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Biomedical subjects

C G Roehrborn

Publications and source records attributed to C G Roehrborn.

At least 19 recordsLinked to original sources
PubMed2007

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.

Adrenergic alpha-Antagonists↗
PubMed2006

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.

5-alpha Reductase Inhibitors↗
PubMed2006

Three months' treatment with the alpha1-blocker alfuzosin does not affect total or transition zone volume of the prostate.

Treatment with alpha(1)-adrenergic receptor blockers improves lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia. This study was conducted to test the hypothesis that induction of apoptosis in prostate tissue could be a mechanism underlying the observed clinical benefit. This placebo-controlled, double-blind, randomized trial enrolled 536 men with LUTS who were treated with alfuzosin (10 or 15 mg) once daily or placebo for 3 months. Total prostate and transition zone volume was measured by standardized transrectal ultrasound measurements at baseline and 3 months. Total prostate volume increased by 0.4 ml from baseline in placebo patients but decreased by -0.25 ml in the combined alfuzosin groups. Percentage change was not statistically significantly different between the placebo and alfuzosin groups. Changes in transition zone volumes from baseline were similar in both treatment arms; percentage change was not statistically significantly different between the placebo and alfuzosin groups. Volume changes did not correlate with prostate volumes at baseline. Overall, neither total prostate nor transition zone volume increased or decreased systematically within the 3-month treatment period. If alfuzosin-induced apoptosis in prostate tissue, it was not evident by a measurable change in prostate volume after 3 months' treatment. Further analysis at 1 and 2 years will determine the effect of longer-term treatment.

Adrenergic alpha-Antagonists↗
PubMed2006

Enlarged prostate: a landmark national survey of its prevalence and impact on US men and their partners.

This questionnaire-based survey evaluated the frequency and severity of lower urinary tract symptoms (LUTS) and the prevalence of enlarged prostate (EP) diagnosis and its impact on quality of life and spousal relationships among >1000 American men aged >50 years. A quarter of men suffered moderate to severe LUTS and 55% of those consulting a doctor had EP. EP negatively affected patient quality of life and caused relationship strain with spouses. These findings confirm that LUTS and EP are prevalent in the US population, affecting both patient and spouse, and may help in developing management strategies for EP.

Aged↗
PubMed2003

Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies.

OBJECTIVES: To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia. PATIENTS AND METHODS: Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR). RESULTS: Alfuzosin significantly improved the mean (sd) IPSS, by - 6.0 (5.1) vs - 4.2 (5.7) with placebo (P < 0.005) and the PFR, by + 2.3 (3.8) vs + 1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensive patients. Sexual adverse events were rare (abnormal ejaculation, 0.6%). CONCLUSIONS: The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensive patients.

Adrenergic alpha-Antagonists↗
PubMed2002

Gleason score predicts androgen independent progression after androgen deprivation therapy.

OBJECTIVE: The Gleason system is the most widely utilized histologic grading system for prostate cancer and a powerful predictor of cancer behavior. In this study, we evaluated the prognostic value of the Gleason grading system in predicting progression to androgen independent prostate cancer (AIPC). METHODS: Records from 150 patients with advanced or metastatic prostate cancer treated with androgen deprivation therapy (ADT) were retrospectively reviewed. Androgen independent progression was defined as two consecutive elevations of serum prostate specific antigen (PSA) above the nadir value. Kaplan-Meier and the Cox proportional hazards methods were used to assess potential predictors of progression to AIPC. RESULTS: Patients with low and moderate Gleason scores experienced significantly longer remissions compared to those with Gleason score of 8-10 (p=0.0006, Log-Rank test). The cumulative hazard of progressing to AIPC increased by almost 70% for each unit increase in total Gleason score. CONCLUSION: In this patient cohort the Gleason score was the only independent predictor of progression to AIPC.

Aged↗
PubMed2002

Clearance rates of total prostate specific antigen (PSA) after radical prostatectomy in African-Americans and Caucasians.

Racial differences in serum prostate specific antigen (PSA) values in men with and without prostate cancer have been observed but have yet to be explained. We aimed to determine if ethnic variations in the rate of metabolism of PSA could explain the different levels of PSA found in African-American and Caucasian men. In a prospective fashion, patients diagnosed with biopsy-proven clinically localized adenocarcinoma of the prostate and scheduled for radical prostatectomy were selected for the study. Eleven patients (six Caucasian, five African-American) were enrolled in the study. All patients demonstrated normal liver and renal function. Sera for total PSA were obtained at the following time intervals: preoperative (within 3 months of operation), time 0 (at time of prostate removal), 1, 4, 8, 24, 48, 72, 168 and 336 h after removal of the prostate. A log-linear regression model was then used to determine the metabolic clearance rate and half-life of serum total PSA. There were no statistically significant differences between Caucasian and African-American patients with regard to age, PSA prior to surgery, prostate weight, Gleason sum and PSA half-life. The metabolic clearance of total PSA followed first order kinetics. When comparing serum PSA levels expressed as a fraction of the baseline PSA, Caucasian and African-American patients demonstrated similar rates of metabolism. This study found similar rates of elimination of serum total PSA between African-Americans and Caucasians. These findings suggest that the rate of metabolism of PSA is similar for these groups. Further studies are needed to explain racial differences of serum PSA in patients with and without prostate cancer.

Aged↗
PubMed2001

Targeted transurethral microwave thermotherapy versus alpha-blockade in benign prostatic hyperplasia: outcomes at 18 months.

OBJECTIVES: To compare directly the efficacy, safety, and durability of targeted transurethral microwave thermotherapy with that of alpha-blocker treatment for lower urinary tract symptoms of benign prostatic hyperplasia. METHODS: In a randomized, controlled clinical trial, 52 patients with lower urinary tract symptoms due to benign prostatic hyperplasia received terazosin treatment and 51 underwent microwave treatment under topical anesthesia. The patient evaluation included the International Prostate Symptom Score, peak flow rate, and quality-of-life score before microwave treatment or initiation of terazosin treatment and at periodic intervals thereafter up to 18 months. RESULTS: The mean International Prostate Symptom Score, peak flow rate, and quality-of-life score all improved significantly in both groups by 6 months. However, the magnitude of improvement was significantly greater in the microwave group than in the terazosin group. The significant between-group differences observed at 6 months in the mean International Prostate Symptom Score, peak flow rate, and quality-of-life score were fully maintained at 18 months, at which time the improvements in these three outcome measures were significantly greater (P <0.0005), by 35%, 22%, and 43%, respectively, in the microwave group than in the terazosin group. The actuarial rate of treatment failure at 18 months was significantly greater by sevenfold in the terazosin group. Adverse events were generally infrequent and readily manageable in both groups. CONCLUSIONS: Although the initial onset of terazosin action was more rapid, the longer term clinical outcomes of targeted microwave treatment were markedly superior. The more favorable results in patients who underwent microwave treatment were maintained for at least 18 months.

Adrenergic alpha-Antagonists↗
PubMed2001

Postvoid residual urine in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: pooled analysis of eleven controlled studies with alfuzosin.

OBJECTIVES: A pooled analysis was conducted in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia to examine the relationship between the postvoid residual urine (PVR) volume and various clinical characteristics and to assess the effect of alfuzosin, a clinically uroselective alpha(1)-blocker, on PVR volume and any other associated outcome. METHODS: Nine hundred fifty-three patients, 42 to 89 years old, with a baseline PVR volume between 50 and 350 mL (mean 106 mL) were enrolled in 11 double-blind controlled studies and received either alfuzosin (n = 607) or placebo (n = 346) for 1 to 6 months. The relationships between the baseline PVR volume measured by transabdominal ultrasound and age, symptoms, maximum flow rate (Qmax), estimated bladder capacity, and prostate-specific antigen level were assessed. The changes in the PVR volume with treatment were evaluated in all available patients at three endpoints (1, 3, and 6 months). RESULTS: At baseline, a PVR volume of 100 mL or greater was observed in 60%, 47%, and 39% of patients with a Qmax less than 8, 8 to 11, and greater than 11 mL/s, respectively (P = 0.001). The bladder capacity was also significantly related to the Qmax (P = 0.0001). No relationship was found between PVR volume and age, symptoms, or prostate-specific antigen level. The changes in the PVR volume with treatment were related to the baseline PVR volume. However, at all endpoints and whatever the baseline PVR volume, the decreases in the PVR volume were significantly (P <0.01) greater with alfuzosin than with placebo. Acute urinary retention occurred in 7 patients (2 [0.3%] of 607 patients taking alfuzosin and 5 [1.4%] of 346 patients taking placebo); 6 of these 7 patients had a baseline PVR volume greater than 100 mL. CONCLUSIONS: In this population of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, the PVR olume and bladder capacity were related to the baseline Qmax. Alfuzosin significantly reduced the PVR volume compared with placebo, and this effect was more marked in patients with a high PVR volume at baseline. Acute urinary retention occurred mainly in patients with a PVR volume greater than 100 mL and was less frequent in patients taking alfuzosin than in those taking placebo.

Adrenergic alpha-Antagonists↗
PubMed2001

Interexaminer reliability and validity of a three-dimensional model to assess prostate volume by digital rectal examination.

OBJECTIVES: To evaluate the interexaminer reliability and accuracy compared with transrectal ultrasound (TRUS) of a three-dimensional (3D) model and other scales to improve the estimation of prostate volume by digital rectal examination (DRE). METHODS: Volunteers from a urology clinic (n = 121) were examined independently by three examiners with different levels of experience in randomized order. During DRE, the examiners estimated the prostate size in increments of 5 g, using various rating scales and a 3D sizing model, without access to the findings of the other investigators. TRUS was then performed by each examiner. RESULTS: The 121 volunteers were 39 to 82 years old, with a mean +/- SD total TRUS prostate size of 35.9 +/- 27.2 g. The DRE size estimates ranged from 15 to 100 g across all examiners and patients. The interexaminer reliability across examiners for the best DRE prostate size estimates (in grams) was 0.78 (95% confidence interval 0.70 to 0.84), and the correlation coefficients (r(s)) with the TRUS volume ranged from 0.61 to 0.72 for the three examiners. A 3D model showed good reliability (intraclass correlation coefficient 0.86, 95% confidence interval 0.75 to 0.93), and correlated well with the TRUS volume (r(s) = 0.67 to 0.75). Other scales showed fair reliability (0.58 to 0.68) and correlated with the TRUS measurements (0.57 to 0.67). The area under the receiver operating characteristic curve to identify prostate volumes greater than 40 g ranged from 0.78 to 0.90 for DRE estimates (in grams) and 0.69 to 0.89 for the 3D model. CONCLUSIONS: DRE size estimates and TRUS volume were moderately to highly correlated in men without prostate cancer. A 3D sizing model showed comparable reliability and correlation with TRUS. Although the DRE estimates generally tend to underestimate the TRUS-measured prostate volume, these tools may be useful in identifying men with enlarged prostate glands.

Adult↗
PubMed2001

Standing cystourethrogram: an outcome measure after anti-incontinence procedures and cystocele repair in women.

OBJECTIVES: To evaluate the standing voiding cystourethrogram (VCUG) with lateral views as an outcome measure to objectively document the correction of the urethral angle and cystocele in women who underwent various types of pelvic surgery. METHODS: A control group of 76 continent patients was selected who had VCUGs performed for indications other than incontinence. Patients with preoperative and postoperative VCUGs after anterior vaginal wall suspension for urethral hypermobility and grade 1 or 2 cystocele (UH group) or repair of grade 3 cystocele (C group) were selected and compared with age-matched controls from the control group. RESULTS: Among the control group, the mean +/- SD urethral angle at rest was 12.5 degrees +/- 13.1 degrees and the urethral angle at straining was 24.7 degrees +/- 15.6 degrees (P <0.001). The urethral angle at rest increased significantly from women in their 20s to their 80s. In the UH group (n = 52), the preoperative mean urethral angle at rest and at straining was 25.7 degrees +/- 13.6 degrees and 42.6 degrees +/- 15.9 degrees, respectively, a difference of approximately 20 degrees. The postoperative urethral angles at rest and at straining did not statistically differ from those of the age-matched controls. In the C group (n = 36), the postoperative urethral angle at rest did not statistically differ from that of the age-matched controls. The lateral height of the cystocele demonstrated significant improvement in the UH and C groups. CONCLUSIONS: The standing VCUG is a reproducible outcome measure to preoperatively and postoperatively document the urethral angle. Using age-matched controls, a more objective definition of urethral hypermobility was obtained. Changes in cystocele height were observed postoperatively with a return to comparable age-matched control values.

Adult↗
PubMed2001

Clinical predictors of spontaneous acute urinary retention in men with LUTS and clinical BPH: a comprehensive analysis of the pooled placebo groups of several large clinical trials.

OBJECTIVES: To comprehensively evaluate clinical predictors of spontaneous acute urinary retention (AUR) across pooled data of placebo-treated patients from clinical trials conducted in men with lower urinary tract symptoms and clinically diagnosed benign prostatic hyperplasia. METHODS: Data from the placebo-treatment groups of several prospective, randomized clinical trials conducted in the United States (n = 3040), Scandinavia, Canada, and worldwide (n = 2295) were combined in the analyses. More than 110 variables were considered individually and in combination as predictors of AUR using logistic regression analysis and classification and regression tree methods with a split-sample approach to cross-validation. RESULTS: The different methods of analysis identified consistent potential predictors of episodes of AUR. When prostate volume was included in the analyses, it was selected as the initial variable discriminating men with and without subsequent AUR. Omitting prostate volume because of its availability in only a subset of men, a logistic model including serum prostate-specific antigen (PSA), urinating more than every 2 hours, symptom problem index, maximum urinary flow rate, and hesitancy of urination had good predictive properties (area under the receiver-operating characteristic curve [AUC] = 0.742 +/- 0.047), as did a model with PSA (AUC = 0.716 +/- 0.045). A classification and regression decision tree with the same variables predicted AUR (AUC = 0.74, sensitivity = 72%, specificity = 67%) as well as did a tree with PSA alone (AUC = 0.70, sensitivity = 75%, specificity = 64%). CONCLUSIONS: Prostate volume and serum PSA are strong predictors of AUR in placebo-treated men with lower urinary tract symptoms and clinically diagnosed benign prostatic hyperplasia who were screened for prostate cancer. From more than 110 variables, logistic models and decision trees with PSA alone were comparable to expanded models that included PSA, urinary frequency and hesitancy, flow rate parameters, and symptom problem index, and to a scoring algorithm.

Algorithms↗
PubMed2001

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.

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 resulted. 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.

Adrenergic alpha-Antagonists↗
PubMed2001

Alfuzosin: overview of pharmacokinetics, safety, and efficacy of a clinically uroselective alpha-blocker.

Efficacy and safety of alfuzosin administered as 3-times-daily and 2-times-daily formulations have been previously demonstrated in placebo-controlled studies, and these formulations have been commercially available in many countries. A once-daily formulation of alfuzosin administered through a novel prolonged-release system has been recently developed to improve the convenience of dosing and to provide optimal pharmacokinetic coverage over 24 hours. The results of 2 double-blind, placebo-controlled phase 3 studies in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia suggests that 10 mg of alfuzosin administered once daily without dose titration is superior to placebo in terms of symptom and urinary flow rate improvement. Orthostatic hypotension and first-dose phenomenon related to the alpha-blocking property were rare. The incidences of asthenia and fatigue were comparable to those seen with placebo. Ejaculatory disorders were very rare. The most frequently reported adverse event potentially related to alpha blockade was dizziness, which occurred in 5.0% of patients treated with 10 mg alfuzosin compared with 2.1% of patients given placebo.

Adrenergic alpha-Antagonists↗
PubMed2001

Meta-analysis of randomized trials of terazosin in the treatment of benign prostatic hyperplasia.

OBJECTIVES: To determine the effectiveness of the long-acting alpha(1)-adrenergic receptor blocking agent terazosin compared with placebo on lower urinary tract symptoms and peak urinary flow rate in men with clinical benign prostatic hyperplasia. METHODS: A formal meta-analysis of all nine randomized trials of terazosin using both an Empirical Bayes and a fully Bayesian approach was conducted. A pooled analysis was conducted on those studies in which patients had a baseline assessment of prostate volume by transrectal ultrasonography. RESULTS: No evidence of heterogeneity was found in the estimated effects of terazosin on the change in peak flow rates in the studies. Terazosin treatment was associated with an increase in the peak flow rate of 1.4 mL/s (95% confidence interval [1.0, 1.7]) compared with placebo. Terazosin resulted in an average reduction of 2.2 points over placebo (95% confidence interval [1.6, 3.0]) regarding the common symptom score (range 0 to 36 points). A mild heterogeneity was found across the studies, with the decrease in symptom score slightly greater with longer treatment duration. No evidence was found that the baseline prostate volume influenced the effect of terazosin. CONCLUSIONS: Terazosin was effective and superior to placebo in reducing symptoms and increasing the peak urinary flow rate. The effect of terazosin on the peak urinary flow rate was apparent in studies as short as 8 weeks. Most importantly, the effect of terazosin on symptoms and peak urinary flow rate was independent of the baseline prostate size for the range of prostate volumes reported.

Adrenergic alpha-Antagonists↗