Formalin disinfection of prostate biopsy needles may reduce post-biopsy infectious complications.

BACKGROUND: We sought to determine whether formalin disinfection of prostate biopsy needles between cores reduces post-biopsy urinary tract infections (UTIs). METHODS: We reviewed a single-surgeon experience of transrectal prostate biopsies from 2010 to 2014. Biopsies were performed in either an operative suite, where 10% formalin was used to disinfect the needle tip between each biopsy core, or an outpatient clinic, where formalin was not used. Our primary outcome was post-biopsy UTI rates, defined as a positive urine culture within 30 days of biopsy. Infection severity was characterized by the need for admission. Patient demographics, prostate size, prior biopsies, prior UTIs, pre-biopsy antibiotics and cultures and post-biopsy cultures were analyzed. Logistic regression was used to assess predictors of post-biopsy UTIs. Statistical significance was defined as P<0.05. RESULTS: A total of 756 patients were included for analysis, including 253 who received formalin disinfection and 503 who did not. Of these, 32 patients (4.2%) experienced post-biopsy UTIs, with 8 requiring admission (all without formalin use). Infection rates were more than double in the group that did not receive formalin (5.2% vs 2.3%, P=0.085). More patients in the formalin group had undergone prior biopsies (73.9% vs 31.8%, P<0.001). On multivariable analysis, prior UTI (odds ratio (OR) 3.77, P=0.006) was a significant predictor for post-biopsy infection, whereas formalin disinfection trended towards a protective effect (OR 0.41, P=0.055). CONCLUSION: Infectious complications following prostate biopsy may be mitigated by the use of formalin disinfection of the biopsy needle between cores.

Do baseline estrogen and testosterone affect lower urinary tract symptoms (LUTS) prior to or after pharmacologic treatment with tadalafil?

Little is known about how total testosterone and estradiol-17ß influence lower urinary tract symptoms (LUTS) in men with benign prostatic hypertrophy (BPH). We analyzed data from a subset of men aged ≥18 years randomized to tadalafil 5 mg once-daily or placebo who had ≥6 month history of LUTS and an International Prostate Symptom Score (IPSS)≥13 enrolled in one of three randomized, placebo-controlled tadalafil clinical trials (N = 958). Three specific aims were addressed, as follows: (i) To characterize enrolled men by treatment randomization and testosterone level; (ii) to assess cross-sectional associations of estradiol-17ß, testosterone, and LUTS prior to treatment with tadalafil; and, (iii) to assess longitudinal associations between baseline estradiol-17ß and testosterone and improvements or worsening of LUTS during a 12-week period of tadalafil or placebo administration. LUTS were assessed by total IPSS, IPSS voiding sub-score (IPSS-V) and IPSS storage sub-score (IPSS-S) for cross-sectional analyses, and change in total IPSS (ΔIPSS), ΔIPSS-V, and ΔIPSS-S between baseline and 12-week visit for longitudinal analyses. Correlation analyses and linear regression examined associations. Baseline testosterone was not significantly associated with IPSS. In contrast, estradiol-17ß was inversely correlated with IPSS (r = -0.08; p < 0.05) and IPSS-S (r = -0.14; p < 0.05). Tadalafil treatment resulted in greater IPSS improvements in men with lower baseline estradiol-17ß versus those with higher baseline estradiol-17ß. Lower baseline estradiol-17ß was significantly associated with modestly improved ΔIPSS-V (p = 0.04) and Δtotal IPSS (p = 0.05) but not with ΔIPSS-S, following treatment which may substantiate the role of bladder dysfunction because of nerve and smooth muscle changes in the bladder in addition to benign prostatic enlargement in LUTS. Circulating baseline testosterone did not predict ΔIPSS. Men with lower baseline estradiol-17ß levels showed greater responsiveness to tadalafil 5 mg treatment than those with higher baseline estradiol-17ß levels when responsiveness was measured using total IPSS and IPSS-V.

Estrogen receptor beta agonist LY500307 fails to improve symptoms in men with enlarged prostate secondary to benign prostatic hypertrophy.

BACKGROUND: To assess the efficacy and safety of LY500307, a selective estrogen receptor beta agonist, on lower urinary tract symptoms (LUTS) in patients with enlarged prostate secondary to BPH. METHODS: In a randomized, double-blind, placebo-controlled, parallel phase 2, efficacy and safety study, eligible patients with moderate to severe LUTS and prostatic enlargement (⩾30 ml) were randomized to placebo or LY500307 at 1, 3, 10 and 25 mg once daily for 24 weeks. Primary efficacy end point was change in total International Prostate Symptoms Score (IPSS) after 24 weeks. Secondary end points included changes in total prostate volume (TPV) that served as a proof of concept end point, as well as IPSS quality of life, maximum peak urine flow rate (Qmax) and PSA and safety (adverse events, laboratory test). RESULTS: A total of 414 patients were randomized when the study was terminated because of insufficient TPV reduction, based on a priori defined interim analysis. The IPSS mean change from baseline to end point was -3.4±6.8 in the placebo group and -1.3±6.6, -2.6±7.0, -3.7±6.7 and -4.4±5.7 in the 1, 3, 10 and 25 mg LY500307-treated groups, respectively (P>0.05). Similarly, no treatment effect was observed for any of the secondary efficacy measures. Incidence of adverse events was comparable between treatment groups, and no clinically meaningful changes in laboratory tests were observed. CONCLUSIONS: LY500307 was well tolerated in BPH patients with LUTS at doses up to 25 mg once daily for 24 weeks. The study was terminated early because of inadequate efficacy.

Progression and remission of urologic symptoms in the community: results of a longitudinal cluster analysis approach.

OBJECTIVE: To investigate the natural history of urologic symptom progression and remission by means of cluster analysis in a large, well-characterized cohort of men and women. METHODS: Cluster analysis was used to assign men and women to symptom clusters on the basis of the prevalence of 14 self-reported urologic symptoms. Data were analyzed from the Boston Area Community Health study at baseline (T1) and 5-year follow-up (T2). Cluster progression was defined as any change from a less symptomatic to a more symptomatic cluster; conversely, cluster remission was defined as movement from more symptomatic to less symptomatic clusters. Logistic regression models examined the association of sociodemographic, psychosocial, and health outcome measures with cluster progression and remission. RESULTS: Follow-up data were available from 4145 participants (1610 men; 2535 women). More than two thirds of men (69.2%) and women (68.2%) had stable symptom cluster assignments. Cluster progression occurred in 280 of 1610 (15.2%) men and 390 of 2535 (14.6%) women; cluster remission in 280 of 1610 (15.6%) men and 409 of 2535 (17.4%) women. In multivariate analyses, cluster progression was twice as common in men with incident depression (odds ratio = 2.43, 95% confidence interval 1.26-4.67) and 3 times more likely in men with ≥ 3 comorbidities at baseline. Urologic surgeries were uncommon in men and women and were not consistently related to cluster progression or remission. CONCLUSION: Urologic symptom clusters were relatively stable over a 5-year follow-up period for more than two thirds of men and women in our sample. Specific risk factors for progression were identified in men and women.

Evaluation and treatment of lower urinary tract symptoms in older men.

PURPOSE: The 6th International Consultation on New Developments in Prostate Cancer and Prostate Diseases met from June 24-28, 2005 in Paris, France to review new developments in benign prostatic disease. MATERIALS AND METHODS: A series of committees were asked to produce recommendations on the evaluation and treatment of lower urinary tract symptoms in older men. Each committee was asked to base recommendations on a thorough assessment of the available literature according to the International Consultation on Incontinence level of evidence and grading system adapted from the Oxford system. RESULTS: The Consultation endorsed the appropriate use of the current terminology lower urinary tract symptoms/benign prostatic hyperplasia/benign prostate enlargement and benign prostatic obstruction, and recommended that terms such as "clinical benign prostatic hyperplasia" or "the benign prostatic hyperplasia patient" be abandoned, and asked the authorities to endorse the new nomenclature. The diagnostic evaluation describes recommended and optional tests, and in general places the focus on the impact (bother) of lower urinary tract symptoms on the individual patient when determining investigation and treatment. The importance of symptom assessment, impact on quality of life, physical examination and urinalysis is emphasized. The frequency volume chart is recommended when nocturia is a bothersome symptom to exclude nocturnal polyuria. The recommendations are summarized in 2 algorithms, 1 for basic management and 1 for specialized management of persistent bothersome lower urinary tract symptoms. CONCLUSIONS: The use of urodynamics and transrectal ultrasound should be limited to situations in which the results are likely to benefit the patient such as in selection for surgery. It is emphasized that imaging and endoscopy of the urinary tract have specific indications such as dipstick hematuria. Treatment should be holistic, and may include conservative measures, lifestyle interventions and behavioral modifications as well as medication and surgery. Only treatments with a strong evidence base for their clinical effectiveness should be used.

Prevalence of BPH and lower urinary tract symptoms in West Africans.

BACKGROUND: BPH and lower urinary tract symptoms (LUTS) are very common among older men in Western countries. However, the prevalence of these two conditions in the developing countries is less clear. METHODS: We assessed the age-standardized prevalence of BPH and/or LUTS among West Africans in a probability sample of 950 men aged 50-74 in Accra, Ghana, with no evidence of biopsy-confirmed prostate cancer after screening with PSA and digital rectal examination (DRE). Information on LUTS was based on self-reports of the International Prostate Symptom Score (IPSS). BPH was estimated using DRE, PSA levels and imputed prostate volume. RESULTS: The prevalence of DRE-detected enlarged prostate was 62.3%, while that of PSA≥1.5 ng ml(-1) (an estimate of prostate volume ≥ 30 cm(3)) was 35.3%. The prevalence of moderate-to-severe LUTS (IPSS≥8) was 19.9%. The prevalence of IPSS≥8 and an enlarged prostate on DRE was 13.3%. Although there is no universally agreed-upon definition of BPH/LUTS, making comparisons across populations difficult, BPH and/or LUTS appear to be quite common among older Ghanaian men. CONCLUSIONS: We found that after age standardization, the prevalence of DRE-detected enlarged prostate in Ghanaian men is higher than previously reported for American men, but the prevalence of LUTS was lower than previously reported for African Americans. Further studies are needed to confirm these findings and identify the risk factors for BPH in both Africans and African Americans.

Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review.

Despite potential benefits, primary care clinicians may avoid using antimuscarinics in men with overactive bladder (OAB) symptoms because of safety concerns. To review the efficacy and safety of antimuscarinics, alone or in combination with an α-blocker, for the treatment of men with OAB symptoms, we conducted a systematic review of articles published before 22 July 2010, using PubMed. Data from 12-week, randomised, double-blind, placebo-controlled trials of tolterodine extended release (ER), oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms. The efficacy and safety of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen (PSA) level. In men meeting entry criteria for OAB and benign prostatic obstruction trials, tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians. Incidence of acute urinary retention (AUR) in men receiving antimuscarinics with or without an α-blocker was ≤3% in all of these trials; changes in postvoid residual volume and maximum flow rate did not appear clinically meaningful. Post hoc analyses from double-blind, placebo-controlled trials and prospective studies of fesoterodine, oxybutynin, propiverine, solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men. A retrospective database study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter. Antimuscarinics, alone or with an α-blocker, appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment. However, antimuscarinics are not approved for the treatment of benign prostatic hyperplasia. Monitoring men for AUR is recommended, especially those at increased risk, and particularly within 30 days after starting antimuscarinic treatment.

Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH.

Data from phase 3 studies (NCT00224107, NCT00224120) of silodosin for treatment of BPH symptoms were analyzed to examine the relationship between treatment efficacy and occurrence of abnormal ejaculation. Men aged ≥50 years with International Prostate Symptom Scores (IPSS) ≥13 and peak urinary flow rates (Qmax) of 4-15 ml s(-1) received placebo or silodosin 8 mg once daily for 12 weeks. Silodosin-treated patients were stratified by absence or presence of 'retrograde ejaculation' (RE). Groups were compared using analysis of covariance (for change from baseline) and responder analyses. Of the 466 patients receiving silodosin, 131 (28%) reported RE and 335 (72%) did not; 4 of the 457 patients receiving placebo (0.9%) reported RE. Most RE events in silodosin-treated patients (110/134; 82%) were reported as 'orgasm with absence of seminal emission.' Silodosin-treated patients with (+) and without (-) RE showed significant improvement in IPSS, Qmax and quality of life versus placebo (P<0.02). RE+ patients versus RE- patients experienced numerically greater improvement, but differences were not statistically significant (P>0.05). For RE+ patients, the odds of achieving improvement of ≥3 points in IPSS and ≥3 ml s(-1) in Qmax by study end were 1.75 times those for RE- patients (P=0.0127). Absence of seminal emission may predict superior treatment efficacy of silodosin in individual patients.

Use of electronic medical records to identify patients at risk for prostate cancer in an academic institution.

One purported advantage of electronic medical records (EMRs) is to improve patient care. This study uses a search of EMR to identify patients at risk for prostate cancer who were not evaluated by an urologist. The University of Texas Southwestern Medical Center (UTSW) has an institutional outpatient EMR that is used by all providers in all specialties. Since March 2009, all PSA tests were reported with specific interpretative comments including a recommendation for referral to urology for a PSA >2.5 ng ml(-1). All PSA tests were performed on campus since institution of these recommendations were analyzed, and charts reviewed for all patients not seen in urology with a serum PSA >2.5 ng ml(-1). Of the 2884 non-urology patients that had a serum PSA drawn between March 2009 and February 2010 at UTSW, 293 patients had a serum PSA >2.5 ng ml(-1). Of these, 39 patients had known prostate cancer and were seeing an oncologist. There were 59 patients seeing urologists outside the institution. A total of 195 patients were not seen by an urologist and only 11 patients were recommended to see one but did not make an appointment. There were 151 patients with more than one PSA in the system, and of these 103 had a rise in PSA with a median rise of 0.53 ng ml(-1) per year. EMR allows identification of patients at increased risk of prostate cancer who are not evaluated. Prospective studies are needed to identify ways to improve appropriate evaluation and detection of prostate cancer.

Long-term medical-care costs related to prostate cancer: estimates from linked SEER-Medicare data.

Limited data are available concerning long-term prostate cancer (PCa)-related medical costs for use in assessing PCa prevention strategies. The aim of this study was to examine treatment, long-term survival, and long-term PCa-related costs by cancer stage. Costs in phases of care based on the natural history of PCa were also examined. Our data illustrate that initial care is characteristic of a rapid rate of cost accrual. This rate then decreases during continuing care. For terminal care, only stage IV resumes a rate of cost accrual similar to initial care. With average PCa-related costs of $18,168 observed over an average follow-up of 4 years, prevention strategies may result in a reduction in medical costs.

The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study.

This article reports the results of a post hoc analysis of the multicenter, randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) study, which aimed to investigate the effects of dutasteride (0.5 mg), tamsulosin (0.4 mg), and their combination on storage and voiding symptoms in 4844 men aged > or =50 years with moderate-to-severe lower urinary tract symptoms (International Prostate Symptom Score > or =12), prostate volume (PV) > or =30 cm(3) and PSA 1.5-10 ng ml(-1). After 24 months, combination treatment achieved significantly greater mean reductions in both voiding and storage symptoms than either monotherapy, in each of the three baseline PV tertiles (30 to <42, 42 to <58, > or =58 cm(3)). Dutasteride was as effective as tamsulosin for control of storage symptoms, but provided significantly greater relief of voiding symptoms than tamsulosin.

First-year costs of treating prostate cancer: estimates from SEER-Medicare data.

Pharmacologic therapies are currently being evaluated for the prevention of prostate cancer (PCa). As additional clinical data become available regarding their benefits and risks, an examination of their economic impact will also be important. The purpose of this study was to estimate mean per patient PCa-related costs during the first year following diagnosis and to examine the extent to which initial therapies are used, by initial cancer stage. Our data show that health-care costs were significant and varied by stage. With average first-year PCa-related costs of US$13,091, prevention strategies have the potential to reduce health-care costs.

Evaluation and treatment of lower urinary tract symptoms in older men.

PURPOSE: The 6th International Consultation on New Developments in Prostate Cancer and Prostate Diseases met from June 24-28, 2005 in Paris, France to review new developments in benign prostatic disease. MATERIALS AND METHODS: A series of committees were asked to produce recommendations on the evaluation and treatment of lower urinary tract symptoms in older men. Each committee was asked to base recommendations on a thorough assessment of the available literature according to the International Consultation on Incontinence level of evidence and grading system adapted from the Oxford system. RESULTS: The Consultation endorsed the appropriate use of the current terminology lower urinary tract symptoms/benign prostatic hyperplasia/benign prostate enlargement and benign prostatic obstruction, and recommended that terms such as "clinical benign prostatic hyperplasia" or "the benign prostatic hyperplasia patient" be abandoned, and asked the authorities to endorse the new nomenclature. The diagnostic evaluation describes recommended and optional tests, and in general places the focus on the impact (bother) of lower urinary tract symptoms on the individual patient when determining investigation and treatment. The importance of symptom assessment, impact on quality of life, physical examination and urinalysis is emphasized. The frequency volume chart is recommended when nocturia is a bothersome symptom to exclude nocturnal polyuria. The recommendations are summarized in 2 algorithms, 1 for basic management and 1 for specialized management of persistent bothersome lower urinary tract symptoms. CONCLUSIONS: The use of urodynamics and transrectal ultrasound should be limited to situations in which the results are likely to benefit the patient such as in selection for surgery. It is emphasized that imaging and endoscopy of the urinary tract have specific indications such as dipstick hematuria. Treatment should be holistic, and may include conservative measures, lifestyle interventions and behavioral modifications as well as medication and surgery. Only treatments with a strong evidence base for their clinical effectiveness should be used.

Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH.

Although ethnicity-based differences in prostate size and physiology have been reported, results of benign prostatic hyperplasia (BPH) treatment trials in predominantly Caucasian patients are assumed to be applicable to non-Caucasian populations. This post hoc analysis investigated whether an Asian subpopulation of men with moderate-to-severe BPH in the CombAT study achieves treatment responses in line with those of the overall study population. In this double-blind, randomized, parallel-group trial, 325 Asian men were assigned to treatment with 0.5 mg dutasteride once daily, 0.4 mg tamsulosin once daily or the combination. Decrease in international prostate symptom score (IPSS) at month 24 from baseline (the primary endpoint) was significantly greater with combination treatment compared with tamsulosin (P<0.05), and numerically, but not statistically significantly, greater compared with dutasteride. Mean IPSS was reduced from baseline by 7.5 (+/-0.84) in the combination group, by 6.3 (+/-0.86) in the dutasteride group and by 4.5 (+/-0.78) in the tamsulosin group, resulting in respective mean IPSS at months 24 of 11.4 (+/-0.60), 12.7 (+/-0.70) and 14.3 (+/-0.74). The adverse event profile was similar to that observed in the overall CombAT population, and drug-related adverse events were more common with combination therapy (26%) than with tamsulosin (15%) or dutasteride (9%). No unexpected adverse events emerged. In conclusion, in Asian men with moderate-to-severe lower urinary tract symptoms and an enlarged prostate, combination therapy achieved significantly greater improvements from baseline BPH symptoms, flow rate, quality of life, reduced prostate volume and improved treatment satisfaction compared with tamsulosin monotherapy.

Pathology of benign prostatic hyperplasia.

The epidemiology of benign prostatic hyperplasia (BPH) is complex and not fully understood. The androgenic hormones testosterones and dihydrotestosterone play at least a permissive and important role. Growth factors and other hormones including estrogens may also play a role. BPH is a truely hyperplastic process resulting in growth of glandular-epithelial and stromal/muscle tissue in the prostate, leading to often measurable growth taking on different shapes and configurations which may impact symptoms and secondary outcomes. It is important to recognize that BPH is a histological conditions, which is one but not the only cause of lower urinary tract symptoms, and may or may not be associated with prostate enlargement and bladder outlet obstruction. Recognizing the different entities and determining their presence in individual patients may help with therapeutic decision making.

The utility of serum prostatic-specific antigen in the management of men with benign prostatic hyperplasia.

Several analyses have demonstrated a clinically useful relationship between serum prostate specific antigen (PSA) and prostate volume in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). Both prostate volume and serum PSA predict certain aspects of the natural history of LUTS and BPH, and men with higher PSA and larger glands in general have a higher rate of progression measured by various parameters. Serum PSA also predicts the response to certain types of medical therapy in men with LUTS and BPH and is thus useful in the evaluation and management of these patients. Lastly, serum PSA does not loose its usefulness as a cancer marker for prostate cancer even if certain medications reduce serum PSA values predictably by 50%.

Dutasteride significantly improves quality of life measures in patients with enlarged prostate.

The purpose of this study was to determine the effect of dutasteride on quality of life of men with lower urinary tract symptoms associated with enlarged prostate or benign prostatic hyperplasia (BPH) as measured by symptom problem index (SPI), BPH-specific interference with activities (BSIA), BPH-specific psychological well-being (BPWB) and BPH-specific lifestyle adaptations (BSLA). Data were derived from three randomized, double-blind studies conducted in 4325 men treated with placebo or dutasteride (0.5 mg/day). Primary analyses included changes from baseline in mean SPI, BSIA, BPWB and BSLA scores. Men treated with dutasteride showed significant improvements in SPI, BSIA, BPWB and BSLA scores compared with placebo.

Effects of alfuzosin 10 mg once daily on sexual function in men treated for symptomatic benign prostatic hyperplasia.

We evaluated the effects of extended-release alfuzosin HCl 10 mg once daily (q.d.) on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). In a randomized, double-blind, placebo-controlled study of men aged > or = 50 years, after a 28-day placebo run-in period, patients were randomized to receive alfuzosin 10 mg q.d. or matching placebo for 28 days. The mean change from baseline (day 1) in sexual function on day 29 was assessed using the Danish Prostate Symptom Score Sex (DAN-PSSsex) questionnaire. A total of 372 patients were randomized to receive alfuzosin (n=186) or placebo (n=186), with 355 completing the study. At baseline, 64% of the patients reported erectile dysfunction (ED) and 63% reported ejaculatory dysfunction (EjD). For the 320 patients who completed the DAN-PSSsex, alfuzosin treatment was associated with a significant improvement in the mean change from baseline in erectile function on day 29 compared with placebo (P=0.02). No significant difference was observed between the two treatment groups in the mean change from baseline in ejaculatory function on day 29. For patients with ED at baseline, a marginal improvement in erectile function was demonstrated with alfuzosin treatment (P=0.09 vs placebo). For patients with EjD at baseline, the mean change from baseline in ejaculatory function with alfuzosin was comparable to that with placebo. Dizziness was the most common adverse event with alfuzosin treatment (5 vs 0% with placebo), with other adverse events reported with comparable frequency in both treatment groups. After 1 month of treatment, alfuzosin 10 mg q.d. significantly improved erectile function in men with lower urinary tract symptoms/ benign prostatic hypertrophy and had no adverse effect on ejaculatory function.

Rapid onset of action with alfuzosin 10 mg once daily in men with benign prostatic hyperplasia: a randomized, placebo-controlled trial.

This randomized, double-blind, placebo-controlled study was conducted to investigate whether alfuzosin 10 mg once daily improves the maximum flow rate (Q(max)) and lower urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH) after 1 week and 1 month of treatment. A total of 372 men aged > or = 50 years with symptomatic BPH received alfuzosin or placebo for 28 days. Q(max) increased significantly from baseline at day 8 with alfuzosin (P<0.001 versus placebo); this improvement was evident within 24 h after the first dose and was maintained at day 29. LUTS improved from baseline with alfuzosin at day 8 (P=0.07 versus placebo) and day 29 (P=0.003 versus placebo). Alfuzosin 10 mg once daily exhibits a rapid onset of action, with improvements in Q(max) and LUTS maintained through 1 month of treatment.

Efficacy and tolerability of the dual 5alpha-reductase inhibitor, dutasteride, in the treatment of benign prostatic hyperplasia in African-American men.

The efficacy and tolerability of dutasteride (0.5 mg daily for 2 years) in African-Americans (n=161), compared with Caucasians (n=3961), was assessed in a post hoc analysis of data from three Phase III clinical trials. Dutasteride significantly reduced serum dihydrotestosterone levels by >90% and significantly improved subjective (symptom score) and objective (prostate volume, peak urinary flow rate, risk of benign prostatic hyperplasia-related surgery and acute urinary retention) outcomes in both African-Americans and Caucasians. For all efficacy measures, there was no statistically significant treatment-by-race interaction and dutasteride was well tolerated in both racial groups. Therefore, dutasteride demonstrated similar efficacy and safety profiles in African-Americans and Caucasians.