title: Intra- and interobserver variability of MRI prostate volume measurements. Finasteride in the treatment of benign prostatic hyperplasia. A urodynamic evaluation. Therapeutic effects of finasteride in benign prostatic hyperplasia: a randomized double-blind controlled trial. Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome Proscar: five-year experience. A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia Pharmacotherapy of benign prostatic hyperplasia: Inhibitor of 5 alpha-reductase Combined analysis of two multicenter studies of finasteride 5 mg in the treatment of symptomatic benign prostatic hyperplasia The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia. Long-term effects of finasteride on prostate tissue composition. 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. Urodynamic effects of finasteride in the treatment of bladder outlet obstruction due to benign prostatic hyperplasia. Sustained decrease in incidence of acute urinary retention and surgery with finasteride for 6 years in men with benign prostatic hyperplasia. Endocrine therapy for benign prostatic hyperplasia in the 90's. The relationship among lower urinary tract symptoms, prostate specific antigen and erectile dysfunction in men with benign prostatic hyperplasia: results from the proscar long-term efficacy and safety study. The mechanism of adverse events associated with terazosin: an analysis of the Veterans Affairs cooperative study. Serum prostate specific antigen is a strong predictor of future prostate growth in men with benign prostatic hyperplasia. PROSCAR long-term efficacy and safety study. Finasteride in the treatment of benign prostatic hyperplasia. 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. Maximum urinary flow rate by uroflowmetry: automatic or visual interpretation. Long-term effects of finasteride on invasive urodynamics and symptoms in the treatment of patients with bladder outflow obstruction due to benign prostatic hyperplasia. Prostate Volume and Serum Prostate–Specific Antigen as Predictors of Acute Urinary Retention Transition zone volume and transition zone ratio: predictor of uroflow response to finasteride therapy in benign prostatic hyperplasia patients. Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia. Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. [Can finasteride reverse the progress of benign prostatic hyperplasia? A two-year placebo-controlled study.]. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. 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. 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. Treatment with finasteride preserves usefulness of prostate-specific antigen in the detection of prostate cancer: results of a randomized, double-blind, placebo-controlled clinical trial. PLESS Study Group. Proscar Long-term Efficacy and Safety Study. Comparison of Tamsulosin and Finasteride for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia in Korean Patients Changes in nocturia from medical treatment of benign prostatic hyperplasia: secondary analysis of the Department of Veterans Affairs Cooperative Study Trial. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study. Continued improvement in pressure-flow parameters in men receiving finasteride for 2 years. Finasteride Urodynamics Study Group. 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. The effect of finasteride on prostate volume, urinary flow rate and symptom score in men with benign prostatic hyperplasia. Prostate tissue composition and response to finasteride in men with symptomatic benign prostatic hyperplasia. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. The influence of finasteride on the volume of the peripheral and periurethral zones of the prostate in men with benign prostatic hyperplasia. Effect of discontinuation of 5alpha-reductase inhibitors on prostate volume and symptoms in men with BPH: a prospective study. Effects of finasteride on health-related quality of life in men with symptomatic benign prostatic hyperplasia. Finasteride Study Group. Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia. Long-term treatment with finasteride in men with symptomatic benign prostatic hyperplasia: 10-year follow-up. 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 impact of medical therapy on bother due to symptoms, quality of life and global outcome, and factors predicting response. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. Scandinavian clinical study of finasteride in the treatment of benign prostatic hyperplasia. Effects of finasteride and cyproterone acetate on hematuria associated with benign prostatic hyperplasia: a prospective, randomized, controlled study. Five-year follow-up of patients with benign prostatic hyperplasia treated with finasteride. Impact of baseline symptom severity on future risk of benign prostatic hyperplasia-related outcomes and long-term response to finasteride. The Pless Study Group. Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. Three-year safety and efficacy data on the use of finasteride in the treatment of benign prostatic hyperplasia. The influence of finasteride on the development of prostate cancer. Improvement of pressure flow parameters with finasteride is greater in men with large prostates. Finasteride Urodynamics Study Group. Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia. Urinary Retention in Patients with BPH Treated with Finasteride or Placebo over 4 Years
abstract: BACKGROUND The Early Intervention Study , a placebo-controlled clinical trial , enrolled approximately 200 patients between age 45 - 65 years who had mild symptoms associated with early benign hyperplasia ( BPH ) . Prostate volume was measured by magnetic resonance imaging ( MRI ) and read by the local radiologist , who was blinded to the treatment group but not to the sequence of MRI scans . In order to ascertain whether knowledge of the sequence of the MRI scans by the local radiologist was introducing bias in prostate volume changes , a single radiologist was selected to reread all MRI scans at the end of the study . METHODS Each film was masked as to patient identity , study drug , and date . A new r and omization schedule was prepared to blind the single reader to both sequence and treatment . The two sets of readings were compared . RESULTS Accuracy was dramatically improved when defined as percentage of patients with a 20 % or more decrease in prostate volume , from 14 % to 0 % in placebo patients , and from 38 % to 29 % in finasteride patients . The variability was significantly reduced ( by 50 % ) when read by a single observer [ 1 ] . CONCLUSIONS A single reader , blinded to time sequence as well as to therapy , improves the accuracy and precision of the measurements when compared to multiple readers , blinded only to drug therapy 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 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 Objective To test the hypothesis that in patients with benign prostatic hyperplasia ( BPH ) , the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL , using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy 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 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 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 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 We evaluated the effectiveness of single or combination drug therapy on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 3,047 men with lower urinary tract symptoms/benign prostatic hyperplasia enrolled in the Medical Therapy of Prostatic Symptoms trial were r and omly assigned to receive doxazosin alone , finasteride alone , combination therapy or placebo . Treatment effectiveness was assessed according to intent to treat by mean reduction in self-reported nightly nocturia at 1 and 4 years . A subgroup analysis by age ( younger than 70 vs 70 years old or older ) was also performed . RESULTS Of the men 2,583 reported 1 or more episodes of nocturia and finished 12 or more months of the trial .  Mean nocturia was similar in all groups at baseline . Mean nocturia was reduced at 1 year by 0.35 , 0.40 , 0.54 and 0.58 in the placebo , finasteride , doxazosin and combination groups , respectively . Reductions with doxazosin and combination therapy were statistically greater than with placebo ( p < 0.05 ) . At 4 years nocturia was also significantly reduced in patients treated with doxazosin and combination therapy ( p < 0.05 vs placebo ) . In men older than 70 years ( 495 ) all drugs significantly reduced nocturia at 1 year ( finasteride 0.29 , doxazosin 0.46 and combination 0.42 ) compared to placebo ( 0.11 , p < 0.05 ) . CONCLUSIONS Doxazosin and combination therapy reduced nocturia more than placebo , but the net benefit of active drug compared to placebo was often modest with a net difference of less than 0.20 fewer nightly nocturia episodes at 1 and 4 years . Findings in men 70 years old or older were similar , with an even smaller effect observed for finasteride OBJECTIVES To determine the long-term effects of finasteride treatment on prostate tissue composition ; to relate these effects to clinical outcomes ; and to test the hypothesis that finasteride exerts a selective or preferential action on the transition zone . METHODS Nineteen men with symptomatic benign prostatic hyperplasia ( BPH ) who completed a 6-month double-blind trial of finasteride  were enrolled in a 24-month open-label extension study of drug responders . Magnetic resonance imaging and prostate biopsy for morphometric analysis were performed together 70 times : at baseline ( n = 19 ) , after treatment periods of intermediate duration ( 6 to 18 months , n = 32 ) , and after long-term drug treatment ( 24 to 30 months , n = 19 ) . At baseline , prostate volume averaged 51 cc , of which 57 % was transition zone . RESULTS Decreases in symptom score , dihydrotestosterone and prostate-specific antigen levels , and prostate volume occurred at 6 months ( P < 0.01 ) , stabilized , and were maintained without further long-term decreases . Prostate epithelium contracted progressively from baseline ( 19.2 % tissue composition ; 6.0-cc volume ; 3.2 stroma/epithelial ratio ) to intermediate ( 12.5 % , 3.3 cc , and 5.6 , respectively ) to long-term treatment ( 6.4 % , 2.0 cc , and 17.4 , respectively , P < 0.01 for all ) . Percent epithelial contraction was similar in the peripheral and transition zones ( P = NS ) . The transition zone remained a relatively constant proportion ( 53 % to 58 % ) of whole-prostate volume from baseline to long-term observation . CONCLUSIONS Long-term finasteride treatment ( 24 to 30 months ) results in a marked involution of the prostate epithelium , which continues to progress for many months after clinical effects stabilize . The effect on the epithelium is similar in the peripheral and transition zones for both morphometric and volumetric changes . Progressive contraction of the prostate epithelium appears to constitute the underlying mechanism for sustained action of finasteride 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 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 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 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 PURPOSE We evaluated the associations among lower urinary tract symptoms , prostate specific antigen ( PSA ) and erectile dysfunction ( ED ) in men with benign prostatic enlargement enrolled in the Proscar ( Merck , Whitehouse Station , New Jersey ) Long-Term Efficacy and Safety Study . MATERIAL S AND METHODS The Proscar Long-Term Efficacy and Safety Study was a 4-year , r and omized , double-blind , placebo controlled study that enrolled 3,040 men with moderate to severe lower urinary tract symptoms and an enlarged prostate gl and . Two questions assessed ED . A logistic regression model , including the effect of patient age , was used to examine the relationships among  quasi-American Urological Association Symptom Score ( AUASS ) , PSA , and ED at baseline . Changes in ED scores from baseline to study closeout were analyzed with ANOVA . RESULTS A total of 2,981 patients had baseline data available for analysis . Mean age was 64 years , mean  quasi-AUASS  was 15 , mean  PSA was 2.8 ng/ml and mean prostate volume was 55 cm . At baseline every 1 point increase in quasi-AUASS was associated with a 2 % increased risk of ED even after controlling for age ( p < 0.001 ) . At 48 months in placebo but not in finasteride treated men a 1-unit decrease in quasi-AUASS was associated with a slight but statistically significant decrease in ED . No association existed between increasing PSA and ED on baseline or longitudinal analysis . CONCLUSIONS We found a moderately strong association between baseline quasi-AUASS and the ED rate in men with an enlarged prostate , a finding that was supported by longitudinal data in the placebo arm . The absence of a relationship between PSA and ED highlights the need for further investigation into the mechanisms of benign prostatic hyperplasia related sexual dysfunction PURPOSE We determined the mechanism of adverse events associated with alpha1-blockers for treating benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS We r and omized 1,229 men with clinical BPH at 31 Veterans Affairs medical centers into equal treatment groups , including those who received placebo , terazosin , finasteride , and combined terazosin and finasteride therapy , respectively . Adverse events were captured at all study visits during our 1-year study . Our current review of adverse events is limited to patients r and omized to the placebo and terazosin groups . We compared the incidence of orthostatic blood pressure change , postural symptoms and orthostatic hypotension in men who were normotensive and hypertensive at baseline , respectively . We also determined the association of changes in systolic blood pressure with the incidence of treatment related adverse events . RESULTS The treatment related rates of dizziness , asthenia , postural hypotension and syncope were 19 % , 6 % , 6 % and 1 % , respectively . Of these adverse events only postural hypotension was associated with orthostatic blood pressure changes . The incidence of asthenia , dizziness and postural hypotension was not significantly greater in patients with a systolic blood pressure decrease of 5 or greater and less than 5 mm . Hg , respectively . CONCLUSIONS Dizziness and asthenia are not associated with changes in blood pressure , suggesting that these treatment related adverse events associated with alpha1-blockers are not related to vascular events . Design ing a subtype selective alpha1 antagonist that has less effect on blood pressure may not result in marked improvement in tolerability over commercially available alpha1-blockers PURPOSE We analyze patterns of prostate growth in men diagnosed with benign prostatic hyperplasia ( BPH ) and treated with placebo  during 4 years , and determine which baseline parameters were the strongest predictors of growth . MATERIAL S AND METHODS A total of 3,040 men were enrolled in the 4-year r and omized , placebo controlled Proscar Long-Term Efficacy and Safety study . Of these men a subgroup of 10 % underwent pelvic magnetic resonance imaging prostate volume measurement at baseline and yearly thereafter . Absolute and percent volume changes during 4 years were calculated in the 164 placebo treated men in the subgroup . The ability of age , baseline prostate volume and prostate specific antigen ( PSA ) to predict prostate growth in placebo treated patients was assessed by multiple linear regression analyses , receiver operator characteristics curves , and evaluations of growth stratified by tertiles of baseline serum PSA and decades of life . RESULTS In placebo treated patients a steady increase in mean plus or minus st and ard deviation prostate volume from year to year was noted ( 2.5+/-6.1 , 4.9+/-6.8 , 6.4+/-8.5 and 7.2+/-8.8 ml . at years 1 , 2 , 3 and 4 , respectively ) . Mean volume changes at 4 years ranged from -9 to + 30 ml . Mean percent change from baseline ranged from 12.5 % to 16.6 % for men 50 to 59 years old to those 70 to 79 years old . Baseline serum PSA was a strong predictor of growth with 7.4 % to 22.0 % change at 4 years from the lowest to highest PSA tertiles . Annualized growth rates from baseline were 0.7 ml . per year for PSA 0.2 to 1.3 , 2.1 for PSA 1.4 to 3.2 and 3.3 for PSA 3.3 to 9.9 ng./ml . Multiple linear regression analysis showed that serum PSA was a stronger predictor of prostate growth than age or baseline prostate volume . All but 1 man with baseline serum PSA greater than 2.0 ng./ml . had prostate growth during 4 years , and 32.6 % of men with serum PSA less than 2.0 exhibited a decrease in volume . CONCLUSIONS Serum PSA is a stronger predictor of growth of the prostate in placebo treated patients than age or baseline prostate volume . Since prostate volume is a risk factor for acute urinary retention and the need for BPH related surgery , the ability of PSA to predict prostate growth may be an important factor when considering individual treatment options for BPH . Such use of PSA represents a shift in paradigm away from focusing solely on symptoms of BPH toward a more comprehensive approach with consideration of predicting and preventing risk factors of BPH related outcomes 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 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 ) We measured the maximum urinary flow rate monthly for 1 year by uroflowmetry in 1,645 patients in a double-blind , placebo-controlled study of finasteride therapy for benign prostatic hyperplasia . Patients were r and omized to receive placebo ( 555 ) or finasteride ( 1,090 ) . A total of 23,857 flow measurements was obtained . Because of the presence of artifacts on many uroflow curves , we read the maximum urinary flow rate values manually and compared them to the values provided electronically by the uroflowmeter . On average , the manually read values were 1.5 ml . per second lower than the machine read values . Artifacts causing a difference of 2 ml . per second or more between the 2 methods were found in 20 % and of more than 3 ml . per second in 9 % of the tracings . The difference between treatment groups in mean maximum urinary flow rate change at the end of the study was the same with both reading methods . However , confidence intervals were 15 to 25 % larger for the machine read compared to the manually read values . This larger variability in machine read maximum urinary flow rate has a marked negative impact on the power of statistical tests to assess any given difference in maximum urinary flow rate between treatment groups . Furthermore , it increases sample size requirements by 50 % to achieve any given statistical power . We conclude that maximum urinary flow rate artifacts contribute significantly to the variability of maximum urinary flow rate measurement by uroflowmetry . Manual reading of the maximum urinary flow rate eliminates an important fraction of such variability PURPOSE We assess the long-term effects of finasteride on bladder outlet obstruction and symptoms in the treatment of patients with benign prostatic hyperplasia . MATERIAL S AND METHODS Of the original 36 patients assigned to treatment with 5 mg . finasteride daily ( group 1 ) or placebo ( group 2 ) for 6 months 27 completed an open extension study of 5 mg . finasteride  for 4 more years . The possible relief of bladder outlet obstruction was monitored with repeated pressure-flow studies at baseline , 6 months and 4.5 years . RESULTS The treatment result ed in a further slight decrease in detrusor pressure at maximum flow rate in group 1 and a significant decrease in group 2 during the 4-year period , whereas improvement in maximum flow rate did not achieve statistical significance . Concomitantly , there was a significant improvement in obstructive and irritative symptoms . CONCLUSIONS Finasteride decreases bladder outlet obstruction moderately and only occasionally relieves it completely . However , the decrease in obstruction achieved in many patients is sufficient to improve the symptoms significantly . The beneficial effect is long-lasting Objectives : We evaluated prostate volume and  prostate – specific antigen ( PSA ) as predictors of acute urinary retention ( AUR ) in men with benign prostatic enlargement ( BPE ) . Methods : Data were pooled from 3 identical 2–year , multinational , multicenter , non – US , placebo – controlled finasteride trials in 4,222 men with BPE and no evidence of prostate cancer . Results : The 2–year incidence of spontaneous AUR was higher in placebo patients with enlarged prostates ( 4.2 % in men with prostate volume ≥40 ml vs 1.6 % in the < 40 ml group ) and higher PSA levels ( 3.9 % in men with PSA ≥1.4 ng/ml vs. 0.5 % in the < 1.4 ng/ml group ) at baseline . Finasteride reduced AUR incidence by 61 % in men with larger prostates , by 63 % in men with higher PSA levels , and by 47 % in men with smaller prostates , compared with placebo . Conclusions : BPE patients with larger prostate volumes , higher PSA levels and no evidence of prostate cancer have an increased risk of developing AUR and therefore derive the greatest benefit from the risk reduction seen with finasteride therapy OBJECTIVES The aim of this study was to : ( 1 ) determine effects of finasteride on transition zone ( TZ ) volume , TZ ratio ( TZ volume/total prostate volume ) , and total prostate volume ; ( 2 ) analyze differences in TZ and total volume reduction among patients who improve peak urinary flow rates following finasteride therapy with those who do not ; ( 3 ) investigate which parameters correlate with improvement in peak urinary flow rate and urinary symptom score ; and ( 4 ) establish if there is any predictive value of these parameters for response to therapy . METHODS Twenty-three patients with symptomatic benign prostatic hyperplasia ( BPH ) were treated with finasteride ( 5 mg/d ) for 12 months and underwent transrectal ultrasound ( TRUS ) evaluation of total and TZ volume of prostate and measurement of peak flow rate and modified Boyarsky symptom score at baseline and at 12 months . Statistical analysis was done by unpaired t , Mann-Whitney , and Spearman rank correlation tests among responders ( more than 3 cc/s improvement in peak flow rate ) and nonresponders ( less than 3 cc/s improvement in peak flow rate ) to therapy . RESULTS ( 1 ) Responders had substantial reduction in TZ volume ( 44.8 % versus 16.05 % ; P < 0.03 ) and TZ ratio ( 25 % versus 5 % increase , P < 0.02 ) compared with nonresponders . ( 2 ) There was a significant correlation between reduction in TZ volume ( r = 0.50 ; P < 0.03 ) and TZ ratio ( r = 0.60 ; P < 0.006 ) with improvement in peak flow rates . No similar correlation was seen with total prostate volume changes . ( 3 ) Pretreatment TZ ratio helped in predicting peak flow improvement following finasteride therapy ( r = 0.52 ; P < 0.01 ) and there was a 2.5-fold increased chance of improvement if baseline TZ ratio was more than 0.51 . The modified Boyarsky symptom score decreased by 3.1 ( mean ) , but there was no correlation with changes in peak urinary flow rate , total prostate volume , TZ volume , and TZ ratio . TZ ratio did not have significant predictive value for improvement in symptom score . CONCLUSIONS This study provides data that simple measurable parameters are available which may be used prior to therapy to predict uroflow response to finasteride and similar agents OBJECTIVES To summarize the 6-year clinical trial data with finasteride . Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important . METHODS The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate gl and s. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension . In total , 6-year finasteride data were available in 487 patients originally r and omized to finasteride , and 5-year data were available on 238 patients originally r and omized to placebo .  RESULTS After 6 years of treatment with finasteride 5 mg , the mean quasi-American Urological Association Symptom Score improved by 4.0 points , the median prostate volume decreased by 24 % , and the mean maximal urinary flow rate increased by 2.9 mL/s ( P < 0.001 for all parameters ) . Long-term finasteride treatment was well tolerated , with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension . CONCLUSIONS Treatment with finasteride leads to durable improvement in urinary tract symptoms , flow rate , and prostate volume , with no increase in the prevalence of drug-related adverse events over time OBJECTIVES To evaluate the incidence and resolution of sexual adverse experiences ( AEs ) in men with benign prostatic hyperplasia treated with finasteride 5 mg compared with placebo . 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 , aged 45 to 78 years , with symptomatic benign prostatic hyperplasia , enlarged prostates , and no evidence of prostate cancer . Patients completed a question naire at screening regarding their history of sexual dysfunction . During treatment , spontaneously self-reported sexual AEs were recorded . RESULTS At screening , 46 % of patients in each treatment group reported some history of sexual dysfunction . During year 1 of the study , 15 % of finasteride-treated patients and 7 % of placebo-treated patients had sexual AEs that were considered drug related by the investigator ( P < 0.001 ) . During years 2 to 4 , no between-group difference was noted in the incidence of new sexual AEs ( 7 % in each group ) . The drug-related sexual AE profile for finasteride was similar for men with or without a history of sexual dysfunction . Sexual AEs resolved while continuing therapy in 12 % of finasteride patients and 19 % of placebo patients . Only 4 % of finasteride and 2 % of placebo patients discontinued the study because of sexual AEs . In men who discontinued with a sexual AE , 50 % and 41 % experienced resolution of their sexual AE after discontinuing finasteride or placebo therapy , respectively . CONCLUSIONS Compared with placebo , men treated with finasteride experienced new drug-related sexual AEs with an increased incidence only during the first year of therapy 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 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 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 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 OBJECTIVES To evaluate prostate cancer detection and prostate-specific antigen ( PSA ) among men with benign prostatic hyperplasia treated with finasteride .  METHODS Three thous and forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were r and omized in a double-blind , placebo-controlled trial to finasteride ( n = 1524 ) or placebo ( n = 1516 ) for up to 4 years . A prer and omization biopsy negative for prostate cancer was obtained in 98 % of patients with a screening PSA of 4.0 ng/mL or more , and an end-of- study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis . RESULTS Overall , 644 patients ( 21 % ) underwent biopsy  and 201 ( 6.6 % ) underwent transurethral resection of the prostate .  Prostate cancer was diagnosed in 4.7 % of men on finasteride and 5.1 % on placebo ( P = 0.7 ) . Elevated PSA prompted diagnosis in 35 % of cases on finasteride and 34 % on placebo . The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo ( P = 0.07 ) . Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity ( 66 % versus 70 % , P = 0.6 ) , higher specificity ( 82 % versus 74 % , P < 0.0001 ) , and a higher likelihood ratio ( 3.6 versus 2.7 , P < 0.05 ) for finasteride than for placebo . CONCLUSIONS In men treated with finasteride , multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection 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 PURPOSE We evaluate the efficacy of medical therapy on nocturia in men with benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS We performed a secondary analysis of data from the VA Cooperative Study Program Trial in which 1,229 men with BPH 45 to 80 years old were r and omly assigned to receive terazosin , finasteride , combination or placebo . RESULTS The 1,078 men who completed 12 months of the trial are included in this study . Of those men 1,040 ( 96.5 % ) had at least 1 episode of nocturia at baseline and 38 ( 3.5 % ) had less than 1 episode ( baseline nocturia is an average of 2 measures ) . Of those 1,040 men 788 ( 75.8 % ) had 2 or more nocturia episodes . Overall , nocturia decreased from a baseline mean of 2.5 to 1.8 , 2.1 , 2.0 and 2.1 episodes in the terazosin , finasteride , combination and placebo groups , respectively . Of men with 2 or more episodes of nocturia 50 % reduction in nocturia was seen in 39 % , 25 % , 32 % and 22 % in the terazosin , finasteride , combination and placebo groups , respectively . Changes in nocturia were correlated with changes in reported bother from nocturia ( Pearson correlation 0.48 ) , BPH impact index ( 0.32 ) and overall satisfaction with urinary symptoms ( 0.33 ) . CONCLUSIONS Terazosin and combination therapy reduced nocturia in men with BPH , yet the net advantage of terazosin over placebo was a net reduction of 0.3 nocturia episode . For a person to reach a 50 % or greater reduction in nocturia , the advantage of terazosin over placebo was 17 percentage points . Changes in nocturia had a moderate impact on symptom specific quality of life measures OBJECTIVE To evaluate the efficacy and safety of 2 years ' treatment of moderate benign prostatic hyperplasia ( BPH ) with finasteride . DESIGN Double-blind , parallel-group , placebo-controlled , multicentre , prospect i ve r and omized study . SETTING Outpatient care in 28 centres across Canada . PARTICIPANTS Men aged 45 to 80 , in good health , with moderate BPH and no evidence of prostate cancer . A total of 613 men were entered into the study ; 472 completed the 2 years of treatment . INTERVENTION After 1 month of receiving a placebo ( run-in period ) , patients were given either finasteride ( 5 mg/d ) or a placebo for 2 years . OUTCOME MEASURES EFFICACY changes from baseline in BPH symptom scores , maximum urinary flow rates and prostate volume . SAFETY onset , course and resolution of all adverse events during the treatment period . RESULTS In the efficacy analyses the mean BPH symptom scores decreased 2.1 points ( from 15.8 to 13.7 ) in the finasteride group , as compared with a decrease of 0.7 points ( from 16.6 to 15.9 ) in the placebo group ( P < or = 0.01 ) . The maximum urinary flow rate increased by a mean of 1.4 mL/s ( from 11.1 to 12.5 mL/s ) in the finasteride group , as compared with an increase of 0.3 mL/s ( from 10.9 to 11.2 mL/s ) in the placebo group ( p < or = 0.01 ) . The mean prostate volume decreased by 21 % ( from a mean volume of 44.1 cm3 at baseline ) in the treatment group ; it increased by 8.4 % ( from a mean volume of 45.8 cm3 at baseline ) in the placebo group ( p < or = 0.01 ) . In the safety analysis , the proportion of patients who experienced any adverse event was similar in the two groups ( 81.0 % in the treatment group and 81.2 % in the placebo group ) . However , the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group ( ejaculation disorder 7.7 % v. 1.7 % and impotence 15.8 % v. 6.3 % ; p < or = 0.01 for both parameters ) . CONCLUSION Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH OBJECTIVES To assess the long-term effects of finasteride on pressure-flow parameters in men with urodynamically documented bladder outflow obstruction ( BOO ) . METHODS One hundred twenty-one men with benign prostatic enlargement ( BPE ) and lower urinary tract symptoms ( LUTS ) underwent a pressure-flow study ( PFS ) at 1 of 11 clinical centers . The PFS technique was st and ardized , and all tracings were read by a single reader unaware of the treatment group . Patients who were obstructed according to a modified Abrams-Griffiths nomogram  were r and omized to 5 mg finasteride ( n = 81 ) or placebo ( n = 40 ) for 12 months ; all patients continuing into an open extension received finasteride during the second 12 months of therapy . Results of the initial 12-month study demonstrated the benefit of finasteride treatment on PFS parameters . To examine the continuing effects over time , an analysis of the data from 54 patients who completed 24 months of treatment with finasteride is provided . RESULTS Detrusor pressure at maximum flow ( PdetQmax ) continued to decrease during the second 12 months of therapy ( decreases of 5.3 and 11.7 cm H2O at months 12 and 24 , respectively ) . The percentage of patients obstructed by Abrams-Griffiths classification decreased from 76.2 % at baseline to 66.7 % at month 12 and 59.6 % at month 24 . An intention-to-treat analysis yielded similar results . CONCLUSIONS Finasteride improves urodynamic measures of obstruction in men with BPE and LUTS , with continued improvement during the second 12 months of therapy 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 ) 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 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 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 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 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 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 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 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 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 PURPOSE We determine the effect of placebo , finasteride , terazosin and a combination of drugs on bother due to symptoms , quality of life and patient perception of improvement , and identify baseline clinical factors that predict clinical response to medical therapy . MATERIAL S AND METHODS A total of 1,229 subjects with clinical benign prostatic hyperplasia ( BPH ) were r and omized to 1 year of placebo , finasteride , terazosin or drug combination . The primary outcome measures were American Urological Association ( AUA ) symptom score and peak flow rate . Relevant secondary outcome measures were symptom problem score , BPH impact score and global rating of improvement . RESULTS Group mean differences in symptom problem and BPH impact scores between the finasteride versus placebo , and terazosin versus combination groups were not statistically or clinical ly significant . Group mean differences in all outcome measures were highly statistically significant between the terazosin and finasteride , and combination and finasteride groups . The percentage of subjects who rated improvement as marked or moderate with placebo , finasteride , terazosin and combination was 39 , 44 , 61 and 65 % , respectively . In the subsets of men in the placebo , finasteride , terazosin and combination groups with prostates greater than 50 cm.3 group mean decrease from baseline in AUA symptom score was -2.5 , -3.6 , -6 and -7 , group mean increase in peak flow rate was 0.6 , 2.7 , 3.6 and 3.7 ml . per second , group mean decrease in symptom problem score was -2.2 , - 1.9 , -3.1 and -4.5 , and group mean decrease in BPH impact score was -0.6 , -0.3 , -1.1 and -1.5 , respectively . A correlational analysis failed to show a significant relationship between baseline prostate volume and treatment response to finasteride . There was a significant but weak relationship between change in AUA symptom score and peak flow rate in the finasteride and combination groups . The symptom responses with terazosin were independent of baseline peak flow rate . CONCLUSIONS In men with clinical BPH  finasteride and placebo are equally effective , while terazosin and combination are significantly more effective . In men with clinical BPH and large prostates the advantage of finasteride over placebo in terms of symptom reduction , impact on bother due to symptoms and quality of life is small at best , while the advantage of terazosin and combination over finasteride and placebo is highly significant . Baseline prostate volume was not a predictor of response to finasteride in the overall study population . On the basis of our results alpha1 blockers , such as terazosin , should be first line medical treatment for BPH 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 OBJECTIVES To evaluate the influence of two differently acting anti and rogens , finasteride ( FIN ) and cyproterone acetate ( CPA ) , on the natural history of hematuria associated with benign prostatic hyperplasia ( BPH ) in a prospect i ve , r and omized , controlled study . METHODS Forty-two patients with hematuria episodes due to BPH were r and omly allocated to three subgroups of 14 patients each and treated daily with either 5 mg FIN or 100 mg CPA or were placed in a watchful waiting arm . Patients were evaluated at 3-month intervals , and 40 patients had at least 1 year of follow-up . RESULTS Four patients in the FIN group ( 30 % ) and three in the CPA group ( 23 % ) presented with recurrent hematuria . In both groups , the bleeding episodes were treated conservatively and required no hospitalization . In the control group , 8 patients ( 57 % ) presented with recurrent bleeding ; in 4 , the bleeding was severe and required some form of intervention ( catheterization or transurethral prostatectomy ) . When the frequency and severity of the hematuria episodes were analyzed over time , a statistically significant difference for FIN versus control was present at 9 and 12 months ( analysis of variance , P = 0.035 and P = 0.009 , respectively ) . A similar difference was evident for CPA versus control at 9 and 12 months ( P = 0.028 and P = 0.008 , respectively ) . No statistically significant difference was present between the FIN and CPA groups . Interestingly , no statistically significant effect in bleeding recurrence for both CPA and FIN over controls was present at 3 and 6 months of follow-up . CONCLUSIONS Both FIN and CPA seem to exert a comparable control in hematuria recurrence in patients with BPH , thus confirming the rationale behind the use of anti and rogens for such a purpose . Our results support the hypothesis that any anti and rogen , irrespective of the mode of action , would alter the natural history of BPH-associated hematuria . Interestingly , our results indicate that the speed of action of FIN may not be as rapid as previously described In 18 of 55 original patients who completed 5 years of treatment with finasteride , significant reductions in prostate size were noted at 1 year and sustained thereafter . Symptom scores in these same patients were significantly improved or stable over the 5 years while maximal urinary flow rates were unchanged . Data from 15 of 18 other patients who dropped out of the study before 5 years showed changes in prostate size , symptom score and flow rates that were similar to those noted in patients treated for 5 years . No side effects were noted in this study except for sexual dysfunction , which occurred in less than 5 % of the patients . With few exceptions , finasteride appears to arrest the process of BPH over a 5 year period as indicated by sustained reductions in prostate size accompanied by either symptomatic improvement or stability in all other patients 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 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 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 OBJECTIVE To assess the long-term safety and efficacy of finasteride in the treatment of symptomatic benign prostatic hyperplasia in patients treated with finasteride 5 mg for thirty-six months . METHODS Two large multicenter studies were used . Patients were r and omly assigned to treatment with finasteride , 1 or 5 mg , or placebo for twelve months . After completing twelve months of therapy , patients were invited to enter an open extension to the study in which all patients received finasteride 5 mg .  Urinary symptoms , urinary flow rate , prostate volume , and serum concentrations of prostate-specific antigen and dihydrotestosterone were measured periodically during the study . RESULTS After thirty-six months of treatment with finasteride 5 mg , prostate volume was reduced from baseline by approximately 27 percent , maximum urinary flow rate improved by approximately 2.3 mL/second , and symptom scores improved by 3.6 points . Forty-two percent of patients had a 30 percent or greater decrease in prostate volume , 40 percent of patients showed an increase of 3 mL/second or more in maximum urinary flow rate , and 48 percent of patients experienced a 50 percent or greater improvement in symptom scores .  Finasteride was well tolerated and there was no evidence of increased adverse experiences with increased duration of treatment . CONCLUSIONS The excellent safety profile and sustained clinical efficacy , over thirty-six months , of daily treatment with finasteride 5 mg recommend finasteride as a low-risk medical option for the treatment of symptomatic benign prostatic hyperplasia BACKGROUND And rogens are involved in the development of prostate cancer . Finasteride , an inhibitor of 5alpha-reductase , inhibits the conversion of testosterone to dihydrotestosterone , the primary and rogen in the prostate , and may reduce the risk of prostate cancer . METHODS In the Prostate Cancer Prevention Trial , we r and omly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen ( PSA ) level of 3.0 ng per milliliter or lower to treatment with finasteride ( 5 mg per day ) or placebo for seven years .  Prostate biopsy was recommended if the annual PSA level , adjusted for the effect of finasteride , exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal . It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study . The primary end point was the prevalence of prostate cancer during the seven years of the study . RESULTS Prostate cancer was detected in 803 of the 4368 men in the  finasteride  group who had data for the final analysis ( 18.4 percent ) and 1147 of the 4692 men in the placebo group who had such data ( 24.4 percent ) , for a 24.8 percent reduction in prevalence over the seven-year period ( 95 percent confidence interval , 18.6 to 30.6 percent ; P<0.001 ) . Tumors of Gleason grade 7 , 8 , 9 , or 10 were more common in the finasteride group ( 280 of 757 tumors [ 37.0 percent ] , or 6.4 percent of the 4368 men included in the final analysis ) than in the placebo group ( 237 of 1068 tumors [ 22.2 percent ] , P<0.001 for the comparison between groups ; or 5.1 percent of the 4692 men included in the final analysis , P=0.005 for the comparison between groups ) . Sexual side effects were more common in finasteride-treated men , whereas urinary symptoms were more common in men receiving placebo . CONCLUSIONS Finasteride prevents or delays the appearance of prostate cancer , but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high- grade prostate cancer PURPOSE We assess the effect of finasteride , a 5alpha-reductase inhibitor , on objective voiding parameters in men with lower urinary tract symptoms and benign prostatic enlargement on digital rectal examination ( known as clinical benign prostatic enlargement ) in a double-blind placebo controlled multicenter study using strict st and ard pressure flow study techniques . MATERIAL S AND METHODS A modification of the Abrams-Griffiths nomogram was used by 1 reader to ensure that all patients met objective criteria for bladder outlet obstruction at baseline . After performing a pressure flow study patients with obstruction were r and omized 2:1 to receive 5 mg . finasteride ( 81 ) or placebo ( 40 ) daily . A second pressure flow study was performed at month 12 . At baseline and month 12 free urinary flow studies and transrectal ultrasound were performed , and International Prostate Symptom Score question naires were completed . Patients were treated between May 1994 and July 1996 . RESULTS Finasteride caused a significant decrease ( -8.1 cm . water ) in detrusor pressure at maximum flow ( p < 0.05 versus placebo p = 0.02 ) , increase ( + 1.1 ml . per second ) in maximum flow rate ( p < 0.05 versus placebo p = 0.02 ) and decrease ( -22.8 % ) in prostate volume ( p < 0.05 versus placebo p < 0.001 ) . Men with prostates larger than 40 cc had greater improvement in detrusor pressure at maximum flow ( between group difference -14.5 cm . water , 95 % confidence interval -26.2 to -2.6 , p = 0.02 ) and maximum flow rate ( mean treatment effect + 1.6 ml . per second , 95 % confidence interval -0.2 to 3.0 , p = 0.02 ) compared to those with prostates 40 cc or less ( between group differences not significant ) . CONCLUSIONS Finasteride treatment result ed in improvements in urodynamic parameters , which were greater in men with large prostates 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 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
target: 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: 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 ) .