David F. Mobley

Once daily controlled versus immediate release oxybutynin chloride for urge urinary incontinence

PURPOSE We compared the efficacy and safety of once daily controlled and immediate release oxybutynin for incontinence. MATERIALS AND METHODS This multicenter, randomized, double-blind, active control, parallel study was designed to evaluate urge urinary incontinence episodes using a 7-day diary. RESULTS A total of 97 women and 8 men 34 to 76 years old with urge incontinence or mixed incontinence with a clinically significant urge component were enrolled in the study. The number of weekly urge incontinence episodes decreased from 27.4 to 4.8 after controlled and from 23.4 to 3.1 after immediate release oxybutynin (p = 0.56), and total incontinence episodes decreased from 29.3 to 6 and from 26.3 to 3.8, respectively (p = 0.6). Weekly urge incontinence episodes from baseline to end of study also decreased to 84% after controlled and 88% after immediate release oxybutynin (p = 0.7). Continence was achieved in 41% of the controlled and 40% of the immediate release group (p = 0.9). Dry mouth of any severity was reported by 68 and 87% of the controlled and immediate release groups, respectively (p = 0.04), and moderate or severe dry mouth occurred in 25 and 46%, respectively (p = 0.03). CONCLUSIONS Participants taking a single daily does of controlled release oxybutynin had similar reductions in urge incontinence and total incontinence episodes compared to those taking oxybutynin 1 to 4 times daily. A lower incidence of dry mouth was reported for controlled release oxybutynin.

Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence

Objective To compare the efficacy and safety of controlled-release oxybutynin with conventional, immediate-release oxybutynin and determine rates of dry mouth. Methods Patients (n = 226) who were known to be responsive to anticholinergic therapy and who had seven or more urge incontinence episodes per week were randomized to receive controlled-release oxybutynin or immediate-release oxybutynin. After an initial placebo run-in period, dosing in each began at 5 mg per day and increased weekly by 5 mg per day to a maximum of 20 mg per day or when a balance between improvement of incontinence symptoms and tolerability of side effects was achieved. Rates of urge incontinence and dry mouth were compared. Post hoc Kaplan-Meier survival analysis was used to describe elimination of incontinence episodes by dose and to analyze dry mouth risk by dose. Results Reductions in urge urinary incontinence episodes from baseline to the end of treatment were 18.6 to 2.9 per week (83% mean decrease) and 19.8 to 4.4 per week (76% mean decrease) in the controlled- and immediate-release oxybutynin groups (P = .36), respectively. At equal doses, comparable proportions of patients in both groups reported the absence of urge incontinence (P = .85). The incidence of dry mouth increased with dose in both groups, but there was no difference in dry mouth rates between the groups: 47.7% and 59.1% for the controlled- and immediate-release oxybutynin (P = .09), respectively. However, Kaplan-Meier analysis to examine first report of dry mouth at a given dose revealed that a significantly lower proportion of patients taking controlled-release oxybutynin had moderate to severe dry mouth (P = .007) or any dry mouth (P = .003) compared with those taking immediate-release oxybutynin. Conclusion At the same daily dose, controlled- and immediate-release oxybutynin demonstrated comparable efficacy in reduction of urge incontinence episodes. The incidence of dry mouth was dose dependent but equal in both groups; first report of moderate to severe dry mouth was significantly lower in the controlled-release group.

Doxazosin for Benign Prostatic Hyperplasia: Long-term Efficacy and Safety in Hypertensive and Normotensive Patients

PURPOSE We evaluated the sustained efficacy and safety of doxazosin for long-term treatment (up to 48 months) of normotensive and hypertensive patients with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS A total of 272 normotensive and 178 mildly to moderately hypertensive men entered a long-term extension study of doxazosin therapy (1 to 8 and 1 to 12 mg. 1 time daily, respectively) for BPH following participation in double-blind, placebo controlled studies. The starting dose of doxazosin was 1 mg. with upward titrations at 2-week intervals to a stable, efficacious and well tolerated dose. At the time of data analysis patients had received between 1 and 48 months of stable dose doxazosin therapy (mean 668 days for normotensive and 807 for hypertensive patients). Mean daily doses were 4 and 6.4 mg. for normotensive and hypertensive men, respectively. RESULTS At the end point analysis doxazosin treatment resulted in significant increases above baseline in maximum and average urinary flow rates (1.9 and 1.0 ml. per second, respectively). As assessed by the patient, total, obstructive and irritative BPH symptoms also improved significantly with doxazosin treatment. In the 28 patients who completed 45 to 48 months of treatment improvement in symptom bothersomeness (13.2%) was similar to that of the overall group at the end point (14.8%). Sustained blood pressure decreases (approximately 8/11 mm. Hg systolic/diastolic blood pressure) with doxazosin were statistically and clinically significant in hypertensive patients. Blood pressure decreases in normotensive patients were not clinically significant (approximately 4/2 mm. Hg) and few withdrew from study for reasons related directly to decreased blood pressure or hypotension. Changes in heart rate were not significant. Doxazosin was well tolerated with almost 90% of adverse experiences considered mild or moderate in severity. The most common adverse events were dizziness, headache and fatigue in normotensive and hypertensive patients. CONCLUSIONS In this study long-term doxazosin treatment was significantly effective and well tolerated for treating BPH in normotensive and hypertensive patients.

The Long-Term Effect Of Specific Type II 5α-Reductase Inhibition With Finasteride on Bone Mineral Density in Men: Results of a 4-Year Placebo Controlled Trial

Purpose: We determine the effect of long-term suppression of dihydrotestosterone with finasteride, a specific type II 5α-reductase inhibitor, on bone mineral density.Materials and Methods: As part of a large (3,040 cases) 4-year, double-blind, placebo controlled trial designed to assess the long-term effects of finasteride in men with benign prostatic hyperplasia, 157 men 46 to 76 years old who were randomized to receive either 5 mg. finasteride or placebo underwent dual energy x-ray absorptiometry of the lumbar spine at baseline and at years 2, 3 and 4.Results: Of 117 patients who had a baseline measurement and at least 1 additional measurement during the study baseline mean plus or minus standard deviation bone mineral density values were 1.12 ± 0.17 gm./cm.2 in the finasteride group (63) and 1.10 ± 0.17 gm./cm.2 in the placebo group (54). After 4 years bone mineral density was not different between treatment groups (finasteride 1.14 ± 0.17 gm./cm.2 and placebo 1.13 ± 0.18 gm./cm.2). Similar results wer...

Semen Cultures in the Diagnosis of Bacterial Prostatitis

The bacterial flora of semen from normal men has been studied. Positive cultures were obtained in 45 per cent of these individuals but only in smally colony counts of non-pathogenic bacteria. The seminal flora of patients with bacterial prostatitis was then studied. Excellent correlations have been noted between cultures of prostatic secretions and semen. Semen cultures will almost invariably be diagnostic in patients with bacterial prostatis. This technique has definite usefulness in selected patients in whom it is otherwise difficult to establish a diagnosis of bacterial prostatis.

Phenoxybenzamine in the Management of Neurogenic Vesical Dysfunction

The clinical effect of phenoxybenzamine, an alpha blocking agent, was studied in a series of 37 patients with varying degrees of neurogenic vesical dysfunction. An over-all 78 per cent success rate was achieved, with an 86 per cent success rate in patients with reflex neurogenic bladder. Phenoxybenzamine demonstrates excellent results in patients with neurovesical dysnfunction who are unable to empty their bladders by other means. The drug demonstrated effectiveness regardless of the level of the lesion, cystometric findings or duration of neurogenic vesical disease.

Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia.

OBJECTIVES To compare the efficacy and safety of finasteride 5 mg in older (65 years old or older) versus younger (45 to younger than 65 years old) men with benign prostatic hyperplasia (BPH). METHODS The Proscar Long-Term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men 45 to 78 years old with symptomatic BPH, enlarged prostates, and no evidence of prostate cancer. The endpoints included urinary symptoms, prostate volume, occurrence of acute urinary retention and/or BPH-related surgery, and safety. RESULTS In both age cohorts, finasteride treatment led to a 51% reduction (P <0.001) in the relative risk for acute urinary retention and/or BPH-related surgery, a significant (P <0.001) and durable improvement in symptom score, and a significant (P <0.001) and sustained reduction in prostate volume. Within each age cohort, no significant differences were found between the placebo and finasteride-treated patients in the incidence of cardiovascular adverse events. Significant differences were evident between the placebo and finasteride groups in the incidence of the typical, known, drug-related adverse events, but no specific differences were associated with age. No drug interactions of clinical importance were observed in the finasteride-treated patients. CONCLUSIONS The present analysis from PLESS demonstrates that in both older (65 years old or older) and younger men with symptomatic BPH and enlarged prostates, finasteride is highly effective in improving symptoms and reducing prostate volume in many men and in reducing the risk of acute urinary retention and BPH-related surgery. In addition, the safety profile of finasteride in both older and younger men is similar and no drug interactions of clinical importance were observed.

Interstitial cystitis. When urgency and frequency mean more than routine inflammation.

Preview Although its not a malignant or infectious condition, interstitial cystitis can be as disabling and sometimes even more difficult to manage. Many women undergo ineffective gynecologic surgery, and some men have inappropriate transurethral prostatectomy in a desperate attempt to subdue their pain. The authors provide tips for primary care physicians on making a presumptive diagnosis and suggest symptomatic relief methods to try before referral.

Left spermatic vein cortisol in subfertile men with varicocele

Abstract Varicocele is one of a number of well-documented causes of male subfertility. In patients undergoing varicocelectomy high success rates are achieved postoperatively, with improved women quality and subsequent pregnancies. Why varicocele causes subfertility in some men is unknown. Recently, it has been hypothesized that the left spermatic vein might be rich in by-products of adrenal metabolism, thus leading to diminished spermatogenesis. This study does not support this hypothesis, finding no significant difference in plasma cortisol in the left spermatic vein than from distant peripheral circulation. Further investigation into the etiologic factors causing subfertility with varicocele is recommended.

Erythromycin plus sodium bicarbonate in chronic bacterial prostatitis

Abstract The problem of chronic bacterial prostatitis has remained one of marked difficulty in achieving chemotherapeutic cure due to the lack of an antibacterial agent which would enter prostatic fluid in sufficient quantity and in a form which retained its antibacterial properties. Erythromycin is known to enter the prostatic fluid, and in this study alkalinization has been demonstrated to make the drug effective in achieving bacteriologic cure of chronic bacterial prostatitis due to gram-negative organisms. Twenty-six men were treated with erythromycin and sodium bicarbonate, and bacteriologic cure was achieved in 88 per cent with symptomatic relief obtained in all patients. This regimen is recommended as the treatment of choice for chronic bacterial prostatitis.