Clinical Diagnosis Of Benign Prostatic Hyperplasia Research Articles

Erectile Dysfunction after Transuretheral Resection of the Prostate in Patients with Benign Prostatic Hyperplasia

Background: Benign prostatic hyperplasia (BPH) is commonly associated with lower urinary tract symptoms (LUTS) in aging men, which can significantly impact their quality of life. Transurethral resection of the prostate (TURP) is a standard treatment for BPH, yet its effects on erectile function remain controversial. Objective: To assess the impact of TURP on erectile function in patients with BPH and to evaluate the potential relationship between the relief of obstructive urinary symptoms and changes in erectile function postoperatively. Methods: This single-center, non-randomized study enrolled 177 male patients aged 50 to 80 years with a clinical diagnosis of BPH and an International Prostate Symptom Score (IPSS) greater than 8. Participants underwent monopolar TURP and were evaluated using the International Index of Erectile Function (IIEF-5) questionnaire one month post-surgery. Data were analyzed using SPSS version 21 with Chi-square tests applied to examine the influence of age and IPSS scores on erectile function, considering a p-value ≤0.05 as significant. Results: The mean age of participants was 57.53 ± 6.96 years, and the mean resected prostate tissue weight was 122.82 ± 12.05 grams. Post-TURP, 44.6% of patients were found to have some degree of erectile dysfunction. However, no significant changes in erectile function were observed one month following TURP (p=0.602 for age, p=0.878 for IPSS score). Conclusion: TURP did not significantly affect erectile function one month postoperatively in BPH patients with severe urinary symptoms. While some improvement in erectile function was noted, the results suggest that the benefits of TURP on erectile function may not be immediate. Further longitudinal studies with larger sample sizes are required to provide more definitive conclusions.

Evolving Hypothesis that Prostate/BPH Size Matters in Protection against Prostate Cancer

Benign prostatic hyperplasia (BPH) and prostate cancer (PCa) are the two predominant urologic diseases affecting aging men. As a matter of fact, 95–98% of elderly men with prostate as their “primary organ disease” for consulting urologists have either the clinical diagnosis of BPH, PCa or both. Other primary diagnoses of the prostate such as sarcoma, lymphoma or isolated bacterial prostatitis (not in the context of a systemic urinary tract infection) are rare entities. Although BPH and PCa are very common, their interaction is currently not well understood. Numerous clinical studies and meta-analysis reviews have demonstrated a negative correlation between prostate BPH size and the probability of PCa presence, but little is known to explain this clinical phenomenon. Recent histo-anatomical and magnetic resonance imaging studies have revealed data leading to a hypothesis indicating the expanding transition zone (TZ) in a growing BPH prostate causes mechanical stress within the peripheral zone (PZ) with secondary fibrosis and atrophy of the glands within the PZ. This dynamic interaction of the TZ against the PZ in a growing BPH-prostate could explain the negative correlation between BPH size and PCa incidence. The purpose of this review is to present and discuss the evolving hypothesis that prostate size may matter and be protective against prostate cancer.

MP28-05 PHENOTYPING MEN WITH BENIGN PROSTATIC HYPERPLASIA BASED ON LUTS QUESTIONNAIRES AND BLADDER DIARIES

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Epidemiology & Evaluation (MP28)1 Sep 2021MP28-05 PHENOTYPING MEN WITH BENIGN PROSTATIC HYPERPLASIA BASED ON LUTS QUESTIONNAIRES AND BLADDER DIARIES Lakshay Khosla, Philip Lee, Kevin Rychik, Max Edeson, Wade Bushman, and Jerry G Blaivas Lakshay KhoslaLakshay Khosla More articles by this author , Philip LeePhilip Lee More articles by this author , Kevin RychikKevin Rychik More articles by this author , Max EdesonMax Edeson More articles by this author , Wade BushmanWade Bushman More articles by this author , and Jerry G BlaivasJerry G Blaivas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002025.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Men with Benign Prostatic Hyperplasia (BPH) may exhibit normal urine output, oliguria, or polyuria. The etiologies of polyuria have been previously investigated. This study was done to quantify clinical differences based on urinary output and test whether oliguria results from a patient-directed effort to reduce fluid intake to ameliorate lower urinary tract symptoms (LUTS). Specifically, we postulated that oliguria would be associated with more severe LUTS scores. METHODS: A retrospective analysis was performed utilizing a database for patients who completed a 24-hour bladder diary (24HBD) and the LUTS questionnaire from 2015 through 2019. Data on clinical diagnosis, demographics, uroflow (Q), post-void residual urine (PVR), and prostate size was obtained from the EMR. Patients with a clinical diagnosis of BPH with complete data were included. Patients were divided into three urinary phenotypes based on urine output: normal (>1 - <2500 L/24 H), oliguria (<1 L/24 H), and polyuria (>2.5 L/24 H).The data was analyzed using SPSS statistics software by utilizing one-way MANOVA, one-way ANOVA and Tukey’s HSD post-hoc tests. RESULTS: Of the 139 men in the database with BPH, 124 (mean age ± SD, 65.3 ± 11.9 years) had complete data available. Of these, 85 had normal urine output (69%), 14 had oliguria (11%), and 25 had polyuria (20%). Prostate size data was available for 45 men. There was no difference in the LUTSS or any of its subscores amongst the 3 groups. However, compared to the polyuria group, the oliguria group exhibited lower mean 24 hour voided volumes (24H VV), max voided volumes (MVV), daytime voids, total voids, maximum flow rate (Qmax), voided volume at Qmax, and PVR (Table 1). CONCLUSIONS: Our hypothesis was rejected; LUTS scores amongst men with oliguria were no different from LUTS scores amongst men with polyuria or normal 24H VV. However, men with oliguria had lower 24H VV, MVV, total voids, Qmax and PVR compared to men with polyuria. Differences in parameters demonstrate a need for the development of precise nomenclature for BPH phenotypes. To determine whether oliguria in BPH results from a patient’s self-restriction of fluid intake to mitigate LUTS that would otherwise be present, the patient’s role in managing symptoms should be investigated. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e482-e482 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Lakshay Khosla More articles by this author Philip Lee More articles by this author Kevin Rychik More articles by this author Max Edeson More articles by this author Wade Bushman More articles by this author Jerry G Blaivas More articles by this author Expand All Advertisement Loading ...

Combination of α-blocker and 5α-reductase inhibitor for treatment of benign prostatic hyperplasia.

This study compared the efficacy of an α-blocker monotherapy alone with a combination of α-blocker plus 5α-reductase in treatment of benign prostatic hyperplasia (BPH). Medline (PubMed), EMBASE, CENTRAL (Cochrane databases) and Google Scholar were searched until May 2015 using the following search terms: ([α-blocker] AND 5α-reductase inhibitor) AND benign prostatic hyperplasia; and benign prostatic hyperplasia AND (adrenergic alpha blockers OR 5 alpha reductase inhibitor). Randomized controlled trials (RCTs) that included men with a clinical diagnosis of BPH were included. Eligible studies had to have an intervention group that received combination therapy (5α reductase inhibitor plus α-blocker) and a control group that received only α-blocker. Quality assessment and sensitivity analysis were performed. Six studies were included. Combination therapy was found to significantly reduce urinary retention incidence rate (OR=0.286, 95%CI: 0.199 - 0.412, P.

Influence of baseline variables on changes in International Prostate Symptom Score after combined therapy with dutasteride plus tamsulosin or either monotherapy in patients with benign prostatic hyperplasia and lower urinary tract symptoms: 4‐year results of the CombAT study

To examine, using post hoc analysis, the influence of baseline variables on changes in international prostate symptom score (IPSS), maximum urinary flow rate (Qmax ) and IPSS quality of life (QoL) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) treated with either the α-blocker tamsulosin or the dual 5-alpha reductase inhibitor dutasteride, alone or in combination, as part of the 4-year Combination of Avodart and Tamsulosin (CombAT) study. CombAT was a 4-year, multicentre, randomized, double-blind, parallel-group study in 4844 men ≥50 years of age with a clinical diagnosis of BPH by medical history and physical examination, an IPSS ≥12 points, prostate volume (PV) ≥30 mL, total serum PSA level ≥1.5 ng/mL, and Qmax >5 mL/s and ≤15 mL/s with a minimum voided volume ≥125 mL. Eligible subjects were randomized to receive oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. Baseline variable subgroups analysed were as follows: PV (30 to <40; 40 to <60; 60 to <80; ≥80 mL), PSA level (1.5 to <2.5; 2.5 to <4; ≥4 ng/mL), age (median: <66, ≥66 years), IPSS (median: <16, ≥16; IPSS thresholds, <20, ≥20), IPSS QoL score (question 8, Q8) (median: <4, ≥4), Qmax (median: <10.4, ≥10.4 mL/s), BPH impact index (BII) (median: <5, ≥5) and body mass index (BMI, median: <26.8, ≥26.8 kg/m(2) ). Within each baseline variable subgroup, changes in IPSS, Qmax and IPSS QoL Q8 from baseline were evaluated using a generalized linear model with effects for baseline IPSS, Qmax or IPSS QoL Q8 and treatment group at each post-baseline assessment up to and including the month 48 visit using a last observation carried forward approach. The treatment comparisons of combination therapy vs dutasteride and combination therapy vs tamsulosin were performed from the general linear model with statistical significance defined as P ≤ 0.01. Combination therapy resulted in a significantly greater improvement from baseline IPSS at 48 months vs tamsulosin monotherapy across all baseline subgroups. The benefit of combination therapy over dutasteride was confined to groups with lower baseline PV (<60 mL) and PSA (<4 ng/mL). In groups with baseline PV ≥60 mL and PSA ≥4 ng/mL, dutasteride and combination therapy show similar improvements in symptoms. Combination therapy resulted in significantly improved Qmax compared with tamsulosin but not dutasteride monotherapy. Qmax improvement appeared to increase with PV and PSA level in combination therapy subjects. The proportion of subjects with an IPSS QoL ≤2 (at least mostly satisfied) at 48 months was significantly higher with combination therapy than with dutasteride for subgroups with PV 40-60 mL and PSA level <4 ng/mL and than with tamsulosin for all PSA subgroups and PV subgroups ≥40 mL. CombAT data support the use of long-term combination therapy with dutasteride and tamsulosin in patients considered at risk for progression of BPH, as determined by high PV (≥30 mL) and high PSA (≥1.5 ng/mL). Combination therapy, dutasteride monotherapy and tamsulosin monotherapy all improved Qmax , but to different extents (combination therapy > dutasteride >> tamsulosin), suggesting that dutasteride contributes most to the Qmax benefit in combination therapy. Combination therapy provided consistent improvement over tamsulosin in LUTS across all analysed baseline variables at 48 months. Compared with dutasteride, the superiority of combination therapy at 48 months was shown in patients with PV <60 mL or PSA <4 ng/mL.

The efficacy of procin-x and celloid-s in the management of benign prostatic enlargement

Background and Objective: Despite a decent efficacy and safety profile, α1 - blockers (A1B) and the 5α - reductase inhibitors (5ARI), the conventional drugs used in the treatment of the symptoms of Benign Prostatic Hyperplasia (BPH), are commonly associated with adverse effects including sexual dysfunction and postural hypotension. Phytotherapy for the treatment BPH symptoms has been used for centuries. However, scientific data on their efficacy are sparse. Procin-X and Celloid-S (PC) are powdered plant material products with acclaimed anti- BPH properties. This study assessed their usefulness in the management of BPH. Materials and Methods: This was a single blind, randomized, placebo-controlled study conducted at our hospital involving 80 patients (divided in to 2 equal groups) with the clinical diagnosis of BPH. The study group were given PC while the controls were given multivitamin Capsules daily for a period of 14 weeks. All patients were evaluated at intervals for severity of symptoms, flow rates, prostate size, prostate specific antigen (PSA) and possible adverse effects including erectile function. Test of significance between the means was done using the Students Paired t-test. A P < 0.05 was considered significant. Results: At the end of 14 weeks there was an reduction in symptom score by 5.7 and 1.6 in subjects and controls respectively (P < 0.05) and an increase in flow rate by 4.0mls/s and 1.1mls/s respectively (P < 0.05). There was a 60% and 14% reduction in PSA in the subjects and control respectively. There was also statistically significant increase in the erection score in the subjects. Conclusion: PC appear to be effective and in the management of the symptoms of BPH. The positive effects of PC on erectile function may however give them an advantage over the A1B and 5ARI drugs while the reduction in PSA may also give it a role in chemoprevention of prostate cancer. A large scale cohort study is needed to confirm these findings.

1386 URINARY RETENTION FOLLOWING ANTIMUSCARINICS IN PATIENTS WITH BPH IN REAL LIFE PRACTICE - A NATION-WIDE DATABASE STUDY

You have accessJournal of UrologyBenign Prostatic Hyperlasia: Medical and Hormonal Therapy1 Apr 20131386 URINARY RETENTION FOLLOWING ANTIMUSCARINICS IN PATIENTS WITH BPH IN REAL LIFE PRACTICE - A NATION-WIDE DATABASE STUDY Eric Yi-Hsiu Huang, Chih-Chieh Lin, Hsiao-Jen Chung, Jian-Ping Lin, Alex T.L. Lin, and Kuang-Kuo Chen Eric Yi-Hsiu HuangEric Yi-Hsiu Huang Taipei, Taiwan More articles by this author , Chih-Chieh LinChih-Chieh Lin Taipei, Taiwan More articles by this author , Hsiao-Jen ChungHsiao-Jen Chung Taipei, Taiwan More articles by this author , Jian-Ping LinJian-Ping Lin Taipei, Taiwan More articles by this author , Alex T.L. LinAlex T.L. Lin Taipei, Taiwan More articles by this author , and Kuang-Kuo ChenKuang-Kuo Chen Taipei, Taiwan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2740AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Urinary retention (UR) is the main concern of using antimuscarinics in men with benign prostatic hyperplasia (BPH) presenting storage symptoms. Most clinical trials reported less than 1% UR rate. However, there is little information in real life clinical practice. We investigated the risks of UR following antimuscarinics in men with clinical diagnosis of BPH in real life practice by analyzing a nation-wide database. METHODS A urology dataset including 3,433,230 individuals was selected from the National Health Insurance Research Database (NHIRD) of Taiwan for the year 2006 to 2010. Their claim data was used for the study. Male patients more than 40 years old with a clinical diagnosis of BPH (ICD-9-CM code 600.0) and the use of available antimuscarinics (tolterodine, solifenacin, trospium, oxybutynin, propiverine) in Taiwan for more than 2 weeks were enrolled. All the enrolled patients used only one category of medication throughout the study period without switching (Group A: antimuscarinics only or Group B: antimuscarinics plus alpha-blockers). Patients receiving procedures that might cause UR such as intravesical therapy, urodynamic study and prostate biopsy during antimuscarinics treatment were excluded. UR was identified by the coding of urinary catheterization in the claim data during the medication period. The UR rate between Group A and Group B was compared. The association of UR with age was also explored. RESULTS The overall incidence of UR in this study cohort (n=27,461) was 2.37%. The UR rates for Group A (n=10,126) and Group B (n=16,935) were 2.5% and 2.3%, respectively without a significant difference (p=0.37). UR rate is increased with age. The UR rate for both groups was similar from 40 to 90 years and higher thereafter for Group A. (figure). CONCLUSIONS In real life practice, UR rate following antimuscarinics in patients with BPH is higher than reported in most clinical trials. Patients using alpha blocker plus antimuscarinics have similar UR rate as using antimuscarinics alone. Besides, age is an important risk factor for UR. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e567 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Eric Yi-Hsiu Huang Taipei, Taiwan More articles by this author Chih-Chieh Lin Taipei, Taiwan More articles by this author Hsiao-Jen Chung Taipei, Taiwan More articles by this author Jian-Ping Lin Taipei, Taiwan More articles by this author Alex T.L. Lin Taipei, Taiwan More articles by this author Kuang-Kuo Chen Taipei, Taiwan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

1388 THE ASSOCIATION BETWEEN THE DURATION OF ANTIMUSCARINICS USE AND URINARY RETENTION IN PATIENTS WITH BPH- A NATION-WIDE DATABASE STUDY

You have accessJournal of UrologyBenign Prostatic Hyperlasia: Medical and Hormonal Therapy1 Apr 20131388 THE ASSOCIATION BETWEEN THE DURATION OF ANTIMUSCARINICS USE AND URINARY RETENTION IN PATIENTS WITH BPH- A NATION-WIDE DATABASE STUDY Alex T.L. Lin, Eric Yi-Hsiu Huang, Chih-Chieh Lin, Hsiao-Jen Chung, Jian-Ping Lin, and Kuang-Kuo Chen Alex T.L. LinAlex T.L. Lin Taipei, Taiwan More articles by this author , Eric Yi-Hsiu HuangEric Yi-Hsiu Huang Taipei, Taiwan More articles by this author , Chih-Chieh LinChih-Chieh Lin Taipei, Taiwan More articles by this author , Hsiao-Jen ChungHsiao-Jen Chung Taipei, Taiwan More articles by this author , Jian-Ping LinJian-Ping Lin Taipei, Taiwan More articles by this author , and Kuang-Kuo ChenKuang-Kuo Chen Taipei, Taiwan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2742AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The use of antimuscarinics may increase the risk of urinary retention (UR) in men with benign prostatic hyperplasia (BPH). The chances to develop UR may be increased after a prolonged period of antimuscarinics use. We investigated the association of the duration of antimuscarinics use and the occurrence of UR in patients with BPH by analyzing a nationwide database. METHODS A urology dataset including 3,433,230 individuals was selected from the National Health Insurance Research Database (NHIRD) for the year 2006 to 2010. Their claim data was used for the study. Patients more than 40 years old with a clinical diagnosis of BPH (ICD-9-CM code 600.0) and concurrent prescription of antimuscarinics were enrolled. The use of antimuscarinics has to be consecutive without a pause for more than 7 days. Patients receiving procedures that might cause UR such as intravesical therapy, urodynamic study and prostate biopsy during antimuscarinics treatment were excluded. The patients had urinary catheterization within 2 weeks prior to the prescription of antimuscarinics were also excluded. UR was identified by the coding of urinary catheterization in the claim data during the period of antimuscarinic use. The interval from the start of antimuscarinics use to the occurrence of UR and the cumulative percent of UR were determined. RESULTS There were 2,138 patients had UR in this study cohort. The mean age was 75.8 years (range 42-101). Eighty percent of the patients developed UR within 90 days after antimuscarinics use. While taking age into consideration, there were 1416 patients younger and 722 patients older than 80 years old. Both groups showed the same trend as the whole patient cohort. (figure). CONCLUSIONS The probability to develop UR after consecutive use of antimuscarinics in patients with BPH was the highest in the first 90 days. However, the chances to have UR can still be as high as 20% after 90 days. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e568 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alex T.L. Lin Taipei, Taiwan More articles by this author Eric Yi-Hsiu Huang Taipei, Taiwan More articles by this author Chih-Chieh Lin Taipei, Taiwan More articles by this author Hsiao-Jen Chung Taipei, Taiwan More articles by this author Jian-Ping Lin Taipei, Taiwan More articles by this author Kuang-Kuo Chen Taipei, Taiwan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Validation of a Model to Develop a Symptom Index for Benign Prostatic Hyperplasia in Dogs

Benign prostatic hyperplasia (BPH) is a spontaneous and age-related condition in humans and intact male dogs. A symptom index for BPH in men was created by the American Urological Association. In this study, it has been developed and statistically validated as a model to assign an objective score to canine BPH severity based on clinical signs observed and/or subjectively reported to the veterinarian by dog owners. The medical records of the Animal Reproduction Unit of University of Bologna (Italy) were used to select dogs with a clinical diagnosis of BPH. A data set was built up, and the animals were included in the statistical analysis as dependent variables. A score of 1-3 was assigned to the disease severity of each case based on signs annotated, graded using a scale ranging from 1 to 4. Signs of BHP were entered as predictors while disease severity as dependent variable to generate the predictive model. The model was finally used to re-classify each case of the data set, and the percentage of corrected predictions calculated. Overall, 373 subjects were entered in the model. Between them, 243, 107 and 23 animals have been represented based on medical records with a BPH severity score of 1, 2 and 3, respectively. The model correctly predicted the response variable in 97.3% of the cases. In this study, a BPH symptom index was created for the first time in dogs, which may be useful to standardize BPH severity with an objective score and to evaluate the necessity, the kind and the effectiveness of treatment.

Correlations Among Cardiovascular Risk Factors, Prostate Blood Flow, and Prostate Volume in Patients With Clinical Benign Prostatic Hyperplasia

To investigate the relationships among the cardiovascular risk factors, prostate blood flow, and prostate volume in patients with clinical benign prostatic hyperplasia (BPH). A total of 130 patients with the clinical diagnosis of BPH were recruited. The presence of 5 cardiovascular risk factors, including obesity, diabetes, hypertension, hyperlipidemia, and a history of cardiovascular events, was recorded. The urologic evaluation included digital rectal examination, serum prostate-specific antigen, International Prostate Symptom Score, and transrectal ultrasonography. Doppler spectrum analysis was performed with the patient in the right lateral decubitus position to measure the blood flow in the prostate capsular arteries, periurethral arteries, and neurovascular bundles. The correlations were analyzed between the resistive indexes of the prostatic branches and the cardiovascular risk factors, as well as the transrectal ultrasound findings. The resistive indexes of the periurethral arteries and right neurovascular bundles showed positive correlations with the number of cardiovascular risk factors in the patients (r=.228, P=.01 and r=.225, P=.011, respectively). The periurethral artery resistive index also correlated positively with both prostate and transitional zone volumes, with the capsular artery correlating positively only with the latter. No significant correlations were noted between the resistive indexes and the International Prostate Symptom Score. Prostate vascular resistance in patients with BPH has positive correlations with cardiovascular risk factors and prostate size. These findings suggest that prostate hypoxia might play a role in the pathogenesis of BPH.

A placebo‐controlled study investigating the efficacy and safety of the phosphodiesterase type 5 inhibitor UK‐369,003 for the treatment of men with lower urinary tract symptoms associated with clinical benign prostatic hyperplasia

To evaluate the efficacy and safety of the phosphodiesterase type 5 inhibitor UK-369,003 for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in men with and without erectile dysfunction (ED). This was a multicentre, double-blind, placebo- and active-controlled, parallel-group study conducted across 45 centres in North and South America, Europe, and Australia. In all, 418 men aged ≥ 40 years with a clinical diagnosis of BPH, an International Prostate Symptom Score (IPSS) of ≥ 13, and maximum urinary flow rate (Q(max) ) of 5-15 mL/s for a voided volume of > 150 mL were stratified into two groups (with and without ED) and randomized to one of seven treatment groups, i.e. UK-369,003 at 10, 25, 50 or 100 mg modified release (MR), UK-369,003 40 mg immediate release (IR), tamsulosin 0.4 mg prolonged release, or placebo, for 12 weeks. The primary study endpoint was the change in total IPSS after 12 weeks of treatment. Secondary efficacy measures were IPSS storage and voiding subscores, Q(max) , International Index of Erectile Function-Erectile Function domain, questions 5 and 6 of the Quality of Erection Questionnaire, the International Consultation on Incontinence Questionnaire-Male LUTS, the patient-reported treatment-impact questionnaire, and a bladder diary in which patients recorded the number of voluntary urinary voids, volume of urine voided per micturition, leaks, and urgency episodes. The mean change in the IPSS from baseline at week 12 for UK-369,003 100 mg MR and 40 mg IR was -2.91 and -2.50 better than placebo, respectively. There was increasing efficacy with increasing dose of the MR formulation. For UK-369,003 100 mg MR, Q(max) improved by 2.10 mL/s compared with 0.84 mL/s in the placebo group. UK-369,003 had clinically meaningful efficacy and was well tolerated in men with LUTS associated with BPH. The Bayesian statistical analysis gave high posterior probabilities for true differences between UK-369,003 100 mg MR and placebo. There was greater preference, satisfaction and willingness to use UK-369,003 again for all treatment groups compared with placebo.

The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study

BackgroundCombination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. ObjectiveTo investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participantsThe Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30cm3, prostate-specific antigen 1.5–10ng/ml, and maximum urinary flow rate (Qmax) >5 and ≤15ml/s with minimum voided volume ≥125ml. InterventionOral daily tamsulosin, 0.4mg; dutasteride, 0.5mg; or a combination of both. MeasurementsThe 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax, prostate volume, safety, and tolerability. Results and limitationsCombination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. ConclusionsThe 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifierNCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).

The Influence of Baseline Parameters on Changes in International Prostate Symptom Score with Dutasteride, Tamsulosin, and Combination Therapy among Men with Symptomatic Benign Prostatic Hyperplasia and an Enlarged Prostate: 2-Year Data from the CombAT Study

BackgroundKnowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness. ObjectivesTo examine the influence of baseline parameters on changes in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in men with BPH receiving dutasteride, tamsulosin, or a combination of the two using 2-yr Combination of Avodart and Tamsulosin (CombAT) study data. Design, setting, and participantsCombAT is an ongoing, 4-yr, multicentre, randomised, double-blind study in 4844 men aged ≥50 yr with clinical diagnosis of BPH, IPSS ≥12, prostate volume ≥30cm3, prostate-specific antigen (PSA) 1.5–10ng/ml, and Qmax >5 and ≤15ml/s with minimum voided volume ≥125ml. InterventionDaily tamsulosin 0.4mg, dutasteride 0.5mg, or the combination. MeasurementsPost hoc analyses of mean IPSS and Qmax changes from baseline by treatment group and by baseline prostate volume, PSA, age, body mass index (BMI), IPSS, IPSS quality of life (QoL) score, BPH Impact Index score, Qmax, and previous BPH medical therapy. Results and limitationsCombination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups, with benefit onset varying by baseline prostate volume. Combination therapy was also more effective in improving Qmax versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups. At 24 mo, dutasteride monotherapy resulted in significantly greater IPSS improvements versus tamsulosin in men with lower age, worse symptoms, worse QoL, less bother, higher BMI, greater Qmax, higher prostate volume, and higher PSA at baseline. Post hoc analyses, the lack of placebo control, and the exclusion of men with unsuccessful medical BPH treatment are study limitations. ConclusionsCombination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy. Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms.

The Change of Prostate-specific Antigen and Prostate-specific Antigen Density in Patients with Benign Prostatic Hyperplasia after Dutasteride Treatment

Purpose: Dihydrotestosterone (DHT) is key to the initiation and maintenance of abnormal prostatic growth in benign prostatic hyperplasia (BPH). Five α-reductase inhibitor reduces prostatic growth and serum prostate-specific antigen (PSA) by blocking the conversion of testosterone to DHT. Dutasteride is a dual (type 1 and 2) 5α-reductase inhibitor. We evaluated the effects of dutasteride on prostate volume, PSA, and PSA density in men with BPH. Materials and Methods: A total of 83 men with a clinical diagnosis of BPH were treated with dutasteride and an alpha-blocker. We investigated the change in prostate volume, PSA, and PSA density 6 and 12 months after initiation of dutasteride therapy. Results: After 6 months of dutasteride therapy, the total prostate volume was reduced from baseline by a mean of 15.46%, the PSA was reduced by a mean of 48.24%, and the PSA density was reduced by a mean of 37.97% (p<0.001). After 12 months of dutasteride therapy, the total prostate volume was reduced from baseline by a mean of 23.3%, the PSA was reduced by a mean of 52.57%, and the PSA density was reduced by a mean of 36.2% (p<0.001). There were no differences in the regression rate of PSA and PSA density, in contrast to prostate volume, between 6 and 12 months of dutasteride therapy by repeated measures ANOVA. Conclusions: The findings in this study demonstrate that the actual PSA in men receiving dutasteride would be multiplied by 2 considering the PSA regression rate after 12 months. (Korean J Urol 2008;49:893-898) 󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏

Serial prostate-specific antigen measurements in men with clinically benign prostatic hyperplasia during a 12-month placebo-controlled study with terazosin

Objectives To prospectively analyze whether the treatment of men with clinically benign prostatic hyperplasia (BPH) with alpha blocking agents affects the serum prostate-specific antigen (PSA) levels, and to determine the magnitude of such effect. Methods Serial PSA measurements were performed using the Abbott IMx assay over 1 year in 134 men over the age of 55 years participating in the Hytrin Community Assessment Trial (HYCAT). HYCAT is a 1 -year, randomized, placebo-controlled, double-blinded study of the alpha 1-adrenergic antagonist terazosin. All men had lower urinary tract symptoms and a clinical diagnosis of BPH with an American Urological Association (AUA) symptom index of 13 points or more, an AUA bother score of 8 points or more, and a peak urinary flow rate of less than 15 mL/s. PSA was measured at baseline and at 8, 26, 39, and 52 (end of study) weeks. Results Baseline serum PSA levels weakly correlated with patients' age at study entry, and modestly with residual urine (positive correlation) and peak flow rate (negative correlation), although none of the levels were statistically significant. Changes of serum PSA during the course of the study did not correlate with either one of the symptom severity or bother assessment tools, residual urine, or peak flow rate. Mean PSA increased from a baseline of 2.5 ± 0.22 ng/mL (mean ± SE) by 0.5 ± 0.11 ng/mL in the placebo- and from 2.7 ± 0.23 ng/mL by 0.3 ± 0.11 ng/mL in the terazosin-treated patients ( P = 0.36 by ANOVA). There were no differences in the changes in serum PSA when patients were stratified by decade of life according to the age-specific PSA reference ranges, or by the final dose of terazosin (2, 5, or 10 mg daily). Conclusions The treatment of men with lower urinary tract symptoms and clinical BPH with the alpha 1-adrenergic antagonist terazosin does not affect serum PSA concentration, and thus does not confound longitudinal monitoring of serum PSA levels in patients at risk for prostate carcinoma.

The ratio of free to total serum prostate specific antigen and its use in differential diagnosis of prostate carcinoma in japan

To improve the clinical usefulness of prostate specific antigen (PSA), unique methods have been proposed. The percentage of free PSA in serum facilitates the distinction between benign histologic conditions and prostate carcinoma while retaining high sensitivity. Using monoclonal antibodies, an AIA total PSA assay system was established that recognized PSA equally in free or complex form. The clinical usefulness of the ratio of two different molecular forms of PSA was investigated using 268 archival serum samples. Men with prostate carcinoma had significantly lower ratios of free to total PSA than those with benign prostatic hyperplasia (BPH) (P = 0.0001). At total PSA levels between 2.1 and 10 ng/mL, medians of total PSA were not significantly different between men with prostate carcinoma and men with BPH. Differences in median percentages of free PSA for these two groups were statistically significant (P = 0.0001). The ratio of free to total PSA was useful for identifying prostate carcinoma in palpably benign glands with total PSA of 2.1-10 ng/mL (P = 0.0001), whereas total PSA was not useful for such identification. When calculated for low total PSA levels between 2.1 and 4 ng/mL, sensitivity and specificity were 91.7% and 72.2%, respectively, with a cutoff value of 17%. This ratio of free to total PSA was as useful as PSA density in receiver-operating curve analysis. The use of the ratio of free to total PSA renders total PSA of greater use of distinguishing prostate carcinoma and is applicable to patients with low total PSA. Elderly men with a clinical diagnosis of BPH who are scheduled for surgery may benefit from the determination of this ratio.

The cost-effectiveness of terazosin and placebo in the treatment of moderate to severe benign prostatic hyperplasia

Objectives To evaluate the cost-effectiveness and functional status effects of terazosin, an alpha,-adrenoceptor antagonist, compared with placebo in the treatment of men with moderate to severe, symptomatic, benign prostatic hyperplasia (BPH). Methods Prospective, randomized, double-blind, placebo-controlled multicenter trial of 2084 patients was conducted at 15 academic regional centers and 141 community-based satellite centers. Information about the use of health care resources and nondisease-specific functional status measures was collected by a standardized telephone interview of patients at baseline and every month thereafter for 12 months. Other information, such as American Urologie Association (AUA) disease-specific functional status scores, was obtained from the patient study records. Patients had a mean age of 65.7 years (range, 46 to 94), with a clinical diagnosis of BPH. At baseline men had at least moderate BPH symptoms by AUA Symptom Score (13 or more) and Bother Score (8 or more). On entry, patients at regional sites had peak urinary flow rates 15 mL/s or less and total voided urine volumes 150 mL or greater. A total of 1053 patients were randomized to terazosin and 1031 to placebo treatment. Primary outcome measures included payments for all direct medical resource consumption (inpatient care, emergency department care, outpatient care, and medications); changes in three AUA disease-specific functional status indicators (Symptom, Bother, and Quality of Life scores), and nondisease-specific functional status measures (days of work loss, days of customary activity loss, and days of bed rest). Results Total payments for health care resources (including study drug medication), adjusted to reflect 1000 patients per treatment group, were $3,781,803 and $3,568,263 in the placebo and terazosin groups, respectively. All three AUA disease-specific functional status scores improved significantly more in the terazosin group than in the placebo group. We found no difference between terazosin and placebo in all three nonspecific functional status measures. Conclusions Compared with placebo, terazosin therapy for moderate to severe symptomatic BPH results in approximately equivalent payments for direct medical care, better disease-specific functional status improvement, and comparable change in nondisease-specific functional status measures, urology ® 47: 169-178, 1996.