weeks according to the response of the maximal urinary flow rate ( Qmax ) and International Prostate Symptom Score ( IPSS ) . The IPSS and Qmax were assessed at baseline and at weeks 10 , 14 , 26 , 39 , and 52 or at the endpoint . RESULTS An intent-to-treat analysis of 1007 men showed doxazosin and doxazosin plus finasteride combination therapy produced statistically significant improvements in total IPSS and Qmax compared with placebo and finasteride alone ( P < 0.05 ) . Finasteride alone was not significantly different statistically from placebo with respect to total IPSS and Qmax . All treatments were generally well tolerated . CONCLUSIONS Doxazosin was effective in improving urinary symptoms and urinary flow rate in men with benign prostatic hyperplasia , and was more effective than finasteride alone or placebo . The addition of finasteride did not provide further benefit to that achieved with doxazosin alone BACKGROUND Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia ( BPH ) symptoms after the first dose and achieve long-term efficacy in European and American population s ; however , the corresponding studies from China are rarely seen . The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms ( LUTS ) suggestive of BPH in China . METHODS Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study . Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study . The efficacy and safety parameters were evaluated at the end of treatment period I ( 0 - 12 weeks ) and period II ( 13 - 60 weeks ) . The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS A total of 113 patients were recruited to the study . Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II . Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate ( Q(max ) ) ( 1.7 ml/s , 3 ml/s ) and a significant decrease in mean international prostate symptom score ( IPSS ) ( 4.1 , 6.4 ) after 12-week and 60-week treatments , respectively . At the end of treatment period II , there were significant improvement in IPSS , quality of life ( QOL ) score , Q(max ) and average flow rate ( Q(ave ) ) for combination therapy group compared with the treatment period I ( all P < 0.05 ) . No serious adverse events ( SAE ) were recorded during the study . CONCLUSION Long-term tamsulosin hydrochloride therapy is a safe , effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China In this multicentre , double-blind study , patients with LUTS/BPH were r and omised to 26 weeks with finasteride 5 mg once daily ( n=204 ) or tamsulosin 0.4 mg once daily ( n=199 ) . Double-blind treatment was continued for another 26 weeks ( total treatment duration : 1 y ) . The primary efficacy parameter was the difference in mean change in total Symptom Problem Index ( SPI ) from baseline to end point at week-26 in the intention-to-treat ( ITT ) and per protocol ( PP ) population s. Tamsulosin induced a greater improvement in total SPI ( −5.2 points or −37 % ) compared to finasteride ( −4.5 points or −31 % ) at week-26 ( P=0.055 in ITT and P=0.032 in PP ) . Tamsulosin  improved urinary symptoms ( particularly the more bothersome storage symptoms ) and flow more quickly than finasteride . The difference was statistically significant for the SPI from week-1 ( reduction , respectively , −2.5 vs −1.8 points , P=0.043 ) to week-18 and for Qmax from week-1 ( increase , respectively , 2.3 vs 0.7 ml/s , P=0.0007 ) to week-12 . Both treatments were well tolerated with a comparable incidence of adverse events , including urinary retention OBJECTIVES To determine the effect of discontinuation of alpha-blockade and continuation of finasteride in men with lower urinary tract symptoms and enlarged prostates receiving combination treatment and to determine whether the alpha-blocker dose influences the ability to discontinue it . METHODS We treated 272 consecutive men with a prostate size greater than 40 g and American Urological Association symptom score greater than 20 with 5 mg finasteride and 2 mg doxazosin daily . Two hundred forty men reported a favorable response to therapy , defined as any reduction in symptom score and toleration of the medications . The dose was maintained at 2 mg doxazosin in 100 men and was titrated to 4 mg doxazosin in 80 patients and to 8 mg doxazosin in an additional 60 patients . We discontinued doxazosin at 3 , 6 , 9 , or 12 months , while continuing finasteride , and then re-evaluated the patients 1 month later to determine whether any worsening of symptoms had result ed . RESULTS In patients discontinuing doxazosin at 3 months , success ( defined as no increase in symptom score and no desire to resume doxazosin ) was reported by 20 % , 15 % , and 13 % of those taking 2 , 4 , and 8 mg , respectively . In patients discontinuing doxazosin at 6 months , success was reported by 48 % , 45 % , and 40 % of those taking 2 , 4 , and 8 mg , respectively . In patients discontinuing doxazosin at 9 months , success was reported by 84 % , 80 % , and 73 % of those taking 2 , 4 , and 8 mg , respectively . In patients discontinuing doxazosin at 12 months , success was reported by 84 % , 85 % , and 87 % of those taking 2 , 4 , and 8 mg , respectively . CONCLUSIONS Patients with lower urinary tract symptoms and moderately enlarged prostates initially receiving combination therapy using finasteride and an alpha-blocker are likely to experience no significant symptom deterioration after discontinuing the alpha-blocker after 9 to 12 months of combination therapy regardless of the dose of alpha-blocker chosen OBJECTIVE To assess the effect of tamsulosin on the Sexual Health Inventory for Men ( SHIM ) score in men diagnosed with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . PATIENTS AND METHODS Analysis from the national data base of a programme of the Prostate Cancer Educational Council identified 7974 men who completed the American Urologic Association Symptom Score ( AUA-SS ) and SHIM question naires . The patients were divided into three groups ; group 1 , men taking tamsulosin ;  group 2 , men on other prescription medications for treating BPH symptoms ;  and group 3 , men not currently taking any BPH medications .  Linear regression was used to assess the association of tamsulosin and other alpha-blocker prescriptions for treating BPH symptoms with the decline in SHIM score . The interaction terms between AUA and the intake of tamsulosin was also adjusted for in the final analysis . RESULTS The median age of the men was 60 years . In groups 1 , 2 and 3 , ( 234 , 291 and 7449 men , respectively ) the mean ( sd ) AUA-SS was 13.0 ( 7.2 ) , 12.1 ( 7.2 ) and 6.9 ( 5.8 ) , and the mean SHIM scores 11.7 ( 6.8 ) , 12.7 ( 6.5 ) and 15.9 ( 6.0 ) , respectively . Adjusting for the AUA-SS , men in group 1 on tamsulosin had a significantly higher SHIM score with increasing AUA-SS score than men on other medications ( P < 0.01 ) , off setting the negative correlation between the AUA-SS and SHIM ( P < 0.01 ) . Moreover , men in group 1 were more likely to have a higher AUA-SS and lower SHIM score than men in the other two groups , suggesting more severe symptoms in these men . CONCLUSIONS Men taking tamsulosin to treat LUTS appear to be at an advantage over men taking other alpha-blockers when the effect of LUTS on sexual health is considered . Furthermore , this effect was more profound in patients with more severe LUTS than those with mild and moderate symptoms . Future prospect i ve trials are warranted to confirm this effect The effects of finasteride , a potent 5 alpha-reductase inhibitor , were assessed in patients with benign prostatic hyperplasia . Patients were treated with finasteride or placebo for 24 weeks in a double-blind multicenter study followed by a 12-month open-extension period . After 24 weeks , finasteride-treated patients , when compared to placebo-treated patients , showed a significant reduction in prostate volume ( 22.5 % median decrease ) and prostate significant antigen ( 32.4 % median decrease ) , a significant increase in maximum urinary flow ( 1.6 ml/s mean increase from baseline ) and a significant improvement in their obstructive symptom scores ( two-point decrease from baseline ) . Finasteride was well tolerated , and the improvements in prostate volume , maximum urinary flow rate and obstructive symptom scores observed in the controlled study were maintained throughout the extension study PURPOSE In the present analysis we examined data from the MTOPS ( Medical Therapy of Prostatic Symptoms ) trial to determine the effect of long-term finasteride treatment , either alone or in combination with doxazosin , on total prostate volume across the full range of baseline total prostate volume values in men enrolled in this study . MATERIAL S AND METHODS In this trial a total of 3,047 patients with lower urinary tract symptoms were r and omized to placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) or the combination of doxazosin and finasteride ( average length of treatment 4.5 years ) . Total prostate volume was measured by transrectal ultrasound in all patients at baseline , yearly and at study end or at termination of participation . RESULTS Long-term treatment with finasteride led to a consistent reduction of approximately 25 % in total prostate volume compared to placebo in men with a relatively small prostate ( less than 25 to 30 ml ) , as well as in those with a moderate size ( 30 to less than 40 ml ) or enlarged prostate ( 40 ml or greater ) at baseline . CONCLUSIONS In this MTOPS data analysis long-term ( more than 4 years ) treatment with finasteride , either alone or in combination with doxazosin , led to a consistent , clinical ly significant reduction in total prostate volume compared to placebo in patients with lower urinary tract symptoms and benign prostatic hyperplasia whose baseline prostate size ranged from relatively small ( less than 25 to 30 ml ) to enlarged ( 40 ml or greater ) Objectives : Knowledge regarding the incidence and prevalence of acute urinary retention  and the ultimate outcome is very limited . The purpose of the present analysis was to document the natural history and outcomes of acute urinary retention ( AUR ) further specified as being either precipitated or spontaneous , and to evaluate the potential benefit of finasteride therapy . Material s and Methods : Three thous and and forty men with moderate to severe symptoms of BPH and enlarged prostate gl and s by digital rectal examination were enrolled into the 4–year placebo – controlled PLESS trial and were evaluated for occurrences of AUR and BPH – related surgery . Men in the study were seen every 4 months ; discontinued patients were followed up 6 months after discontinuation and again at the end of the 4–year trial . Complete 4–year data on outcomes ( occurrence of AUR or BPH – related surgery ) was available for 92 % of the enrolled subjects in each treatment group . An endpoint committee , blinded to treatment group and center , review ed and categorized all study –related documentation relating to retention and surgery . Results : Over the 4–year period , 99 of 1,503 placebo – treated patients ( 6.6 % ) experienced one or more episodes of AUR in comparison with 42 or 1,513 finasteride – treated patients ( 2.8 % ; p<0.001 ) . Approximately half of the episodes of retention were spontaneous and clearly BPH – related , while the other episodes were precipitated by another factor ( PAUR ) . After spontaneous AUR , subsequent surgery was performed in 39 of 52 ( 75 % ) placebo – treated patients versus 8 of 20 ( 40 % ) finasteride – treated patients ( p = 0.01 ) . BPH – related surgery was less common in men who had a prior episode of PAUR ( 26 % in the placebo group and 14 % in the finasteride group ) . Conclusion : There is a continual risk of spontaneous and precipitated acute urinary retention in men with moderate to severe lower urinary tract symptoms and an enlarged prostate gl and . Fewer patients who developed precipitated AUR than spontaneous AUR go on to need subsequent BPH – related surgery . Significantly fewer finasteride – than placebo – treated patients developed AUR , and among those men , fewer ultimately needed BPH – related surgery OBJECTIVE To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia ( BPH ) in order to ensure the optimal indication for different BPH patients . METHODS A r and omized , parallel-controlled , multicenter clinical trial was conducted . From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups , including selective-adrenoceptor antagonist ( terazosin , doxazosin tamsulosin and naftopidil ) , 5 alpha-reductase inhibitor ( finasteride and epristeride ) and natural product ( cernilton ) . International Prostate Symptom Score ( IPSS ) and Quality of Life ( QOL ) , uroflowmetry , total prostatic volume ( TPV ) and transitional zone volume and residual urine  were used as efficacy criteria . RESULTS According to the baseline , the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume ( P < 0.01 ) . At average follow-up of 6 months , significant improvements in IPSS , QOL , Qmax and residual urine volume were observed in each therapeutic group , and no difference in IPSS improvement was found among the groups . Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups ( P < 0.05 ) . In patients with baseline TPV greater than 35.5 cm3 , the improvement of Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group ( P < 0.01 ) ( 5.7 ml/s and 2.2 ml/s respectively ) , and more significant symptomatic improvements were also found in cernilton , doxazosin and naftopidil group . In each group , the improvement of symptom were more significant in patients with IPSS higher than 20 points ( P < 0.01 ) . CONCLUSIONS Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients , especially for patients with higher IPSS baseline . When using 5alpha-reductase inhibitor , prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3 OBJECTIVES To evaluate the safety and efficacy of finasteride 5 mg during a 10-year period in men with enlarged prostates from a single center who participated in the double-blind and extension phases of the multicenter , Phase III , North American benign prostatic hyperplasia ( BPH ) trial . It is important that the long-term safety and efficacy of drugs intended for chronic administration in men with BPH be well understood . METHODS The Phase III North American BPH trial involved a 1-year , placebo-controlled , double-blind study , followed by a 5-year open extension with finasteride 5 mg/day . The trial enrolled men with symptomatic BPH , an enlarged prostate on digital rectal examination , and no evidence of prostate cancer . Of the 46 patients originally enrolled from our institution , 43 were r and omized to receive finasteride or placebo  , of whom 41 ( 95 % ) completed the double-blind study and entered the 5-year extension . Thirty ( 73 % ) of these 41 patients completed the 5-year extension . Patients continued to be followed up by their physicians for an additional 5 years , for a total follow-up of at least 10 years . RESULTS Twenty-four ( 56 % ) of the original 43 patients r and omized to finasteride or placebo were judged as successfully treated during the 10-year finasteride follow-up ( 17 patients taking finasteride alone at 10 years and 7 patients who were taking finasteride alone when they discontinued during the 10-year follow-up for reasons not related to finasteride treatment ) . Altogether , 22 ( 51 % ) of the original 43 r and omized patients continued finasteride treatment at 10 years ( 17 taking finasteride alone , 4 taking finasteride plus an alpha-blocker , and 1 taking finasteride for treatment of hematuria ) . Finasteride was well tolerated , with no new adverse experiences occurring with increasing duration of exposure to the drug . CONCLUSIONS This long-term follow-up study has demonstrated that appropriately selected patients with symptomatic BPH and enlarged prostates are likely to have a long-term response to taking finasteride 5 mg daily Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals , Introduction : To investigate the incidence of ejaculatory disorders caused by naftopidil and tamsulosin in patients with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Material s and Methods : Ninety-five patients with LUTS/BPH who had International Prostate Symptom Scores ( IPSS ) of 8 or more were r and omly assigned to receive naftopidil ( 50 mg/day , n = 48 ) or tamsulosin ( 0.2 mg/day , n = 47 ) . Before and 12 weeks after treatment , a question naire was used to evaluate ejaculation . Results : Among men who had sexual activity during the 12 weeks , the proportion who reported an abnormal feeling on ejaculation was higher in the tamsulosin group ( 16.7 % ) than in the naftopidil group ( 7.4 % ) , although the difference was not significant ( p = 0.402 ) . The proportion of men who reported reduced ejaculatory volume after treatment was significantly higher in the tamsulosin group ( 96.0 % ) than in the naftopidil group ( 73.1 % , p = 0.0496 ) . On the other h and , the improvements in IPSS and the quality of life index were significantly higher in the tamsulosin group than in the naftopidil group . Conclusions : Tamsulosin may cause a higher incidence of ejaculatory disorders than naftopidil , although the efficacy of 0.2 mg tamsulosin may be better than that of 50 mg naftopidil PURPOSE The International Continence Society ( ICS ) ICSmale question naire was devised to provide a thorough evaluation of the occurrence and bothersomeness of lower urinary tract symptoms and their impact on the lives of men with benign prostatic disease . This report completes the developmental work on the question naire , producing the concise short form instrument , ICSmaleSF , with a valid , reliable and scientifically justified scoring system . MATERIAL S AND METHODS Two data sets were used . The short form version of the question naire was devised and initially evaluated using data on men with uncomplicated lower urinary tract symptoms who were involved in the CLasP r and omized controlled trial comparing laser therapy with transurethral prostatic resection and conservative management or monitoring without active intervention . External validation of the scoring system was undertaken using data from phase II of the ICS benign prostatic hyperplasia ( BPH ) study , an observational study of outcome in men with lower urinary tract symptoms related to benign prostatic enlargement . All patients completed the developmental version of the ICSmale question naire . Parallel analysis on the CLasP data set identified items that were responsive to change or highly problematic , allowing other redundant and overlapping items to be eliminated . Factor analysis and Cronbach 's alpha coefficients were used to examine the clustering of items . Regression models were used to investigate the validity of followup scores within and across treatment groups in the CLasP and ICS/BPH studies . RESULTS The question naire , which originally comprised 22 items , was shortened to 11 items in the 2 distinct factors of voiding ( ICSmaleVS ) and incontinence ( ICSmaleIS ) symptoms . Cronbach 's alpha coefficients were high at 0.76 for ICSmaleVS and 0.78 for ICSmaleIS . A simple additive score was calculated by adding the 5 items in ICSmaleVS and 6 in ICSmaleIS . ICSmaleVS and ICSmaleIS detected expected improvement in the laser therapy and transurethral prostatic resection groups , and stability in the conservative management group within CLasP. Similarly each subscore but particularly ICSmaleVS was sensitive to differences in the outcome of the range of treatments in the ICS/BPH study . While frequency and nocturia were highly problematic and sensitive to change individually , they did not load into the other main factors or correlate with each other . It is suggested that these symptoms should be evaluated separately with the additional inclusion of a single item measure of the impact of lower urinary tract symptoms on daily life . CONCLUSIONS The ICSmaleSF represents a comprehensive , concise , valid and reliable instrument for evaluating men with lower urinary tract symptoms . Unlike other question naires in the field it contains subscores for the domains of voiding and incontinent symptoms as well as the separate consideration of frequency , nocturia and impact on daily life . We hope that it will become the tool of choice for the comprehensive evaluation of treatment of men with lower urinary tract symptoms associated with benign prostatic disease BACKGROUND The present study investigated the efficacy , safety , and utility of starting an alpha(1d)-selective antagonist , naftopidil , at 75 or 25 mg/day in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . METHODS In this prospect i ve comparative study , the subjects comprised 153 patients with LUTS associated with BPH . Patients were r and omized to receive either 25 mg/day ( Group LD ) or 75 mg/day ( Group HD ) of naftopidil for 4 weeks . The lower urinary tract disease symptom score ( LUTDSS ) , the International Prostate Symptom Score ( IPSS ) , the Quality of life assessment index , the maximum flow rate ( Q(max ) ) , and the residual urine volume were compared between the groups . RESULTS In both groups , the LUTDSS and the IPSS were significantly improved at the endpoint and no significant intergroup differences were identified . However , the improvement in the Q(max ) was significantly better for Group HD than for Group LD . The overall efficacy did not differ significantly between the groups . The degree of improvement in voiding symptoms and LUTDSS among patients with moderate symptoms was significantly greater for Group HD than for Group LD . The frequency of adverse reactions did not differ significantly between the groups . CONCLUSIONS Starting administration at 75 mg/day rather than 25mg/day is helpful for LUTS associated with BPH for patients with moderate symptoms , particularly in improving voiding symptoms . The 75 mg/day administration was considered to be a recommendable therapeutic dose in some patients Purpose The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) . While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies . We therefore sought to further assess nocturia based on data integrated from four tadalafil registration al studies . Methods Data were integrated from four r and omized , placebo-controlled  , double-blind , 12-week registration al studies of tadalafil for LUTS/BPH . Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 ( IPSS Q7 ) . Efficacy results were analyzed using analysis of covariance . Results For the tadalafil 5 mg once daily ( N = 752 ) and placebo ( N = 748 ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2 . The mean treatment change was −0.4 with placebo and −0.5 with tadalafil ; the least-squares mean ( st and ard error ) treatment difference was −0.2 ( 0.05 ) , p = 0.002 . For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was 41.3 and 47.5 % , with no change was 44.8 and 41.0 % , and with worsening was 13.9 and 11.5 % . Conclusions A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinical ly meaningful . Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH OBJECTIVE To compare the efficacy and safety of a combination therapy , doxazosin plus tenoxicam , and doxazosin alone for lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) , as various combination therapies increase the efficacy of medical therapy . Alpha blocker agents have been widely used for the treatment of LUTS secondary to BPH . METHOD Fifty-seven patients complaining of LUTS secondary to BPH were enrolled in this clinical trial . Patients were r and omly assigned to receive doxazosin 4 mg or doxazosin 4 mg plus tenoxicam 20 mg treatment . Patients were evaluated for BPH according to the European Association of Urology and American Urological Association clinical guidelines . In addition , patients were assessed with Overactive Bladder Symptom Score ( OABSS ) and International Index of Erectile Function ( IIEF ) . Patients were reevaluated after a 6-week treatment course . The International Prostatic Symptom Score ( IPSS ) , IPSS- Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Q(max ) ) , and average urinary flow rates ( AFR ) were determined at baseline and again at 6 weeks as efficacy parameters . RESULTS The total IPSS , IPSS-QoL , and OABSS decreased significantly in both tenoxicam plus doxazosin group and doxazosin alone group compared with baseline ( P < .01 ) . Also , Q(max ) and AFR significantly improved in both groups ( P < .01 ) . The improvements in IPSS , IPSS-QoL , and OABSS were significantly better in patients treated with combination therapy ( P < .05 ) . CONCLUSIONS COX-2 inhibitors in combination with an alpha blocker may increase the effectiveness of the therapy for LUTS secondary to BPH without significant effects on side effect profile To determine the influence of and rogen deprivation induced by the potent 5 alpha-reductase inhibitor finasteride on the volume of the zones of the prostate , 20 symptomatic men with established BPH were r and omized to one of three groups : placebo , finasteride 1 mg , and finasteride 5 mg/day . The volume of the entire prostate gl and , periurethral zone , and peripheral zone and the seminal vesicles were determined by three dimensional reconstructions of magnetic resonance contoured images of the prostate . There was no significant difference between the results achieved with 1 and 5 mg of finasteride per day ; thus the results in these two groups were combined . In the placebo group there was no significant change in the volume of any structure . Following treatment for 1 year with finasteride there was a significant ( P < 0.02 ) 17 % decrease in total gl and size ( 11.5 + /- 3.2 cc ) . Similarly , there was a significant ( P < 0.02 ) 17 % decrease in total gl and size ( 11.5 + /- 3.2 cc ) . Similarly , there was a significant ( P < 0.03 ) decrease in the size of the periurethral zone of the prostate ( 6.2 + /- 3 cc ) . Although there was also a decrease in the size of the peripheral zone of the prostate ( 2.8 + /- 1.2 cc ) this did not reach statistical significance . There was no significant change in the volume of the seminal vesicles . These findings indicate for the first time that and rogen deprivation induces a significant decrease in the size of the periurethral zone of the prostate in men with established BPH
MAIN RESULTS Finasteride consistently improved urinary symptom scores more than placebo in trials of > 1 year duration , and significantly lowered the risk of BPH progression ( acute urinary retention , risk of surgical intervention , ≥ 4 point increase in the AUASI/IPSS ) .
In comparison to alpha-blocker monotherapy , finasteride was less effective than either doxazosin or terazosin , but equally effective compared to tamsulosin .
Both doxazosin and terazosin were significantly more likely than finasteride to improve peak urine flow and nocturia , versus finasteride .
Versus tamsulosin , peak urine flow and QoL improved equally well versus finasteride .
However , finasteride was associated with a lower risk of surgical intervention compared to doxazosin , but not to terazosin , while finasteride and doxazosin were no different for risk of acute urinary retention .
Finasteride + doxazosin and doxazosin monotherapy  improved urinary symptoms equally well ( ≥ 4 point improvement).For finasteride , there was an increased risk of ejaculation disorder , impotence , and lowered libido , versus placebo .
Versus doxazosin , finasteride had a lower risk of asthenia , dizziness , and postural hypotension , and versus terazosin , finasteride had a significant , lower risk of asthenia , dizziness , and postural hypotension .
Finasteride improves long-term urinary symptoms versus placebo , but is less effective than doxazosin .
Long-term combination therapy with alpha blockers ( doxazosin , terazosin ) improves symptoms significantly better than finasteride monotherapy .
Finasteride + doxazosin improves symptoms equally - and clinical ly - to doxazosin alone .
Finasteride + doxazosin versus doxazosin  improves scores equally for short and long term .
Drug-related adverse effects for finasteride are rare ; nevertheless , men  taking  finasteride are at increased risk for impotence , erectile dysfunction , decreased libido , and ejaculation disorder , versus placebo .
Versus doxazosin , which has higher rates of dizziness , postural hypotension , and asthenia , men taking finasteride are at increased risk for impotence , erectile dysfunction , decreased libido , and ejaculation disorder .
Finasteride significantly reduces asthenia , postural hypotension , and dizziness versus terazosin .
Finasteride significantly lowers the risk of asthenia , dizziness , ejaculation disorder , and postural hypotension , versus finasteride + terazosin
BACKGROUND Benign prostatic hyperplasia ( BPH ) , a non-malignant enlargement of the prostate in aging men , can cause bothersome urinary symptoms ( intermittency , weak stream , straining , urgency , frequency , incomplete emptying ) .
Finasteride , a five-alpha reductase inhibitor ( 5ARI ) , blocks the conversion of testosterone to dihydrotestosterone , reduces prostate size , and is commonly used to treat symptoms associated with BPH .
OBJECTIVES To compare the clinical effectiveness and harms of finasteride versus placebo and active controls in the treatment of lower urinary tract symptoms ( LUTS ) .