Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial.

OBJECTIVES: To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. PATIENTS AND METHODS: The study included 458 women aged 27-79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF < 14 and > or = 14). Analysis of covariance was used to analyse I-QOL scores. RESULTS: The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of > or = 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial. CONCLUSIONS: These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.

Biochemical analysis of tunica vaginalis fluid in patients with or without idiopathic hydroceles.

OBJECTIVE: To establish the differences, if any, between the biochemical composition of idiopathic hydrocele fluid and the fluid normally present in the tunica vaginalis. PATIENTS AND METHODS: Aspiration and sclerotherapy of 37 idiopathic hydroceles from patients who presented to this urology clinic were performed. The biochemical content of the fluid was compared with that of the tunica vaginalis fluid from a small group of controls (n = 8), taken from patients undergoing orchidectomy for carcinoma of the prostate. RESULTS: Differences in several measurements were recorded; in particular, there were significantly higher concentrations of calcium, albumin, total protein and creatine-kinase in the hydrocele group. The levels of potassium, aspartate transaminase, alanine transaminase and alkaline phosphatase were significantly lower in the hydrocele group. CONCLUSION: Whether these differences have a role in the causation of an idiopathic hydrocele is, at this stage, speculative. A similar study on a larger scale would probably be more conclusive.

Trauma of the ureter.

Thirty-three ureteric injuries were treated over a 2-year period. The majority of patients presented late. The most common modes of repair were either ureteroneocystostomy or transuretero-ureterostomy. Complications were few and of little significance.

Venous infarction of the testis--a cause of non-response to conservative therapy in epididymo-orchitis. A case report.

Acute epididymo-orchitis occasionally responds poorly to conservative measures. Testicular infarction may be one reason for this complication. Ultrasonography and radionuclide scanning can elucidate the cause. A patient with this complication is described.

Sclerotherapy for hydroceles.

Sclerotherapy with 3% sodium tetradecyl sulfate and 3.5% rolitetracycline on an outpatient basis was applied to 55 hydroceles. The over-all cure rate was 96% with an average followup of 13 months. Of the patients 64% were cured after only 1 sclerosant instillation. A post-sclerotherapy operation was necessary in 4% of the patients. Pain of a significant degree occurred after sclerotherapy in only 29% of the patients. Sclerotherapy appears to be an effective, economical and safe form of outpatient therapy for hydroceles.

Comparative trial of sclerotherapy for hydroceles.

We present a prospective single-blind trial of sclerotherapy for hydroceles with tetradecyl sulphate and rolitetracycline as sclerosants. Twenty-seven hydroceles were treated with tetradecyl sulphate and 28 with rolitetracycline. The median follow-up was 13 months. There were no statistically significant differences between the 2 drugs in respect of cure rate and complications. The overall cure rate for both drugs was 96%. Complications were rare and common to both drugs. Tetradecyl sulphate and rolitetracycline were found to be equally effective as sclerosants.